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NCT00004554
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Sertraline for Alcohol Dependence and Depression
Brief Summary: This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
|
{
"A": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed | Arm Label: B; Type: EXPERIMENTAL; Interventions: Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine | Arm Label: C; Type: SHAM_COMPARATOR; Interventions: Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine | Intervention Type: OTHER; Name: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed; Assigned to Arm(s): A | Intervention Type: OTHER; Name: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine; Assigned to Arm(s): B | Intervention Type: OTHER; Name: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine; Assigned to Arm(s): C",
"B": "Intervention Type: DRUG; Name: citalopram; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: BuproprionSR; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: buspirone; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Lithium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: mirtazapine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: nortriptyline; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: sertraline; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: tranylcypromine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: VenlafaxineXR; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: T3 (Triiodothyronine); Assigned to Arm(s): N/A",
"C": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Escitalopram | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sertraline | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Venlafaxine-XR | Arm Label: D; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Escitalopram; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Venlafaxine-XR; Assigned to Arm(s): C",
"D": "Arm Label: Sertraline; Type: EXPERIMENTAL; Interventions: Drug: sertraline (Zoloft) | Arm Label: Naltrexone; Type: EXPERIMENTAL; Interventions: Drug: naltrexone (Revia) | Arm Label: Nal/Sert; Type: EXPERIMENTAL; Interventions: Drug: naltrexone (Revia), Drug: sertraline (Zoloft) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: naltrexone (Revia); Assigned to Arm(s): Nal/Sert, Naltrexone | Intervention Type: DRUG; Name: sertraline (Zoloft); Assigned to Arm(s): Nal/Sert, Sertraline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00714090",
"NCT00021528",
"NCT00693849",
"NCT00004554"
] | 200 |
train
|
NCT00004562
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Occluded Artery Trial (OAT) - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI
Brief Summary: The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an average 2.9-year follow-up with extended follow up for an average of six years. Long term follow-up of patients were completed in March 2010. Final collection of all regulatory documentation was completed June 2011.
|
{
"A": "Intervention Type: DRUG; Name: clopidogrel (SR25990C); Assigned to Arm(s): N/A",
"B": "Arm Label: Optimal Medical Therapy Only (MED); Type: ACTIVE_COMPARATOR; Interventions: Drug: Beta adrenergic blockers, Drug: Platelet inhibitors, Drug: ACE Inhibitors | Arm Label: Percutaneous Coronary Intervention (PCI); Type: EXPERIMENTAL; Interventions: Drug: Beta adrenergic blockers, Drug: Platelet inhibitors, Procedure: PTCA and stents, Drug: ACE Inhibitors | Intervention Type: DRUG; Name: Beta adrenergic blockers; Assigned to Arm(s): Optimal Medical Therapy Only (MED), Percutaneous Coronary Intervention (PCI) | Intervention Type: DRUG; Name: Platelet inhibitors; Assigned to Arm(s): Optimal Medical Therapy Only (MED), Percutaneous Coronary Intervention (PCI) | Intervention Type: PROCEDURE; Name: PTCA and stents; Assigned to Arm(s): Percutaneous Coronary Intervention (PCI) | Intervention Type: DRUG; Name: ACE Inhibitors; Assigned to Arm(s): Optimal Medical Therapy Only (MED), Percutaneous Coronary Intervention (PCI)",
"C": "Arm Label: gentamicin Group; Type: EXPERIMENTAL; Interventions: Drug: gentamicin-collagen sponge dipped in saline | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: gentamicin-collagen sponge dipped in saline; Assigned to Arm(s): gentamicin Group",
"D": "Arm Label: Enoxaparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: enoxaparin | Arm Label: Fondaparinux; Type: EXPERIMENTAL; Interventions: Drug: Fondaparinux | Intervention Type: DRUG; Name: Fondaparinux; Assigned to Arm(s): Fondaparinux | Intervention Type: DRUG; Name: enoxaparin; Assigned to Arm(s): Enoxaparin"
}
|
B
|
[
"NCT00243178",
"NCT00004562",
"NCT00600483",
"NCT00139815"
] | 201 |
train
|
NCT00004563
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cyclophosphamide Versus Placebo in Scleroderma Lung Study
Brief Summary: To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.
|
{
"A": "Arm Label: Mycophenolate Arm; Type: EXPERIMENTAL; Interventions: Drug: Mycophenolate mofetil | Arm Label: Cyclophosphamide Arm; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Placebo | Intervention Type: DRUG; Name: Mycophenolate mofetil; Assigned to Arm(s): Mycophenolate Arm | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Cyclophosphamide Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cyclophosphamide Arm",
"B": "Arm Label: mHSCT; Type: EXPERIMENTAL; Interventions: Biological: mHSCT | Arm Label: cyclophosphamide; Type: EXPERIMENTAL; Interventions: Drug: cyclophosphamide | Intervention Type: BIOLOGICAL; Name: mHSCT; Assigned to Arm(s): mHSCT | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): cyclophosphamide",
"C": "Arm Label: stem cell trasplantation; Type: EXPERIMENTAL; Interventions: Procedure: stem cell transplantation | Arm Label: standard of care; Type: ACTIVE_COMPARATOR; Interventions: Drug: standard of care | Intervention Type: DRUG; Name: standard of care; Assigned to Arm(s): standard of care | Intervention Type: PROCEDURE; Name: stem cell transplantation; Assigned to Arm(s): stem cell trasplantation",
"D": "Arm Label: Cylophosphamide; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Cylophosphamide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00883129",
"NCT00114530",
"NCT00278525",
"NCT00004563"
] | 202 |
train
|
NCT00004563
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cyclophosphamide Versus Placebo in Scleroderma Lung Study
Brief Summary: To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.
|
{
"A": "Arm Label: Cylophosphamide; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Cylophosphamide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Active Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pirfenidone | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Pirfenidone; Assigned to Arm(s): Active Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Arm",
"C": "Arm Label: 2403 mg/day pirfenidone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pirfenidone | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Pirfenidone; Assigned to Arm(s): 2403 mg/day pirfenidone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo",
"D": "Arm Label: 2403 mg/day pirfenidone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pirfenidone | Arm Label: 1197 mg/day pirfenidone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pirfenidone | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Pirfenidone; Assigned to Arm(s): 1197 mg/day pirfenidone, 2403 mg/day pirfenidone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo"
}
|
A
|
[
"NCT00004563",
"NCT01366209",
"NCT00287729",
"NCT00287716"
] | 203 |
train
|
NCT00004732
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
Brief Summary: The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
|
{
"A": "N/A",
"B": "Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)",
"C": "Intervention Type: DEVICE; Name: Cordis Nitinol Stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: PRECISE tapered stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: ANGIOGUARD XP Emboli Capture Guidewire (ECGW); Assigned to Arm(s): N/A",
"D": "Arm Label: MICHI NPS+f; Type: EXPERIMENTAL; Interventions: Device: MICHI NPS+f | Intervention Type: DEVICE; Name: MICHI NPS+f; Assigned to Arm(s): MICHI NPS+f"
}
|
B
|
[
"NCT02536378",
"NCT00004732",
"NCT00231270",
"NCT01685567"
] | 204 |
train
|
NCT00004732
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
Brief Summary: The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
|
{
"A": "Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)",
"B": "Arm Label: Intracranial stenting group; Type: EXPERIMENTAL; Interventions: Procedure: Intracranial stenting group | Arm Label: medical group; Type: ACTIVE_COMPARATOR; Interventions: Drug: medical group | Intervention Type: PROCEDURE; Name: Intracranial stenting group; Assigned to Arm(s): Intracranial stenting group | Intervention Type: DRUG; Name: medical group; Assigned to Arm(s): medical group",
"C": "Arm Label: aggressive medical treatment; Type: N/A; Interventions: Device: intravascular stent therapy | Intervention Type: DEVICE; Name: intravascular stent therapy; Assigned to Arm(s): aggressive medical treatment",
"D": "Arm Label: Wingspan Stent System; Type: OTHER; Interventions: Device: Wingspan Stent System | Intervention Type: DEVICE; Name: Wingspan Stent System; Assigned to Arm(s): Wingspan Stent System"
}
|
A
|
[
"NCT00004732",
"NCT01763320",
"NCT01968122",
"NCT02034058"
] | 205 |
train
|
NCT00004732
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
Brief Summary: The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
|
{
"A": "Arm Label: Intracranial stenting group; Type: EXPERIMENTAL; Interventions: Procedure: Intracranial stenting group | Arm Label: medical group; Type: ACTIVE_COMPARATOR; Interventions: Drug: medical group | Intervention Type: PROCEDURE; Name: Intracranial stenting group; Assigned to Arm(s): Intracranial stenting group | Intervention Type: DRUG; Name: medical group; Assigned to Arm(s): medical group",
"B": "Arm Label: intensive medical management plus stenting; Type: EXPERIMENTAL; Interventions: Device: intracranial angioplasty and stenting | Arm Label: intensive medical management alone; Type: EXPERIMENTAL; Interventions: Other: intensive medical management | Intervention Type: DEVICE; Name: intracranial angioplasty and stenting; Assigned to Arm(s): intensive medical management plus stenting | Intervention Type: OTHER; Name: intensive medical management; Assigned to Arm(s): intensive medical management alone",
"C": "Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)",
"D": "Arm Label: Antiplatelet; Type: ACTIVE_COMPARATOR; Interventions: Drug: aspirin, Drug: clopidogrel, Other: placebo | Arm Label: Blood pressure; Type: ACTIVE_COMPARATOR; Interventions: Other: Target of Blood Pressure | Intervention Type: DRUG; Name: aspirin; Assigned to Arm(s): Antiplatelet | Intervention Type: DRUG; Name: clopidogrel; Assigned to Arm(s): Antiplatelet | Intervention Type: OTHER; Name: Target of Blood Pressure; Assigned to Arm(s): Blood pressure | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Antiplatelet"
}
|
C
|
[
"NCT01763320",
"NCT00576693",
"NCT00004732",
"NCT00059306"
] | 206 |
train
|
NCT00004732
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
Brief Summary: The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
|
{
"A": "Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)",
"B": "Arm Label: Carotid Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid endarterectomy (CEA) | Arm Label: Carotid Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Stenting (CAS) | Arm Label: Intensive Medical Management - no CEA; Type: EXPERIMENTAL; Interventions: Other: Intensive Medical Management - no CEA | Arm Label: Intensive Medical Management - no CAS; Type: EXPERIMENTAL; Interventions: Other: Intensive Medical Management - no CAS | Intervention Type: PROCEDURE; Name: Carotid endarterectomy (CEA); Assigned to Arm(s): Carotid Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Stenting (CAS); Assigned to Arm(s): Carotid Stenting (CAS) | Intervention Type: OTHER; Name: Intensive Medical Management - no CEA; Assigned to Arm(s): Intensive Medical Management - no CEA | Intervention Type: OTHER; Name: Intensive Medical Management - no CAS; Assigned to Arm(s): Intensive Medical Management - no CAS",
"C": "Arm Label: Closed-cell stent (Xact stent); Type: ACTIVE_COMPARATOR; Interventions: Device: closed-cell stent (Xact stent) | Arm Label: Open-cell stent (Acculink carotid); Type: ACTIVE_COMPARATOR; Interventions: Device: Open-cell stent (Acculink carotid) | Intervention Type: DEVICE; Name: closed-cell stent (Xact stent); Assigned to Arm(s): Closed-cell stent (Xact stent) | Intervention Type: DEVICE; Name: Open-cell stent (Acculink carotid); Assigned to Arm(s): Open-cell stent (Acculink carotid)",
"D": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid artery stenting with filter (interventional) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid artery endarterectomy (surgical) | Intervention Type: DEVICE; Name: Carotid artery stenting with filter (interventional); Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Carotid artery endarterectomy (surgical); Assigned to Arm(s): 2"
}
|
A
|
[
"NCT00004732",
"NCT02089217",
"NCT00830232",
"NCT00106938"
] | 207 |
train
|
NCT00004857
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
|
{
"A": "Arm Label: Arm A (CLL/SLL subjects); Type: EXPERIMENTAL; Interventions: Drug: ABT-199 | Arm Label: Arm B (NHL subjects); Type: EXPERIMENTAL; Interventions: Drug: ABT-199 | Intervention Type: DRUG; Name: ABT-199; Assigned to Arm(s): Arm A (CLL/SLL subjects), Arm B (NHL subjects)",
"B": "Arm Label: Fludarabine + Campath-1H; Type: EXPERIMENTAL; Interventions: Biological: alemtuzumab, Drug: fludarabine phosphate | Intervention Type: BIOLOGICAL; Name: alemtuzumab; Assigned to Arm(s): Fludarabine + Campath-1H | Intervention Type: DRUG; Name: fludarabine phosphate; Assigned to Arm(s): Fludarabine + Campath-1H",
"C": "Intervention Type: DRUG; Name: HuMax-CD20; Assigned to Arm(s): N/A",
"D": "Arm Label: ibrutinib; Type: EXPERIMENTAL; Interventions: Drug: Ibrutinib | Intervention Type: DRUG; Name: Ibrutinib; Assigned to Arm(s): ibrutinib"
}
|
B
|
[
"NCT01328626",
"NCT00004857",
"NCT00093314",
"NCT01744691"
] | 208 |
train
|
NCT00004978
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial
Brief Summary: The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.
Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
|
{
"A": "Arm Label: rIL-2; Type: EXPERIMENTAL; Interventions: Drug: Recombinant interleukin-2 (rIL-2) | Arm Label: No rIL-2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Recombinant interleukin-2 (rIL-2); Assigned to Arm(s): rIL-2",
"B": "Arm Label: No IL-2; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: IL-2 without ART; Type: EXPERIMENTAL; Interventions: Drug: IL-2 | Arm Label: IL-2 with pericycle HAART; Type: EXPERIMENTAL; Interventions: Drug: IL-2 | Intervention Type: DRUG; Name: IL-2; Assigned to Arm(s): IL-2 with pericycle HAART, IL-2 without ART",
"C": "Intervention Type: DRUG; Name: Indinavir sulfate; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Lamivudine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Stavudine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Zidovudine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Didanosine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Aldesleukin; Assigned to Arm(s): N/A",
"D": "Arm Label: Antiretroviral therapy alone; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Proleukin plus antiretroviral therapy; Type: EXPERIMENTAL; Interventions: Drug: Proleukin | Intervention Type: DRUG; Name: Proleukin; Assigned to Arm(s): Proleukin plus antiretroviral therapy"
}
|
A
|
[
"NCT00004978",
"NCT00110812",
"NCT00000923",
"NCT00013611"
] | 209 |
train
|
NCT00004992
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: TV viewing reduction | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: No TV viewing reduction | Intervention Type: BEHAVIORAL; Name: No TV viewing reduction; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: TV viewing reduction; Assigned to Arm(s): 1",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Short breaks; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short breaks | Arm Label: Long breaks; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Long breaks | Intervention Type: BEHAVIORAL; Name: Short breaks; Assigned to Arm(s): Short breaks | Intervention Type: BEHAVIORAL; Name: Long breaks; Assigned to Arm(s): Long breaks",
"D": "Arm Label: Behavioral intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral intervention to reduce sedentary time delivered via mobile smartphone | Intervention Type: BEHAVIORAL; Name: Behavioral intervention to reduce sedentary time delivered via mobile smartphone; Assigned to Arm(s): Behavioral intervention"
}
|
B
|
[
"NCT00622050",
"NCT00004992",
"NCT02609438",
"NCT01688804"
] | 210 |
train
|
NCT00004992
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
|
{
"A": "Intervention Type: BEHAVIORAL; Name: obesity intervention; Assigned to Arm(s): N/A",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: High intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Low intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): High intensity intervention group, Low intensity intervention group",
"D": "Arm Label: 1 Original Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Behavioral: DPPOS Boost Lifestyle, Behavioral: Intensive Lifestyle Group Session | Arm Label: 2 Original Metformin; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Drug: Metformin, Behavioral: Intensive Lifestyle Group Session | Arm Label: 3 Original Placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Behavioral: Intensive Lifestyle Group Session | Intervention Type: BEHAVIORAL; Name: DPPOS Group Lifestyle; Assigned to Arm(s): 1 Original Lifestyle, 2 Original Metformin, 3 Original Placebo | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 2 Original Metformin | Intervention Type: BEHAVIORAL; Name: DPPOS Boost Lifestyle; Assigned to Arm(s): 1 Original Lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive Lifestyle Group Session; Assigned to Arm(s): 1 Original Lifestyle, 2 Original Metformin, 3 Original Placebo"
}
|
B
|
[
"NCT00435734",
"NCT00004992",
"NCT00289237",
"NCT00038727"
] | 211 |
train
|
NCT00004992
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
|
{
"A": "Arm Label: Short Message Service (SMS); Type: EXPERIMENTAL; Interventions: Behavioral: Short Message Service (SMS) | Arm Label: Standard usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Short Message Service (SMS); Assigned to Arm(s): Short Message Service (SMS)",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive lifestyle counselling | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle counselling; Assigned to Arm(s): 1",
"C": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Intervention Type: BEHAVIORAL; Name: weight management program; Assigned to Arm(s): N/A"
}
|
C
|
[
"NCT01556880",
"NCT00518167",
"NCT00004992",
"NCT00409422"
] | 212 |
train
|
NCT00004992
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
|
{
"A": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Empagliflozin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Empagliflozin | Intervention Type: DRUG; Name: Empagliflozin; Assigned to Arm(s): Empagliflozin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Dapagliflozin; Type: EXPERIMENTAL; Interventions: Drug: Dapagliflozin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dapagliflozin; Assigned to Arm(s): Dapagliflozin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Exenatide Once Weekly; Type: EXPERIMENTAL; Interventions: Drug: Exenatide Once Weekly | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Exenatide Once Weekly; Assigned to Arm(s): Exenatide Once Weekly | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
B
|
[
"NCT02998970",
"NCT00004992",
"NCT03036150",
"NCT01144338"
] | 213 |
train
|
NCT00005014
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Placebo-Controlled Study of Risperidone for the Treatment of Children and Adolescents With Autism and Negative Behavioral Symptoms
Brief Summary: This study is designed to determine the effectiveness of risperidone, a drug treatment for the interfering symptoms of Autistic Disorder in children and adolescents between the ages of 5 and 17. Between 100 and 120 patients will be participating in this research study at five academic medical centers in the United States. The primary aim of the treatment is to reduce impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious behavior, without significant side effects. A secondary aim is to evaluate possible improvement in the level of social relatedness, attention, motor coordination, and short-term memory.
This study is a placebo-controlled, double-blind study (neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance, placebo). Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months. The last two months of the study are again double-blind (neither patients nor investigators know treatment). Patients will either continue risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms. Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits for the following 4 months, and weekly visits during the last 2 months of the study.
|
{
"A": "Arm Label: Memantine 1; Type: EXPERIMENTAL; Interventions: Drug: Memantine Hydrochloride (HCl) | Arm Label: Memantine 2; Type: EXPERIMENTAL; Interventions: Drug: Memantine Hydrochloride (HCl) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsules | Intervention Type: DRUG; Name: Memantine Hydrochloride (HCl); Assigned to Arm(s): Memantine 1 | Intervention Type: DRUG; Name: Memantine Hydrochloride (HCl); Assigned to Arm(s): Memantine 2 | Intervention Type: DRUG; Name: Placebo capsules; Assigned to Arm(s): Placebo",
"B": "Arm Label: Aripiprazole; Type: EXPERIMENTAL; Interventions: Drug: Aripiprazole | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebos | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): Aripiprazole | Intervention Type: DRUG; Name: Placebos; Assigned to Arm(s): Placebo",
"C": "Arm Label: Memantine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Memantine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Memantine; Assigned to Arm(s): Memantine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Intervention Type: DRUG; Name: Risperidone; Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT01592747",
"NCT00468130",
"NCT01372449",
"NCT00005014"
] | 214 |
train
|
NCT00005014
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Placebo-Controlled Study of Risperidone for the Treatment of Children and Adolescents With Autism and Negative Behavioral Symptoms
Brief Summary: This study is designed to determine the effectiveness of risperidone, a drug treatment for the interfering symptoms of Autistic Disorder in children and adolescents between the ages of 5 and 17. Between 100 and 120 patients will be participating in this research study at five academic medical centers in the United States. The primary aim of the treatment is to reduce impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious behavior, without significant side effects. A secondary aim is to evaluate possible improvement in the level of social relatedness, attention, motor coordination, and short-term memory.
This study is a placebo-controlled, double-blind study (neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance, placebo). Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months. The last two months of the study are again double-blind (neither patients nor investigators know treatment). Patients will either continue risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms. Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits for the following 4 months, and weekly visits during the last 2 months of the study.
|
{
"A": "Arm Label: Fluoxetine; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): Fluoxetine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Intervention Type: DRUG; Name: Risperidone; Assigned to Arm(s): N/A",
"C": "Intervention Type: DRUG; Name: secretin, synthetic porcine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: secretin, biologically derived porcine; Assigned to Arm(s): N/A",
"D": "Arm Label: Atomoxetine; Type: EXPERIMENTAL; Interventions: Drug: Atomoxetine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Atomoxetine; Assigned to Arm(s): Atomoxetine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
B
|
[
"NCT00515320",
"NCT00005014",
"NCT00065962",
"NCT00380692"
] | 215 |
train
|
NCT00005014
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Placebo-Controlled Study of Risperidone for the Treatment of Children and Adolescents With Autism and Negative Behavioral Symptoms
Brief Summary: This study is designed to determine the effectiveness of risperidone, a drug treatment for the interfering symptoms of Autistic Disorder in children and adolescents between the ages of 5 and 17. Between 100 and 120 patients will be participating in this research study at five academic medical centers in the United States. The primary aim of the treatment is to reduce impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious behavior, without significant side effects. A secondary aim is to evaluate possible improvement in the level of social relatedness, attention, motor coordination, and short-term memory.
This study is a placebo-controlled, double-blind study (neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance, placebo). Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months. The last two months of the study are again double-blind (neither patients nor investigators know treatment). Patients will either continue risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms. Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits for the following 4 months, and weekly visits during the last 2 months of the study.
|
{
"A": "Arm Label: MPH Trial-Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: MPH Trial: Low Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate-extended release, Drug: Methylphenidate-immediate release | Arm Label: MPH Trial: Med Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate-extended release, Drug: Methylphenidate-immediate release | Arm Label: MPH Trial: High Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate-extended release, Drug: Methylphenidate-immediate release | Intervention Type: DRUG; Name: Methylphenidate-extended release; Assigned to Arm(s): MPH Trial: High Dose, MPH Trial: Low Dose, MPH Trial: Med Dose | Intervention Type: DRUG; Name: Methylphenidate-immediate release; Assigned to Arm(s): MPH Trial: High Dose, MPH Trial: Low Dose, MPH Trial: Med Dose | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): MPH Trial-Placebo",
"B": "Intervention Type: DRUG; Name: fluoxetine; Assigned to Arm(s): N/A",
"C": "Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: Risperidone low dose | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Drug: Risperidone high dose | Arm Label: 003; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 003 | Intervention Type: DRUG; Name: Risperidone high dose; Assigned to Arm(s): 002 | Intervention Type: DRUG; Name: Risperidone low dose; Assigned to Arm(s): 001",
"D": "Intervention Type: DRUG; Name: Risperidone; Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT00178503",
"NCT00004486",
"NCT00576732",
"NCT00005014"
] | 216 |
train
|
NCT00005052
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation
Brief Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.
PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.
|
{
"A": "Arm Label: Arm A: 2 courses ipi 3 + nivo 1; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: Arm B: 2 courses ipi 1 + nivo 3; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: Arm C: 2 courses ipi 3 + 2 courses nivo 3; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: PRADO extension cohort; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Surgery; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Blood for PBMCs; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Biopsies; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort",
"B": "Intervention Type: BIOLOGICAL; Name: GM2-KLH vaccine; Assigned to Arm(s): N/A | Intervention Type: BIOLOGICAL; Name: QS21; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): N/A",
"C": "Arm Label: Arm A (ipilimumab and sargramostim); Type: EXPERIMENTAL; Interventions: Biological: Ipilimumab, Biological: Sargramostim | Arm Label: Arm B (ipilimumab); Type: ACTIVE_COMPARATOR; Interventions: Biological: Ipilimumab | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Arm A (ipilimumab and sargramostim), Arm B (ipilimumab) | Intervention Type: BIOLOGICAL; Name: Sargramostim; Assigned to Arm(s): Arm A (ipilimumab and sargramostim)",
"D": "Arm Label: GSK2118436; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436 | Arm Label: Dacarbazine (DTIC); Type: ACTIVE_COMPARATOR; Interventions: Drug: Dacarbazine (DTIC) | Arm Label: Crossover; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436 | Intervention Type: DRUG; Name: GSK2118436; Assigned to Arm(s): Crossover, GSK2118436 | Intervention Type: DRUG; Name: Dacarbazine (DTIC); Assigned to Arm(s): Dacarbazine (DTIC)"
}
|
B
|
[
"NCT02977052",
"NCT00005052",
"NCT01134614",
"NCT01227889"
] | 217 |
train
|
NCT00005052
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation
Brief Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.
PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.
|
{
"A": "Intervention Type: BIOLOGICAL; Name: GM2-KLH vaccine; Assigned to Arm(s): N/A | Intervention Type: BIOLOGICAL; Name: QS21; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): N/A",
"B": "Arm Label: Ipilimumab 10 mg/kg + HDI; Type: EXPERIMENTAL; Interventions: Drug: administration of ipilimumab10mg/kg | Arm Label: Ipilimumab 3mg/kg + HDI; Type: EXPERIMENTAL; Interventions: Drug: administration of ipilimumab 3mg/kg + HDI | Intervention Type: DRUG; Name: administration of ipilimumab10mg/kg; Assigned to Arm(s): Ipilimumab 10 mg/kg + HDI | Intervention Type: DRUG; Name: administration of ipilimumab 3mg/kg + HDI; Assigned to Arm(s): Ipilimumab 3mg/kg + HDI",
"C": "Arm Label: Arm I (sargramostim, peptide vaccine); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Biological: Sargramostim, Biological: Tyrosinase Peptide | Arm Label: Arm II (sargramostim placebo, peptide vaccine); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Other: Placebo, Biological: Tyrosinase Peptide | Arm Label: Arm III (sargramostim, peptide placebo); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Other: Placebo, Biological: Sargramostim | Arm Label: Arm IV (placebo, peptide placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: Laboratory Biomarker Analysis, Other: Placebo | Arm Label: Arm V (sargramostim); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Biological: Sargramostim | Arm Label: Arm VI (sargramostim placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: Laboratory Biomarker Analysis, Other: Placebo | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (sargramostim, peptide vaccine), Arm II (sargramostim placebo, peptide vaccine), Arm III (sargramostim, peptide placebo), Arm IV (placebo, peptide placebo), Arm V (sargramostim), Arm VI (sargramostim placebo) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm II (sargramostim placebo, peptide vaccine), Arm IV (placebo, peptide placebo), Arm VI (sargramostim placebo) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm III (sargramostim, peptide placebo), Arm IV (placebo, peptide placebo) | Intervention Type: BIOLOGICAL; Name: Sargramostim; Assigned to Arm(s): Arm I (sargramostim, peptide vaccine), Arm III (sargramostim, peptide placebo), Arm V (sargramostim) | Intervention Type: BIOLOGICAL; Name: Tyrosinase Peptide; Assigned to Arm(s): Arm I (sargramostim, peptide vaccine), Arm II (sargramostim placebo, peptide vaccine)",
"D": "Arm Label: Ipilimumab, 10 mg/kg, IV in corticosteroid-free patients; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab | Arm Label: Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Corticosteroid: Betamethasone, Drug: Corticosteroid: Dexamethasone, Drug: Corticosteroid: Fludrocortisone, Drug: Corticosteroid: Hydrocortisone, Drug: Corticosteroid: Meprednisone, Drug: Corticosteroid: Methylprednisolone, Drug: Corticosteroid: Prednisolone, Drug: Corticosteroid: Prednisone, Drug: Corticosteroid: Triamcinolone | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients, Ipilimumab, 10 mg/kg, IV in corticosteroid-free patients | Intervention Type: DRUG; Name: Corticosteroid: Betamethasone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Dexamethasone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Fludrocortisone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Hydrocortisone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Meprednisone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Methylprednisolone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Prednisolone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Prednisone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients | Intervention Type: DRUG; Name: Corticosteroid: Triamcinolone; Assigned to Arm(s): Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients"
}
|
A
|
[
"NCT00005052",
"NCT01608594",
"NCT01989572",
"NCT00623766"
] | 218 |
train
|
NCT00005094
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of Sporadic Colorectal Adenomas With Celecoxib
Brief Summary: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.
|
{
"A": "Arm Label: A; Type: PLACEBO_COMPARATOR; Interventions: Drug: Celecoxib | Intervention Type: DRUG; Name: Celecoxib; Assigned to Arm(s): A",
"B": "Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix™ | Arm Label: Havrix Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Havrix™-based investigational formulation | Intervention Type: BIOLOGICAL; Name: Cervarix™; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Havrix™-based investigational formulation; Assigned to Arm(s): Havrix Group",
"C": "Arm Label: Arm I (celecoxib); Type: EXPERIMENTAL; Interventions: Drug: celecoxib | Arm Label: Arm II (placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: celecoxib; Assigned to Arm(s): Arm I (celecoxib) | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm II (placebo)",
"D": "Arm Label: Arm I (celecoxib); Type: EXPERIMENTAL; Interventions: Drug: Celecoxib, Other: Laboratory Biomarker Analysis | Arm Label: Arm II (placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: Laboratory Biomarker Analysis, Other: Placebo | Intervention Type: DRUG; Name: Celecoxib; Assigned to Arm(s): Arm I (celecoxib) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (celecoxib), Arm II (placebo) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm II (placebo)"
}
|
C
|
[
"NCT00141193",
"NCT00122681",
"NCT00005094",
"NCT00081263"
] | 219 |
train
|
NCT00005578
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.
|
{
"A": "Arm Label: Cancer survivors; Type: N/A; Interventions: N/A | Arm Label: Sibling Controls; Type: N/A; Interventions: N/A",
"B": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Biological: bleomycin sulfate, Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: prednisone, Drug: vincristine sulfate, Radiation: radiation therapy | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Biological: bleomycin sulfate, Biological: filgrastim, Drug: cyclophosphamide, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: prednisone, Drug: vincristine sulfate, Radiation: radiation therapy | Intervention Type: BIOLOGICAL; Name: bleomycin sulfate; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: BIOLOGICAL; Name: filgrastim; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: DRUG; Name: dexrazoxane hydrochloride; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: doxorubicin hydrochloride; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: DRUG; Name: etoposide; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: DRUG; Name: prednisone; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): Arm 1, Arm 2",
"C": "Intervention Type: DRUG; Name: asparaginase (E. Coli); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: asparaginase (Erwina); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: dexrazoxane; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: doxorubicin; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: cranial radiation (once daily fractionation); Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: cranial radiation (twice-daily fractionation); Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Intrathecal chemotherapy without radiation; Assigned to Arm(s): N/A",
"D": "Arm Label: Ancillary-Correlative (laboratory biomarker analysis); Type: N/A; Interventions: Other: Assessment of Therapy Complications, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire Administration | Intervention Type: OTHER; Name: Assessment of Therapy Complications; Assigned to Arm(s): Ancillary-Correlative (laboratory biomarker analysis) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Ancillary-Correlative (laboratory biomarker analysis) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Ancillary-Correlative (laboratory biomarker analysis) | Intervention Type: OTHER; Name: Questionnaire Administration; Assigned to Arm(s): Ancillary-Correlative (laboratory biomarker analysis)"
}
|
B
|
[
"NCT01120353",
"NCT00005578",
"NCT00165087",
"NCT01790152"
] | 220 |
train
|
NCT00005669
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Metformin on Energy Intake, Energy Expenditure, and Body Weight in Overweight Children With Insulin Resistance
Brief Summary: This study will examine the safety and effectiveness of the medicine metformin to help overweight children control their food intake, weight, insulin, cholesterol, and triglyceride (blood fat) levels. Obesity and high insulin levels can lead to high blood pressure, diabetes, high cholesterol and triglyceride levels and heart disease. Metformin-approved by the Food and Drug Administration to treat adults with type 2 diabetes mellitus-helps lower insulin levels and may control weight gain in adults.
Overweight children 6 to 11 years old who are in general good health may be eligible for this study. Children will be studied at the National Institutes of Health in Bethesda, Maryland. Candidates will have a medical history and physical examination and fasting blood test, and will provide a 7-day record of their food intake as part of the screening process. Those enrolled will be randomly assigned to receive either metformin or placebo (a look-alike tablet with no active medicine) twice a day for a six month period. After the 6 month study period, all children will be offered the opportunity to take metformin for another 6 months.
Participants will be hospitalized for 2-3 days for the following procedures: history and physical examination; fasting blood test; several urine collections; X-ray studies to determine bone age and amount of body fat and muscle; magnetic resonance imaging (MRI) scan to measure body fat; "hyperglycemic clamp study" to evaluate insulin resistance; food intake testing; nutrition consultation; resting metabolic rate; and a "doubly labeled water" test.
For the hyperglycemic clamp study, a catheter (thin flexible tube) is inserted into a vein in each arm. A sugar solution is given through one tube and blood samples are drawn every 5 minutes through the other to measure insulin. For the food intake testing, the child is asked about his or her hunger level, then given various foods he or she may choose to eat, then questioned again at various intervals both during and after finishing eating about his or her hunger level. The doubly labeled water study involves drinking "heavy water" (water which is enriched to have special kinds of hydrogen and oxygen). Urine specimens are collected 2, 3 and 4 hours after drinking the water. The child also drinks a special milk shake called a Scandishake and repeats the calorie intake and hunger study. (Two food intake studies are done on separate days.) One week after the heavy water test, additional urine samples are collected one week later.
After completing the tests, the child will begin treatment with metformin or placebo, plus a daily vitamin tablet. Participants will be followed once a month with a brief history and physical examination, including a blood test. After 6 months, all of the tests described above will be repeated. All children who complete the second round of tests-both those who took metformin and those who took placebo-will be offered metformin for an additional 6 months and will be seen once a month for follow-up evaluations. Parents will not be told which children received metformin and which received placebo until all children in the study complete the first 6 months of the trial.
|
{
"A": "Arm Label: Litramine; Type: EXPERIMENTAL; Interventions: Device: Litramine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Device: Placebo | Intervention Type: DEVICE; Name: Litramine; Assigned to Arm(s): Litramine | Intervention Type: DEVICE; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Depression Prevention; Type: EXPERIMENTAL; Interventions: Other: The Blues Program | Arm Label: Health Education; Type: ACTIVE_COMPARATOR; Interventions: Other: Hey Durham | Intervention Type: OTHER; Name: The Blues Program; Assigned to Arm(s): Depression Prevention | Intervention Type: OTHER; Name: Hey Durham; Assigned to Arm(s): Health Education",
"C": "Arm Label: 1 - Metformin HCL; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin HCL | Arm Label: 2 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Metformin HCL; Assigned to Arm(s): 1 - Metformin HCL | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 - Placebo",
"D": "Intervention Type: DRUG; Name: glucophage XR; Assigned to Arm(s): N/A"
}
|
C
|
[
"NCT01233349",
"NCT01425905",
"NCT00005669",
"NCT00120146"
] | 221 |
train
|
NCT00005775
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
Brief Summary: This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.
|
{
"A": "Arm Label: Cycling Parenteral Nutrition; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Parenteral Nutrition | Arm Label: Continuous Parenteral Nutrition; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Parenteral Nutrition | Intervention Type: DIETARY_SUPPLEMENT; Name: Parenteral Nutrition; Assigned to Arm(s): Continuous Parenteral Nutrition, Cycling Parenteral Nutrition",
"B": "Arm Label: Experimental Infant Formula; Type: EXPERIMENTAL; Interventions: Other: Experimental Infant Formula | Intervention Type: OTHER; Name: Experimental Infant Formula; Assigned to Arm(s): Experimental Infant Formula",
"C": "Arm Label: New Amino Acid formula; Type: EXPERIMENTAL; Interventions: Other: Amino Acid formula | Arm Label: Control formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Commercially available Amino Acid Formula | Intervention Type: OTHER; Name: Amino Acid formula; Assigned to Arm(s): New Amino Acid formula | Intervention Type: OTHER; Name: Commercially available Amino Acid Formula; Assigned to Arm(s): Control formula",
"D": "Arm Label: Glutamine; Type: EXPERIMENTAL; Interventions: Drug: Glutamine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Glutamine; Assigned to Arm(s): Glutamine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT01062815",
"NCT01813526",
"NCT01569776",
"NCT00005775"
] | 222 |
train
|
NCT00005889
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition
Brief Summary: RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known.
PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
|
{
"A": "Arm Label: Amino acid based infant formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Amino acid based infant formula | Arm Label: Extensively hydrolyzed casein infant formula; Type: EXPERIMENTAL; Interventions: Other: Extensively hydrolyzed casein infant formula | Arm Label: Mother's own breast milk; Type: OTHER; Interventions: Other: Mother's own breast milk | Intervention Type: OTHER; Name: Amino acid based infant formula; Assigned to Arm(s): Amino acid based infant formula | Intervention Type: OTHER; Name: Extensively hydrolyzed casein infant formula; Assigned to Arm(s): Extensively hydrolyzed casein infant formula | Intervention Type: OTHER; Name: Mother's own breast milk; Assigned to Arm(s): Mother's own breast milk",
"B": "Intervention Type: DRUG; Name: alanine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: amino acids; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glucagon; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glucose; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glutamine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glycerol; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: insulin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: leucine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: lipids; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: urea; Assigned to Arm(s): N/A",
"C": "Arm Label: Amino acid based formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Special Medical Food | Arm Label: New amino acid based formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Special Medical Food | Intervention Type: OTHER; Name: Special Medical Food; Assigned to Arm(s): Amino acid based formula | Intervention Type: OTHER; Name: Special Medical Food; Assigned to Arm(s): New amino acid based formula",
"D": "Arm Label: New Amino Acid formula; Type: EXPERIMENTAL; Interventions: Other: Amino Acid formula | Arm Label: Control formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Commercially available Amino Acid Formula | Intervention Type: OTHER; Name: Amino Acid formula; Assigned to Arm(s): New Amino Acid formula | Intervention Type: OTHER; Name: Commercially available Amino Acid Formula; Assigned to Arm(s): Control formula"
}
|
B
|
[
"NCT02500563",
"NCT00005889",
"NCT01109966",
"NCT01569776"
] | 223 |
train
|
NCT00005970
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Brief Summary: This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
|
{
"A": "Arm Label: Conventional radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Conventional radiotherapy | Arm Label: Tomotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Tomotherapy | Intervention Type: RADIATION; Name: Conventional radiotherapy; Assigned to Arm(s): Conventional radiotherapy | Intervention Type: RADIATION; Name: Tomotherapy; Assigned to Arm(s): Tomotherapy",
"B": "Arm Label: Hypofractionated whole breast radiation; Type: EXPERIMENTAL; Interventions: Radiation: Hypofractionated whole breast radiation schedule | Arm Label: Conventional whole breast radiation; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Conventional whole breast radiation schedule | Intervention Type: RADIATION; Name: Conventional whole breast radiation schedule; Assigned to Arm(s): Conventional whole breast radiation | Intervention Type: RADIATION; Name: Hypofractionated whole breast radiation schedule; Assigned to Arm(s): Hypofractionated whole breast radiation",
"C": "Arm Label: Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate | Arm Label: Arm II (AC, paclitaxel, trastuzumab, tamoxifen); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate, Biological: Trastuzumab | Arm Label: Arm III (AC, paclitaxel, trastuzumab, tamoxifen); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate, Biological: Trastuzumab | Intervention Type: DRUG; Name: Aromatase Inhibition Therapy; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Doxorubicin Hydrochloride; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Tamoxifen Citrate; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: BIOLOGICAL; Name: Trastuzumab; Assigned to Arm(s): Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen)",
"D": "Arm Label: Arm 1: adriamycin + cyclophosphamide then taxol; Type: ACTIVE_COMPARATOR; Interventions: Drug: adriamycin, Drug: cyclophosphamide, Drug: taxol | Arm Label: Arm 2: adriamycin + cyclophosphamide then taxol + herceptin; Type: EXPERIMENTAL; Interventions: Biological: herceptin, Drug: adriamycin, Drug: cyclophosphamide, Drug: taxol | Intervention Type: BIOLOGICAL; Name: herceptin; Assigned to Arm(s): Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: adriamycin; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: taxol; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin"
}
|
C
|
[
"NCT00459628",
"NCT00156052",
"NCT00005970",
"NCT00004067"
] | 224 |
train
|
NCT00005970
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Brief Summary: This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
|
{
"A": "Arm Label: Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate | Arm Label: Arm II (AC, paclitaxel, trastuzumab, tamoxifen); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate, Biological: Trastuzumab | Arm Label: Arm III (AC, paclitaxel, trastuzumab, tamoxifen); Type: EXPERIMENTAL; Interventions: Drug: Aromatase Inhibition Therapy, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Drug: Tamoxifen Citrate, Biological: Trastuzumab | Intervention Type: DRUG; Name: Aromatase Inhibition Therapy; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Doxorubicin Hydrochloride; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: DRUG; Name: Tamoxifen Citrate; Assigned to Arm(s): Arm I (AC, paclitaxel, tamoxifen, aromatase inhibitor), Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen) | Intervention Type: BIOLOGICAL; Name: Trastuzumab; Assigned to Arm(s): Arm II (AC, paclitaxel, trastuzumab, tamoxifen), Arm III (AC, paclitaxel, trastuzumab, tamoxifen)",
"B": "Arm Label: Arm 1: adriamycin + cyclophosphamide then taxol; Type: ACTIVE_COMPARATOR; Interventions: Drug: adriamycin, Drug: cyclophosphamide, Drug: taxol | Arm Label: Arm 2: adriamycin + cyclophosphamide then taxol + herceptin; Type: EXPERIMENTAL; Interventions: Biological: herceptin, Drug: adriamycin, Drug: cyclophosphamide, Drug: taxol | Intervention Type: BIOLOGICAL; Name: herceptin; Assigned to Arm(s): Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: adriamycin; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin | Intervention Type: DRUG; Name: taxol; Assigned to Arm(s): Arm 1: adriamycin + cyclophosphamide then taxol, Arm 2: adriamycin + cyclophosphamide then taxol + herceptin",
"C": "Intervention Type: BIOLOGICAL; Name: trastuzumab; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: capecitabine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: docetaxel; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: epirubicin hydrochloride; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: neoadjuvant therapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Observation Arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Herceptin 1-Year Arm; Type: EXPERIMENTAL; Interventions: Drug: Herceptin | Arm Label: Herceptin 2-Year Arm; Type: EXPERIMENTAL; Interventions: Drug: Herceptin | Intervention Type: DRUG; Name: Herceptin; Assigned to Arm(s): Herceptin 1-Year Arm | Intervention Type: DRUG; Name: Herceptin; Assigned to Arm(s): Herceptin 2-Year Arm"
}
|
A
|
[
"NCT00005970",
"NCT00004067",
"NCT00288002",
"NCT00045032"
] | 225 |
train
|
NCT00006161
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Decompression Intervention of Variceal Rebleeding Trial
Brief Summary: The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.
This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: red blood cell transfusion | Intervention Type: PROCEDURE; Name: red blood cell transfusion; Assigned to Arm(s): 1, 2",
"B": "Intervention Type: PROCEDURE; Name: Transjugular Intrahepatic Portosystemic Shunt (TIPS); Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Distal Splenorenal Shunt; Assigned to Arm(s): N/A",
"C": "Arm Label: Injection Sclerotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Injection Sclerotherapy | Arm Label: N-butyl-2-cyanoacrylate; Type: ACTIVE_COMPARATOR; Interventions: Drug: N-butyl-2-cyanoacrylate | Intervention Type: DRUG; Name: Injection Sclerotherapy; Assigned to Arm(s): Injection Sclerotherapy | Intervention Type: DRUG; Name: N-butyl-2-cyanoacrylate; Assigned to Arm(s): N-butyl-2-cyanoacrylate",
"D": "Arm Label: Sclerotherapy group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Sclerotherapy | Arm Label: Endoscopic band ligation group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Band ligation | Arm Label: Sclero-ligation (SL) group; Type: EXPERIMENTAL; Interventions: Procedure: Scleroligation | Intervention Type: PROCEDURE; Name: Sclerotherapy; Assigned to Arm(s): Sclerotherapy group | Intervention Type: PROCEDURE; Name: Band ligation; Assigned to Arm(s): Endoscopic band ligation group | Intervention Type: PROCEDURE; Name: Scleroligation; Assigned to Arm(s): Sclero-ligation (SL) group"
}
|
B
|
[
"NCT00414713",
"NCT00006161",
"NCT03388125",
"NCT02646202"
] | 226 |
train
|
NCT00006164
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
|
{
"A": "Arm Label: Peginterferon Alfa-2a + Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Peginterferon alfa-2a [Pegasys] | Arm Label: Peginterferon Alfa-2b + Ribavirin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2b (PEG-Intron), Drug: Ribavirin | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Peginterferon Alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2b (PEG-Intron); Assigned to Arm(s): Peginterferon Alfa-2b + Ribavirin | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Peginterferon Alfa-2b + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a [Pegasys]; Assigned to Arm(s): Peginterferon Alfa-2a + Ribavirin",
"B": "Arm Label: PegIntron 1.5 ug/kg/wk plus REBETOL; Type: EXPERIMENTAL; Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: REBETOL (ribavirin; SCH 18908) | Arm Label: PegIntron 1.0 ug/kg/wk plus REBETOL; Type: EXPERIMENTAL; Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: REBETOL (ribavirin; SCH 18908) | Arm Label: PEGASYS 180 ug/wk Plus COPEGUS; Type: ACTIVE_COMPARATOR; Interventions: Biological: PEGASYS (peginterferon alfa-2a), Drug: COPEGUS (ribavirin) | Intervention Type: BIOLOGICAL; Name: PegIntron (peginterferon alfa-2b; SCH 54031); Assigned to Arm(s): PegIntron 1.5 ug/kg/wk plus REBETOL | Intervention Type: BIOLOGICAL; Name: PegIntron (peginterferon alfa-2b; SCH 54031); Assigned to Arm(s): PegIntron 1.0 ug/kg/wk plus REBETOL | Intervention Type: DRUG; Name: REBETOL (ribavirin; SCH 18908); Assigned to Arm(s): PegIntron 1.0 ug/kg/wk plus REBETOL, PegIntron 1.5 ug/kg/wk plus REBETOL | Intervention Type: BIOLOGICAL; Name: PEGASYS (peginterferon alfa-2a); Assigned to Arm(s): PEGASYS 180 ug/wk Plus COPEGUS | Intervention Type: DRUG; Name: COPEGUS (ribavirin); Assigned to Arm(s): PEGASYS 180 ug/wk Plus COPEGUS",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1",
"D": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pegylated interferon alpha 2a, Drug: Ribavirin | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pegylated interferon alpha 2 b plus ribavirin | Intervention Type: DRUG; Name: Pegylated interferon alpha 2a; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Pegylated interferon alpha 2 b plus ribavirin; Assigned to Arm(s): 2"
}
|
C
|
[
"NCT00087607",
"NCT00081770",
"NCT00006164",
"NCT00502099"
] | 227 |
train
|
NCT00006164
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
|
{
"A": "Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Placebo | Arm Label: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Intervention Type: DRUG; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1",
"C": "Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Other: Placebo | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week",
"D": "Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group A); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group B); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group C); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group D); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group E); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group F); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Arm Label: Pegylated-interferon Alfa-2a + Ribavirin (Group NR); Type: EXPERIMENTAL; Interventions: Drug: Pegylated-interferon Alfa-2a, Drug: Ribavirin | Intervention Type: DRUG; Name: Pegylated-interferon Alfa-2a; Assigned to Arm(s): Pegylated-interferon Alfa-2a + Ribavirin (Group A), Pegylated-interferon Alfa-2a + Ribavirin (Group B), Pegylated-interferon Alfa-2a + Ribavirin (Group C), Pegylated-interferon Alfa-2a + Ribavirin (Group D), Pegylated-interferon Alfa-2a + Ribavirin (Group E), Pegylated-interferon Alfa-2a + Ribavirin (Group F), Pegylated-interferon Alfa-2a + Ribavirin (Group NR) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Pegylated-interferon Alfa-2a + Ribavirin (Group A), Pegylated-interferon Alfa-2a + Ribavirin (Group B), Pegylated-interferon Alfa-2a + Ribavirin (Group C), Pegylated-interferon Alfa-2a + Ribavirin (Group D), Pegylated-interferon Alfa-2a + Ribavirin (Group E), Pegylated-interferon Alfa-2a + Ribavirin (Group F), Pegylated-interferon Alfa-2a + Ribavirin (Group NR)"
}
|
B
|
[
"NCT00372385",
"NCT00006164",
"NCT00336479",
"NCT00483938"
] | 228 |
train
|
NCT00006164
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
|
{
"A": "Arm Label: Cohort A, Group 1 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 1 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (12 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (24 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (12 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (24 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (12 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (24 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH",
"B": "Arm Label: LDV/SOF; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: Placebo to match RBV | Arm Label: LDV/SOF + RBV; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV, Drug: Placebo to match LDV/SOF, Drug: Placebo to match RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match LDV/SOF; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1",
"D": "Arm Label: Healthy control; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Metastatic liver cancer patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Hepatocellular carcinoma patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Chronic liver disease patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Intervention Type: DIAGNOSTIC_TEST; Name: PIVKA-II; Assigned to Arm(s): Chronic liver disease patients, Healthy control, Hepatocellular carcinoma patients, Metastatic liver cancer patients"
}
|
C
|
[
"NCT01938430",
"NCT01965535",
"NCT00006164",
"NCT03047603"
] | 229 |
train
|
NCT00006164
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
|
{
"A": "Arm Label: 1. Placebo + PEG + RBV; Type: PLACEBO_COMPARATOR; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Placebo | Arm Label: 2. Boceprevir + PEG + RBV - 24 Weeks (RGT); Type: EXPERIMENTAL; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Boceprevir | Arm Label: 3. Boceprevir + PEG + RBV - 44 Weeks; Type: EXPERIMENTAL; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Boceprevir | Intervention Type: BIOLOGICAL; Name: Peginterferon alfa-2b (PEG); Assigned to Arm(s): 1. Placebo + PEG + RBV, 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): 1. Placebo + PEG + RBV, 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1. Placebo + PEG + RBV | Intervention Type: DRUG; Name: Boceprevir; Assigned to Arm(s): 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks",
"B": "Arm Label: PegIntron; Type: EXPERIMENTAL; Interventions: Biological: peginterferon alfa-2b (SCH 54031) | Arm Label: Untreated Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: peginterferon alfa-2b (SCH 54031); Assigned to Arm(s): PegIntron",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1",
"D": "Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Biological: Pegylated Interferon Alfa 2a, Drug: Ribavirin, Other: Placebo | Arm Label: Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week; Type: EXPERIMENTAL; Interventions: Biological: Pegylated Interferon Alfa 2a, Drug: Telaprevir, Drug: Ribavirin, Other: Placebo | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week; Type: EXPERIMENTAL; Interventions: Biological: Pegylated Interferon Alfa 2a, Drug: Telaprevir, Drug: Ribavirin | Intervention Type: BIOLOGICAL; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week"
}
|
C
|
[
"NCT00705432",
"NCT00048724",
"NCT00006164",
"NCT00627926"
] | 230 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Standard support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support | Arm Label: Proactive telephone support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support | Arm Label: Standard support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Arm Label: Proactive support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Intervention Type: BEHAVIORAL; Name: Proactive telephone support; Assigned to Arm(s): Proactive support & offer NRT, Proactive telephone support | Intervention Type: BEHAVIORAL; Name: Reactive (standard) telephone support; Assigned to Arm(s): Standard support, Standard support & offer NRT | Intervention Type: DRUG; Name: Offer of voucher for cost-free Nicotine Replacement Therapy; Assigned to Arm(s): Proactive support & offer NRT, Standard support & offer NRT",
"B": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"C": "Arm Label: Positive psychotherapy; Type: EXPERIMENTAL; Interventions: Behavioral: Positive Psychotherapy for smoking cessation, Drug: Nicotine polacrilex, Behavioral: Behavioral smoking cessation treatment | Arm Label: Standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine polacrilex, Behavioral: Relaxation training, Behavioral: Behavioral smoking cessation treatment | Intervention Type: BEHAVIORAL; Name: Positive Psychotherapy for smoking cessation; Assigned to Arm(s): Positive psychotherapy | Intervention Type: DRUG; Name: Nicotine polacrilex; Assigned to Arm(s): Positive psychotherapy, Standard treatment | Intervention Type: BEHAVIORAL; Name: Relaxation training; Assigned to Arm(s): Standard treatment | Intervention Type: BEHAVIORAL; Name: Behavioral smoking cessation treatment; Assigned to Arm(s): Positive psychotherapy, Standard treatment",
"D": "Arm Label: Integrated Intensive Smoking + Alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge, Behavioral: Intensive Alcohol Intervention | Arm Label: Usual Care; Type: PLACEBO_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge | Intervention Type: DRUG; Name: nicotine patch plus nicotine gum/lozenge; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol, Usual Care | Intervention Type: BEHAVIORAL; Name: Intensive Alcohol Intervention; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol"
}
|
B
|
[
"NCT00775944",
"NCT00006170",
"NCT01451814",
"NCT01932996"
] | 231 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: P; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion HCl ER | Intervention Type: DRUG; Name: Bupropion HCl ER; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): P",
"B": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"C": "Arm Label: Healthy Control - Non-smoking; Type: OTHER; Interventions: Other: Biological Control | Arm Label: Healthy Control - Smoker; Type: OTHER; Interventions: Other: Biological Control | Arm Label: HIV Smoking Cessation Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline tartrate, Drug: Nicotine Replacement Therapy | Arm Label: Motivational Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational Interview | Intervention Type: DRUG; Name: Varenicline tartrate; Assigned to Arm(s): HIV Smoking Cessation Arm | Intervention Type: DRUG; Name: Nicotine Replacement Therapy; Assigned to Arm(s): HIV Smoking Cessation Arm | Intervention Type: OTHER; Name: Biological Control; Assigned to Arm(s): Healthy Control - Non-smoking, Healthy Control - Smoker | Intervention Type: BEHAVIORAL; Name: Motivational Interview; Assigned to Arm(s): Motivational Intervention",
"D": "Arm Label: Active bupropion + counseling; Type: ACTIVE_COMPARATOR; Interventions: Drug: Active bupropion + counseling | Arm Label: Active bupropion , No counseling; Type: ACTIVE_COMPARATOR; Interventions: Drug: Active bupropion, No counseling | Arm Label: Placebo medication + counseling; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo medication + counseling | Arm Label: Placebo medication, No counseling; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo medication, No counseling | Intervention Type: DRUG; Name: Active bupropion + counseling; Assigned to Arm(s): Active bupropion + counseling | Intervention Type: DRUG; Name: Active bupropion, No counseling; Assigned to Arm(s): Active bupropion , No counseling | Intervention Type: DRUG; Name: Placebo medication + counseling; Assigned to Arm(s): Placebo medication + counseling | Intervention Type: DRUG; Name: Placebo medication, No counseling; Assigned to Arm(s): Placebo medication, No counseling"
}
|
B
|
[
"NCT00689611",
"NCT00006170",
"NCT00701896",
"NCT01621009"
] | 232 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline(Chantix) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline(Chantix); Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: placebo; Type: N/A; Interventions: Drug: placebo | Arm Label: varenicline; Type: N/A; Interventions: Drug: varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline",
"C": "Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): N/A",
"D": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation"
}
|
D
|
[
"NCT00523445",
"NCT01532232",
"NCT00463918",
"NCT00006170"
] | 233 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"B": "Arm Label: Varenicline and Placebo Patch; Type: PLACEBO_COMPARATOR; Interventions: Drug: Varenicline and Placebo Patch | Arm Label: Varenicline and Nicotine Patch; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Nicotine Patch | Intervention Type: DRUG; Name: Varenicline, Nicotine Patch; Assigned to Arm(s): Varenicline and Nicotine Patch | Intervention Type: DRUG; Name: Varenicline and Placebo Patch; Assigned to Arm(s): Varenicline and Placebo Patch",
"C": "Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: nicotine patch | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: nicotine lozenge | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: nicotine patch + nicotine lozenge | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: bupropion | Arm Label: 5; Type: EXPERIMENTAL; Interventions: Drug: bupropion + lozenge | Arm Label: 6; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: nicotine patch; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: nicotine lozenge; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: nicotine patch + nicotine lozenge; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: bupropion; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: bupropion + lozenge; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 6"
}
|
A
|
[
"NCT00006170",
"NCT01444131",
"NCT01509547",
"NCT00332644"
] | 234 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Bupropion; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: Weekly Motivational Emails | Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Weekly Motivational Emails | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: BEHAVIORAL; Name: Weekly Motivational Emails; Assigned to Arm(s): Bupropion, Varenicline",
"B": "Arm Label: patch; Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine patch | Arm Label: nicotine lozenge; Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine lozenge | Arm Label: bupropion; Type: ACTIVE_COMPARATOR; Interventions: Drug: bupropion | Arm Label: patch + lozenge; Type: ACTIVE_COMPARATOR; Interventions: Drug: patch + lozenge | Arm Label: buproion + lozenge; Type: ACTIVE_COMPARATOR; Interventions: Drug: bupropion + lozenge | Intervention Type: DRUG; Name: nicotine patch; Assigned to Arm(s): patch | Intervention Type: DRUG; Name: nicotine patch; Assigned to Arm(s): patch | Intervention Type: DRUG; Name: nicotine lozenge; Assigned to Arm(s): nicotine lozenge | Intervention Type: DRUG; Name: bupropion; Assigned to Arm(s): bupropion | Intervention Type: DRUG; Name: patch + lozenge; Assigned to Arm(s): patch + lozenge | Intervention Type: DRUG; Name: bupropion + lozenge; Assigned to Arm(s): buproion + lozenge",
"C": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"D": "Arm Label: Bupropion SR; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion SR | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Oral Tablet | Intervention Type: DRUG; Name: Bupropion SR; Assigned to Arm(s): Bupropion SR | Intervention Type: DRUG; Name: Placebo Oral Tablet; Assigned to Arm(s): Placebo"
}
|
C
|
[
"NCT02146911",
"NCT00296647",
"NCT00006170",
"NCT00176449"
] | 235 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Bupropion SR + Contingency Management; Type: EXPERIMENTAL; Interventions: Drug: Bupropion SR, Behavioral: Contingency Management | Arm Label: Placebo + Contingency Management; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Contingency Management, Other: Placebo | Arm Label: Bupropion SR + No Contingency Management; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion SR | Arm Label: Placebo + No Contingency Management; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Bupropion SR; Assigned to Arm(s): Bupropion SR + Contingency Management, Bupropion SR + No Contingency Management | Intervention Type: BEHAVIORAL; Name: Contingency Management; Assigned to Arm(s): Bupropion SR + Contingency Management, Placebo + Contingency Management | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo + Contingency Management, Placebo + No Contingency Management",
"B": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"C": "Arm Label: Brief Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Bupropion/Low Contact; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Placebo/Low Contact; Type: PLACEBO_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Bupropion/High Contact; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Placebo/High Contact; Type: PLACEBO_COMPARATOR; Interventions: Drug: Bupropion and NRT | Intervention Type: DRUG; Name: Bupropion and NRT; Assigned to Arm(s): Brief Treatment, Extended Bupropion/High Contact, Extended Bupropion/Low Contact, Extended Placebo/High Contact, Extended Placebo/Low Contact",
"D": "Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Counseling and Nicotine replacement (CN) | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Behavioral: Counseling, Nicotine replacement and Bupropion (CNB) | Intervention Type: BEHAVIORAL; Name: Counseling and Nicotine replacement (CN); Assigned to Arm(s): 2 | Intervention Type: BEHAVIORAL; Name: Counseling, Nicotine replacement and Bupropion (CNB); Assigned to Arm(s): 3"
}
|
B
|
[
"NCT00330187",
"NCT00006170",
"NCT00087880",
"NCT00628225"
] | 236 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: PROOF cohort; Type: N/A; Interventions: N/A",
"B": "Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A",
"C": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"D": "Arm Label: 1 - CBT Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Motivational interviewing for smoking cessation, Behavioral: Cognitive behaviors therapy | Arm Label: 2 - Counseling + NRT; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational interviewing for smoking cessation, Drug: CBT + NRT | Intervention Type: BEHAVIORAL; Name: Motivational interviewing for smoking cessation; Assigned to Arm(s): 1 - CBT Counseling, 2 - Counseling + NRT | Intervention Type: BEHAVIORAL; Name: Cognitive behaviors therapy; Assigned to Arm(s): 1 - CBT Counseling | Intervention Type: DRUG; Name: CBT + NRT; Assigned to Arm(s): 2 - Counseling + NRT"
}
|
C
|
[
"NCT00759304",
"NCT00141206",
"NCT00006170",
"NCT00224419"
] | 237 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline",
"B": "Intervention Type: DRUG; Name: CP-526,555 (varenicline); Assigned to Arm(s): N/A",
"C": "Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A",
"D": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation"
}
|
D
|
[
"NCT00691483",
"NCT00150228",
"NCT00143325",
"NCT00006170"
] | 238 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Comprehensive intervention; Type: EXPERIMENTAL; Interventions: Other: Comprehensive smoking cessation intervention | Arm Label: Enhanced usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced usual care | Intervention Type: OTHER; Name: Comprehensive smoking cessation intervention; Assigned to Arm(s): Comprehensive intervention | Intervention Type: BEHAVIORAL; Name: Enhanced usual care; Assigned to Arm(s): Enhanced usual care",
"B": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"C": "Arm Label: Bupropion Arm; Type: EXPERIMENTAL; Interventions: Behavioral: smoking cessation intervention, Drug: bupropion hydrochloride, Genetic: gene expression analysis, Genetic: polymerase chain reaction, Other: counseling intervention, Other: educational intervention, Procedure: psychosocial assessment and care | Arm Label: Health Education Arm; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: smoking cessation intervention, Genetic: gene expression analysis, Genetic: polymerase chain reaction, Other: counseling intervention, Other: educational intervention, Procedure: psychosocial assessment and care | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion Arm, Health Education Arm | Intervention Type: DRUG; Name: bupropion hydrochloride; Assigned to Arm(s): Bupropion Arm | Intervention Type: GENETIC; Name: gene expression analysis; Assigned to Arm(s): Bupropion Arm, Health Education Arm | Intervention Type: GENETIC; Name: polymerase chain reaction; Assigned to Arm(s): Bupropion Arm, Health Education Arm | Intervention Type: OTHER; Name: counseling intervention; Assigned to Arm(s): Bupropion Arm, Health Education Arm | Intervention Type: OTHER; Name: educational intervention; Assigned to Arm(s): Bupropion Arm, Health Education Arm | Intervention Type: PROCEDURE; Name: psychosocial assessment and care; Assigned to Arm(s): Bupropion Arm, Health Education Arm",
"D": "Arm Label: Brief Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Bupropion/Low Contact; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Placebo/Low Contact; Type: PLACEBO_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Bupropion/High Contact; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion and NRT | Arm Label: Extended Placebo/High Contact; Type: PLACEBO_COMPARATOR; Interventions: Drug: Bupropion and NRT | Intervention Type: DRUG; Name: Bupropion and NRT; Assigned to Arm(s): Brief Treatment, Extended Bupropion/High Contact, Extended Bupropion/Low Contact, Extended Placebo/High Contact, Extended Placebo/Low Contact"
}
|
B
|
[
"NCT02188563",
"NCT00006170",
"NCT00666978",
"NCT00087880"
] | 239 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Champix | Intervention Type: DRUG; Name: Champix; Assigned to Arm(s): Placebo",
"B": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"C": "Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: Sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): Varenicline | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Sugar pill",
"D": "Arm Label: Group I (varenicline and placebo); Type: EXPERIMENTAL; Interventions: Other: Placebo, Other: Tobacco Cessation Counseling, Drug: Varenicline | Arm Label: Group II (placebo, nicotine patch and lozenge); Type: PLACEBO_COMPARATOR; Interventions: Drug: Nicotine Lozenge, Drug: Nicotine Patch, Other: Placebo, Other: Tobacco Cessation Counseling | Intervention Type: DRUG; Name: Nicotine Lozenge; Assigned to Arm(s): Group II (placebo, nicotine patch and lozenge) | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Group II (placebo, nicotine patch and lozenge) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) | Intervention Type: OTHER; Name: Tobacco Cessation Counseling; Assigned to Arm(s): Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Group I (varenicline and placebo)"
}
|
B
|
[
"NCT01243203",
"NCT00006170",
"NCT00794573",
"NCT02271919"
] | 240 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"B": "Arm Label: Standard support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support | Arm Label: Proactive telephone support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support | Arm Label: Standard support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Arm Label: Proactive support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Intervention Type: BEHAVIORAL; Name: Proactive telephone support; Assigned to Arm(s): Proactive support & offer NRT, Proactive telephone support | Intervention Type: BEHAVIORAL; Name: Reactive (standard) telephone support; Assigned to Arm(s): Standard support, Standard support & offer NRT | Intervention Type: DRUG; Name: Offer of voucher for cost-free Nicotine Replacement Therapy; Assigned to Arm(s): Proactive support & offer NRT, Standard support & offer NRT",
"C": "Intervention Type: DRUG; Name: transdermal nicotine patches; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Motivational interview; Assigned to Arm(s): N/A",
"D": "Arm Label: High intensity disease management; Type: EXPERIMENTAL; Interventions: Behavioral: High intensity disease management, Drug: Bupropion | Arm Label: Low intensity disease management; Type: EXPERIMENTAL; Interventions: Behavioral: Low intensity disease management, Drug: Bupropion | Arm Label: Comparison group; Type: OTHER; Interventions: Behavioral: Comparison group, Drug: Bupropion | Intervention Type: BEHAVIORAL; Name: High intensity disease management; Assigned to Arm(s): High intensity disease management | Intervention Type: BEHAVIORAL; Name: Low intensity disease management; Assigned to Arm(s): Low intensity disease management | Intervention Type: BEHAVIORAL; Name: Comparison group; Assigned to Arm(s): Comparison group | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Comparison group, High intensity disease management, Low intensity disease management"
}
|
A
|
[
"NCT00006170",
"NCT00775944",
"NCT00297466",
"NCT00440115"
] | 241 |
train
|
NCT00006170
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bupropion and Weight Control for Smoking Cessation
Brief Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
|
{
"A": "Arm Label: Bupropion and Weight Concerns intervention; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Behavioral: weight concerns intervention | Arm Label: Placebo and Weight Concerns; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Behavioral: weight concerns intervention | Arm Label: Bupropion and standard smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion, Behavioral: smoking cessation intervention | Arm Label: Placebo and standard smoking cessation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: smoking cessation intervention | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Bupropion and standard smoking cessation | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and Weight Concerns, Placebo and standard smoking cessation | Intervention Type: BEHAVIORAL; Name: weight concerns intervention; Assigned to Arm(s): Bupropion and Weight Concerns intervention, Placebo and Weight Concerns | Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): Bupropion and standard smoking cessation, Placebo and standard smoking cessation",
"B": "Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: Sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): Varenicline | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Sugar pill",
"C": "Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A",
"D": "Arm Label: Nicotine Replacement Therapy Responder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine Patches | Arm Label: Pre-Quit Rescue to Bupropion & Nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then bupropion & nicotine patches (Pre-Quit) | Arm Label: Pre-Quit Rescue to Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then varenicline (Pre-Quit) | Arm Label: Pre-Quit Rescue to Nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then nicotine patches (Pre-Quit) | Arm Label: Post-Quit Rescue to Bupropion & Nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then bupropion & nicotine patches (Post-Quit) | Arm Label: Post-Quit Rescue to Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then varenicline (Post-Quit) | Arm Label: Post-Quit Rescue to Nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, then nicotine patches (Post-Quit) | Intervention Type: DRUG; Name: Nicotine Patches; Assigned to Arm(s): Nicotine Replacement Therapy Responder | Intervention Type: DRUG; Name: Nicotine patches, then bupropion & nicotine patches (Pre-Quit); Assigned to Arm(s): Pre-Quit Rescue to Bupropion & Nicotine | Intervention Type: DRUG; Name: Nicotine patches, then varenicline (Pre-Quit); Assigned to Arm(s): Pre-Quit Rescue to Varenicline | Intervention Type: DRUG; Name: Nicotine patches, then nicotine patches (Pre-Quit); Assigned to Arm(s): Pre-Quit Rescue to Nicotine | Intervention Type: DRUG; Name: Nicotine patches, then bupropion & nicotine patches (Post-Quit); Assigned to Arm(s): Post-Quit Rescue to Bupropion & Nicotine | Intervention Type: DRUG; Name: Nicotine patches, then varenicline (Post-Quit); Assigned to Arm(s): Post-Quit Rescue to Varenicline | Intervention Type: DRUG; Name: Nicotine patches, then nicotine patches (Post-Quit); Assigned to Arm(s): Post-Quit Rescue to Nicotine"
}
|
A
|
[
"NCT00006170",
"NCT00794573",
"NCT00141206",
"NCT00894166"
] | 242 |
train
|
NCT00006177
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder
Brief Summary: This research protocol seeks to learn more about bipolar disorder in children and adolescents ages 6-17. Researchers will describe the moods and behaviors of children with bipolar disorder and use specialized testing and brain imaging to learn about specific brain changes associated with the disorder. This protocol studies children who have been diagnosed with bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus considered "at risk" for developing the disorder.
|
{
"A": "Arm Label: Stepping Stones Triple P; Type: EXPERIMENTAL; Interventions: Behavioral: Level 4 Stepping Stones Triple P (SSTP) | Arm Label: Treatment as usual (TAU); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Level 4 Stepping Stones Triple P (SSTP); Assigned to Arm(s): Stepping Stones Triple P",
"B": "Arm Label: PBS based staff training; Type: EXPERIMENTAL; Interventions: Behavioral: PBS based staff training, Other: Treatment as Usual | Arm Label: Treatment as usual; Type: OTHER; Interventions: Other: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: PBS based staff training; Assigned to Arm(s): PBS based staff training | Intervention Type: OTHER; Name: Treatment as Usual; Assigned to Arm(s): PBS based staff training, Treatment as usual",
"C": "Arm Label: Adult bipolar patients; Type: N/A; Interventions: N/A | Arm Label: Adult Extended Relatives of BD probands; Type: N/A; Interventions: N/A | Arm Label: Bipolar Children and Youth; Type: N/A; Interventions: N/A | Arm Label: Child/Adolescent Extended Relatives of BD probands; Type: N/A; Interventions: N/A | Arm Label: Children with ADHD only (controls); Type: N/A; Interventions: N/A | Arm Label: First degree relatives of BD patients; Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer adults (parents or not); Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer children and youth; Type: N/A; Interventions: N/A",
"D": "Arm Label: Cognitus and Me; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive remediation program | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive remediation program | Intervention Type: BEHAVIORAL; Name: Cognitive remediation program; Assigned to Arm(s): Cognitus and Me, control group"
}
|
C
|
[
"NCT03086876",
"NCT01680276",
"NCT00006177",
"NCT02797418"
] | 243 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Intervention Type: PROCEDURE; Name: blood transfusion; Assigned to Arm(s): N/A",
"B": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm",
"C": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"D": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1"
}
|
C
|
[
"NCT00000592",
"NCT01425307",
"NCT00006182",
"NCT00122980"
] | 244 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Arm Label: Blood Transfusion Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Biological: Single blood transfusion | Arm Label: Standard Care Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Arm Label: Standard Care Observational Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Intervention Type: BIOLOGICAL; Name: Single blood transfusion; Assigned to Arm(s): Blood Transfusion Trial Cohort | Intervention Type: BEHAVIORAL; Name: Standard care; Assigned to Arm(s): Standard Care Observational Cohort, Standard Care Trial Cohort",
"B": "Arm Label: Prasugrel; Type: EXPERIMENTAL; Interventions: Drug: Prasugrel | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Prasugrel; Assigned to Arm(s): Prasugrel | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group",
"D": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT00951808",
"NCT01794000",
"NCT00072761",
"NCT00006182"
] | 245 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm",
"B": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"C": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group",
"D": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1"
}
|
B
|
[
"NCT01425307",
"NCT00006182",
"NCT00072761",
"NCT00122980"
] | 246 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group",
"B": "Intervention Type: PROCEDURE; Name: blood transfusion; Assigned to Arm(s): N/A",
"C": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"D": "Arm Label: Standard Therapy: Observation; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Hydroxyurea; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea"
}
|
C
|
[
"NCT00072761",
"NCT00000592",
"NCT00006182",
"NCT01531387"
] | 247 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group",
"C": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"D": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm"
}
|
C
|
[
"NCT00006400",
"NCT00072761",
"NCT00006182",
"NCT01425307"
] | 248 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1",
"C": "Arm Label: Blood Transfusion Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Biological: Single blood transfusion | Arm Label: Standard Care Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Arm Label: Standard Care Observational Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Intervention Type: BIOLOGICAL; Name: Single blood transfusion; Assigned to Arm(s): Blood Transfusion Trial Cohort | Intervention Type: BEHAVIORAL; Name: Standard care; Assigned to Arm(s): Standard Care Observational Cohort, Standard Care Trial Cohort",
"D": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm"
}
|
A
|
[
"NCT00006182",
"NCT00122980",
"NCT00951808",
"NCT01425307"
] | 249 |
train
|
NCT00006182
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.
|
{
"A": "Intervention Type: PROCEDURE; Name: blood transfusion; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1",
"C": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"D": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm"
}
|
C
|
[
"NCT00000592",
"NCT00122980",
"NCT00006182",
"NCT01425307"
] | 250 |
train
|
NCT00006183
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hematocrit Strategy in Infant Heart Surgery
Brief Summary: The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35% versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of the great arteries, a malformation of the heart vessels.
|
{
"A": "Arm Label: Shorter-storage red blood cell units; Type: ACTIVE_COMPARATOR; Interventions: Biological: Red blood cell units stored <= 10 days | Arm Label: Longer-storage red blood cell units; Type: ACTIVE_COMPARATOR; Interventions: Biological: Red blood cell units stored >= 21 days | Intervention Type: BIOLOGICAL; Name: Red blood cell units stored <= 10 days; Assigned to Arm(s): Shorter-storage red blood cell units | Intervention Type: BIOLOGICAL; Name: Red blood cell units stored >= 21 days; Assigned to Arm(s): Longer-storage red blood cell units",
"B": "Arm Label: Biological; Type: EXPERIMENTAL; Interventions: Biological: Transfusion | Arm Label: Standard PRBCs; Type: EXPERIMENTAL; Interventions: Biological: Transfusion | Intervention Type: BIOLOGICAL; Name: Transfusion; Assigned to Arm(s): Biological, Standard PRBCs",
"C": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: Standard leukoreduced irradiated blood cell transfusion | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Biological: Washed leukoreduced irradiated blood cell transfusions | Intervention Type: BIOLOGICAL; Name: Standard leukoreduced irradiated blood cell transfusion; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Washed leukoreduced irradiated blood cell transfusions; Assigned to Arm(s): 2",
"D": "Intervention Type: PROCEDURE; Name: Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Thoracic Surgery; Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT00991341",
"NCT00326924",
"NCT00693498",
"NCT00006183"
] | 251 |
train
|
NCT00006206
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions
Brief Summary: Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
|
{
"A": "Intervention Type: DRUG; Name: naltrexone (Revia); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: acamprosate (Campral); Assigned to Arm(s): N/A",
"B": "Intervention Type: DRUG; Name: methylphenidate hydrochloride extended-release tablets; Assigned to Arm(s): N/A",
"C": "N/A",
"D": "Arm Label: Medication Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vyvanse, Drug: Methylphenidate | Arm Label: Behavioral Parent Training Arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral Parent Training | Intervention Type: DRUG; Name: Vyvanse; Assigned to Arm(s): Medication Arm | Intervention Type: BEHAVIORAL; Name: Behavioral Parent Training; Assigned to Arm(s): Behavioral Parent Training Arm | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Medication Arm"
}
|
A
|
[
"NCT00006206",
"NCT00326300",
"NCT00550667",
"NCT02675400"
] | 252 |
train
|
NCT00006206
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions
Brief Summary: Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naltrexone | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naltrexone plus Gabapentin | Arm Label: 3; Type: SHAM_COMPARATOR; Interventions: Other: Inactive Placebo | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Naltrexone plus Gabapentin; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Inactive Placebo; Assigned to Arm(s): 3",
"B": "Arm Label: Levetiracetam; Type: ACTIVE_COMPARATOR; Interventions: Drug: levetiracetam (Keppra) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: levetiracetam (Keppra); Assigned to Arm(s): Levetiracetam | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Intervention Type: DRUG; Name: topiramate; Assigned to Arm(s): N/A",
"D": "Intervention Type: DRUG; Name: naltrexone (Revia); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: acamprosate (Campral); Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT00183196",
"NCT00758277",
"NCT00210925",
"NCT00006206"
] | 253 |
train
|
NCT00006249
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
Brief Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody, Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody | Intervention Type: DRUG; Name: MDX-010 (anti-CTLA4) monoclonal antibody; Assigned to Arm(s): 2, 3 | Intervention Type: BIOLOGICAL; Name: MDX-1379 (gp100) Melanoma Peptide Vaccine; Assigned to Arm(s): 1, 2",
"B": "Arm Label: observation; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: pegylated interferon alfa; Type: EXPERIMENTAL; Interventions: Biological: pegylated interferon alfa, Procedure: adjuvant therapy | Intervention Type: BIOLOGICAL; Name: pegylated interferon alfa; Assigned to Arm(s): pegylated interferon alfa | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): pegylated interferon alfa",
"C": "Arm Label: WEX only; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Wide Excision | Arm Label: WEX + SLND; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Sentinel Lymph Node Dissection | Arm Label: WEX+SLND+CLND; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Complete Lymph Node Dissection | Intervention Type: PROCEDURE; Name: Sentinel Lymph Node Dissection; Assigned to Arm(s): WEX + SLND | Intervention Type: PROCEDURE; Name: Complete Lymph Node Dissection; Assigned to Arm(s): WEX+SLND+CLND | Intervention Type: PROCEDURE; Name: Wide Excision; Assigned to Arm(s): WEX only",
"D": "Arm Label: Vemurafenib; Type: EXPERIMENTAL; Interventions: Drug: Vemurafenib | Arm Label: Dacarbazine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dacarbazine | Intervention Type: DRUG; Name: Vemurafenib; Assigned to Arm(s): Vemurafenib | Intervention Type: DRUG; Name: Dacarbazine; Assigned to Arm(s): Dacarbazine"
}
|
B
|
[
"NCT00094653",
"NCT00006249",
"NCT00275496",
"NCT01006980"
] | 254 |
train
|
NCT00006286
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.
The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?
The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.
The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aripiprazole | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aripiprazole | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 3",
"B": "Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): N/A",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Drug: Citalopram | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Behavioral: Cognitive Behavioral Therapy (CBT), Drug: Citalopram | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine, Behavioral: Cognitive Behavioral Therapy (CBT) | Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Venlafaxine; Assigned to Arm(s): 2, 4 | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy (CBT); Assigned to Arm(s): 3, 4 | Intervention Type: DRUG; Name: Citalopram; Assigned to Arm(s): 1, 3",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Attachment-Based Family Therapy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: Attachment-Based Family Therapy; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care; Assigned to Arm(s): 2"
}
|
B
|
[
"NCT00110461",
"NCT00006286",
"NCT00018902",
"NCT00604097"
] | 255 |
train
|
NCT00006286
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.
The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?
The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.
The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.
|
{
"A": "Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Drug: Citalopram | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Behavioral: Cognitive Behavioral Therapy (CBT), Drug: Citalopram | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine, Behavioral: Cognitive Behavioral Therapy (CBT) | Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Venlafaxine; Assigned to Arm(s): 2, 4 | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy (CBT); Assigned to Arm(s): 3, 4 | Intervention Type: DRUG; Name: Citalopram; Assigned to Arm(s): 1, 3",
"C": "Intervention Type: DRUG; Name: fluoxetine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: sertraline; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: citalopram; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: escitalopram; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: bupropion; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: mirtazapine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: venlafaxine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: lithium; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Active, 1; Type: EXPERIMENTAL; Interventions: Drug: Sertraline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): Active, 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo"
}
|
A
|
[
"NCT00006286",
"NCT00018902",
"NCT00080158",
"NCT00508859"
] | 256 |
train
|
NCT00006286
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.
The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?
The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.
The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.
|
{
"A": "Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive behavioral therapy (CBT), Drug: Drug therapy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Drug therapy | Intervention Type: BEHAVIORAL; Name: Cognitive behavioral therapy (CBT); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Drug therapy; Assigned to Arm(s): 1, 2",
"C": "Arm Label: Escitalopram; Type: EXPERIMENTAL; Interventions: Drug: Escitalopram | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Escitalopram; Assigned to Arm(s): Escitalopram | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2",
"D": "Arm Label: Active, 1; Type: EXPERIMENTAL; Interventions: Drug: Sertraline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): Active, 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo"
}
|
A
|
[
"NCT00006286",
"NCT00158301",
"NCT00107120",
"NCT00508859"
] | 257 |
train
|
NCT00006294
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment
Brief Summary: To examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.
|
{
"A": "Arm Label: Chlorthalidone; Type: N/A; Interventions: Drug: Chlorthalidone | Arm Label: Amlodipine; Type: N/A; Interventions: Drug: Amlodipine | Arm Label: Lisinopril; Type: N/A; Interventions: Drug: Lisinopril | Arm Label: Doxazosin; Type: N/A; Interventions: Drug: Doxazosin | Intervention Type: DRUG; Name: Chlorthalidone; Assigned to Arm(s): Chlorthalidone | Intervention Type: DRUG; Name: Lisinopril; Assigned to Arm(s): Lisinopril | Intervention Type: DRUG; Name: Amlodipine; Assigned to Arm(s): Amlodipine | Intervention Type: DRUG; Name: Doxazosin; Assigned to Arm(s): Doxazosin",
"B": "Arm Label: Candesartan; Type: EXPERIMENTAL; Interventions: Drug: candesartan, Drug: nifedipine, long acting, Drug: metoprolol, long-acting | Arm Label: Lisinopril; Type: EXPERIMENTAL; Interventions: Drug: lisinopril, Drug: nifedipine, long acting, Drug: metoprolol, long-acting | Arm Label: HCTZ; Type: ACTIVE_COMPARATOR; Interventions: Drug: hydrochlorothiazide | Intervention Type: DRUG; Name: candesartan; Assigned to Arm(s): Candesartan | Intervention Type: DRUG; Name: lisinopril; Assigned to Arm(s): Lisinopril | Intervention Type: DRUG; Name: hydrochlorothiazide; Assigned to Arm(s): HCTZ | Intervention Type: DRUG; Name: nifedipine, long acting; Assigned to Arm(s): Candesartan, Lisinopril | Intervention Type: DRUG; Name: metoprolol, long-acting; Assigned to Arm(s): Candesartan, Lisinopril",
"C": "Intervention Type: DRUG; Name: Inhibitors, ACE; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: amlodipine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: lisinopril; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: doxazosin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: chlorthalidone; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: pravastatin; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A",
"D": "Intervention Type: DRUG; Name: MK0954, /Duration of Treatment : 5 Years; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Comparator : atenolol /Duration of Treatment : 5 Years; Assigned to Arm(s): N/A"
}
|
A
|
[
"NCT00006294",
"NCT00605072",
"NCT00000542",
"NCT00338260"
] | 258 |
train
|
NCT00006305
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).
SPECIFIC AIMS
A. Primary Aim
The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:
1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.
B. Secondary Aims
The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.
|
{
"A": "Arm Label: desvenlafaxine succinate sustained-release (DVS SR) 50mg; Type: EXPERIMENTAL; Interventions: Drug: DVS SR | Arm Label: desvenlafaxine succinate sustained-release (DVS SR) 100mg; Type: EXPERIMENTAL; Interventions: Drug: DVS SR | Arm Label: desvenlafaxine succinate sustained-release (DVS SR) 200mg; Type: EXPERIMENTAL; Interventions: Drug: DVS SR | Arm Label: desvenlafaxine succinate sustained-release (DVS SR) 400mg; Type: EXPERIMENTAL; Interventions: Drug: DVS SR | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: DVS SR; Assigned to Arm(s): desvenlafaxine succinate sustained-release (DVS SR) 100mg, desvenlafaxine succinate sustained-release (DVS SR) 200mg, desvenlafaxine succinate sustained-release (DVS SR) 400mg, desvenlafaxine succinate sustained-release (DVS SR) 50mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: DVS SR Open Label; Type: OTHER; Interventions: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR) | Intervention Type: DRUG; Name: Desvenlafaxine Succinate Sustained-Release (DVS SR); Assigned to Arm(s): DVS SR Open Label",
"C": "Arm Label: Revascularization and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Revascularization and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Intervention Type: PROCEDURE; Name: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: PROCEDURE; Name: Coronary Artery Bypass; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Biguanides, thiazolidinediones; Assigned to Arm(s): Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Insulin, sulfonylurea; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Revascularization and Insulin Providing (IP) | Intervention Type: DRUG; Name: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS)",
"D": "Arm Label: Standard glycemic control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Arm Label: Intensive glycemic control; Type: EXPERIMENTAL; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control"
}
|
C
|
[
"NCT00283842",
"NCT01050218",
"NCT00006305",
"NCT00032487"
] | 259 |
train
|
NCT00006305
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).
SPECIFIC AIMS
A. Primary Aim
The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:
1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.
B. Secondary Aims
The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.
|
{
"A": "Arm Label: Lira 1.8; Type: EXPERIMENTAL; Interventions: Drug: liraglutide, Drug: placebo | Arm Label: Lira 1.2; Type: EXPERIMENTAL; Interventions: Drug: liraglutide, Drug: placebo | Arm Label: Glimepiride - 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: glimepiride, Drug: placebo | Arm Label: Glimepiride - 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: glimepiride, Drug: placebo | Intervention Type: DRUG; Name: liraglutide; Assigned to Arm(s): Lira 1.8 | Intervention Type: DRUG; Name: glimepiride; Assigned to Arm(s): Glimepiride - 1, Glimepiride - 2 | Intervention Type: DRUG; Name: liraglutide; Assigned to Arm(s): Lira 1.2 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Lira 1.2, Lira 1.8 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Glimepiride - 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Glimepiride - 2",
"B": "Arm Label: Standard glycemic control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Arm Label: Intensive glycemic control; Type: EXPERIMENTAL; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control",
"C": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Vildagliptin; Type: EXPERIMENTAL; Interventions: Drug: vildagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: vildagliptin; Assigned to Arm(s): Vildagliptin",
"D": "Arm Label: Revascularization and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Revascularization and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Intervention Type: PROCEDURE; Name: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: PROCEDURE; Name: Coronary Artery Bypass; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Biguanides, thiazolidinediones; Assigned to Arm(s): Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Insulin, sulfonylurea; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Revascularization and Insulin Providing (IP) | Intervention Type: DRUG; Name: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS)"
}
|
D
|
[
"NCT00294723",
"NCT00032487",
"NCT01472432",
"NCT00006305"
] | 260 |
train
|
NCT00006305
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).
SPECIFIC AIMS
A. Primary Aim
The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:
1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.
B. Secondary Aims
The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.
|
{
"A": "Arm Label: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Glyburide, Drug: Metformin | Arm Label: Saxagliptin 5 mg + Glyburide 7.5 mg (B); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Glyburide, Drug: Metformin | Arm Label: Placebo + Glyburide 7.5 mg (C); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Glyburide, Drug: Metformin | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 5 mg + Glyburide 7.5 mg (B) | Intervention Type: DRUG; Name: Glyburide; Assigned to Arm(s): Saxagliptin 2.5 mg + Glyburide 7.5 mg (A), Saxagliptin 5 mg + Glyburide 7.5 mg (B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C) | Intervention Type: DRUG; Name: Glyburide; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C), Saxagliptin 2.5 mg + Glyburide 7.5 mg (A), Saxagliptin 5 mg + Glyburide 7.5 mg (B)",
"B": "Arm Label: Standard Treatment Arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diet, Behavioral: Exercise, Behavioral: Stop smoking, Drug: Glucose lowering therapy, Drug: Blood pressure lowering therapy, Drug: Lipid lowering therapy | Arm Label: Intensive Treatment Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Behavioral: Stop smoking, Drug: Glucose lowering therapy, Drug: Blood pressure lowering therapy, Drug: Lipid lowering therapy | Intervention Type: BEHAVIORAL; Name: Diet; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: BEHAVIORAL; Name: Stop smoking; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Glucose lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Blood pressure lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Lipid lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm",
"C": "Arm Label: Revascularization and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Revascularization and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Intervention Type: PROCEDURE; Name: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: PROCEDURE; Name: Coronary Artery Bypass; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Biguanides, thiazolidinediones; Assigned to Arm(s): Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Insulin, sulfonylurea; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Revascularization and Insulin Providing (IP) | Intervention Type: DRUG; Name: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS)",
"D": "Arm Label: linagliptin 5mg; Type: EXPERIMENTAL; Interventions: Drug: Linagliptin 5mg | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Linagliptin 5mg; Assigned to Arm(s): linagliptin 5mg"
}
|
C
|
[
"NCT00313313",
"NCT00320008",
"NCT00006305",
"NCT01792518"
] | 261 |
train
|
NCT00006327
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Brief Summary: The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
|
{
"A": "Intervention Type: BIOLOGICAL; Name: MN rgp120/HIV-1 and A244 rgp120/HIV-1; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Screening for intimate partner violence | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Screening for intimate partner violence; Assigned to Arm(s): 1",
"C": "Arm Label: FEM-CARE; Type: EXPERIMENTAL; Interventions: Behavioral: FEM-CARE | Arm Label: Health Promotion; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Health Promotion | Intervention Type: BEHAVIORAL; Name: FEM-CARE; Assigned to Arm(s): FEM-CARE | Intervention Type: BEHAVIORAL; Name: Health Promotion; Assigned to Arm(s): Health Promotion",
"D": "Arm Label: Extended-release naltrexone (XR-NTX); Type: ACTIVE_COMPARATOR; Interventions: Drug: Extended-Release Naltrexone | Arm Label: Motivational Enhancement Counseling Only; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Motivational Enhancement Counseling | Intervention Type: DRUG; Name: Extended-Release Naltrexone; Assigned to Arm(s): Extended-release naltrexone (XR-NTX) | Intervention Type: BEHAVIORAL; Name: Motivational Enhancement Counseling; Assigned to Arm(s): Motivational Enhancement Counseling Only"
}
|
A
|
[
"NCT00006327",
"NCT00182468",
"NCT02258425",
"NCT01180647"
] | 262 |
train
|
NCT00006327
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Brief Summary: The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
|
{
"A": "Intervention Type: BIOLOGICAL; Name: MN rgp120/HIV-1 and A244 rgp120/HIV-1; Assigned to Arm(s): N/A",
"B": "Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Methadone | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methadone | Intervention Type: DRUG; Name: Methadone; Assigned to Arm(s): A, B",
"C": "Arm Label: Parolee Comprehensive Care + Phone Coach; Type: EXPERIMENTAL; Interventions: Behavioral: Parolee Comprehensive Care + Phone Coach | Arm Label: Parolee Brief HBV program + Phone Coach; Type: EXPERIMENTAL; Interventions: Behavioral: Parolee Brief HBV Program + Phone Coach | Arm Label: Usual Care Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Care Group | Intervention Type: BEHAVIORAL; Name: Parolee Comprehensive Care + Phone Coach; Assigned to Arm(s): Parolee Comprehensive Care + Phone Coach | Intervention Type: BEHAVIORAL; Name: Parolee Brief HBV Program + Phone Coach; Assigned to Arm(s): Parolee Brief HBV program + Phone Coach | Intervention Type: BEHAVIORAL; Name: Usual Care Group; Assigned to Arm(s): Usual Care Group",
"D": "Arm Label: Recovery management intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Recovery management | Intervention Type: BEHAVIORAL; Name: Recovery management; Assigned to Arm(s): Recovery management intervention"
}
|
A
|
[
"NCT00006327",
"NCT00657397",
"NCT01844414",
"NCT01270100"
] | 263 |
train
|
NCT00006353
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
|
{
"A": "Arm Label: Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Radiation therapy | Arm Label: Radiotherapy plus Bevacizumab; Type: EXPERIMENTAL; Interventions: Drug: Bevacizumab | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Radiotherapy plus Bevacizumab | Intervention Type: RADIATION; Name: Radiation therapy; Assigned to Arm(s): Radiotherapy",
"B": "Arm Label: Bevacizumab/Irinoecan; Type: EXPERIMENTAL; Interventions: Drug: Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures) | Arm Label: Stupp; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temodal/radiotherapy | Intervention Type: DRUG; Name: Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures); Assigned to Arm(s): Bevacizumab/Irinoecan | Intervention Type: DRUG; Name: Temodal/radiotherapy; Assigned to Arm(s): Stupp",
"C": "Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Arm I (radiation therapy, temozolomide, placebo); Type: ACTIVE_COMPARATOR; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Quality-of-Life Assessment, Drug: Temozolomide | Arm Label: Arm II (radiation therapy, temozolomide, bevacizumab); Type: EXPERIMENTAL; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Biological: Bevacizumab, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Drug: Temozolomide | Intervention Type: RADIATION; Name: 3-Dimensional Conformal Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: RADIATION; Name: Intensity-Modulated Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab)"
}
|
C
|
[
"NCT01443676",
"NCT01022918",
"NCT00006353",
"NCT00884741"
] | 264 |
train
|
NCT00006353
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
|
{
"A": "Arm Label: Vaccination; Type: EXPERIMENTAL; Interventions: Biological: autologous dendritic cells | Intervention Type: BIOLOGICAL; Name: autologous dendritic cells; Assigned to Arm(s): Vaccination",
"B": "Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"C": "Arm Label: Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Radiotherapy of the partial brain. | Arm Label: Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Temozolomide | Intervention Type: RADIATION; Name: Radiotherapy of the partial brain.; Assigned to Arm(s): Radiotherapy",
"D": "Arm Label: Rindopepimut/GM-CSF plus Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Rindopepimut (CDX-110) with GM-CSF, Drug: Temozolomide | Arm Label: KLH plus Temozolomide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide, Drug: KLH | Intervention Type: DRUG; Name: Rindopepimut (CDX-110) with GM-CSF; Assigned to Arm(s): Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): KLH plus Temozolomide, Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: KLH; Assigned to Arm(s): KLH plus Temozolomide"
}
|
B
|
[
"NCT01006044",
"NCT00006353",
"NCT01502241",
"NCT01480479"
] | 265 |
train
|
NCT00006353
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
|
{
"A": "Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"B": "Arm Label: Cediranib & Gefitinib; Type: ACTIVE_COMPARATOR; Interventions: Drug: cediranib maleate, Drug: gefitinib | Arm Label: Cediranbib & placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: cediranib maleate, Drug: Placebo | Intervention Type: DRUG; Name: cediranib maleate; Assigned to Arm(s): Cediranbib & placebo, Cediranib & Gefitinib | Intervention Type: DRUG; Name: gefitinib; Assigned to Arm(s): Cediranib & Gefitinib | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cediranbib & placebo",
"C": "Arm Label: Temozolomide; Type: ACTIVE_COMPARATOR; Interventions: Drug: temozolomide, Genetic: DNA methylation analysis, Procedure: quality-of-life assessment | Arm Label: Radiation; Type: ACTIVE_COMPARATOR; Interventions: Genetic: DNA methylation analysis, Procedure: quality-of-life assessment, Radiation: Radiation | Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): Temozolomide | Intervention Type: GENETIC; Name: DNA methylation analysis; Assigned to Arm(s): Radiation, Temozolomide | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Radiation, Temozolomide | Intervention Type: RADIATION; Name: Radiation; Assigned to Arm(s): Radiation",
"D": "Arm Label: O6-BG + BCNU + Radiation Therapy; Type: EXPERIMENTAL; Interventions: Drug: carmustine, Radiation: radiation therapy, Drug: O6-Benzylguanine | Arm Label: BCNU + Radiation Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: carmustine, Radiation: radiation therapy | Intervention Type: DRUG; Name: carmustine; Assigned to Arm(s): BCNU + Radiation Therapy, O6-BG + BCNU + Radiation Therapy | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): BCNU + Radiation Therapy, O6-BG + BCNU + Radiation Therapy | Intervention Type: DRUG; Name: O6-Benzylguanine; Assigned to Arm(s): O6-BG + BCNU + Radiation Therapy"
}
|
A
|
[
"NCT00006353",
"NCT01310855",
"NCT00482677",
"NCT00017147"
] | 266 |
train
|
NCT00006353
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
|
{
"A": "Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"B": "Arm Label: Specialised palliative care (SPC) group; Type: EXPERIMENTAL; Interventions: Other: Specialised palliative care (SPC) | Arm Label: Standard care group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Specialised palliative care (SPC); Assigned to Arm(s): Specialised palliative care (SPC) group",
"C": "Arm Label: Early entry group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Early palliative care intervention | Arm Label: Later entry group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Later entry group | Intervention Type: BEHAVIORAL; Name: Later entry group; Assigned to Arm(s): Later entry group | Intervention Type: BEHAVIORAL; Name: Early palliative care intervention; Assigned to Arm(s): Early entry group",
"D": "Arm Label: Early Palliative Care Referral; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Early Palliative Care Referral | Arm Label: Conventional Cancer Care; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Early Palliative Care Referral | Intervention Type: BEHAVIORAL; Name: Early Palliative Care Referral; Assigned to Arm(s): Conventional Cancer Care, Early Palliative Care Referral"
}
|
A
|
[
"NCT00006353",
"NCT01348048",
"NCT01245621",
"NCT01248624"
] | 267 |
train
|
NCT00006353
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
|
{
"A": "Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"B": "Arm Label: Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Radiotherapy of the partial brain. | Arm Label: Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Temozolomide | Intervention Type: RADIATION; Name: Radiotherapy of the partial brain.; Assigned to Arm(s): Radiotherapy",
"C": "Intervention Type: DRUG; Name: lomustine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: procarbazine hydrochloride; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Temozolomide; Type: ACTIVE_COMPARATOR; Interventions: Drug: temozolomide, Genetic: DNA methylation analysis, Procedure: quality-of-life assessment | Arm Label: Radiation; Type: ACTIVE_COMPARATOR; Interventions: Genetic: DNA methylation analysis, Procedure: quality-of-life assessment, Radiation: Radiation | Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): Temozolomide | Intervention Type: GENETIC; Name: DNA methylation analysis; Assigned to Arm(s): Radiation, Temozolomide | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Radiation, Temozolomide | Intervention Type: RADIATION; Name: Radiation; Assigned to Arm(s): Radiation"
}
|
A
|
[
"NCT00006353",
"NCT01502241",
"NCT00002840",
"NCT00482677"
] | 268 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin C; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin E; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: beta-carotene; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: folic acid/Vitamin B6/Vitamin B12; Assigned to Arm(s): N/A",
"B": "Arm Label: 1; Type: N/A; Interventions: N/A | Arm Label: 2; Type: N/A; Interventions: N/A | Arm Label: 3; Type: N/A; Interventions: N/A | Arm Label: 4; Type: N/A; Interventions: N/A",
"C": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"D": "Arm Label: Vitamin E; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin E | Arm Label: Vitamin C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin C | Arm Label: Multivitamin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamin | Arm Label: Beta-carotene; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Beta-carotene | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Vitamin E | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin C; Assigned to Arm(s): Vitamin C | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamin; Assigned to Arm(s): Multivitamin | Intervention Type: DIETARY_SUPPLEMENT; Name: Beta-carotene; Assigned to Arm(s): Beta-carotene"
}
|
C
|
[
"NCT00000541",
"NCT00671346",
"NCT00006392",
"NCT00270647"
] | 269 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"B": "Arm Label: Nutriceutical formulation; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Nutriceutical formulation | Arm Label: Placebo 1; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Placebo 2; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutriceutical formulation; Assigned to Arm(s): Nutriceutical formulation | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo 1, Placebo 2",
"C": "Arm Label: PGZ; Type: EXPERIMENTAL; Interventions: Drug: pioglitazone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): PGZ | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Vitamin E; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin E | Arm Label: Vitamin C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin C | Arm Label: Multivitamin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamin | Arm Label: Beta-carotene; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Beta-carotene | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Vitamin E | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin C; Assigned to Arm(s): Vitamin C | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamin; Assigned to Arm(s): Multivitamin | Intervention Type: DIETARY_SUPPLEMENT; Name: Beta-carotene; Assigned to Arm(s): Beta-carotene"
}
|
A
|
[
"NCT00006392",
"NCT01320527",
"NCT00982202",
"NCT00270647"
] | 270 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"B": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: vitamin and mineral supplement, Drug: Escherichia coli Endotoxin (LPS), Drug: 100% O2, Drug: nitroglycerin | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Escherichia coli Endotoxin (LPS), Drug: 100% O2, Drug: nitroglycerin | Intervention Type: DRUG; Name: vitamin and mineral supplement; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Escherichia coli Endotoxin (LPS); Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: 100% O2; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: nitroglycerin; Assigned to Arm(s): 1, 2",
"C": "Intervention Type: DRUG; Name: Natural source Vitamin E 400IU/day; Assigned to Arm(s): N/A",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aspirin, Drug: Vitamin E | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Behavioral: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Aspirin, Behavioral: Placebo | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Placebo | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: Placebo; Assigned to Arm(s): 2, 3, 4"
}
|
A
|
[
"NCT00006392",
"NCT00431691",
"NCT00220831",
"NCT00000479"
] | 271 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Vitamin E; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin E | Arm Label: Vitamin C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin C | Arm Label: Multivitamin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamin | Arm Label: Beta-carotene; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Beta-carotene | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Vitamin E | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin C; Assigned to Arm(s): Vitamin C | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamin; Assigned to Arm(s): Multivitamin | Intervention Type: DIETARY_SUPPLEMENT; Name: Beta-carotene; Assigned to Arm(s): Beta-carotene",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Prostate Screening; Type: ACTIVE_COMPARATOR; Interventions: Other: Laboratory Biomarker Analysis, Procedure: Medical Examination Assessment, Other: Screening Questionnaire Administration | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Prostate Screening | Intervention Type: PROCEDURE; Name: Medical Examination Assessment; Assigned to Arm(s): Prostate Screening | Intervention Type: OTHER; Name: Screening Questionnaire Administration; Assigned to Arm(s): Prostate Screening",
"C": "Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A",
"D": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo"
}
|
D
|
[
"NCT00270647",
"NCT00002540",
"NCT00000611",
"NCT00006392"
] | 272 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: telephone; Type: EXPERIMENTAL; Interventions: Behavioral: telephone | Arm Label: face-to-face; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: consultation face-to-face | Intervention Type: BEHAVIORAL; Name: telephone; Assigned to Arm(s): telephone | Intervention Type: BEHAVIORAL; Name: consultation face-to-face; Assigned to Arm(s): face-to-face",
"B": "Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A",
"C": "Arm Label: Copy of audio recording; Type: EXPERIMENTAL; Interventions: Other: audio recorded information | Arm Label: No copy of audio recording; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: audio recorded information; Assigned to Arm(s): Copy of audio recording",
"D": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo"
}
|
D
|
[
"NCT02570061",
"NCT00000611",
"NCT01502254",
"NCT00006392"
] | 273 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"B": "Intervention Type: BEHAVIORAL; Name: ascorbic acid, vitamin E, beta carotene, selenium, zinc; Assigned to Arm(s): N/A",
"C": "Arm Label: Vitamin E; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin E | Arm Label: Vitamin C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin C | Arm Label: Multivitamin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamin | Arm Label: Beta-carotene; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Beta-carotene | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Vitamin E | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin C; Assigned to Arm(s): Vitamin C | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamin; Assigned to Arm(s): Multivitamin | Intervention Type: DIETARY_SUPPLEMENT; Name: Beta-carotene; Assigned to Arm(s): Beta-carotene",
"D": "Arm Label: Nutriceutical formulation; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Nutriceutical formulation | Arm Label: Placebo 1; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Placebo 2; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutriceutical formulation; Assigned to Arm(s): Nutriceutical formulation | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo 1, Placebo 2"
}
|
A
|
[
"NCT00006392",
"NCT00272428",
"NCT00270647",
"NCT01320527"
] | 274 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Study Arm A | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Study Arm B | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Study Arm C | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Study Arm D | Intervention Type: DIETARY_SUPPLEMENT; Name: Study Arm A; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: Study Arm B; Assigned to Arm(s): 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: Study Arm C; Assigned to Arm(s): 3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Study Arm D; Assigned to Arm(s): 4",
"B": "Intervention Type: BEHAVIORAL; Name: ascorbic acid, vitamin E, beta carotene, selenium, zinc; Assigned to Arm(s): N/A",
"C": "Arm Label: PGZ; Type: EXPERIMENTAL; Interventions: Drug: pioglitazone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): PGZ | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo"
}
|
D
|
[
"NCT00362518",
"NCT00272428",
"NCT00982202",
"NCT00006392"
] | 275 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Saffron; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Saffron | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Saffron; Assigned to Arm(s): Saffron | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"C": "Arm Label: Vitamin E; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin E | Arm Label: Vitamin C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin C | Arm Label: Multivitamin; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamin | Arm Label: Beta-carotene; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Beta-carotene | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Vitamin E | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin C; Assigned to Arm(s): Vitamin C | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamin; Assigned to Arm(s): Multivitamin | Intervention Type: DIETARY_SUPPLEMENT; Name: Beta-carotene; Assigned to Arm(s): Beta-carotene",
"D": "Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Beta-Carotene; Assigned to Arm(s): N/A"
}
|
B
|
[
"NCT00951288",
"NCT00006392",
"NCT00270647",
"NCT00000152"
] | 276 |
train
|
NCT00006392
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
|
{
"A": "Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo",
"B": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: 50ug selenium enriched yeast; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 50ug selenium enriched yeast | Arm Label: 100ug selenium enriched yeast; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 100ug selenium enriched yeast | Arm Label: 200ug selenium enriched yeast; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 200ug selenium enriched yeast | Arm Label: Control onion; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Control onion | Arm Label: Enriched onion; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Enriched onion | Intervention Type: DIETARY_SUPPLEMENT; Name: 50ug selenium enriched yeast; Assigned to Arm(s): 50ug selenium enriched yeast | Intervention Type: DIETARY_SUPPLEMENT; Name: 100ug selenium enriched yeast; Assigned to Arm(s): 100ug selenium enriched yeast | Intervention Type: DIETARY_SUPPLEMENT; Name: 200ug selenium enriched yeast; Assigned to Arm(s): 200ug selenium enriched yeast | Intervention Type: DIETARY_SUPPLEMENT; Name: Control onion; Assigned to Arm(s): Control onion | Intervention Type: DIETARY_SUPPLEMENT; Name: Enriched onion; Assigned to Arm(s): Enriched onion | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 20 µg selenium | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 40 µg selenium | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 60 µg selenium | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 80 µg selenium | Arm Label: 5; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 100 µg selenium | Arm Label: 6; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 120 µg selenium | Arm Label: 7; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: 20 µg selenium; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: 40 µg selenium; Assigned to Arm(s): 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: 60 µg selenium; Assigned to Arm(s): 3 | Intervention Type: DIETARY_SUPPLEMENT; Name: 80 µg selenium; Assigned to Arm(s): 4 | Intervention Type: DIETARY_SUPPLEMENT; Name: 100 µg selenium; Assigned to Arm(s): 5 | Intervention Type: DIETARY_SUPPLEMENT; Name: 120 µg selenium; Assigned to Arm(s): 6 | Intervention Type: DIETARY_SUPPLEMENT; Name: placebo; Assigned to Arm(s): 7",
"D": "Intervention Type: BEHAVIORAL; Name: ascorbic acid, vitamin E, beta carotene, selenium, zinc; Assigned to Arm(s): N/A"
}
|
A
|
[
"NCT00006392",
"NCT00279812",
"NCT00428649",
"NCT00272428"
] | 277 |
train
|
NCT00006398
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Double-Blind Study of Timolol (A Nonselective Beta-Adrenergic Blocker) vs Placebo to Prevent Complications of Hepatic Portal Hypertension in Patients With Cirrhosis
Brief Summary: The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
|
{
"A": "Arm Label: Endoscopic Variceal Ligation; Type: ACTIVE_COMPARATOR; Interventions: Device: multi band ligator for esophageal varices | Arm Label: Propranolol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Propranolol | Intervention Type: DRUG; Name: Propranolol; Assigned to Arm(s): Propranolol | Intervention Type: DEVICE; Name: multi band ligator for esophageal varices; Assigned to Arm(s): Endoscopic Variceal Ligation",
"B": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency portacaval shunt | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency and long-term endoscopic sclerotherapy | Intervention Type: PROCEDURE; Name: Emergency portacaval shunt; Assigned to Arm(s): A | Intervention Type: PROCEDURE; Name: Emergency and long-term endoscopic sclerotherapy; Assigned to Arm(s): B",
"C": "Arm Label: Timolol Maleate; Type: EXPERIMENTAL; Interventions: Drug: Timolol Maleate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Timolol Maleate; Assigned to Arm(s): Timolol Maleate | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency portacaval shunt | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Other: Emergency TIPS | Intervention Type: PROCEDURE; Name: Emergency portacaval shunt; Assigned to Arm(s): A | Intervention Type: OTHER; Name: Emergency TIPS; Assigned to Arm(s): B"
}
|
C
|
[
"NCT01000779",
"NCT00690027",
"NCT00006398",
"NCT00734227"
] | 278 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Patients With Prior Hydroxyurea; Type: N/A; Interventions: N/A | Arm Label: Patients Without Prior Hydroxyurea; Type: N/A; Interventions: N/A",
"C": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Enalapril; Type: ACTIVE_COMPARATOR; Interventions: Drug: Enalapril | Arm Label: N-Acetylcysteine; Type: ACTIVE_COMPARATOR; Interventions: Drug: N-Acetylcysteine | Intervention Type: DRUG; Name: Enalapril; Assigned to Arm(s): Enalapril | Intervention Type: DRUG; Name: N-Acetylcysteine; Assigned to Arm(s): N-Acetylcysteine",
"D": "Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Enalapril | Intervention Type: DRUG; Name: Enalapril; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2"
}
|
A
|
[
"NCT00006400",
"NCT00305175",
"NCT01891292",
"NCT01096121"
] | 279 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Cannabis; Type: EXPERIMENTAL; Interventions: Drug: Cannabis | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Cannabis | Intervention Type: DRUG; Name: Cannabis; Assigned to Arm(s): Cannabis, Placebo",
"C": "Arm Label: Intrevention arm; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gum Arabic | Intervention Type: DIETARY_SUPPLEMENT; Name: Gum Arabic; Assigned to Arm(s): Intrevention arm",
"D": "Arm Label: Broccoli sprout homogenate ingestion; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate | Intervention Type: DIETARY_SUPPLEMENT; Name: Broccosprouts® (Brassica Protection Products LLC) homogenate; Assigned to Arm(s): Broccoli sprout homogenate ingestion"
}
|
A
|
[
"NCT00006400",
"NCT01771731",
"NCT02467257",
"NCT01715480"
] | 280 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm",
"B": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1",
"D": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group"
}
|
B
|
[
"NCT01425307",
"NCT00006400",
"NCT00122980",
"NCT00072761"
] | 281 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"B": "Arm Label: Transfusion Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: transfusion therapy | Arm Label: Observation Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: transfusion therapy; Assigned to Arm(s): Transfusion Group",
"C": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Stem Cell Transplantation; Type: EXPERIMENTAL; Interventions: Procedure: Stem cell transplantation | Arm Label: Transfusion program; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Transfusion program | Intervention Type: PROCEDURE; Name: Stem cell transplantation; Assigned to Arm(s): Stem Cell Transplantation | Intervention Type: PROCEDURE; Name: Transfusion program; Assigned to Arm(s): Transfusion program"
}
|
C
|
[
"NCT00006182",
"NCT00072761",
"NCT00006400",
"NCT01340404"
] | 282 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Blood Transfusion Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Biological: Single blood transfusion | Arm Label: Standard Care Trial Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Arm Label: Standard Care Observational Cohort; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Intervention Type: BIOLOGICAL; Name: Single blood transfusion; Assigned to Arm(s): Blood Transfusion Trial Cohort | Intervention Type: BEHAVIORAL; Name: Standard care; Assigned to Arm(s): Standard Care Observational Cohort, Standard Care Trial Cohort",
"B": "Intervention Type: PROCEDURE; Name: Blood Transfusion; Assigned to Arm(s): N/A",
"C": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1",
"D": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00951808",
"NCT00006182",
"NCT00122980",
"NCT00006400"
] | 283 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Placebo Pills and Placebo Liquid; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo Pills and Placebo Liquid | Arm Label: Hydroxyurea Pills and Placebo Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo Pills and Magnesium Pidolate Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Magnesium Pidolate | Arm Label: Hydroxyurea Pills and Magnesium Pidolate Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Drug: Magnesium Pidolate | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea Pills and Magnesium Pidolate Liquid, Hydroxyurea Pills and Placebo Liquid | Intervention Type: DRUG; Name: Magnesium Pidolate; Assigned to Arm(s): Hydroxyurea Pills and Magnesium Pidolate Liquid, Placebo Pills and Magnesium Pidolate Liquid | Intervention Type: OTHER; Name: Placebo Pills and Placebo Liquid; Assigned to Arm(s): Placebo Pills and Placebo Liquid",
"B": "Arm Label: Hydroxyurea; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm",
"D": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00532883",
"NCT01976416",
"NCT01425307",
"NCT00006400"
] | 284 |
train
|
NCT00006400
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
|
{
"A": "Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Hydroxyurea; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Moderate Dose Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea (Moderate Dose) | Arm Label: Low Dose Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea (Low Dose) | Intervention Type: DRUG; Name: Hydroxyurea (Moderate Dose); Assigned to Arm(s): Moderate Dose Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea (Low Dose); Assigned to Arm(s): Low Dose Hydroxyurea",
"D": "Arm Label: Standard Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Alternative Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Alternative Arm, Standard Arm"
}
|
A
|
[
"NCT00006400",
"NCT01976416",
"NCT02560935",
"NCT03789591"
] | 285 |
train
|
NCT00006401
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Inhaled NO for the Prevention of Chronic Lung Disease
Brief Summary: To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of chronic lung disease (CLD) in premature infants.
|
{
"A": "Intervention Type: PROCEDURE; Name: mechanical ventilation; Assigned to Arm(s): N/A",
"B": "Arm Label: Inhaled Nitric Oxide (iNO); Type: EXPERIMENTAL; Interventions: Drug: iNO | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: iNO; Assigned to Arm(s): Inhaled Nitric Oxide (iNO) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Inhaled Nitric Oxide (iNO); Type: EXPERIMENTAL; Interventions: Drug: Inhaled Nitric Oxide (iNO) | Arm Label: Nitrogen (placebo); Type: PLACEBO_COMPARATOR; Interventions: Drug: Nitrogen (placebo) | Intervention Type: DRUG; Name: Inhaled Nitric Oxide (iNO); Assigned to Arm(s): Inhaled Nitric Oxide (iNO) | Intervention Type: DRUG; Name: Nitrogen (placebo); Assigned to Arm(s): Nitrogen (placebo)",
"D": "Arm Label: Inhaled Nitric Oxide (INO); Type: ACTIVE_COMPARATOR; Interventions: Drug: Nitric oxide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Nitric oxide; Assigned to Arm(s): Inhaled Nitric Oxide (INO) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
B
|
[
"NCT00000548",
"NCT00006401",
"NCT00955487",
"NCT00551642"
] | 286 |
train
|
NCT00006409
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Activity for Adolescent Girls (TAAG)
Brief Summary: To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
|
{
"A": "Arm Label: SCORES; Type: EXPERIMENTAL; Interventions: Behavioral: America SCORES, Bay Area | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: America SCORES, Bay Area; Assigned to Arm(s): SCORES",
"B": "Arm Label: School based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: integrated program of nutrition, activity, behavior, and promotion | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: integrated program of nutrition, activity, behavior, and promotion; Assigned to Arm(s): School based intervention",
"C": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Trial of Activity for Adolescent Girls (TAAG) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Trial of Activity for Adolescent Girls (TAAG); Assigned to Arm(s): School-based intervention",
"D": "Intervention Type: BEHAVIORAL; Name: physical exercise; Assigned to Arm(s): N/A"
}
|
C
|
[
"NCT01156103",
"NCT00458029",
"NCT00006409",
"NCT00176371"
] | 287 |
train
|
NCT00006409
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Activity for Adolescent Girls (TAAG)
Brief Summary: To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physical activity guidance, Behavioral: Health education | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Physical activity guidance; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Health education; Assigned to Arm(s): Intervention",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Short Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short-term educational program | Arm Label: Long Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Long-term educational program | Intervention Type: BEHAVIORAL; Name: Long-term educational program; Assigned to Arm(s): Long Intervention | Intervention Type: BEHAVIORAL; Name: Short-term educational program; Assigned to Arm(s): Short Intervention",
"C": "Arm Label: School based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: integrated program of nutrition, activity, behavior, and promotion | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: integrated program of nutrition, activity, behavior, and promotion; Assigned to Arm(s): School based intervention",
"D": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Trial of Activity for Adolescent Girls (TAAG) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Trial of Activity for Adolescent Girls (TAAG); Assigned to Arm(s): School-based intervention"
}
|
D
|
[
"NCT02074332",
"NCT03504059",
"NCT00458029",
"NCT00006409"
] | 288 |
train
|
NCT00006409
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Activity for Adolescent Girls (TAAG)
Brief Summary: To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
|
{
"A": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: Primary (Environmental) Weight Gain Prevention | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Behavioral: Primary (Environmental) Weight Gain Prevention, Behavioral: Secondary (Behavioral) Weight Gain Prevention | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Behavioral: Control | Intervention Type: BEHAVIORAL; Name: Primary (Environmental) Weight Gain Prevention; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: BEHAVIORAL; Name: Secondary (Behavioral) Weight Gain Prevention; Assigned to Arm(s): Arm 2 | Intervention Type: BEHAVIORAL; Name: Control; Assigned to Arm(s): Arm 3",
"B": "Intervention Type: BEHAVIORAL; Name: In-school Sexual Health Education; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Youth-friendly health services; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Youth condom promotion & distribution; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Community activities related to adolescent sexual health; Assigned to Arm(s): N/A",
"C": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Trial of Activity for Adolescent Girls (TAAG) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Trial of Activity for Adolescent Girls (TAAG); Assigned to Arm(s): School-based intervention",
"D": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: School children and adolescents as health experts | Arm Label: B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: School children and adolescents as health experts; Assigned to Arm(s): A"
}
|
C
|
[
"NCT00289315",
"NCT00248469",
"NCT00006409",
"NCT00988754"
] | 289 |
train
|
NCT00006409
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Activity for Adolescent Girls (TAAG)
Brief Summary: To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
|
{
"A": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Trial of Activity for Adolescent Girls (TAAG) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Trial of Activity for Adolescent Girls (TAAG); Assigned to Arm(s): School-based intervention",
"B": "Intervention Type: BEHAVIORAL; Name: FLOW; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: SelfHelp; Assigned to Arm(s): N/A",
"C": "Intervention Type: BEHAVIORAL; Name: Physical activity and diet; Assigned to Arm(s): N/A",
"D": "Intervention Type: BEHAVIORAL; Name: Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program; Assigned to Arm(s): N/A"
}
|
A
|
[
"NCT00006409",
"NCT00454610",
"NCT00107692",
"NCT00067925"
] | 290 |
train
|
NCT00006409
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Activity for Adolescent Girls (TAAG)
Brief Summary: To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
|
{
"A": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: Primary (Environmental) Weight Gain Prevention | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Behavioral: Primary (Environmental) Weight Gain Prevention, Behavioral: Secondary (Behavioral) Weight Gain Prevention | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Behavioral: Control | Intervention Type: BEHAVIORAL; Name: Primary (Environmental) Weight Gain Prevention; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: BEHAVIORAL; Name: Secondary (Behavioral) Weight Gain Prevention; Assigned to Arm(s): Arm 2 | Intervention Type: BEHAVIORAL; Name: Control; Assigned to Arm(s): Arm 3",
"B": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: School intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: School intervention; Assigned to Arm(s): School-based intervention",
"C": "Arm Label: School-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Trial of Activity for Adolescent Girls (TAAG) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Trial of Activity for Adolescent Girls (TAAG); Assigned to Arm(s): School-based intervention",
"D": "Arm Label: Tailored intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Monitoring and Tailored prescription, Behavioral: General Health Education | Arm Label: Happy 10 exercise group; Type: EXPERIMENTAL; Interventions: Behavioral: Happy 10 program, Behavioral: General Health Education | Arm Label: Nutrition education group; Type: EXPERIMENTAL; Interventions: Behavioral: Specified nutrition education, Behavioral: General Health Education | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Monitoring and Tailored prescription; Assigned to Arm(s): Tailored intervention group | Intervention Type: BEHAVIORAL; Name: Happy 10 program; Assigned to Arm(s): Happy 10 exercise group | Intervention Type: BEHAVIORAL; Name: Specified nutrition education; Assigned to Arm(s): Nutrition education group | Intervention Type: BEHAVIORAL; Name: General Health Education; Assigned to Arm(s): Happy 10 exercise group, Nutrition education group, Tailored intervention group"
}
|
C
|
[
"NCT00289315",
"NCT01602796",
"NCT00006409",
"NCT02228434"
] | 291 |
train
|
NCT00006479
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Intermittent Pringle maneuver | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Intermittent Pringle maneuver; Assigned to Arm(s): 1",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Normovolemic Hemodilution (ANH) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard of care | Intervention Type: PROCEDURE; Name: Normovolemic Hemodilution (ANH); Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Standard of care; Assigned to Arm(s): 2",
"C": "Intervention Type: DRUG; Name: FOLFOX regimen; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: fluorouracil; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: oxaliplatin; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: neoadjuvant therapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Pringle manoeuvre 15 minutes; Type: EXPERIMENTAL; Interventions: Procedure: Pringle manoeuvre 15 minutes | Arm Label: Pringle manoeuvre 30 minutes; Type: EXPERIMENTAL; Interventions: Procedure: Pringle manoeuvre 30 minutes | Intervention Type: PROCEDURE; Name: Pringle manoeuvre 15 minutes; Assigned to Arm(s): Pringle manoeuvre 15 minutes | Intervention Type: PROCEDURE; Name: Pringle manoeuvre 30 minutes; Assigned to Arm(s): Pringle manoeuvre 30 minutes"
}
|
C
|
[
"NCT00730743",
"NCT00200148",
"NCT00006479",
"NCT01099475"
] | 292 |
train
|
NCT00006489
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder
Brief Summary: This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.
|
{
"A": "Arm Label: Seeking Safety; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Modified Seeking Safety integrated into std outpatient SUD care | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard outpatient SUD care | Intervention Type: BEHAVIORAL; Name: Modified Seeking Safety integrated into std outpatient SUD care; Assigned to Arm(s): Seeking Safety | Intervention Type: BEHAVIORAL; Name: Standard outpatient SUD care; Assigned to Arm(s): Usual Care",
"B": "Arm Label: Naltrexone alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naltrexone | Arm Label: Naltrexone with CBT for PTSD; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive-Behavioral Therapy, Drug: Naltrexone | Arm Label: Placebo with CBT for PTSD; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive-Behavioral Therapy | Arm Label: Placebo alone; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BEHAVIORAL; Name: Cognitive-Behavioral Therapy; Assigned to Arm(s): Naltrexone with CBT for PTSD, Placebo with CBT for PTSD | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): Naltrexone alone, Naltrexone with CBT for PTSD | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo alone",
"C": "Arm Label: Cognitive Behavioral Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy | Arm Label: Individual Addiction Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Individual Addiction Counseling | Arm Label: Treatment-as-usual; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment-as-usual | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy; Assigned to Arm(s): Cognitive Behavioral Therapy | Intervention Type: BEHAVIORAL; Name: Individual Addiction Counseling; Assigned to Arm(s): Individual Addiction Counseling | Intervention Type: BEHAVIORAL; Name: Treatment-as-usual; Assigned to Arm(s): Treatment-as-usual",
"D": "Arm Label: 1) CDM; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Chronic Disease Management for substance abuse | Arm Label: 2) Standard care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care | Intervention Type: BEHAVIORAL; Name: Chronic Disease Management for substance abuse; Assigned to Arm(s): 1) CDM | Intervention Type: BEHAVIORAL; Name: Standard care; Assigned to Arm(s): 2) Standard care"
}
|
B
|
[
"NCT00265564",
"NCT00006489",
"NCT01457391",
"NCT00278447"
] | 293 |
train
|
NCT00006734
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor.
PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.
|
{
"A": "Arm Label: Regimen A; Type: EXPERIMENTAL; Interventions: Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: ifosfamide, Drug: vincristine sulfate, Procedure: adjuvant therapy, Procedure: conventional surgery, Procedure: neoadjuvant therapy, Radiation: brachytherapy, Radiation: radiation therapy | Arm Label: Regimen B; Type: EXPERIMENTAL; Interventions: Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: ifosfamide, Drug: vincristine sulfate, Procedure: adjuvant therapy, Procedure: conventional surgery, Procedure: neoadjuvant therapy, Radiation: brachytherapy, Radiation: radiation therapy | Intervention Type: BIOLOGICAL; Name: filgrastim; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: DRUG; Name: doxorubicin hydrochloride; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: DRUG; Name: etoposide; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: DRUG; Name: ifosfamide; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: PROCEDURE; Name: adjuvant therapy; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: PROCEDURE; Name: neoadjuvant therapy; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: RADIATION; Name: brachytherapy; Assigned to Arm(s): Regimen A, Regimen B | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): Regimen A, Regimen B",
"B": "Intervention Type: BIOLOGICAL; Name: pegfilgrastim; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: doxorubicin hydrochloride; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: ifosfamide; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: multimodality therapy; Assigned to Arm(s): N/A",
"C": "Arm Label: single arm with Tremelimumab; Type: EXPERIMENTAL; Interventions: Drug: Tremelimumab | Intervention Type: DRUG; Name: Tremelimumab; Assigned to Arm(s): single arm with Tremelimumab",
"D": "Arm Label: sorafenib and everolimus; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib, Drug: Everolimus | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): sorafenib and everolimus | Intervention Type: DRUG; Name: Everolimus; Assigned to Arm(s): sorafenib and everolimus"
}
|
A
|
[
"NCT00006734",
"NCT00061984",
"NCT01655888",
"NCT01804374"
] | 294 |
train
|
NCT00007189
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
Brief Summary: The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
|
{
"A": "Arm Label: Evidence-based treatment, lifestyle counseling; Type: EXPERIMENTAL; Interventions: Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment | Intervention Type: OTHER; Name: Systematic detection of vascular risk factors and subsequent evidence-based treatment; Assigned to Arm(s): Evidence-based treatment, lifestyle counseling",
"B": "Arm Label: Intensive Control of SBP; Type: EXPERIMENTAL; Interventions: Drug: Intensive control of SBP | Arm Label: Standard Control of SBP; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of SBP | Intervention Type: DRUG; Name: Intensive control of SBP; Assigned to Arm(s): Intensive Control of SBP | Intervention Type: DRUG; Name: Standard control of SBP; Assigned to Arm(s): Standard Control of SBP",
"C": "Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A",
"D": "Intervention Type: DRUG; Name: Naproxen Sodium (Aleve); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Celecoxib (Celebrex); Assigned to Arm(s): N/A"
}
|
D
|
[
"NCT01107548",
"NCT01206062",
"NCT00000611",
"NCT00007189"
] | 295 |
train
|
NCT00007189
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
Brief Summary: The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
|
{
"A": "Intervention Type: DRUG; Name: Naproxen Sodium (Aleve); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Celecoxib (Celebrex); Assigned to Arm(s): N/A",
"B": "Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): N/A",
"C": "Intervention Type: DRUG; Name: Celecoxib (Celebrex); Assigned to Arm(s): N/A",
"D": "Arm Label: Selenium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Selenium | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Selenium | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Placebo, Selenium"
}
|
A
|
[
"NCT00007189",
"NCT00090974",
"NCT00050479",
"NCT00078897"
] | 296 |
train
|
NCT00007501
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications
Brief Summary: The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.
This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.
|
{
"A": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Biological: Varicella-zoster vaccine | Arm Label: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Varicella-zoster vaccine; Assigned to Arm(s): Arm 1 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Arm 2",
"B": "Arm Label: A - Live zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Zostavax, Biological: Placebo | Arm Label: B - recombinant zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HZ/su vaccine | Arm Label: C - Live zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Zostavax, Biological: Placebo | Arm Label: D - recombinant zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HZ/su vaccine | Intervention Type: BIOLOGICAL; Name: Zostavax; Assigned to Arm(s): A - Live zoster vaccine, C - Live zoster vaccine | Intervention Type: BIOLOGICAL; Name: HZ/su vaccine; Assigned to Arm(s): B - recombinant zoster vaccine, D - recombinant zoster vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): A - Live zoster vaccine, C - Live zoster vaccine",
"C": "Arm Label: Zoster vaccine group; Type: EXPERIMENTAL; Interventions: Biological: Herpes Zoster Vaccine GSK1437173A | Arm Label: Placebo group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Herpes Zoster Vaccine GSK1437173A; Assigned to Arm(s): Zoster vaccine group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo group",
"D": "Arm Label: HZ/su Lot A; Type: EXPERIMENTAL; Interventions: Biological: Herpes Zoster vaccine (GSK 1437173A) | Arm Label: HZ/su Lot B; Type: EXPERIMENTAL; Interventions: Biological: Herpes Zoster vaccine (GSK 1437173A) | Arm Label: HZ/su Lot C; Type: EXPERIMENTAL; Interventions: Biological: Herpes Zoster vaccine (GSK 1437173A) | Intervention Type: BIOLOGICAL; Name: Herpes Zoster vaccine (GSK 1437173A); Assigned to Arm(s): HZ/su Lot A, HZ/su Lot B, HZ/su Lot C"
}
|
A
|
[
"NCT00007501",
"NCT02114333",
"NCT01165229",
"NCT02075515"
] | 297 |
train
|
NCT00007501
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications
Brief Summary: The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.
This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.
|
{
"A": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Biological: Varicella-zoster vaccine | Arm Label: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Varicella-zoster vaccine; Assigned to Arm(s): Arm 1 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Arm 2",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Biological: 7vPnC | Intervention Type: BIOLOGICAL; Name: 13-valent Pneumococcal Conjugate Vaccine; Assigned to Arm(s): 1, 2, 3 | Intervention Type: BIOLOGICAL; Name: 7vPnC; Assigned to Arm(s): 4",
"C": "Intervention Type: BIOLOGICAL; Name: M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®; Assigned to Arm(s): N/A",
"D": "Intervention Type: BIOLOGICAL; Name: Measles, Mumps, Rubella and Chickenpox (live vaccine); Assigned to Arm(s): N/A"
}
|
A
|
[
"NCT00007501",
"NCT00444457",
"NCT00432523",
"NCT00127023"
] | 298 |
train
|
NCT00007501
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications
Brief Summary: The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.
This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.
|
{
"A": "Arm Label: A - Live zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Zostavax, Biological: Placebo | Arm Label: B - recombinant zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HZ/su vaccine | Arm Label: C - Live zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: Zostavax, Biological: Placebo | Arm Label: D - recombinant zoster vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HZ/su vaccine | Intervention Type: BIOLOGICAL; Name: Zostavax; Assigned to Arm(s): A - Live zoster vaccine, C - Live zoster vaccine | Intervention Type: BIOLOGICAL; Name: HZ/su vaccine; Assigned to Arm(s): B - recombinant zoster vaccine, D - recombinant zoster vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): A - Live zoster vaccine, C - Live zoster vaccine",
"B": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Biological: Varicella-zoster vaccine | Arm Label: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Varicella-zoster vaccine; Assigned to Arm(s): Arm 1 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Arm 2",
"C": "Arm Label: SC HZ/su Group; Type: EXPERIMENTAL; Interventions: Biological: Herpes zoster vaccine GSK1437173A | Arm Label: IM HZ/su Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Herpes zoster vaccine GSK1437173A | Intervention Type: BIOLOGICAL; Name: Herpes zoster vaccine GSK1437173A; Assigned to Arm(s): IM HZ/su Group, SC HZ/su Group",
"D": "Arm Label: Full Dose Subcutaneous; Type: ACTIVE_COMPARATOR; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, Biological: Intradermal Placebo | Arm Label: 1/3 Dose Subcutaneous; Type: EXPERIMENTAL; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous, Biological: Intradermal Placebo | Arm Label: Full Dose Intradermal; Type: EXPERIMENTAL; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal, Biological: Full Dose Intradermal Placebo | Arm Label: 1/3 Dose Intradermal; Type: EXPERIMENTAL; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal Placebo | Arm Label: 1/10 Dose Intradermal; Type: EXPERIMENTAL; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal Placebo | Arm Label: 1/27 Dose Intradermal; Type: EXPERIMENTAL; Interventions: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal, Biological: Intradermal Placebo | Intervention Type: BIOLOGICAL; Name: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous; Assigned to Arm(s): Full Dose Subcutaneous | Intervention Type: BIOLOGICAL; Name: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous; Assigned to Arm(s): 1/3 Dose Subcutaneous | Intervention Type: BIOLOGICAL; Name: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal; Assigned to Arm(s): Full Dose Intradermal | Intervention Type: BIOLOGICAL; Name: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Assigned to Arm(s): 1/10 Dose Intradermal, 1/27 Dose Intradermal, 1/3 Dose Intradermal | Intervention Type: BIOLOGICAL; Name: Full Dose Intradermal Placebo; Assigned to Arm(s): Full Dose Intradermal | Intervention Type: BIOLOGICAL; Name: Intradermal Placebo; Assigned to Arm(s): 1/10 Dose Intradermal, 1/27 Dose Intradermal, 1/3 Dose Intradermal, 1/3 Dose Subcutaneous, Full Dose Subcutaneous"
}
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B
|
[
"NCT02114333",
"NCT00007501",
"NCT01777321",
"NCT01385566"
] | 299 |
train
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