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NCT04027517
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group, Phase III Study to Compare the Efficacy and Safety of JTZ-951 With Darbepoetin Alfa in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis. Brief Summary: JTZ-951 is a currently being developed as a treatment for renal anemia. This study aims to evaluate the efficacy and safety of JTZ-951 following a switch from erythropoiesis-stimulating agent (ESA) in Korean subjects receiving HemoDialysis with renal anemia. This study is a Phase III, open, active-controlled, parallel-group, multi-center study. The total duration of the study will be 30 weeks including screening, treatment and follow-up.
{ "A": "Arm Label: JTZ-951; Type: EXPERIMENTAL; Interventions: Drug: JTZ-951 | Arm Label: Darbepoetin Alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin Alfa | Intervention Type: DRUG; Name: JTZ-951; Assigned to Arm(s): JTZ-951 | Intervention Type: DRUG; Name: Darbepoetin Alfa; Assigned to Arm(s): Darbepoetin Alfa", "B": "Arm Label: Vadadustat; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa", "C": "Arm Label: Daprodustat; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: Placebo, Drug: Iron Therapy | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa, Drug: Placebo, Drug: Iron Therapy | Intervention Type: DRUG; Name: Daprodustat; Assigned to Arm(s): Daprodustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Daprodustat, Darbepoetin alfa | Intervention Type: DRUG; Name: Iron Therapy; Assigned to Arm(s): Daprodustat, Darbepoetin alfa", "D": "Arm Label: GSK1278863 4 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 6 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 8 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 10 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 12 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 10 mg, GSK1278863 12 mg, GSK1278863 4 mg, GSK1278863 6 mg, GSK1278863 8 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control" }
A
[ "NCT04027517", "NCT02892149", "NCT02876835", "NCT01977482" ]
27,300
val
NCT04028323
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903): A Multicenter, Single-blind, Randomised Controlled Trial Brief Summary: Acute variceal bleeding is one of the critical complications in patients with cirrhosis. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality that is still around 20% at 6 weeks. Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/hepatorenal syndrome (HRS), which have been further implicated in the increasing mortality in patients with cirrhosis. Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis. The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding.
{ "A": "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", "B": "Arm Label: Experimental group; Type: EXPERIMENTAL; Interventions: Drug: Terlipressin | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Octreotide | Intervention Type: DRUG; Name: Terlipressin; Assigned to Arm(s): Experimental group | Intervention Type: DRUG; Name: Octreotide; Assigned to Arm(s): Control group", "C": "Arm Label: Hemospray; Type: EXPERIMENTAL; Interventions: Device: Hemospray, Drug: Octreotide, Biological: Blood transfusion, Drug: Ceftriaxone | Arm Label: Non Hemospray; Type: ACTIVE_COMPARATOR; Interventions: Drug: Octreotide, Biological: Blood transfusion, Drug: Ceftriaxone | Intervention Type: DEVICE; Name: Hemospray; Assigned to Arm(s): Hemospray | Intervention Type: DRUG; Name: Octreotide; Assigned to Arm(s): Hemospray, Non Hemospray | Intervention Type: BIOLOGICAL; Name: Blood transfusion; Assigned to Arm(s): Hemospray, Non Hemospray | Intervention Type: DRUG; Name: Ceftriaxone; Assigned to Arm(s): Hemospray, Non Hemospray", "D": "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" }
B
[ "NCT00734227", "NCT04028323", "NCT03061604", "NCT00006161" ]
27,301
val
NCT04030234
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study Brief Summary: This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target \<120 mmHg versus \<140 mmHg.
{ "A": "Arm Label: Glycemia Trial: intensive control; Type: EXPERIMENTAL; Interventions: Drug: Anti-hyperglycemic Agents | Arm Label: Glycemia Trial: standard control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Anti-hyperglycemic Agents | Arm Label: BP Trial: intensive control; Type: EXPERIMENTAL; Interventions: Drug: Anti-hypertensive Agents | Arm Label: BP Trial: standard control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Anti-hypertensive Agents | Arm Label: Lipid Trial: fenofibrate; Type: EXPERIMENTAL; Interventions: Drug: Blinded fenofibrate or placebo plus simvastatin | Arm Label: Lipid Trial: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Blinded fenofibrate or placebo plus simvastatin | Intervention Type: DRUG; Name: Anti-hyperglycemic Agents; Assigned to Arm(s): Glycemia Trial: intensive control, Glycemia Trial: standard control | Intervention Type: DRUG; Name: Anti-hypertensive Agents; Assigned to Arm(s): BP Trial: intensive control, BP Trial: standard control | Intervention Type: DRUG; Name: Blinded fenofibrate or placebo plus simvastatin; Assigned to Arm(s): Lipid Trial: fenofibrate, Lipid Trial: placebo", "B": "Arm Label: Intensive treatment group; Type: EXPERIMENTAL; Interventions: Drug: Intensive BP treatment group | Arm Label: Standard treatment group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard BP treatment group | Intervention Type: DRUG; Name: Intensive BP treatment group; Assigned to Arm(s): Intensive treatment group | Intervention Type: DRUG; Name: Standard BP treatment group; Assigned to Arm(s): Standard treatment group", "C": "Arm Label: Blood pressure; Type: EXPERIMENTAL; Interventions: Drug: Losartan, Losartan and HCTZ, Amlodipine , Spironolactone | Intervention Type: DRUG; Name: Losartan, Losartan and HCTZ, Amlodipine , Spironolactone; Assigned to Arm(s): Blood pressure", "D": "Arm Label: SBP < 145-135 mmHg and LDL-C 2.8 - 1.8 mmol/l; Type: OTHER; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Arm Label: SBP < 135-125 mmHg and LDL-C 2.8 - 1.8 mmol/l; Type: ACTIVE_COMPARATOR; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Arm Label: SBP < 125 mmHg and LDL-C 2.8 - 1.8 mmol/l; Type: ACTIVE_COMPARATOR; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Arm Label: SBP < 145-135 mmHg and LDL-C < 1.8 mmol/l; Type: ACTIVE_COMPARATOR; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Arm Label: SBP < 135-125 mmHg and LDL-C < 1.8 mmol/l; Type: ACTIVE_COMPARATOR; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Arm Label: SBP < 125 mmHg and LDL-C < 1.8 mmol/l; Type: ACTIVE_COMPARATOR; Interventions: Drug: all approved antihypertensive drugs; all approved statins | Intervention Type: DRUG; Name: all approved antihypertensive drugs; all approved statins; Assigned to Arm(s): SBP < 125 mmHg and LDL-C 2.8 - 1.8 mmol/l, SBP < 125 mmHg and LDL-C < 1.8 mmol/l, SBP < 135-125 mmHg and LDL-C 2.8 - 1.8 mmol/l, SBP < 135-125 mmHg and LDL-C < 1.8 mmol/l, SBP < 145-135 mmHg and LDL-C 2.8 - 1.8 mmol/l, SBP < 145-135 mmHg and LDL-C < 1.8 mmol/l" }
B
[ "NCT00000620", "NCT04030234", "NCT01198496", "NCT01563731" ]
27,302
val
NCT04030234
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study Brief Summary: This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target \<120 mmHg versus \<140 mmHg.
{ "A": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure", "B": "Arm Label: Intensive; Type: EXPERIMENTAL; Interventions: Other: Anti-hypertensive therapy to SBP 130 mm Hg | Arm Label: Standard; Type: ACTIVE_COMPARATOR; Interventions: Other: Anti-hypertensive therapy to SBP 145 mm Hg | Intervention Type: OTHER; Name: Anti-hypertensive therapy to SBP 130 mm Hg; Assigned to Arm(s): Intensive | Intervention Type: OTHER; Name: Anti-hypertensive therapy to SBP 145 mm Hg; Assigned to Arm(s): Standard", "C": "Arm Label: Intensive treatment group; Type: EXPERIMENTAL; Interventions: Drug: Intensive BP treatment group | Arm Label: Standard treatment group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard BP treatment group | Intervention Type: DRUG; Name: Intensive BP treatment group; Assigned to Arm(s): Intensive treatment group | Intervention Type: DRUG; Name: Standard BP treatment group; Assigned to Arm(s): Standard treatment group", "D": "Arm Label: Intensive BP control; Type: EXPERIMENTAL; Interventions: Drug: Intensive BP control | Arm Label: Standard BP control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard BP control | Intervention Type: DRUG; Name: Intensive BP control; Assigned to Arm(s): Intensive BP control | Intervention Type: DRUG; Name: Standard BP control; Assigned to Arm(s): Standard BP control" }
C
[ "NCT04036409", "NCT01650402", "NCT04030234", "NCT03015311" ]
27,303
val
NCT04031430
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders Brief Summary: The goal of this project is thoroughly evaluate the added value of telemonitoring (TM) program for women at risk for gestational hypertensive disorders (GHD), by investigating it impact on prenatal follow-up, health outcomes for mother and child, costs and satisfaction, and by specifically investigating what are the major contributors to this added value. A substudy (CAPROM) will be conducted at the Department of Obstetrics \& Gynecology at Ziekenhuis Oost-Limburg (ZOL) in collaboration with the Department of Physiology of Hasselt University in the framework of the Limburg Clinical Research Center (LCRC). CAPROM aims at evaluating the relationship between longitudinal (clinical) blood pressure measurements and changes in (subclinical) cardiovascular (CV) hemodynamics throughout pregnancy, as well as their responses to antihypertensive medication. To this end, CV profiling will be performed longitudinally on pregnant women at risk for developing GHD being included in the TM group of the PREMOM II study (group 1) or being followed-up via TM as part of their usual care (group 2). A separate ICF is signed for inclusion in the CAPROM substudy. The results of the CAPROM study will be performed by a researcher who is not involved in the PREMOM II main study. In addition, results of the CV profiling will not be communicated to the clinical decision makers of PREMOM II.
{ "A": "Arm Label: Arm A: Conical then Cylindrical; Type: EXPERIMENTAL; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Arm Label: Arm B: Cylindrical then Conical; Type: ACTIVE_COMPARATOR; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Intervention Type: DEVICE; Name: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: DEVICE; Name: Non-invasive BP recording with traditional cylindrical BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: OTHER; Name: Direct invasive arterial pressure; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical", "B": "Arm Label: Intervention Arm; Type: EXPERIMENTAL; Interventions: Other: Community-based Pre-eclampsia/Eclampsia Detection and Management, Other: Strengthened Referral Network from Community to Referral hospital levels | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Community-based Pre-eclampsia/Eclampsia Detection and Management; Assigned to Arm(s): Intervention Arm | Intervention Type: OTHER; Name: Strengthened Referral Network from Community to Referral hospital levels; Assigned to Arm(s): Intervention Arm", "C": "Arm Label: Mercury; Type: NO_INTERVENTION; Interventions: Device: Automated blood pressure recording device Omron HEM 705CP | Intervention Type: DEVICE; Name: Automated blood pressure recording device Omron HEM 705CP; Assigned to Arm(s): Mercury", "D": "Arm Label: telemonitoring group (TM); Type: EXPERIMENTAL; Interventions: Device: Telemonitoring | Arm Label: Patient self-monitoring group (PSM); Type: ACTIVE_COMPARATOR; Interventions: Device: Telemonitoring | Arm Label: control group (CC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CAPROM - Group 1; Type: EXPERIMENTAL; Interventions: Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication | Arm Label: CAPROM - Group 2; Type: EXPERIMENTAL; Interventions: Other: CV profiling before and after the start/switch of antihypertensive medication | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Patient self-monitoring group (PSM), telemonitoring group (TM) | Intervention Type: OTHER; Name: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 1 | Intervention Type: OTHER; Name: CV profiling before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 2" }
D
[ "NCT03222414", "NCT03978429", "NCT00809666", "NCT04031430" ]
27,304
val
NCT04035395
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley Brief Summary: The purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with nonparticipants receiving the usual care until after the study period, at which time they will be offered access to expansion services.
{ "A": "Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Continued care; Type: EXPERIMENTAL; Interventions: Other: team-based care | Intervention Type: OTHER; Name: team-based care; Assigned to Arm(s): Continued care", "B": "Arm Label: Comprehensive Intervention Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Lifestyle Changes, Drug: Antiplatelet Agents, Drug: Beta Blocker, Drug: ACE Inhibitors | Arm Label: Less Intensive Intervention Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Lifestyle Changes | Intervention Type: BEHAVIORAL; Name: Lifestyle Changes; Assigned to Arm(s): Comprehensive Intervention Group, Less Intensive Intervention Group | Intervention Type: DRUG; Name: Antiplatelet Agents; Assigned to Arm(s): Comprehensive Intervention Group | Intervention Type: DRUG; Name: Beta Blocker; Assigned to Arm(s): Comprehensive Intervention Group | Intervention Type: DRUG; Name: ACE Inhibitors; Assigned to Arm(s): Comprehensive Intervention Group", "C": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Peer-led Support Group, Other: Behavioral Health Consult, Other: Medication Therapy Management Consult, Other: La Cocina Alegre/ The Happy Kitchen, Other: Mind, Exercise, Nutrition, Do it! | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Peer-led Support Group; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Behavioral Health Consult; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Medication Therapy Management Consult; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: La Cocina Alegre/ The Happy Kitchen; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Mind, Exercise, Nutrition, Do it!; Assigned to Arm(s): Intervention", "D": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: mobile application for diabetes | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: mobile application for diabetes; Assigned to Arm(s): Intervention" }
C
[ "NCT02065050", "NCT00241904", "NCT04035395", "NCT03468283" ]
27,305
val
NCT04035590
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Seroma Reduction and Drain Free Mastectomy Brief Summary: To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
{ "A": "Arm Label: Vacuum assisted closure; Type: EXPERIMENTAL; Interventions: Procedure: vacuum assisted closure | Arm Label: Axillary dissection; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Axillary dissection | Intervention Type: PROCEDURE; Name: vacuum assisted closure; Assigned to Arm(s): Vacuum assisted closure | Intervention Type: PROCEDURE; Name: Axillary dissection; Assigned to Arm(s): Axillary dissection", "B": "Arm Label: With drain; Type: ACTIVE_COMPARATOR; Interventions: Procedure: With drain | Arm Label: No drain; Type: EXPERIMENTAL; Interventions: Procedure: No drain | Intervention Type: PROCEDURE; Name: No drain; Assigned to Arm(s): No drain | Intervention Type: PROCEDURE; Name: With drain; Assigned to Arm(s): With drain", "C": "Arm Label: Simple dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing, Device: PREVENA Negative pressure wound versus standard dressing | Arm Label: PICO Dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: PREVENA Negative pressure wound versus standard dressing | Arm Label: PREVENA Dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing | Intervention Type: DEVICE; Name: Smith & Nephew PICO Negative wound pressure versus standard dresing; Assigned to Arm(s): PREVENA Dressing, Simple dressing | Intervention Type: DEVICE; Name: PREVENA Negative pressure wound versus standard dressing; Assigned to Arm(s): PICO Dressing, Simple dressing", "D": "Arm Label: Prophylactic NPWT; Type: EXPERIMENTAL; Interventions: Device: Prophylactic NPWT | Arm Label: Standard Dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard Dressing | Intervention Type: DEVICE; Name: Prophylactic NPWT; Assigned to Arm(s): Prophylactic NPWT | Intervention Type: DEVICE; Name: Standard Dressing; Assigned to Arm(s): Standard Dressing" }
B
[ "NCT02010996", "NCT04035590", "NCT03871023", "NCT03009110" ]
27,306
val
NCT04036175
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study Brief Summary: This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.
{ "A": "Arm Label: High flows; Type: OTHER; Interventions: Device: Use of high flows versus oxygen therapy, Device: oxygen therapy | Arm Label: oxygen therapy; Type: OTHER; Interventions: Device: oxygen therapy | Intervention Type: DEVICE; Name: Use of high flows versus oxygen therapy; Assigned to Arm(s): High flows | Intervention Type: DEVICE; Name: oxygen therapy; Assigned to Arm(s): High flows, oxygen therapy", "B": "Arm Label: high flow nasal cannula (HFNC); Type: ACTIVE_COMPARATOR; Interventions: Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices | Arm Label: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV); Type: ACTIVE_COMPARATOR; Interventions: Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices | Intervention Type: DEVICE; Name: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices; Assigned to Arm(s): high flow nasal cannula (HFNC), nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)", "C": "Intervention Type: DEVICE; Name: High Flow Nasal Cannula; Assigned to Arm(s): N/A", "D": "Arm Label: Group 1; Type: OTHER; Interventions: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen | Arm Label: Group 2; Type: OTHER; Interventions: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen | Intervention Type: DEVICE; Name: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen; Assigned to Arm(s): Group 1, Group 2" }
D
[ "NCT01633801", "NCT04650230", "NCT00356668", "NCT04036175" ]
27,307
val
NCT04036409
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients Brief Summary: Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.
{ "A": "Arm Label: Aggressive Blood Pressure control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aggressive Blood Pressure control | Arm Label: Standard Blood Pressure control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Aggressive Blood Pressure control; Assigned to Arm(s): Aggressive Blood Pressure control", "B": "Arm Label: Intensive treatment group; Type: EXPERIMENTAL; Interventions: Other: Blood pressure lowering strategy | Arm Label: Standard treatment group; Type: ACTIVE_COMPARATOR; Interventions: Other: Blood pressure lowering strategy | Intervention Type: OTHER; Name: Blood pressure lowering strategy; Assigned to Arm(s): Intensive treatment group, Standard treatment group", "C": "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", "D": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure" }
D
[ "NCT00438113", "NCT03585595", "NCT00059306", "NCT04036409" ]
27,308
val
NCT04036409
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients Brief Summary: Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.
{ "A": "Arm Label: intensive blood pressure control; Type: ACTIVE_COMPARATOR; Interventions: Drug: control systolic blood pressure less than 120 mmHg | Arm Label: standard blood pressure control; Type: ACTIVE_COMPARATOR; Interventions: Drug: control systolic blood pressure less than 140 mmHg | Intervention Type: DRUG; Name: control systolic blood pressure less than 120 mmHg; Assigned to Arm(s): intensive blood pressure control | Intervention Type: DRUG; Name: control systolic blood pressure less than 140 mmHg; Assigned to Arm(s): standard blood pressure control", "B": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure", "C": "Arm Label: Intensive treatment group; Type: EXPERIMENTAL; Interventions: Drug: Intensive BP treatment group | Arm Label: Standard treatment group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard BP treatment group | Intervention Type: DRUG; Name: Intensive BP treatment group; Assigned to Arm(s): Intensive treatment group | Intervention Type: DRUG; Name: Standard BP treatment group; Assigned to Arm(s): Standard treatment group", "D": "Arm Label: Aggressive BP lowering; Type: EXPERIMENTAL; Interventions: Procedure: Aggressive BP lowering | Arm Label: Modest BP lowering; Type: ACTIVE_COMPARATOR; Interventions: Procedure: modest blood pressure lowering | Intervention Type: PROCEDURE; Name: Aggressive BP lowering; Assigned to Arm(s): Aggressive BP lowering | Intervention Type: PROCEDURE; Name: modest blood pressure lowering; Assigned to Arm(s): Modest BP lowering" }
B
[ "NCT01230216", "NCT04036409", "NCT04030234", "NCT01104311" ]
27,309
val
NCT04037202
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial Brief Summary: Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.
{ "A": "Arm Label: Study Group; Type: EXPERIMENTAL; Interventions: Other: Foot massage | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Foot massage; Assigned to Arm(s): Study Group", "B": "Arm Label: Binder Arm; Type: EXPERIMENTAL; Interventions: Device: Abdominal binder | Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Abdominal binder; Assigned to Arm(s): Binder Arm", "C": "Arm Label: Lifestyle Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Balance after Baby Lifestyle Intervention Program | Arm Label: Post-gestational diabetes mellitus (GDM) Follow-up Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Balance after Baby Lifestyle Intervention Program; Assigned to Arm(s): Lifestyle Intervention group", "D": "Arm Label: Morphine; Type: EXPERIMENTAL; Interventions: Drug: Preservative Free Morphine | Arm Label: Saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Saline | Intervention Type: DRUG; Name: Preservative Free Morphine; Assigned to Arm(s): Morphine | Intervention Type: DRUG; Name: Saline; Assigned to Arm(s): Saline" }
A
[ "NCT04037202", "NCT03903172", "NCT01158131", "NCT04017442" ]
27,310
val
NCT04039633
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
{ "A": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)", "B": "Arm Label: Spinal Cord Stimulation (SCS); Type: ACTIVE_COMPARATOR; Interventions: Device: Spinal Cord Stimulation | Arm Label: Conventional Medical Management (CMM); Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional Medical Management | Intervention Type: DEVICE; Name: Spinal Cord Stimulation; Assigned to Arm(s): Spinal Cord Stimulation (SCS) | Intervention Type: OTHER; Name: Conventional Medical Management; Assigned to Arm(s): Conventional Medical Management (CMM)", "C": "Arm Label: Burst SCS; Type: ACTIVE_COMPARATOR; Interventions: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) | Intervention Type: DEVICE; Name: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10); Assigned to Arm(s): Burst SCS, Sham", "D": "Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): N/A" }
A
[ "NCT04039633", "NCT04479787", "NCT03733886", "NCT00159679" ]
27,311
val
NCT04039633
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
{ "A": "Arm Label: Burst SCS; Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation, Device: SCS implant | Arm Label: Sham SCS; Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation, Device: SCS implant | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst SCS, Sham SCS | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst SCS, Sham SCS | Intervention Type: DEVICE; Name: SCS implant; Assigned to Arm(s): Burst SCS, Sham SCS", "B": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)", "C": "Arm Label: Sequence 1; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Arm Label: Sequence 2; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Intervention Type: DEVICE; Name: High frequency spinal cord stimulation; Assigned to Arm(s): Sequence 1, Sequence 2", "D": "Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Device: PINS Spinal Cord Stimulator | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: PINS Spinal Cord Stimulator | Intervention Type: DEVICE; Name: PINS Spinal Cord Stimulator; Assigned to Arm(s): Control, Experimental" }
B
[ "NCT03546738", "NCT04039633", "NCT01400282", "NCT03858790" ]
27,312
val
NCT04039633
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
{ "A": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)", "B": "Arm Label: Group A - active treatment; Type: EXPERIMENTAL; Interventions: Device: Spinal cord stimulation by implanted device. | Arm Label: Group B - conservative management; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Spinal cord stimulation by implanted device.; Assigned to Arm(s): Group A - active treatment", "C": "Arm Label: HF10 therapy plus CMM; Type: ACTIVE_COMPARATOR; Interventions: Device: Senza HF10 Therapy | Arm Label: CMM Alone; Type: OTHER; Interventions: Other: CMM | Intervention Type: DEVICE; Name: Senza HF10 Therapy; Assigned to Arm(s): HF10 therapy plus CMM | Intervention Type: OTHER; Name: CMM; Assigned to Arm(s): CMM Alone", "D": "Arm Label: Spinal Cord Stimulation; Type: EXPERIMENTAL; Interventions: Device: WaveWriter | Arm Label: Conventional Medical Management; Type: OTHER; Interventions: Other: Conventional Medical Managament | Intervention Type: DEVICE; Name: WaveWriter; Assigned to Arm(s): Spinal Cord Stimulation | Intervention Type: OTHER; Name: Conventional Medical Managament; Assigned to Arm(s): Conventional Medical Management" }
A
[ "NCT04039633", "NCT03595241", "NCT03228420", "NCT04676022" ]
27,313
val
NCT04040192
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment Brief Summary: This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
{ "A": "Arm Label: Dicillin & Elocon; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dicloxacillin Oral Capsule, Drug: Elocon 0.1 % Topical Cream | Arm Label: Placebo & Elocon; Type: PLACEBO_COMPARATOR; Interventions: Drug: Elocon 0.1 % Topical Cream | Intervention Type: DRUG; Name: Dicloxacillin Oral Capsule; Assigned to Arm(s): Dicillin & Elocon | Intervention Type: DRUG; Name: Elocon 0.1 % Topical Cream; Assigned to Arm(s): Dicillin & Elocon, Placebo & Elocon", "B": "Arm Label: Crisaborole 2%; Type: EXPERIMENTAL; Interventions: Drug: Crisaborole 2% | Arm Label: Vehicle; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle | Intervention Type: DRUG; Name: Crisaborole 2%; Assigned to Arm(s): Crisaborole 2% | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): Vehicle", "C": "Arm Label: Crisaborole ointment; Type: EXPERIMENTAL; Interventions: Drug: Crisaborole ointment 2% BID | Arm Label: Placebo ointment (vehicle); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo ointment (vehicle) | Intervention Type: DRUG; Name: Crisaborole ointment 2% BID; Assigned to Arm(s): Crisaborole ointment | Intervention Type: DRUG; Name: Placebo ointment (vehicle); Assigned to Arm(s): Placebo ointment (vehicle)", "D": "Arm Label: AN2728 Topical Ointment, 2%; Type: EXPERIMENTAL; Interventions: Drug: AN2728 Topical Ointment, 2% | Arm Label: Matching vehicle control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matching vehicle control | Intervention Type: DRUG; Name: AN2728 Topical Ointment, 2%; Assigned to Arm(s): AN2728 Topical Ointment, 2% | Intervention Type: DRUG; Name: Matching vehicle control; Assigned to Arm(s): Matching vehicle control" }
B
[ "NCT05578482", "NCT04040192", "NCT03233529", "NCT02118792" ]
27,314
val
NCT04040634
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES) Brief Summary: High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.
{ "A": "Arm Label: Standard treatment regimen; Type: EXPERIMENTAL; Interventions: Drug: valsartan, Drug: amlodipine | Arm Label: Intensive treatment regimen; Type: EXPERIMENTAL; Interventions: Drug: valsartan, Drug: amlodipine | Intervention Type: DRUG; Name: valsartan; Assigned to Arm(s): Intensive treatment regimen, Standard treatment regimen | Intervention Type: DRUG; Name: amlodipine; Assigned to Arm(s): Intensive treatment regimen, Standard treatment regimen", "B": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure (SBP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure (SBP)", "C": "Arm Label: intensive blood pressure control; Type: ACTIVE_COMPARATOR; Interventions: Drug: control systolic blood pressure less than 120 mmHg | Arm Label: standard blood pressure control; Type: ACTIVE_COMPARATOR; Interventions: Drug: control systolic blood pressure less than 140 mmHg | Intervention Type: DRUG; Name: control systolic blood pressure less than 120 mmHg; Assigned to Arm(s): intensive blood pressure control | Intervention Type: DRUG; Name: control systolic blood pressure less than 140 mmHg; Assigned to Arm(s): standard blood pressure control", "D": "Arm Label: The intensive care group; Type: EXPERIMENTAL; Interventions: Drug: Amlodipine 5mg, Drug: Losartan, Drug: Losartan and Amlodipine, Drug: Amlodipine/Losartan/Chlorthalidone | Arm Label: The usual care group; Type: EXPERIMENTAL; Interventions: Drug: Amlodipine 5mg, Drug: Losartan, Drug: Losartan and Amlodipine, Drug: Amlodipine/Losartan/Chlorthalidone, Drug: current treatment | Intervention Type: DRUG; Name: Amlodipine 5mg; Assigned to Arm(s): The intensive care group, The usual care group | Intervention Type: DRUG; Name: Losartan; Assigned to Arm(s): The intensive care group, The usual care group | Intervention Type: DRUG; Name: Losartan and Amlodipine; Assigned to Arm(s): The intensive care group, The usual care group | Intervention Type: DRUG; Name: Amlodipine/Losartan/Chlorthalidone; Assigned to Arm(s): The intensive care group, The usual care group | Intervention Type: DRUG; Name: current treatment; Assigned to Arm(s): The usual care group" }
B
[ "NCT00523549", "NCT04040634", "NCT01230216", "NCT03666351" ]
27,315
val
NCT04040634
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES) Brief Summary: High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.
{ "A": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure", "B": "Arm Label: Intensive Control of Systolic Blood Pressure (SBP); Type: EXPERIMENTAL; Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP) | Arm Label: Standard Control of Systolic Blood Pressure (SBP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Intensive Control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Intensive Control of Systolic Blood Pressure (SBP) | Intervention Type: DRUG; Name: Standard control of Systolic Blood Pressure (SBP); Assigned to Arm(s): Standard Control of Systolic Blood Pressure (SBP)", "C": "Arm Label: Intensive treatment group; Type: EXPERIMENTAL; Interventions: Other: Blood pressure lowering strategy | Arm Label: Standard treatment group; Type: ACTIVE_COMPARATOR; Interventions: Other: Blood pressure lowering strategy | Intervention Type: OTHER; Name: Blood pressure lowering strategy; Assigned to Arm(s): Intensive treatment group, Standard treatment group", "D": "Arm Label: Intensive Strategy; Type: OTHER; Interventions: Drug: Triatec 10 mg, Drug: Triatec HCT 5, Drug: Lasix 25, Drug: Micardis 80 mg, Drug: Micardis plus 80/12.5, Drug: Catapresan TTS 2, Drug: Norvasc 10 mg, Drug: Triatec 5 mg, Drug: Pluscor | Arm Label: Usual Strategy; Type: OTHER; Interventions: Drug: Triatec 10 mg, Drug: Triatec HCT 5, Drug: Lasix 25, Drug: Micardis 80 mg, Drug: Micardis plus 80/12.5, Drug: Catapresan TTS 2, Drug: Norvasc 10 mg, Drug: Triatec 5 mg, Drug: Pluscor | Intervention Type: DRUG; Name: Triatec 10 mg; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Triatec HCT 5; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Lasix 25; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Micardis 80 mg; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Micardis plus 80/12.5; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Catapresan TTS 2; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Norvasc 10 mg; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Triatec 5 mg; Assigned to Arm(s): Intensive Strategy, Usual Strategy | Intervention Type: DRUG; Name: Pluscor; Assigned to Arm(s): Intensive Strategy, Usual Strategy" }
B
[ "NCT04036409", "NCT04040634", "NCT03585595", "NCT00421863" ]
27,316
val
NCT04041635
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial. Brief Summary: The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
{ "A": "Arm Label: Language Treatment Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Language Treatment | Arm Label: Control Treatment Arm; Type: SHAM_COMPARATOR; Interventions: Behavioral: Control Treatment | Intervention Type: BEHAVIORAL; Name: Language Treatment; Assigned to Arm(s): Language Treatment Arm | Intervention Type: BEHAVIORAL; Name: Control Treatment; Assigned to Arm(s): Control Treatment Arm", "B": "Arm Label: Early Vocal Contact; Type: EXPERIMENTAL; Interventions: Behavioral: Early Vocal Contact | Arm Label: Behavioral observation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral Observation | Intervention Type: BEHAVIORAL; Name: Early Vocal Contact; Assigned to Arm(s): Early Vocal Contact | Intervention Type: BEHAVIORAL; Name: Behavioral Observation; Assigned to Arm(s): Behavioral observation", "C": "Arm Label: Stimuli Reduction; Type: EXPERIMENTAL; Interventions: Procedure: Stimuli reduction | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Usual care | Intervention Type: PROCEDURE; Name: Stimuli reduction; Assigned to Arm(s): Stimuli Reduction | Intervention Type: PROCEDURE; Name: Usual care; Assigned to Arm(s): Usual Care", "D": "Arm Label: Multisensory Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Therapist skin-to-skin Care, Device: Contingent parent's voice exposure, Behavioral: Parental skin-to-skin care, Device: Recorded parent's voice | Arm Label: Standard of Care; Type: OTHER; Interventions: Behavioral: Parental skin-to-skin care, Device: Recorded parent's voice | Intervention Type: BEHAVIORAL; Name: Therapist skin-to-skin Care; Assigned to Arm(s): Multisensory Intervention | Intervention Type: DEVICE; Name: Contingent parent's voice exposure; Assigned to Arm(s): Multisensory Intervention | Intervention Type: BEHAVIORAL; Name: Parental skin-to-skin care; Assigned to Arm(s): Multisensory Intervention, Standard of Care | Intervention Type: DEVICE; Name: Recorded parent's voice; Assigned to Arm(s): Multisensory Intervention, Standard of Care" }
C
[ "NCT04193579", "NCT04759573", "NCT04041635", "NCT03232931" ]
27,317
val
NCT04043806
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Brief Summary: This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
{ "A": "Arm Label: GLPG2222 Dose 1; Type: EXPERIMENTAL; Interventions: Drug: GLPG2222 150 mg q.d. | Arm Label: GLPG2222 Dose 2; Type: EXPERIMENTAL; Interventions: Drug: GLPG2222 300 mg q.d. | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: GLPG2222 150 mg q.d.; Assigned to Arm(s): GLPG2222 Dose 1 | Intervention Type: DRUG; Name: GLPG2222 300 mg q.d.; Assigned to Arm(s): GLPG2222 Dose 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo", "B": "Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/IVA", "C": "Arm Label: Phenylbutyrate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sodium 4-Phenylbutyrate, Drug: Genistein (Unconjugated Isoflavones 100) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Genistein (Unconjugated Isoflavones 100), Drug: Placebo | Intervention Type: DRUG; Name: Sodium 4-Phenylbutyrate; Assigned to Arm(s): Phenylbutyrate | Intervention Type: DRUG; Name: Genistein (Unconjugated Isoflavones 100); Assigned to Arm(s): Phenylbutyrate, Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo", "D": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h" }
B
[ "NCT03045523", "NCT04043806", "NCT00590538", "NCT01807949" ]
27,318
val
NCT04043806
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Brief Summary: This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
{ "A": "Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/IVA) | Arm Label: Part 1: VX-659/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-659/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/VX-561) | Arm Label: Part 3: VX-659/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: VX-659/TEZ/IVA TC, Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/IVA); Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/VX-561); Assigned to Arm(s): Part 3: Placebo", "B": "Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/IVA", "C": "Arm Label: VX-659/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-659/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: VX-659/TEZ/IVA; Assigned to Arm(s): VX-659/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): VX-659/TEZ/IVA", "D": "Arm Label: Part A: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part B: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Arm Label: Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo, Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Tezacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: VX-659 Matching Placebo; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo | Intervention Type: DRUG; Name: Triple Combination (TC) Matching Placebos; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo" }
B
[ "NCT03224351", "NCT04043806", "NCT03633526", "NCT03029455" ]
27,319
val
NCT04045626
Please select the arm or intervention descriptions that belong to the clinical trial below. Title: Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns Brief Summary: To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients
{ "A": "Arm Label: Riboflavin 0.1% eyedrops every 5 minutes; Type: ACTIVE_COMPARATOR; Interventions: Drug: Riboflavin, Device: UVX light | Arm Label: Riboflavin 0.1% eyedrops every 2 minutes; Type: ACTIVE_COMPARATOR; Interventions: Drug: Riboflavin, Device: UVX light | Intervention Type: DRUG; Name: Riboflavin; Assigned to Arm(s): Riboflavin 0.1% eyedrops every 2 minutes, Riboflavin 0.1% eyedrops every 5 minutes | Intervention Type: DEVICE; Name: UVX light; Assigned to Arm(s): Riboflavin 0.1% eyedrops every 2 minutes, Riboflavin 0.1% eyedrops every 5 minutes", "B": "Arm Label: Transepithelial accelerated cross-linking; Type: ACTIVE_COMPARATOR; Interventions: Procedure: corneal cross-linking | Arm Label: Epithelium-off accelerated cross-linking; Type: ACTIVE_COMPARATOR; Interventions: Procedure: corneal cross-linking | Intervention Type: PROCEDURE; Name: corneal cross-linking; Assigned to Arm(s): Epithelium-off accelerated cross-linking, Transepithelial accelerated cross-linking", "C": "Arm Label: CXL without epithelial removal; Type: EXPERIMENTAL; Interventions: Procedure: CXL without epithelial removal | Arm Label: CXL with epithelial removal; Type: ACTIVE_COMPARATOR; Interventions: Procedure: CXL with epithelial removal | Intervention Type: PROCEDURE; Name: CXL without epithelial removal; Assigned to Arm(s): CXL without epithelial removal | Intervention Type: PROCEDURE; Name: CXL with epithelial removal; Assigned to Arm(s): CXL with epithelial removal", "D": "Arm Label: total removal; Type: OTHER; Interventions: Procedure: collagen cross-linking procedure (total removal) | Arm Label: partial removal; Type: OTHER; Interventions: Procedure: collagen cross-linking procedure (partial removal) | Intervention Type: PROCEDURE; Name: collagen cross-linking procedure (total removal); Assigned to Arm(s): total removal | Intervention Type: PROCEDURE; Name: collagen cross-linking procedure (partial removal); Assigned to Arm(s): partial removal" }
B
[ "NCT01143389", "NCT04045626", "NCT01181219", "NCT01809977" ]
27,320
val