Clinical trials: Risk Reduction
Smoking
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a…
- Trial name
- NCT01970995
- Testing
- THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA), Menthol Conventional Cigarette (mCC)
- Where
- Japan
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Metabolic Syndrome
Cardiovascular Risk Evaluation in Clinical Practice in Metabolic Syndrome Patients
Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events.
- Trial name
- NCT00171548
- Where
- Switzerland
- Volunteers
- 600 people
- Sponsor
- Novartis
Major Depressive Disorder With Suicidal Ideation With Intent
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent
- Trial name
- NCT04722666
- Testing
- MIJ821 Intravenous Injection
- Where
- 39 sites in United States, Argentina and 12 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Moderate Risk of CVD
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk.
- Trial name
- ARRIVE (NCT00501059)
- Testing
- Aspirin (Acetylsalicylic acid, BAYE4465)
- Where
- 466 sites in United States, Germany and 6 more
- Volunteers
- 12,546 people
- Sponsor
- Bayer
Diabetes Mellitus, Non-Insulin-Dependent
The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
The primary objectives of the ORIGIN study were: To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired…
- Trial name
- ORIGIN (NCT00069784)
- Testing
- insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), reusable pen device for insulin injection
- Where
- 40 sites in United States, Argentina and 38 more
- Volunteers
- 12,537 people
- Sponsor
- Sanofi
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
- Trial name
- NCT05171491
- Where
- 12 sites in United States
- Volunteers
- 425 people
- Sponsor
- LungLife AI
Post MI Left Ventricular Dysfunction
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%) patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at 8-10 weeks after index MI) and to…
- Trial name
- INSPIRE-ELR (NCT01995552)
- Testing
- External Loop Recorder
- Where
- India
- Volunteers
- 250 people
- Sponsor
- Medtronic BRC
Smoking
Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.
The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette…
- Trial name
- NCT02503254
- Testing
- CHTP 1.0, Conventional Cigarette (CC)
- Where
- Poland
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Burnout, Risk Reduction
Effectiveness of Online Therapy to Prevent Burnout
This study aims to address the reliability and validity of the Empowerment for Participation (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online interventions to provide proactive…
- Conditions
- Burnout, Risk Reduction, Cognitive Change
- Trial name
- NCT05343208
- Testing
- EFP Psychometric assessment to determine level of afflication
- Where
- Sweden
- Volunteers
- 50 people
- Sponsor
- SciensCollege
Atherosclerotic Disease
CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)
This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device.
- Trial name
- CAPTURE (NCT06910111)
- Testing
- Polyglucosamine
- Where
- 3 sites in Italy
- Volunteers
- 240 people
- Sponsor
- Certmedica International GmbH
Atrial Fibrillation, Atrial Flutter
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of…
- Trial name
- GUARD-AF (NCT04126486)
- Testing
- Zio®XT Monitor
- Where
- 176 sites in United States
- Volunteers
- 11,931 people
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes Mellitus (T2DM)
Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
This clinical trial is studying whether combining two commonly used diabetes medications into a single pill works better than taking them separately for people with type 2 diabetes who are already on metformin.
- Trial name
- CONTROL (NCT07057479)
- Testing
- Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione, Control Group 1 Intervention - SGLT2 inhibitor monotherapy, Control Group 2 Intervention - Thiazolidinedione monotherapy
- Where
- Brazil
- Sponsor
- Eurofarma Laboratorios S.A.
Gastric Ulcer
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at…
- Trial name
- NCT01129011
- Testing
- PN400 (VIMOVO), Naproxen
- Volunteers
- 420 people
- Sponsor
- POZEN
Osteoarthritis, Peptic Ulcer
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once…
- Trial name
- NCT00175032
- Testing
- Lansoprazole and naproxen and aspirin, Celecoxib and aspirin
- Volunteers
- 1,045 people
- Sponsor
- Takeda
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD…
- Conditions
- Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
- Trial name
- LIBerate-OLE (NCT04798430)
- Testing
- lerodalcibep
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 2,000 people
- Sponsor
- LIB Therapeutics LLC
Cardiovascular Risk Factor, Cardiovascular Diseases
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a…
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Cardiovascular Stroke, Hypercholesterolemia
- Trial name
- LIBerate-HR (NCT04806893)
- Testing
- lerodalcibep
- Where
- 6 sites in United States, India and 1 more
- Volunteers
- 900 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia, Atherosclerotic Ischemic Disease
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
- Trial name
- LIBerate-VI (NCT05004675)
- Testing
- lerodalcibep, Inclisiran
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 166 people
- Sponsor
- LIB Therapeutics LLC
Clostridium Difficile Infection, Antibiotic Associated Diarrhea
Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea.
- Trial name
- NCT01972932
- Testing
- Bio K+® 2 capsules orally (or via nasogastric tube)
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Bio-K Plus International Inc.