Clinical trials: Adverse Outcomes
Metabolic Dysfunction-Associated Steatotic Liver Disease
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease…
- Trial name
- NCT07165028
- Testing
- Tirzepatide, Retatrutide
- Where
- 563 sites in United States, Argentina and 32 more
- Volunteers
- 4,500 people
- Sponsor
- Eli Lilly and Company
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function.
- Trial name
- NCT06383390
- Testing
- Retatrutide
- Where
- 742 sites in United States, Argentina and 25 more
- Volunteers
- 10,000 people
- Sponsor
- Eli Lilly and Company
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)
This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Acenocoumarol for the first…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947985
- Testing
- Rivaroxoban (Xarelto, Bay59-7939), Standard of care
- Where
- Netherlands
- Volunteers
- 208,958 people
- Sponsor
- Bayer
Obesity, Overweight
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and…
- Trial name
- NCT01601704
- Testing
- NB32, PBO, Weight Management Program
- Where
- 224 sites in United States
- Volunteers
- 8,910 people
- Sponsor
- Orexigen Therapeutics, Inc
Multiple Sclerosis, Autoimmune
Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions
Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and…
- Trial name
- cSVF (NCT02939859)
- Testing
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Where
- 2 sites in United States, Honduras
- Sponsor
- Healeon Medical Inc
Acute Coronary Syndrome
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
- Trial name
- SOLID-TIMI 52 (NCT01000727)
- Testing
- Darapladib 160 mg, Standard Therapy
- Where
- 914 sites in United States, Argentina and 34 more
- Volunteers
- 13,026 people
- Sponsor
- GlaxoSmithKline
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Observational Prospective Study OPTIMA II - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study.
- Trial name
- OPTIMAII (NCT02099565)
- Where
- Russia
- Volunteers
- 572 people
- Sponsor
- AstraZeneca
Chronic Obstructive Pulmonary Disease
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus…
- Trial name
- TRIBE (NCT05652439)
- Testing
- Observational retrospective data collection
- Where
- United Kingdom
- Volunteers
- 25,000 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Acute Coronary Syndrome, Venous Thrombosis
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first…
- Conditions
- Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Trial name
- NCT02468102
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs
- Where
- Sweden
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction
- Trial name
- STEPS A (NCT03356132)
- Testing
- Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Where
- Brazil
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Peripheral Artery Disease (PAD)
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become…
- Trial name
- ROXI-PALISADE (NCT07318610)
- Testing
- REGN7508, REGN9933, Rivaroxaban
- Where
- 29 sites in United States, United Kingdom
- Volunteers
- 7,050 people
- Sponsor
- Regeneron Pharmaceuticals
Mycosis Fungoides
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with Mycosis Fungoides Cutaneous T-cell Lymphoma (MF-CTCL) who are receiving therapy with Valchlor.
- Trial name
- PROVe (NCT02296164)
- Testing
- Valchlor
- Where
- 36 sites in United States
- Volunteers
- 300 people
- Sponsor
- Helsinn Therapeutics (U.S.), Inc
Neurodegenerative Diseases, Osteoarthritis
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF).
- Conditions
- Neurodegenerative Diseases, Osteoarthritis, Erectile Dysfunction, Autoimmune Diseases
- Trial name
- NCT01953523
- Testing
- Administration of autologous adipose derived SVF
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Elliot Lander
Early Breast Cancer, Skin Condition
An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients With Early Breast Cancer Treated With Adjuvant Endocrine Therapy - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)
The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with…
- Conditions
- Early Breast Cancer, Skin Condition, Quality of Life
- Trial name
- BCARE (NCT06690489)
- Where
- 9 sites in France, Greece and 2 more
- Volunteers
- 155 people
- Sponsor
- Pierre Fabre Medicament
Non Small Cell Lung Cancer (NSCLC)
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent.
- Trial name
- ARCHER 1042 (NCT01465802)
- Testing
- Dacomitinib, Doxycycline, Probiotic
- Where
- 81 sites in United States, South Korea
- Volunteers
- 236 people
- Sponsor
- Pfizer
Fetal Growth Complications, Pregnancy Complications
First-trimester Placental Ultrasound Study
An observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes.
- Trial name
- First PLUS (NCT05326191)
- Testing
- Ultrasound
- Where
- United Kingdom
- Volunteers
- 4,000 people
- Sponsor
- Perspectum
Obesity, Cardiovascular Diseases
Naltrexone/Bupropion Cardiovascular Outcomes Study
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse…
- Trial name
- NCT02638129
- Testing
- Naltrexone HCl/Bupropion HCl ER
- Where
- 139 sites in United States
- Volunteers
- 67 people
- Sponsor
- Orexigen Therapeutics, Inc
Asthma
WEUSRTP4850: Phase II: ICS/LABA Use in Pregnancy and Outcomes
Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy.
- Trial name
- NCT01681979
- Testing
- Fluticasone propionate (with and without concurrent salmeterol)
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline