Clinical trials: Adverse Outcomes
Non-Valvular Atrial Fibrillation
Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists
By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly…
- Trial name
- ANTENNA (NCT04297072)
- Testing
- Rivaroxaban (Xarelto, BAY-597939), VKAs
- Where
- United Kingdom
- Volunteers
- 25,000 people
- Sponsor
- Bayer
Autoimmune Diseases, Adverse Pregnancy Outcomes
A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ
This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).
- Trial name
- HPV-PRO-013 (NCT06824896)
- Where
- China
- Volunteers
- 1,322,084 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
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
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (UK)
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 Warfarin for the first time…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947998
- Testing
- Rivaroxaban (Xarelto, Bay59-7939), Warfarin, Antiplatelet drugs
- Where
- United Kingdom
- Volunteers
- 50,299 people
- Sponsor
- Bayer
Gram-Negative Bacterial Infections
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
- Trial name
- NCT03160040
- Testing
- Minocycline IV
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Carcinoid Syndrome
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
- Trial name
- RELAX (NCT03223428)
- Testing
- Xermelo
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- TerSera Therapeutics LLC
Atherosclerosis
Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid
In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways.
- Trial name
- XATOA (NCT03746275)
- Testing
- Rivaroxaban (BAY59-7939, Xarelto), Acetylsalicylic acid
- Where
- 18 sites in Argentina, Brazil and 16 more
- Volunteers
- 5,798 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 With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
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
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
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)
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 Phenprocoumon for the first…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947959
- Testing
- Rivaroxaban (Xarelto, Bay59-7939), Standard of care
- Where
- Germany
- Volunteers
- 665,533 people
- Sponsor
- Bayer
Metastatic Breast Cancer
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative…
- Trial name
- NCT07148505
- Where
- United States
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Chagas Disease, Heart Failure
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of…
- Trial name
- PARACHUTE-HF (NCT04023227)
- Testing
- Sacubitril/valsartan, Enalapril
- Where
- 79 sites in Argentina, Brazil and 2 more
- Volunteers
- 922 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Arteriosclerosis, Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk.
- Trial name
- NCT06008756
- Testing
- Enlicitide Decanoate
- Where
- 669 sites in United States, Argentina and 27 more
- Volunteers
- 14,550 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections
Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and…
- Trial name
- NCT05091931
- Where
- 2 sites in United States
- Volunteers
- 3,308 people
- Sponsor
- Pathnostics
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