Clinical trials: Adverse Outcomes
Epilepsy
Characterization of Epilepsy Patients BEEP 2b
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products.
- Trial name
- BEEP2b (NCT02707965)
- Testing
- Oxcarbazepine (brand name vs generic drugs), Divalproex Sodium (brand name vs generic drugs), Carbamazepine (brand name vs generic drugs)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Food and Drug Administration (FDA)
Chronic Kidney Disease
A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from…
- Trial name
- NCT01688141
- Testing
- Enhanced management
- Where
- 3 sites in United Kingdom
- Volunteers
- 28,304 people
- Sponsor
- University Hospitals, Leicester
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
COVID-19, Myocardial Reperfusion Injury
Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19
The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system.
- Conditions
- COVID-19, Myocardial Reperfusion Injury, Cardiovascular Diseases
- Trial name
- NCT04397939
- Where
- United States
- Volunteers
- 4,695 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Acute Coronary Syndrome
A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)
Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack.
- Trial name
- LATITUDE (NCT02145468)
- Testing
- Losmapimod 7.5 mg twice daily, Standard therapy
- Where
- 341 sites in United States, Argentina and 32 more
- Volunteers
- 3,503 people
- Sponsor
- GlaxoSmithKline
Obstructive Sleep Apnea
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group.
- Trial name
- NCT02755831
- Testing
- CPAP, Pre-natal care
- Where
- United States
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- United States Naval Medical Center, San Diego
Atherosclerosis
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.
- Trial name
- STABILITY (NCT00799903)
- Testing
- Darapladib
- Where
- 650 sites in United States, Argentina and 37 more
- Volunteers
- 15,828 people
- Sponsor
- GlaxoSmithKline
Maternal Health, Mental Health
Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e.
- Conditions
- Maternal Health, Mental Health, Healthcare Provider, Adverse Outcomes
- Trial name
- CPIPE2 (NCT05019131)
- Testing
- Training, Peer support and mentorship, Leadership engagement
- Where
- Kenya
- Volunteers
- 83 people
- Sponsor
- University of California, San Francisco
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
Maternal Behavior, Alcohol Drinking
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
South Africa (SA) has a long history of social and health disparities, resulting in the world's highest rate of fetal alcohol spectrum disorder (FASD; 111.1 per 1,000), where lifelong negative cognitive and physical effects…
- Conditions
- Maternal Behavior, Alcohol Drinking, Fetal Conditions
- Trial name
- MaRISA+ (NCT05747599)
- Testing
- Intervention with contingent incentives and text-based support
- Where
- South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- RTI International
Birth Outcomes, Safety
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart).
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Trial name
- NCT06503900
- Testing
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
- Where
- 6 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Duke University
Bacterial Vaginosis
Rwanda Vaginal Microbiota Restoration Study
A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.
- Trial name
- VMB (NCT02459665)
- Testing
- Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence, Prophylactic use of metronidazole pills (500 mg), Vaginal Lcr35-containing probiotic for prevention of BV recurrence
- Volunteers
- 68 people
- Sponsor
- Janneke van de Wijgert
Tuberculosis, Alcohol Consumption
The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes
After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an infectious disease globally. Retrospective studies from many countries, including the United States and South Africa, have consistently…
- Conditions
- Tuberculosis, Alcohol Consumption, Treatment Adverse Effect
- Trial name
- NCT02840877
- Testing
- DOT Adherence Monitoring
- Where
- South Africa
- Volunteers
- 303 people
- Sponsor
- Boston Medical Center
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
Coronary Artery Disease, Clopidogrel Resistance
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug…
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events
- Trial name
- NCT06665919
- Testing
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
- Where
- 4 sites in Georgia
- Volunteers
- 283 people
- Sponsor
- Vistamedi Ltd.
Preeclampsia Postpartum, Adverse Pregnancy Outcomes
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health.
- Trial name
- AW2H (NCT06353256)
- Testing
- usual postpartum care, usual postpartum care + community health worker intervention
- Where
- 2 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Safety, Adverse Event Following Immunisation
Safety of RIV4 Versus IIV4 in Pregnant Women
This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers.
- Conditions
- Safety, Adverse Event Following Immunisation, Birth Outcomes
- Trial name
- NCT03969641
- Testing
- Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Duke University
Hepatitis C, Medication Adherence
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV).
- Trial name
- NCT03127358
- Testing
- AiCure, AiCure with gamification
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Albert Einstein College of Medicine
Hepatitis C, Medication Adherence
Patient-Centered Models of HCV Care for People Who Inject Drugs
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently.
- Trial name
- HERO (NCT02824640)
- Testing
- Patient Navigation, modified Directly Observed Therapy
- Where
- United States
- Volunteers
- 755 people
- Sponsor
- Prisma Health-Upstate
Transplants and Implants
Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients.
- Trial name
- NCT00522548
- Testing
- Enteric coated mycophenolate sodium, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of Pennsylvania