Clinical trials: Adverse Outcomes
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
High-risk, Non-cardiovascular Surgeries
Esmolol for Treatment of Perioperative Tachycardia
The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and…
- Trial name
- NCT01208402
- Testing
- Esmolol
- Where
- 3 sites in United States
- Volunteers
- 76 people
- Sponsor
- Duke University
Chlamydia Trachomatis Infection
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C.
- Trial name
- RCT (NCT03862495)
- Testing
- C. trachomatis and N. gonorrhoeae, Azithromycin, Partner notification and treatment
- Where
- 2 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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)
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
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
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
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
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
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
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
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
Labor and Delivery
A Randomized Trial of Induction Versus Expectant Management
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.
- Trial name
- ARRIVE (NCT01990612)
- Testing
- Elective Induction of Labor
- Where
- 16 sites in United States
- Volunteers
- 6,106 people
- Sponsor
- The George Washington University Biostatistics Center
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
Hepatitis C, Medication Adherence
Intensive Models of HCV Care for Injection Drug Users
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival.
- Trial name
- NCT01857245
- Testing
- Intensive Models (mDOT and CGT) of HCV Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Prisma Health-Upstate