Clinical trials: Evaluation Studies
Cytomegalovirus Infections
Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus.
- Trial name
- NCT03840174
- Testing
- V160
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
- Trial name
- NCT03800420
- Where
- 11 sites in United States
- Volunteers
- 16 people
- Sponsor
- Bridge Biotherapeutics, Inc.
Delirium
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical…
- Trial name
- NCT04007523
- Testing
- Family Support System, HELP Support System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Michigan
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
- Conditions
- Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- Trial name
- NCT02834780
- Testing
- H3B-6527
- Where
- 44 sites in United States, Belgium and 9 more
- Volunteers
- 128 people
- Sponsor
- H3 Biomedicine Inc.
Schizoaffective Disorder, Psychotic Disorder
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute…
- Trial name
- NCT00412373
- Testing
- Paliperidone ER
- Where
- 44 sites in United States, India and 4 more
- Volunteers
- 307 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Epilepsy
Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of lamotrigine monotherapy on newly diagnosed typical absence seizure in children and adolescents in Japan and South Korea.
- Trial name
- NCT01431976
- Testing
- Lamictal
- Where
- 14 sites in Japan, South Korea
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Arthritis, Rheumatoid
Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad…
- Trial name
- NCT04428424
- Testing
- Enbrel
- Where
- Iraq
- Volunteers
- 1,493 people
- Sponsor
- Pfizer
Gaucher Disease Type 1
Clinical Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease
Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy…
- Trial name
- NCT00319046
- Testing
- Miglustat
- Volunteers
- 42 people
- Sponsor
- Actelion
Rheumatoid Arthritis
A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350
A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350.
- Trial name
- NCT02983227
- Testing
- GDC-0853
- Where
- 104 sites in United States, Argentina and 8 more
- Volunteers
- 496 people
- Sponsor
- Genentech, Inc.
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Autosomal Dominant Polycystic Kidney Disease
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in Autosomal Dominant Polycystic Kidney…
- Trial name
- NCT03487913
- Testing
- Lixivaptan
- Where
- 13 sites in United States
- Volunteers
- 31 people
- Sponsor
- Palladio Biosciences
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and…
- Trial name
- TEXT-TKR (NCT03251482)
- Testing
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg
- Where
- 103 sites in United States, Argentina and 14 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Asthma
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
- Trial name
- NAVIGATOR (NCT03347279)
- Testing
- Experimental: Tezepelumab
- Where
- 289 sites in United States, Argentina and 16 more
- Volunteers
- 1,061 people
- Sponsor
- AstraZeneca
Schizophrenia, Schizophrenia; Psychosis
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and…
- Trial name
- NCT04659161
- Testing
- Xanomeline and Trospium Chloride Capsules
- Where
- 22 sites in United States
- Volunteers
- 252 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Refractory or Relapsed Solid Tumors, Lymphoma
Phase I/II Study of Avelumab in Pediatric Cancer Participants
This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with…
- Trial name
- NCT03451825
- Testing
- Avelumab
- Where
- 11 sites in United States, Belgium and 3 more
- Volunteers
- 21 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Breast Cancer
Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings…
- Trial name
- NCT01817374
- Testing
- 2D US grayscale plus quantitative VCEUS
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Alabama at Birmingham
Healthy Volunteer Study
A Study of LY2140023 in Healthy Participants
The study will evaluate the effect of activated charcoal on absorption of LY2140023. The study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2 times during study (once with activated charcoal…
- Trial name
- NCT01609218
- Testing
- LY2140023, Aqueous activated charcoal
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Denovo Biopharma LLC
Restless Legs Syndrome
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome
This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.
- Trial name
- NCT00530790
- Testing
- ropinirole controlled release (CR)-RLS
- Where
- 11 sites in Japan
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Post-operative Pain
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
- Trial name
- NCT01694199
- Testing
- Pulsed Radiofrequency Energy (PRFE), No Pulsed Radiofrequency Energy (PRFE)
- Where
- 3 sites in United States
- Volunteers
- 139 people
- Sponsor
- Regenesis Biomedical, Inc.
Essential Hypertension
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
- Trial name
- NCT01615198
- Testing
- Olmesartan, LCZ696
- Where
- 79 sites in China, Hong Kong and 5 more
- Volunteers
- 588 people
- Sponsor
- Novartis Pharmaceuticals
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