Clinical trials: RANDOMIZED
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Knee Osteoarthritis
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee…
- Trial name
- NCT03485157
- Testing
- Micronized dHACM, Saline
- Where
- 17 sites in United States
- Volunteers
- 447 people
- Sponsor
- MiMedx Group, Inc.
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Hereditary Angioedema, Angioneurotic Edema
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening.
- Conditions
- Hereditary Angioedema, Angioneurotic Edema, Genetic Disorders
- Trial name
- NCT00262301
- Testing
- recombinant human C1 inhibitor
- Where
- 2 sites in Netherlands, Romania
- Volunteers
- 75 people
- Sponsor
- Pharming Technologies B.V.
Asthma
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Primary Objective To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire…
- Trial name
- FORTUNE (NCT03453112)
- Testing
- Foster 100/6µg NEXThaler, Foster 100/6µg pMDI
- Where
- 51 sites in China
- Volunteers
- 494 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Adult Attention Deficit Hyperactivity Disorder
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
- Trial name
- NCT03324581
- Testing
- OPC-64005, Atomoxetine
- Where
- 26 sites in United States
- Volunteers
- 239 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diabetes Mellitus, Type 2
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).
- Trial name
- NCT01289119
- Testing
- Alogliptin, Metformin, Pioglitazone
- Where
- 21 sites in China, Hong Kong and 1 more
- Volunteers
- 506 people
- Sponsor
- Takeda
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore…
- Trial name
- NCT07217119
- Testing
- Belantamab mafodotin, Feladilimab
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Surgical Wound Infection
NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections
- Trial name
- NCT04955730
- Testing
- Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Plasmodium Falciparum Infection, Malaria
L9LS MAb in Malian Adults
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf)…
- Trial name
- NCT05816330
- Testing
- L9LS (VRC-MALMAB0114-00-AB)
- Where
- 3 sites in Mali
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cardiovascular Disease
The Fibrin Pad Cardiovascular Study
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
- Trial name
- NCT01681030
- Testing
- EVARREST™, Topical hemostat, Standard of Care
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- Ethicon, Inc.
Short Bowel Syndrome
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults.
- Trial name
- NCT04046328
- Testing
- Enteric-Coated Cholestyramine (ECC) Capsule
- Where
- 3 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Pharmascience Inc.
Ovarian Neoplasms
A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC).
- Trial name
- NCT06964165
- Testing
- Niraparib, Carboplatin, Paclitaxel
- Where
- 21 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Tesaro, Inc.
Overdose
Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy
Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being…
- Trial name
- NCT06219967
- Testing
- Activated Charcoal
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- State University of New York - Upstate Medical University
Hepatitis C, Chronic
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who…
- Trial name
- START 4 (NCT01606800)
- Testing
- PEG-IFN alfa-2b, ribavirin
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease (CAD)
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).
- Trial name
- EMINENCE (NCT00543400)
- Testing
- M118, Unfractionated Heparin
- Where
- 44 sites in United States, Canada
- Volunteers
- 503 people
- Sponsor
- Momenta Pharmaceuticals, Inc.
Stage I Multiple Myeloma, Stage II Multiple Myeloma
Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone
This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone.
- Conditions
- Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Trial name
- NCT00522392
- Testing
- bortezomib, lenalidomide, dexamethasone
- Where
- 276 sites in United States, South Africa
- Volunteers
- 48 people
- Sponsor
- National Cancer Institute (NCI)
Menstruation
In-use Study of Four Different Tampons
This study will evaluate the impact on vaginal health of four different tampons using gynecologic assessment and subjective assessment of comfort during in-use conditions
- Trial name
- NCT03478371
- Testing
- tampon D, tampon M, tampon T
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Procter and Gamble
Gaucher Disease
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)
The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated…
- Trial name
- NCT01074944
- Testing
- Eliglustat tartrate
- Where
- 46 sites in United States, Australia and 15 more
- Volunteers
- 170 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
- Trial name
- NCT04041609
- Testing
- LYR-210
- Where
- 22 sites in Australia, Austria and 3 more
- Volunteers
- 71 people
- Sponsor
- Lyra Therapeutics
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