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NCT ID: NCT02330549 Completed - Clinical trials for Type 2 Diabetes Mellitus

ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD

Start date: July 17, 2015
Phase: Phase 2
Study type: Interventional

A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc (CVC) to be conducted in approximately 50 adult obese subjects [body mass index (BMI) ≥ 30 kg/m^2] with prediabetes or type 2 diabetes mellitus and suspected NALFD.

NCT ID: NCT02325791 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Start date: July 21, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

NCT ID: NCT02317432 Completed - Depression Clinical Trials

Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)

Start date: July 2015
Phase: N/A
Study type: Interventional

The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.

NCT ID: NCT02314117 Completed - Clinical trials for Gastroesophageal Junction Adenocarcinoma

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

RAINFALL
Start date: January 20, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

NCT ID: NCT02305732 Completed - Dengue Virus Clinical Trials

A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

TRUE
Start date: March 2015
Phase:
Study type: Observational

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014). The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.

NCT ID: NCT02305381 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

SUSTAIN™ 5
Start date: December 1, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

NCT ID: NCT02302716 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

ELEMENT 5
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).

NCT ID: NCT02300103 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

NCT ID: NCT02294877 Completed - MPS IVA Clinical Trials

A Multicenter, Multinational, Observational Morquio A Registry Study (MARS)

MARS
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®, including, but not limited to, the occurrence of serious hypersensitivity reactions, anaphylaxis, and changes in antibody status; to help the medical community with the development of recommendations for monitoring MPS IVA patients and reports on patient outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate the prevalences of their use and their effectiveness; to characterize the effects and safety of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients will be encouraged to enroll in the applicable Registry Substudy and will be monitored using the MOR-005 and MOR-007 assessment schedules, respectively.

NCT ID: NCT02294682 Completed - Gonorrhea Clinical Trials

A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae

Start date: April 2015
Phase: Phase 2
Study type: Interventional

GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.