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NCT ID: NCT03548220 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

NCT ID: NCT03548077 Completed - Cancer Clinical Trials

POWERPLAY: Promoting Men's Health at Work

POWERPLAY
Start date: September 24, 2014
Phase: N/A
Study type: Interventional

With funding from the Candian Cancer Society, the Men's Healthy Eating Active Living (MHEAL) project began the development, evaluation, and optimization of a program called POWERPLAY to promote men's health at work.

NCT ID: NCT03547583 Completed - Clinical trials for Chronic Heart Failure With Preserved Ejection Fraction

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

VITALITY-HFpEF
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

NCT ID: NCT03547167 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

Start date: July 16, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.

NCT ID: NCT03547050 Completed - Rolandic Epilepsy Clinical Trials

Rolandic Epilepsy Genomewide Association International Study

REGAIN
Start date: June 1, 2018
Phase:
Study type: Observational

We have discovered a small change in the genetic code which increases the risk of the brainwave abnormality that is found in rolandic epilepsy. We now wish to confirm this using a second much larger sample of patients. We will investigate the other genetic changes that cause people with the brainwave abnormality to develop seizures, as well as problems with speech, coordination, attention and learning.

NCT ID: NCT03546907 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. - Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. - Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.

NCT ID: NCT03545958 Completed - Hypertension Clinical Trials

The Heart & Mind Study

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Older adults with subjective cognitive decline (SCD) may represent a portion of the population experiencing early sings of cognitive decline. Systolic hypertension is a major contributor to cognitive impairment. High-intensity aerobic interval training (HIT) yields greater fitness and vascular health improvements compared to moderate-intensity aerobic continuous training (MCT). No randomized controlled trials, however, have investigated the effects HIT or MCT on cognition in older adults with hypertension and SCD. Much less is known regarding whether combining HIT or MCT with mind-motor training would culminate additive benefits to cognition. Therefore, the overarching goal of our research is to deliver a group-based exercise program combining mind-motor training with HIT or MCT to older adults with hypertension and SCD. Participants will be randomized into two groups. Participants in both groups will receive 15 minutes of square stepping exercise (SSE) followed by either 45 minutes of HIT (N=70) or 45 minutes of MCT (N=70). In total, both groups will exercise 60 min/day, 3 days/week for 6 months. The effects of both interventions will be evaluated on systolic and diastolic office/ambulatory blood pressure and global and domain-specific cognitive functioning.

NCT ID: NCT03545191 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT ID: NCT03544281 Completed - Multiple Myeloma Clinical Trials

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

DREAMM 6
Start date: September 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Treatment A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Treatment B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

NCT ID: NCT03543982 Completed - Vaginal Health Clinical Trials

Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.