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NCT ID: NCT03549000 Terminated - Ovarian Cancer Clinical Trials

A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

Start date: July 18, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers

NCT ID: NCT03548935 Completed - Clinical trials for Overweight or Obesity

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 1
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

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: NCT03546699 Active, not recruiting - Respiratory Failure Clinical Trials

Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

Start date: October 24, 2018
Phase:
Study type: Observational

The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: 1. To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; 2. To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).

NCT ID: NCT03546582 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

KEYSTROKE
Start date: November 14, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).