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NCT ID: NCT03039114 Completed - Lymphoma Clinical Trials

Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Start date: February 15, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).

NCT ID: NCT03038100 Completed - Ovarian Cancer Clinical Trials

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

IMagyn050
Start date: March 8, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

NCT ID: NCT03037411 Completed - Atherosclerosis Clinical Trials

A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

REGAL
Start date: December 13, 2016
Phase:
Study type: Observational

The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

NCT ID: NCT03037385 Completed - Neoplasms Clinical Trials

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

ARROW
Start date: March 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

NCT ID: NCT03036852 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

SOF/VEL ESRD
Start date: March 22, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

NCT ID: NCT03036553 Completed - Clinical trials for Chronic Musculoskeletal Pain

Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.

Start date: August 1, 2020
Phase:
Study type: Observational

Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks, changing the mood and concentration of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear understanding of its etiology and pathogenesis remains elusive. Aims: (i) to analyze the possible level of association between pain-related fear, fear of movement, self-efficacy, and pain acceptance with pain intensity and disability at the start of the study and prospectively evaluate its predictive function; (ii) to evaluate the possible mediating role of fear of movement and self-efficacy in the relationship between pain-disability in patients with CMP.

NCT ID: NCT03036462 Completed - Iron Deficiency Clinical Trials

Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

FAIR-HF2
Start date: February 7, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

NCT ID: NCT03036150 Completed - Clinical trials for Chronic Kidney Disease

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Dapa-CKD
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

NCT ID: NCT03034967 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 25, 2017
Phase: Phase 2
Study type: Interventional

Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.

NCT ID: NCT03034915 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 16, 2017
Phase: Phase 4
Study type: Interventional

COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance. This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks. Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week. ELLIPTA and DISKUS are trademarks of GSK group of companies.