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NCT ID: NCT03568929 Completed - Clinical trials for Follicular Non-Hodgkin's Lymphoma Refractory

Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

ZEUS
Start date: May 25, 2018
Phase:
Study type: Observational

The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

NCT ID: NCT03559933 Completed - Clinical trials for Ventilator Induced Diaphragmatic Dysfunction (VIDD)

PEPNS System Feasibility Study

Start date: July 10, 2018
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).

NCT ID: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03559062 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

Start date: May 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

NCT ID: NCT03558152 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

NCT ID: NCT03549871 Completed - Hemophilia Clinical Trials

A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis

ATLAS-PPX
Start date: July 25, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: - To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: - the frequency of spontaneous bleeding episodes - the frequency of joint bleeding episodes - health related quality of life (HRQOL) in participants greater than or equal to (>=) 17 years of age - To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. - To characterize the safety and tolerability of fitusiran. - To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.

NCT ID: NCT03548363 Completed - Dyspepsia Clinical Trials

Effect of Gingest on Symptoms of Dyspepsia

Start date: March 13, 2018
Phase: N/A
Study type: Interventional

This is a randomised, double-blind, placebo controlled study on the effect of Gingest (ginger root extract) on symptoms of dyspepsia in 150 participants with mild to moderate dyspepsia.

NCT ID: NCT03544372 Completed - Concussion, Mild Clinical Trials

Reliability of Self-reported Concussion History in Current Rugby Union Players

Start date: March 15, 2017
Phase:
Study type: Observational

Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.

NCT ID: NCT03537651 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

Start date: April 25, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

NCT ID: NCT03530306 Completed - Tinnitus Clinical Trials

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

TENT-A2
Start date: March 20, 2018
Phase: N/A
Study type: Interventional

This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.