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NCT ID: NCT03505125 Completed - Clinical trials for Phenylketonuria (PKU)

A Non-Interventional Interview Study of Phenylketonuria (PKU) Adults

165-901
Start date: March 31, 2018
Phase:
Study type: Observational

The 165-901 study is designed to identify the appropriate tools for use in future interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.

NCT ID: NCT03505099 Completed - Clinical trials for Spinal Muscular Atrophy

Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2

SPR1NT
Start date: April 2, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2

NCT ID: NCT03505021 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

REFALS
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

NCT ID: NCT03504943 Completed - Clinical trials for Intradialytic Hypotension

Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension

Start date: July 9, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. The investigators expect that there will be little to no difference in occurrence of IDH episodes between the two time periods based on the experience of the 3 centres and imaging studies of the heart with exercise in HD.

NCT ID: NCT03504852 Completed - Clinical trials for Moderate to Severe Chronic Plaque-type Psoriasis

Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis

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

The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.

NCT ID: NCT03504215 Completed - Clinical trials for Prematurity; Extreme

Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.

Start date: March 2, 2018
Phase: N/A
Study type: Interventional

In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.

NCT ID: NCT03504020 Completed - Heart Failure Clinical Trials

ECG Belt for CRT Response

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

The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

NCT ID: NCT03502980 Completed - Clinical trials for Central Venous Catheter

Safety and Efficacy of Midline and PICC

MidLine_PICC
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

NCT ID: NCT03502616 Completed - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Start date: June 7, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

NCT ID: NCT03502564 Completed - Clinical trials for PostTraumatic Stress Disorder

Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder

Start date: October 22, 2015
Phase: N/A
Study type: Interventional

Although psychotherapy for eating disorders (EDs) can be effective, approximately 50% of those who complete a course of the best available therapy continue to have significant ED symptoms at the end of treatment. Posttraumatic stress disorder (PTSD) commonly co-occurs with EDs and is thought to be one reason why some individuals do not remit from their ED with best available treatment or relapse following treatment. In particular, ED behaviours can function as coping methods for PTSD symptoms, and thus interfere with successful and lasting ED recovery. The main objective of this initial treatment trial is to determine whether a concurrent treatment approach, in which PTSD symptoms are treated at the same time as ED symptoms, provides an advantage over standard ED treatment by successfully alleviating PTSD symptoms. Forty participants who have both an ED and PTSD will be assigned to receive either (1) standard ED psychotherapy alone or (2) standard ED psychotherapy concurrent with PTSD psychotherapy. After treatment, participants will be followed for a period of 6 months to determine whether improvements made during therapy are maintained after treatment. ED and PTSD symptoms, as well as concomitant symptoms (e.g., anxiety and depression) will be assessed immediately before and after treatment, as well as 3 and 6 months after treatment.