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NCT ID: NCT04126473 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele

Start date: November 5, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically similar nonsense allele. Up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to G542X, and the remaining patients will be compound heterozygotes with G542X or phenotypically similar nonsense mutation and any Class 1 or Class 2 mutation. Each patient will receive 5 escalating doses as follows: - 0.3 mg/kg per day SC - 0.75 mg/kg per day SC - 1.5 mg/kg per day SC - An individualized dose, as high as 3.0 mg/kg per day SC, based upon the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests - ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid

NCT ID: NCT04121221 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks

NCT ID: NCT04118465 Completed - Clinical trials for Breech Presentation; Before Labor

Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder

ECVBLADDER
Start date: January 2002
Phase: N/A
Study type: Interventional

A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.

NCT ID: NCT04106557 Completed - Clinical trials for Primary Disease or Condition Being Studied: Angelman Syndrome (AS)

A Study of OV101 in Individuals With Angelman Syndrome (AS)

NEPTUNE
Start date: September 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.

NCT ID: NCT04104165 Completed - Retention, Urinary Clinical Trials

Treatment of Postpartum Urinary Retention

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.

NCT ID: NCT04102007 Completed - Plaque Psoriasis Clinical Trials

A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Start date: November 12, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

NCT ID: NCT04098224 Completed - Malnutrition Clinical Trials

Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study

Start date: January 12, 2020
Phase: N/A
Study type: Interventional

The smART+ is a comprehensive modular patient care system intended for ICU patients. The main purpose of the study is the optimization of the delivery of nutrition. The use of the smART+ Feeding tube includes a feature of facilitating correct tube placement and alerting when the tube is displaced during ongoing use. The system will automatically stop feeding if displacement is detected. If a massive reflux episode is detected by the system, a balloon located on the tube will automatically inflate and automatic GRV feature will open to prevent gastric content from regurgitating to the esophagus. In addition to tube placement, the system allows to obtain REE (Resting Energy Expenditure) measurements and calculates the optimized nutritional values required by the patient. Furthermore, the system optimizes feeding by compensating for any lost feeding time or discarded nutritional content that was discarded via the GRV (Gastric Residual Volume). Study participants will be randomly assigned to a study group: Group A- ICU patients receiving the investigational device ("Treated"). Group B- Control group.

NCT ID: NCT04095377 Completed - Healthy Clinical Trials

Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.

Start date: March 24, 2019
Phase:
Study type: Observational

DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.

NCT ID: NCT04089566 Completed - Clinical trials for Muscular Atrophy, Spinal

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

DEVOTE
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).

NCT ID: NCT04087317 Completed - Pain Clinical Trials

Vaginal Postpartum Pain Management Protocol Comparison

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.