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NCT ID: NCT03582007 Terminated - Pneumonia Clinical Trials

Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas

PRISM-UDR
Start date: October 22, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

NCT ID: NCT03580356 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Start date: October 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

NCT ID: NCT03580083 Active, not recruiting - Hurler Syndrome Clinical Trials

RGX-111 Gene Therapy in Patients With MPS I

Start date: April 3, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

RGX-111 is a gene therapy which is intended to deliver a functional copy of the α-L-iduronidase (IDUA) gene to the central nervous system. This is a safety and dose ranging study to determine whether RGX-111 is safe and tolerated by patients with MPS I.

NCT ID: NCT03578809 Completed - Clinical trials for ST Elevation Myocardial Infarction

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

REAL-TIMI 63B
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.

NCT ID: NCT03578250 Recruiting - Stroke Clinical Trials

Error Augmentation Training Post Stroke

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

Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke. The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke. Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field. Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.

NCT ID: NCT03577353 Completed - Stroke Clinical Trials

Dual-task Training Using Virtual Reality

Start date: October 30, 2013
Phase: N/A
Study type: Interventional

The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors

NCT ID: NCT03575481 Completed - Stroke Clinical Trials

Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke

Start date: September 30, 2015
Phase:
Study type: Observational

The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.

NCT ID: NCT03574597 Completed - Obesity Clinical Trials

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

SELECT
Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

NCT ID: NCT03574558 Completed - Type1diabetes Clinical Trials

Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study

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

The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components: A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy. B. MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections). This feasibility study will be divided to two parts: part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.

NCT ID: NCT03573505 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis

SPIRIT
Start date: September 24, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.