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NCT ID: NCT02139306 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

Start date: August 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

NCT ID: NCT02138916 Completed - Clinical trials for Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

GALATHEA
Start date: June 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

NCT ID: NCT02138890 Completed - Clinical trials for Osteoarthritis, Knee

APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)

PROGRESS II
Start date: May 2014
Phase: N/A
Study type: Interventional

This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

NCT ID: NCT02137850 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

pathfinderâ„¢6
Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

NCT ID: NCT02137512 Completed - Type 1 Diabetes Clinical Trials

Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

CTR3
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.

NCT ID: NCT02137330 Completed - Clinical trials for Glycemic Intolerance

Obalon in Children With Severe Obesity

Obalon
Start date: January 2014
Phase: Phase 3
Study type: Interventional

The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity. Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients. Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.

NCT ID: NCT02137278 Completed - Hypotensive Syncope Clinical Trials

Stop Vasodepressor Drugs in Reflex Syncope

STOP-VD
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

NCT ID: NCT02137161 Completed - Cataract Clinical Trials

Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery

REPEX
Start date: November 2013
Phase: Phase 4
Study type: Interventional

OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution). DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial. PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31). INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons. Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.

NCT ID: NCT02136901 Completed - Osteoarthritis Clinical Trials

The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)

VENUS
Start date: June 2014
Phase: N/A
Study type: Interventional

The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

NCT ID: NCT02136693 Completed - Constipation Clinical Trials

Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT

Start date: May 2010
Phase: Phase 4
Study type: Interventional

This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency.