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NCT ID: NCT02497469 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Start date: June 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

NCT ID: NCT02497287 Completed - Clinical trials for Treatment-resistant Depression

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

SUSTAIN-2
Start date: September 30, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

NCT ID: NCT02496767 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year

VITALITY-ALS
Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

NCT ID: NCT02496377 Completed - Knee Arthroplasty Clinical Trials

Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Cross Iron
Start date: August 29, 2014
Phase: N/A
Study type: Interventional

Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

NCT ID: NCT02496325 Completed - Clinical trials for Pudendal Nerve Block

Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility

Start date: September 2014
Phase: N/A
Study type: Interventional

Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under ultrasound-guidance. Methods : Successive inclusions after parental consent of 60 children undergoing perineal surgery under general anesthesia and pudendal nerve block. Data were collected from induction of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease of PNB achievement was the primary objective evaluated. Efficiency in preoperative and postoperative period was also reported.

NCT ID: NCT02495974 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

PREMISE
Start date: September 8, 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

NCT ID: NCT02495090 Completed - Hypospadias Clinical Trials

Hypospadias and Exome: Identification of New Genes for Familial Hypospadias

Start date: November 13, 2014
Phase: N/A
Study type: Interventional

Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases. The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.

NCT ID: NCT02495051 Completed - Clinical trials for Gastroesophageal Reflux

Esophageal Atresia: Metaplasia, Barrett

Oesophagix
Start date: February 2010
Phase: N/A
Study type: Observational

The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

NCT ID: NCT02494648 Completed - Clinical trials for Acute Coronary Syndrome

Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome

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

Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]). If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.

NCT ID: NCT02494531 Completed - Alzheimer Disease Clinical Trials

Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

AVILL
Start date: December 12, 2015
Phase: N/A
Study type: Interventional

The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose - and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral metabolism dysfunction in literate versus illiterate MCI and AD patients.