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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: 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: NCT02495844 Completed - Clinical trials for Highly Drug-resistant Focal Epilepsy

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

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: NCT02493868 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

SUSTAIN-1
Start date: October 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

NCT ID: NCT02493166 Completed - Multiple Sclerosis Clinical Trials

Dual Task Cost in the Upper Limb in Persons With Multiple Sclerosis

DTC
Start date: March 2016
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults. Because the lesions are spread in the brains, there is a variety of symptoms. The most common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after 15 years, have problems with movements in one or both upper extremities. Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although they are less visible, they can have a major determining influence on social or work-related domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of information processing, impaired memory and limited executive functions. When a combination, of motor and cognitive task, is asked, the execution of these tasks could be difficult with the foregoing in mind. For example problems during chatting while cooking, typing a report at a meeting or watching television while ironing. The dual-task paradigm assumes that the attention should be divided between two simultaneous tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the separate task versus simultaneously. Research on dual tasking with persons with MS has already studied extensively, but not specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research on the DTC. They combined the movements of the upper limb with a cognitive task. The research showed a difference between Persons with MS and the control group. At methodological level, there is lacking on the randomization of tasks. That is an important bias because of the learning effect of the tasks. They used only one task for the upper limb; this isn't enough to generalize the concept of motor interference in Persons with MS. The study has two research questions: - Have Persons with MS a greater DTC compared with a healthy control group? The motor task is executed with the upper limb. - Is there a difference on DTC in persons with MS depending on the motor task? This research is an observational case-control study in which individuals with MS will be compared to a healthy control group. They will be two moments of assessments. On the first day the general performance of the persons will be measured, by using clinical evaluation tests and questionnaires. On the second day they will be tests on the dual tasks, specific a comparison between single versus simultaneously performed tasks.

NCT ID: NCT02492815 Completed - Melanoma Clinical Trials

PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced Melanoma

Start date: October 31, 2013
Phase:
Study type: Observational

Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

NCT ID: NCT02492711 Completed - Clinical trials for HER-2 Positive Breast Cancer

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

SOPHIA
Start date: August 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.