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NCT ID: NCT02688231 Completed - Multiple Sclerosis Clinical Trials

Task-oriented Upper Limb Training in MS

Start date: January 2016
Phase: N/A
Study type: Interventional

An adequate upper limb function is crucial to independently perform Activities of Daily Living (ADL). Persons with neurological diseases often experience upper limb dysfunction. Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall disability level, while the detrimental impact on ADL is higher than in stroke, given that symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar rehabilitation principles and effect sizes apply in MS given that this progressive neurodegenerative disease is characterized by multiple lesions and atrophy of brain structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not known in the MS literature neither were characteristics of responders identified. The aim of this explorative study is to investigate the intensity dependent clinical effects of a task-oriented upper limb training in persons with MS with different upper limb disability levels.

NCT ID: NCT02686346 Completed - Hodgkin Disease Clinical Trials

Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE

BV-ICE
Start date: March 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

NCT ID: NCT02684760 Completed - Healthy Clinical Trials

Bioavailability Study Of PF-06651600 In Healthy Subjects

Start date: February 2016
Phase: Phase 1
Study type: Interventional

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

NCT ID: NCT02684058 Completed - Glioblastoma Clinical Trials

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

Start date: December 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

NCT ID: NCT02683083 Completed - Breast Cancer Clinical Trials

Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients

CAM-VHH1
Start date: October 2016
Phase: Phase 1
Study type: Interventional

Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer. Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.

NCT ID: NCT02682979 Completed - Geriatrics Clinical Trials

Continuity of the Therapeutic Limitation Code: Analysis of the Variables of Admission in the Emergency Service That Are Associated With a Therapeutic Limitation Upon Exit

Start date: February 1, 2016
Phase: N/A
Study type: Observational

Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services. Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code. As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered. The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department.

NCT ID: NCT02682927 Completed - Dravet Syndrome Clinical Trials

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

Start date: January 15, 2016
Phase: Phase 3
Study type: Interventional

Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.

NCT ID: NCT02682381 Completed - Clinical trials for Short Bowel Syndrome

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

Start date: June 23, 2016
Phase: Phase 3
Study type: Interventional

Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

NCT ID: NCT02681354 Completed - Clinical trials for Mild Cognitive Impairment

Dual Task Training in Elderly Using the BioRescue

Start date: November 2015
Phase: N/A
Study type: Interventional

Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality), institutionalized elderly people with MCI will relearn dual tasks in combination with balance. Afterwards, the transferring effect on gait in general, balance and cognition will be examined.

NCT ID: NCT02680756 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).