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NCT ID: NCT02916446 Completed - Peanut Allergy Clinical Trials

Safety Study of Viaskin Peanut to Treat Peanut Allergy

REALISE
Start date: October 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.

NCT ID: NCT02915848 Completed - Parkinson's Disease Clinical Trials

Long-term Stability of LFP Recorded From the STN and the Effects of DBS

Start date: September 9, 2016
Phase:
Study type: Observational

Movement disorders such as Parkinson Disease, dystonia, and tremor are related to abnormalities of part of the brain known as the basal ganglia. Recently, it has been suggested that the basal ganglia works by oscillations (group of neurons cycle between activation/deactivation when stimulated) of electrical signals. A treatment that involves insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known as deep brain stimulation (DBS), is an established treatment for advanced Parkinson's disease. However its mechanism of action is still not completely understood. Currently, DBS utilizes an "open loop" system whereby the stimulation settings are manually adjusted depending on the patients' clinical response. 1. Determine whether the local field potential (LFP) recorded from the STN is stable over a 1.5 year period. 2. Address whether STN LFP is a suitable control signal, and how it should be used to change DBS parameters

NCT ID: NCT02915744 Completed - Breast Cancer Clinical Trials

A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

ATTAIN
Start date: November 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

NCT ID: NCT02915705 Completed - Clinical trials for X-Linked Hypophosphatemia

Efficacy and Safety of Burosumab (KRN23) Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)

Start date: September 8, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).

NCT ID: NCT02915640 Completed - Acute Disease Clinical Trials

Use of a Mobile Remote Device to Optimize Pediatric Inter-facility Transportation: A Feasibility Study

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

This study compares the utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.

NCT ID: NCT02915627 Completed - Blood Pressure Clinical Trials

Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments

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

Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.

NCT ID: NCT02915471 Completed - Cancer Clinical Trials

Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Cancer

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

The overall aim of this research program is to develop and examine the impact of a Cancer virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the Skype-based VP2P program providing peer-support from mentors and the magnitude of program effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT will enable us to refine the program and determine the appropriate sample size for a future large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at a major Children's Oncology Group- affiliated centers in Canada and the United States.

NCT ID: NCT02915185 Completed - Stroke Clinical Trials

Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors

Start date: April 28, 2017
Phase: N/A
Study type: Interventional

A substantial proportion of individuals are left with poor residual functioning of the affected arm after a stroke. This has a tremendous impact on the quality of life and the ability for stroke survivors to live independently. While exercise is considered essential to any rehabilitation program, its benefits are generally far from optimal because of the lack of proper dosing in terms of intensity. One way to tackle this problem is to develop better tools that could predict an individual's potential and then adjust the intensity of exercise accordingly. One such predicting tool exists and consists of using non-invasive brain stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of descending motor pathways originating from the brain. TMS consists of applying a magnetic wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of the current proposal is to use TMS to test the integrity of the motor pathway in chronic stroke survivors. The level of responses to TMS will be used to classify participants in terms of potential for recovery and then, to determine the optimal level of exercise. The study will also examine the effect of another non-invasive brain stimulation technique called transcranial Direct-Current Stimulation-tDCS to determine whether it can enhance the response to strength training exercise in the affected arm. Half of the participants will be trained with the tDCS on, while the other half will be trained with the stimulator off. The training program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be performed to determine the impact of the strength training intervention on participants. Overall, the proposed project is expected to have a positive and significant impact on stroke survivors' quality of life.

NCT ID: NCT02914561 Completed - Crohn's Disease Clinical Trials

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

DIVERSITY1
Start date: October 31, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

NCT ID: NCT02914522 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

SELECTION
Start date: November 14, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).