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NCT ID: NCT02197416 Completed - Clinical trials for Venous Thromboembolism

Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

Start date: September 29, 2014
Phase: Phase 3
Study type: Interventional

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.

NCT ID: NCT02197195 Completed - Glycemic Control Clinical Trials

Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children

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

The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.

NCT ID: NCT02197130 Completed - Clinical trials for Huntington's Disease

Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.

NCT ID: NCT02196974 Completed - Lung Nodules Clinical Trials

Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy

Start date: January 2013
Phase: N/A
Study type: Interventional

In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies obtained with flexible cryoprobes compared to standard techniques? For patients with peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue to be obtained and therefore, will increase the diagnostic yield over conventional techniques

NCT ID: NCT02196662 Completed - Healthy Clinical Trials

Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers

IBD98-M
Start date: July 2014
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to compare the rate and extent of absorption of mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x 400 mg delayed-release capsule under fasting conditions.

NCT ID: NCT02196298 Completed - Cerebral Palsy Clinical Trials

A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. The purpose of this two-group randomized study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on walking abilities and related function. The primary (alternate) hypothesis is that children will improve more with Lokomat training in terms of gross motor skills and walking endurance. The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20). In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done first is decided by an independent randomization process that occurs after the first baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities. There is a 6 week break between the Lokomat and PT interventions. Each child has four study assessments during their ~6 months in the study. The first assessment is done before starting the Lokomat or physiotherapy phase. The second happens after the first intervention has finished. The child then has a 6-week break period. The third assessment is done at the end of this break, and the fourth occurs after the second intervention. The PT assessor who does these assessments will not be the same as the PT who gives the intervention. The assessor is blinded to the child's intervention phase and previous assessment results. The primary outcome measures are the Gross Motor Function Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities, participation, health related quality of life and individualized goals. The randomized aspect of the study lets us look at outcome differences between children for Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase evaluates within-child outcomes across the two phases. A qualitative component is concurrently underway to examine child/parent experiences and their views of Lokomat outcomes.

NCT ID: NCT02195245 Completed - CO2 Removal Clinical Trials

A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate

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

CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

NCT ID: NCT02194985 Completed - Fabry Disease Clinical Trials

Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease

Start date: March 14, 2015
Phase: Phase 3
Study type: Interventional

This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.

NCT ID: NCT02194699 Completed - Uncontrolled Asthma Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

STRATOS2
Start date: October 30, 2014
Phase: Phase 3
Study type: Interventional

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

NCT ID: NCT02194595 Completed - Type 2 Diabetes Clinical Trials

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

PREVAIL
Start date: September 2014
Phase: Phase 3
Study type: Interventional

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a randomized controlled trial to determine whether combining basal insulin with a new medication called exenatide is a therapeutic strategy that can preserve beta-cell function early in the course of type 2 diabetes.