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NCT ID: NCT01778972 Completed - Physical Activity Clinical Trials

Fall Prevention for Old Community-dwelling People

Start date: November 2012
Phase: N/A
Study type: Interventional

Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.

NCT ID: NCT01778673 Completed - Clinical trials for Distal Radius Fracture

Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study

Start date: October 2009
Phase: N/A
Study type: Observational

Background: Although fractures of the distal radius are the most common skeletal injury, the utility of the available classification systems to predict fracture stability is limited. We studied if cortical comminution and intra-articular involvement can assess instability in fractures of the distal radius. Methods: A prospective multicenter study was conducted. Distal radius fractures in 417 skeletally mature patients (428 fractures) were studied. Fractures were divided into osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and lateral plain radiographs determined if the fractures were minimally displaced or displaced. The fracture patterns were evaluated depending on the presence and the site of cortical comminution and intra-articular involvement according to a new classification system (Buttazzoni classification). Minimally displaced fractures were treated with cast immobilization. Displaced fractures underwent closed reduction with subsequent cast immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months. Displacement was classified as primary instability, secondary instability or late instability. Endpoints were union of the fracture or re-displacement. Results: Volarly comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni 3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni 1) in 16 % of the cases. One third of the initially minimally displaced fractures did not maintain acceptable alignment. All initially displaced volarly comminuted fractures were unstable. In both initially displaced and minimally displaced fractures, cortical comminution and intra-articular involvement were predictive for primary, secondary and late instability. Conclusions: Cortical comminution and intra-articular involvement seem to be valuable instruments for assessing stability at initial presentation of distal radius fractures. Level of Evidence: Level I, prospective multicenter study. Prognostic study.

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01774695 Completed - Clinical trials for Irritable Bowel Syndrome (IBS)

Physical Activity in IBS - a Long Term Follow up

IBS
Start date: June 2011
Phase: N/A
Study type: Interventional

Increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term effects of the investigators previous intervention in IBS patients to improve physical activity. The investigators aimed to assess the long term effects on IBS symptoms as well as quality of life, fatigue, depression and anxiety.

NCT ID: NCT01774084 Completed - Insulin Sensitivity Clinical Trials

Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.

NCT ID: NCT01773668 Completed - Type 2 Diabetes Clinical Trials

Feasibility Study - Integrated Sensor and Infusion Set. Trial III

Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.

NCT ID: NCT01772576 Completed - Tachycardia Clinical Trials

Safety and Performance Study of the Reliance 4-Front Lead

Start date: October 2012
Phase: N/A
Study type: Interventional

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Active Fixation Defibrillation Leads.

NCT ID: NCT01772199 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

Start date: February 2013
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate.

NCT ID: NCT01768572 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Start date: March 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

NCT ID: NCT01768390 Completed - Dental Caries Clinical Trials

Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients

Start date: January 2008
Phase: Phase 4
Study type: Interventional

AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed orthodontic appliances (FOA). The null hypothesis is that neither incidence nor severity of lesions would differ from a control group using standard fluoride dentifrice. SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4 Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the maxillary incisors, canines and premolars are taken. At debonding, remaining composite material on the surfaces is removed with a slow rotating carbide bur followed by polishing with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is thereafter exposed. The primary outcome measure is the incidence and severity of WSL as registered separately by two blinded experienced and calibrated clinicians according to a validated index. A random sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The intervention is indended run throughout the full duration of the orthodontic treatment, varying between 18 and 24 months.