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NCT ID: NCT02906124 Terminated - Pregnancy Clinical Trials

Study to Evaluate the Safety of Repatha® in Pregnancy

Start date: January 12, 2017
Phase:
Study type: Observational

To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

NCT ID: NCT02906020 Terminated - Parkinson's Disease Clinical Trials

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

MOVES-PD
Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

NCT ID: NCT02905747 Completed - Clinical trials for Osteoarthritis, Knee

The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis

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

The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients

NCT ID: NCT02905630 Recruiting - Angina Clinical Trials

The Syndrome X-ercise Study SYNDEX

SYNDEX
Start date: January 2014
Phase: N/A
Study type: Interventional

This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart rate variability, endothelial function and quality of life in patients with no obstructive coronary artery disease and angina.

NCT ID: NCT02905383 Completed - Stroke Clinical Trials

The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital

OLPADIS
Start date: September 29, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital. The intervention consists of 32 group-based exercise sessions, performed twice a week. In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly. The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.

NCT ID: NCT02904291 Recruiting - Obesity, Morbid Clinical Trials

Bariatric Surgery and Pharmacokinetics of Amlodipine

Start date: November 2016
Phase:
Study type: Observational

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on amlodipine.

NCT ID: NCT02903251 Completed - Clinical trials for Substance-Related Disorders

Oxytocin and Alcohol Withdrawal and Dependence

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

This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.

NCT ID: NCT02901886 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

REU-stop - Effect of Intensive Smoking Cessation Intervention on Smoking Cessation and Disease Activity in Patients With Rheumatoid Arthritis.

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

This study aims to test the effect of an intensive smoking cessation intervention (motivational counseling combined with nicotine replacement) on smoking cessation and disease activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in a smoking cessation intervention; the other half will receive usual treatment.

NCT ID: NCT02901457 Completed - Quality of Life Clinical Trials

"The Healthy Body Image" (HBI) Program: A Program to Promote a Positive Body Image

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

Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive to accomplish the "perfect body". At the same time, only 50 % meet the government's recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical and psychological health. These factors, along with the pressure to obtain the "perfect" body, are threatening the adolescent's physical and psychological health, jfr. Meld St nr 19. It is now a need for knowledge on how the investigators can contribute to promote positive body experience among the adolescents. It has recently, through a controlled study on elite youth athletes at Norwegian sports high schools, been shown that it is possible to change eating habits, improve body image and reduce new cases of eating disorder. It is now desirable to test an adapted program through a school-based program at regular Norwegian high school students (12th grade). Today, no controlled, school-based intervention studies with long-term follow-up have been conducted. The main aim of this project is to investigate if it is possible, through a school-based intervention program (Healthy Body Intervention), to promote positive body image, increase physical activity level, and healthy eating and sleeping habits in both boys and girls at Norwegian high schools. The intervention program will contribute with new evidence-based knowledge on the effect of an adapted health-promoting program.

NCT ID: NCT02900378 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

OUTSTEP-HF
Start date: December 20, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).