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NCT ID: NCT03826134 Completed - Parkinson Disease Clinical Trials

A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects

Start date: January 17, 2019
Phase: Early Phase 1
Study type: Interventional

This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4 receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's disease.

NCT ID: NCT03823027 Completed - Overweight Clinical Trials

STAR Study Investigating Performance and Safety of the Medical Device SiPore15™

Start date: January 28, 2019
Phase: N/A
Study type: Interventional

The primary objective of STAR01 is to evaluate the performance and safety of the medical device (class IIb) SiPore15™ after a 12-week long treatment in the target population of obese and overweight subjects with prediabetes or newly diagnosed type 2 diabetes. The expected performance and safety of the device is based on the safety and efficacy results seen in an earlier First-in-Man (FIM) study. The safety and tolerability of SiPore15™ is based on the well-established and extensive use of food grade silicon dioxide and favorable data from the FIM study. Data on side-effects will be collected for verification of device safety. The study duration is 24 weeks in total, 12 weeks from baseline on investigational medicinal device (IMD) treatment, with additional 12 weeks off treatment. The study population is planned for forty (40) subjects to be enrolled, male and females, age >18 years and fulfilling all inclusion criteria but none of the exclusion criteria.

NCT ID: NCT03822533 Completed - Clinical trials for Osteoarthritis, Knee

A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care

Start date: February 7, 2019
Phase: N/A
Study type: Interventional

Background: Almost half of the Swedish population are overweight or obese. This will probably affect the incidence of osteoarthritis since overweight is a strong risk factor. Osteoarthritis consultations is expected to increase with 30-50% within the next 20 years. Today, in Swedish primary care, both physicians and physiotherapists are primary assessors for patients with suspected knee osteoarthritis. A task shifting with physiotherapists as the only primary assessor could increase the access rate to physicians in primary care for patients with more severe disorders. Yet, it is unclear what effects these different healthcare processes have and the costs of it. Purpose: The overall purpose of this study is to perform an economic evaluation of two healthcare processes, where a healthcare process initiated by a physiotherapist is compared with when it is initiated with a physician for patients with suspected knee osteoarthritis. Methods: 100 patients will be randomized either to a physiotherapists or to a physician for first assessment, diagnosis and treatment. Measurements of health-related quality of life and costs for visits to physiotherapists, physician or other healthcare provider, drug prescriptions and sick-leave will be collected. A cost-effectiveness analysis will be conducted, presenting incremental cost-effectiveness ratio (ICER) and a non-parametric bootstrapping will be conducted to demonstrate the uncertainties surrounding the ICER. Expected results: It is expected that this randomized controlled study will show the effects on quality adjusted life years, cost-efficiency and cost-utility of two different primary assessors for patients with suspected knee osteoarthritis consulting primary care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with suspected knee osteoarthritis in primary care.

NCT ID: NCT03821116 Completed - Inflammation Clinical Trials

Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation

Start date: January 7, 2019
Phase: N/A
Study type: Interventional

This study evaluates a high intake of milk compared with a high intake of soured milk (Swedish filmjölk) on markers of oxidative stress and inflammation in a randomized crossover intervention study.

NCT ID: NCT03818607 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

DAHLIA
Start date: January 22, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

NCT ID: NCT03817463 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Start date: April 15, 2019
Phase:
Study type: Observational

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

NCT ID: NCT03814187 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

ORION-8
Start date: April 16, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.

NCT ID: NCT03813160 Completed - Dermatomyositis Clinical Trials

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

DETERMINE
Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

NCT ID: NCT03812978 Completed - Clinical trials for Flexor Digitorum Profundus Injury

Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Can a mobile application improve adherence, self-efficacy and range of motion after flexor tendon repair? A randomized controlled multicenter trial. Aim Evaluate how the use of a mobile application will affect exercise adherence, range of motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair. Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I or II were included and rehabilitated with early active motion and followed 12 weeks post-surgery. Randomization was performed by a computer-generated concealed block to control (n=60) or intervention group (n=60). Both groups received standard rehabilitation according to early active motion. Intervention group also received a smart phone app including; exercise videos, push-notifications for exercise, exercise diary, written information on the surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and 12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and information.

NCT ID: NCT03812757 Completed - Clinical trials for Central Venous Catheter Placement

Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization

Start date: January 18, 2019
Phase:
Study type: Observational [Patient Registry]

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.