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NCT ID: NCT03115281 Recruiting - Clinical trials for Coronary Self Expanding Stent

Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice

WIN
Start date: March 20, 2017
Phase: N/A
Study type: Observational

WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.

NCT ID: NCT03114241 Completed - COPD Clinical Trials

Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

Start date: May 2, 2017
Phase: N/A
Study type: Interventional

Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

NCT ID: NCT03112603 Completed - Clinical trials for Graft-versus-host Disease (GVHD)

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Start date: June 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

NCT ID: NCT03112525 Completed - Clinical trials for Anticoagulants and Bleeding Disorders

DAPHNE Study: Direct Anticoagulant PHarmacogeNEtic

DAPHNE
Start date: June 28, 2017
Phase:
Study type: Observational

New/direct oral anticoagulants (NOAC/DOAC), like apixaban and rivaroxaban, are an interesting alternative to unfractionated or low molecular weight heparin relayed by oral anti-vitamin K anticoagulants (VKA) for the treatment of venous thromboembolism and atrial fibrillation. This new generation of anticoagulants directly inhibit a factor in the blood coagulation pathway and have a wide therapeutic range overcoming several practical issues associated with VKA therapy including the need of routine coagulation monitoring potentially simplifying patient management. However, despite this wide therapeutic range, a large interindividual dose variability related to factors such as age, body surface, smoking, concomitant diseases as well as differences in drug metabolism, could put susceptible patients at risk for uncontrolled bleeding. Both rivaroxaban and apixaban are cleared primarily via cytochrome P450 (CYP) mediated hepatic metabolism, mainly CYP3A, and renal excretion, involving the P-glycoprotein (P-gp). Both CYP3A and P-gp activity show important interindividual variations due to drug interactions and/or genetic polymorphisms in corresponding genes. The aim of the current study is to evaluate the impact of cytochrome activity and relevant polymorphisms on rivaroxaban/apixaban dosage regimen or treatment efficacy in a hospital setting. The safety issue in this context is particularly relevant, since hospitalisation is linked to a modification of the patient's treatment with often an increase in the number of medications. The resulting changes in metabolism due to modified cytochrome and transporter activities could affect rivaroxaban/apixaban blood concentrations. Our central hypothesis is that genotype and/or phenotype in CYP3A4/5/7 or P-gp may influence the rivaroxaban/apixaban plasma concentration and increase the risk of thrombotic or hemorrhagic events. Thus, investigating how the patient's genotype and/or phenotype for CYP3A4/5/7 and P-gp could potentially alter the bio-disponibility of rivaroxaban and apixaban and therefore the risk to develop adverse events or inefficacy would be of particular interest.

NCT ID: NCT03112395 Completed - Leg Ulcers Venous Clinical Trials

Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation

Start date: April 25, 2017
Phase: N/A
Study type: Interventional

The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Patients suffer from pain and immobility, which dramatically reduces their quality of life. Complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities. The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. The investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. By stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. It is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.

NCT ID: NCT03111407 Completed - Knee Osteoarthritis Clinical Trials

iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty

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

The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).

NCT ID: NCT03110393 Completed - Obese Clinical Trials

Ambu®AuraGain™ Versus I-gel® in Obese Patients

Start date: April 20, 2017
Phase: N/A
Study type: Interventional

The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients

NCT ID: NCT03110263 Terminated - Insomnia Clinical Trials

i-Sleep: Internet-based Treatment for Insomnia

i-Sleep
Start date: June 10, 2016
Phase: N/A
Study type: Interventional

In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.

NCT ID: NCT03110107 Terminated - Advanced Cancer Clinical Trials

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Start date: May 4, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

NCT ID: NCT03108768 Completed - Clinical trials for Hearing Loss, Bilateral Sensorineural, Progressive

Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.