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NCT ID: NCT03467958 Recruiting - Crohn Disease Clinical Trials

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Start date: August 24, 2018
Phase: Phase 3
Study type: Interventional

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03466827 Recruiting - Thymoma Clinical Trials

Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

TET-SEL
Start date: October 12, 2017
Phase: Phase 2
Study type: Interventional

The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients). There are two study arms: Arm A: Thymoma - Stage 1: 15 patients - Stage 2: 10 patients Arm B: Thymic carcinoma - Stage 1: 15 patients - Stage 2: 10 patients

NCT ID: NCT03464097 Recruiting - Crohn Disease Clinical Trials

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03449381 Recruiting - Neoplasms Clinical Trials

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

NCT ID: NCT03444571 Recruiting - Clinical trials for Prosthesis-Related Infections

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

PRO-DIAG
Start date: February 16, 2018
Phase: N/A
Study type: Interventional

Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase. Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis. Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy. The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .

NCT ID: NCT03443817 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up

2-TELEKOL
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Introduction In order to guarantee chronic patients & elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life. Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD. Method and material The study is a prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation. Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.

NCT ID: NCT03435679 Recruiting - Clinical trials for Periprosthetic Knee Infection

One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty. Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure. The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.

NCT ID: NCT03432286 Recruiting - Episodic Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

REBUILD-1
Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

NCT ID: NCT03431727 Recruiting - Clinical trials for Cardiovascular Diseases

Acromegaly - Before and After Treatment

Start date: October 1, 2017
Phase:
Study type: Observational

The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.

NCT ID: NCT03426956 Recruiting - Overweight Clinical Trials

Glucose Absorption and Gut Hormone Secretion After Gastric Bypass

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.