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NCT ID: NCT02884180 Recruiting - Pain, Postoperative Clinical Trials

DEXRAR: DEXamethasone in Revision ARthroplasty

DEXRAR
Start date: May 31, 2017
Phase: Phase 4
Study type: Interventional

Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial Trial acronym: DEXRAR Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy. Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v. Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients. Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.

NCT ID: NCT02872662 Recruiting - MDS Clinical Trials

Individual Molecular MRD Monitoring for MDS Patients After Allo-SCT

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

This study aims to develop highly sensitive methods for early detection of relapse based on the patients unique mutations. Initially, a mutational screen is being performed. Primers directed against these mutations will be constructed and presence of mutations will be followed in bone marrow and blood frequently after transplantation.

NCT ID: NCT02869048 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis and the Innate Immune System

Start date: June 2016
Phase: N/A
Study type: Observational

Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to destruction of the neural pathways which control the conscious movements of the muscles. This destruction leads to muscular dystrophy with increasing difficulties in moving, breathing, swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the time he or she gets the diagnose. The cause of the disease is still unknown and there is currently no treatment which can stop the progression of the disease. Former clinical studies have indicated that the innate immune system and in particular the complement system plays a significant role in the progression of ALS. The complement system, which is activated in cascades, is part of the innate system but participates in the innate as well as the acquired immune system. Former clinical trials have been characterized by limited knowledge about both the complement system as well as to how it is measured. Today it is possible to measure directly on the different components of the complement system and to understand its contribution to the overall immune response. It is also possible today to detect defects of the complement system. All these progressions are the foundation for this project which is carried out in close cooperation with one of the world's leading researchers in the complement system, professor Peter Garred from Rigshospitalet. The aim is to make a national research project about ALS in order to investigate the role of the innate immune system, and especially the complement system, in patients with ALS. In the long term the hope is, that this will lead the way to a targeted and effective medical treatment to the people affected by this grave disease.

NCT ID: NCT02867657 Recruiting - Inflammation Clinical Trials

Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.

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

The purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at Danish Universities and University Colleges. Secondary whether the expression of inflammatory markers can be reduced . It is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.

NCT ID: NCT02866305 Recruiting - Clinical trials for Primary Spontaneous Pneumothorax

Study Designed to Optimize the Treatment of Primary Pneumothorax

TOPP
Start date: March 2009
Phase: Phase 0
Study type: Interventional

Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.

NCT ID: NCT02861573 Recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Start date: November 17, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.

NCT ID: NCT02858258 Recruiting - Clinical trials for Mantle Cell Lymphoma

ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

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

The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.

NCT ID: NCT02829736 Recruiting - Pain Clinical Trials

ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

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

Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease. Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.

NCT ID: NCT02829502 Recruiting - Ischemic Stroke Clinical Trials

The Effect of GLP-1 Receptor Agonist on Cerebral Blood Flow Velocity in Stroke

EGRABIS1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This randomized controlled trial investigates the effect of a single dose of glucagon-like peptide-1 (GLP-1) receptor agonist in the subacute phase of stroke in humans. The primary endpoint is the mean flow velocity in the middle cerebral arteries measured by transcranial doppler and cortical oxygination measured by near infrared spectroscopy (NIRS). The secondary endpoints are changes in endothelial/inflammatory biomarkers in the blood, changes in the ankle-brachial index and changes in the reactive hyperaemia index measured by EndoPAT2000.

NCT ID: NCT02826863 Recruiting - Dravet Syndrome Clinical Trials

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Start date: July 15, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All subjects will be titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects will continue treatment at their randomly assigned dose over a 12-week Maintenance Period. Total treatment time from the beginning of the Titration Period through the end of the Maintenance Period is 14 weeks.