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NCT ID: NCT03011853 Completed - Critical Care Clinical Trials

Survival After Failed First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease

Start date: January 2008
Phase:
Study type: Observational [Patient Registry]

Observational cohort study of mid-to-long term survival of patients with acute on chronic obstructive pulmonary disease, analyzed per type of ventilation support provided during first 24 hours in intensive care.

NCT ID: NCT03011424 Completed - Clinical trials for Post Hepatectomy Liver Failure

Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)

Start date: October 2013
Phase: N/A
Study type: Interventional

Early postoperative extracorporal liver support therapy (ELS) as a tool to manage post hepatectomy liver failure (PLF). Post-operative liver failure (PLF) has been identified as a major risk factor leading to increased morbidity and mortality. The incidence of PLF varies largely between 0-30%, and may be accounted for the main reason of postoperative mortality related to liver surgery (reported figures ranging from 18 to 75 %). Currently, there are only a few treatment options for PLF, mainly restricted to the treatment of complications like bile leakage, infections as well as the prevention of further liver damage caused by e.g. thrombosis or haemorrhage as well as administration of liver toxic drugs. Recently the international study group on liver surgery (ISGLS) published criteria for a new definition of PLF which will greatly facilitate the comparison of results from future studies on a variety of aspects on liver failure. ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified haemodialysis that allows the removal of water-soluble and protein bound toxins over an albumin-coated high flux membrane against recycled exogenous albumin. Thus, MARS can support the compromised detoxification capacity of the liver as well as improve physiological parameters. This would offer the potential for temporary support for the harmed liver after liver resection allowing for a more uneventful recovery. For obvious reasons previous reports contain few patients, present heterogonous treatment groups and all suffer from lack of standardized treatment protocols. Few if any surviving patients, thus providing no evidence to encourage ELS as a possible treatment option for patients suffering of PLF. However, studies with defined patient populations and treatments according to a predefined standardised treatment protocol are warranted. Primary issues to be addressed: 1. Can ELS be applied in an early phase of PLF? 2. Is ELS safe and feasible for the treatment of PLF when practised according to a predefined protocol? Secondary issues to be addressed: 1. The development of predictive laboratory-chemical markers of liver failure 2. Indirect measures of portal flow and portal pressure 3. Indocyanine green clearance (ICG) under ELS treatment 4. Clearance of toxic products as assessed in aliquots taken from the dialysate

NCT ID: NCT03003975 Completed - Atrial Fibrillation Clinical Trials

Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

SD-CRYO-AF
Start date: November 2014
Phase: N/A
Study type: Interventional

This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).

NCT ID: NCT03001193 Completed - Labor, Obstetric Clinical Trials

Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. The intravenous infusion will be initiated by a pre-defined bolus dose infusion.

NCT ID: NCT03001154 Completed - Anxiety Clinical Trials

Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software

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

Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.

NCT ID: NCT03000972 Completed - Clinical trials for Intertrochanteric Fracture

PFN-A Augmentation for Intertrochanteric Femoral Fractures

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

This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

NCT ID: NCT03000452 Completed - Multiple Myeloma Clinical Trials

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

FUSION-MM-005
Start date: March 14, 2017
Phase: Phase 2
Study type: Interventional

This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2 weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.

NCT ID: NCT02999997 Completed - Parkinson Disease Clinical Trials

Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease

RGM/PD
Start date: January 2017
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner Method (RGM) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. The aim with the present randomized controlled single-blinded trial is to evaluate the RGM with main focus on dual-task performance, compared to a control group, in individuals with PD. The control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention. Following outcome measures will be analyzed: 1. dual task performance (motor-motor, and motor-cognitive) 2. level of physical activity, motor function and balance 3. cognitive function including memory and spatial function 4. health-related quality of life, fear of falling, and freezing of gait 5. qualitative interviews from focus group discussions

NCT ID: NCT02999412 Completed - Medication Review Clinical Trials

Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial

MedBridge
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence. Aim: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews. Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial. Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties. Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion criteria: Palliative stage; residing in other than the hospital's county; medication review within the last 30 days; one-day admission. Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care. Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up period. Data collection and analyses: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using log-linear Poisson generalized linear mixed models and frailty models. Relevance: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.

NCT ID: NCT02998996 Completed - Influenza, Human Clinical Trials

Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

Start date: September 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.