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NCT ID: NCT02262299 Completed - Clinical trials for Disorder Related to Lung Transplantation

European Trial of Pirfenidone in BOS, A European Multi-center Study

EPOS
Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

A European multi-centre, randomised, double-blind placebo-controlled trial of Pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. Randomized double blinded, placebo controlled study. Eligible patients are to be randomized in a 1:1 ratio to receive either Pirfenidone 2403 mg/d or the matching placebo treatment for 6 months. Primary objective To evaluate the effect of Pirfenidone on the change in FEV1 in liters over 6 months in lung transplant recipients with bronchiolitis obliterans syndrome.

NCT ID: NCT02262052 Completed - Clinical trials for Deep Vein Thrombosis

Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

Theia
Start date: March 26, 2015
Phase: N/A
Study type: Interventional

The Theia-study is a prospective, multicenter, single-arm management (cohort) study. Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep vein thrombosis (DVT) of the leg, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion and will be managed according to the result of a magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be performed and adjudicated within 24 hours of study inclusion. The final treatment decision will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients will be treated with therapeutically dosed anticoagulants or modified in patients with a recurrent DVT on anticoagulant therapy. Patients with a negative MRDTI ruling will be left untreated, or treatment will be remained unadjusted if they are on anticoagulant treatment at inclusion. All patients with negative MRDTI will be subjected to a standardized compression ultrasonography (CUS) within 48 hours after initial presentation. The latter CUS serves as a reference test in case the patient returns with symptoms of ipsilateral recurrence in the future, and will not be used for management decisions at baseline. The study flowchart can be found in Appendix A. All patients will be followed for three months for the occurrence of acute recurrent venous thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up, MRDTI will be repeated.

NCT ID: NCT02261701 Completed - Rotator Cuff Injury Clinical Trials

Rehabilitation After Rotator Cuff Repair

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

A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

NCT ID: NCT02260674 Completed - Alzheimer's Disease Clinical Trials

A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities]).

NCT ID: NCT02258789 Completed - Stroke Clinical Trials

Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment

RehAtt
Start date: September 2010
Phase: N/A
Study type: Interventional

There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training. Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as well as before and after training with the new VR method Method:- An intense visio spatial scanning training, enhanced by directed visual, audio and tactile stimulation cues and feedback, also including visio-motor activation was designed in a VR game. The in-house developed software was based on the Tetris game. The VR method consists of an interactive 3D environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15 patients with chronic (>6 months) visio spatial neglect was included due to right-sided ischemia. A VR neglect test battery including a Posner task were repeated three times during a 5 weeks baseline before the training started (to establish the chronic state) and again after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training attention after stroke causing visio spatial neglect. The method has been designed for home rehabilitation and is well suited for a tele-medicine approach. It was built with standard components and is easy to manufacture at a low cost. The idea is to give access to effective training, to make it available at the stroke unit with the possibility for the patient to loan it it at discharge for home rehabilitation. The concept of an all in one, easy-to-use device for testing, training and outcome evaluation should be beneficial These preliminare results has been promising and indicates that the RehAtt™ method could become an further developed into an effective and stimulating intervention tool that would lower rehabilitation costs and reduce tiresome travelling to hospitals for training.

NCT ID: NCT02258542 Completed - Asthma Clinical Trials

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

BORA
Start date: November 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

NCT ID: NCT02257931 Completed - Clinical trials for Allogeneic or Autologous HSCT

Gram-negative Bacteremia in HSCT Recipients

GNB
Start date: February 2014
Phase: N/A
Study type: Observational [Patient Registry]

A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% - 42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more antibiotic classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR) strain (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC 11). These resistant bacteria may be associated with increased mortality and have limited treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the currently best empirical coverage and to control the growing resistance, knowledge of trends in antibiotic susceptibility, as well as risk factors is essential. For this reason we propose to perform non-interventional prospective multicentre study in EBMT centres.

NCT ID: NCT02256228 Completed - Pain Clinical Trials

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

IPLA
Start date: October 2014
Phase: Phase 3
Study type: Interventional

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

NCT ID: NCT02256189 Completed - Type 2 Diabetes Clinical Trials

Sitagliptin and Glucagon Counterregulation

SITACLAMP
Start date: April 2015
Phase: Phase 4
Study type: Interventional

To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

NCT ID: NCT02255656 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

TOPAZ
Start date: January 7, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: - To evaluate long term efficacy of alemtuzumab. - To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. - To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. - To evaluate as needed re-treatment with alemtuzumab and other DMTs.