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NCT ID: NCT02266186 Completed - Tocophobia Clinical Trials

Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy

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

The purpose of this project To study the efficacy of Internet-based guided self-help program of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a control group receiving individual support at their antenatal clinics.

NCT ID: NCT02265770 Recruiting - Clinical trials for Childhood Ependymoma

An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma

SIOP-EP-II
Start date: June 2, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment. The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations. Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies. Stratum 1: The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma. Stratum 2: This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX. Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT. Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .

NCT ID: NCT02265614 Recruiting - Infertility Clinical Trials

PGS Using Microarray in IVF Patients With Repeated Implantation Failure

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

This project intends to use preimplantation genetic screening (PGS) with the microarray technique to determine the chromosome composition of fertilized eggs, so that only chromosomally normal embryos are transferred during IVF. The purpose is to increase the probability of pregnancy and childbirth among couples with a history of repeated unsuccessful IVF attempts.

NCT ID: NCT02264574 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Start date: October 6, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

NCT ID: NCT02264470 Completed - Accidental Falls Clinical Trials

Fall Study in Gothenburg (FallsGOT)

FallsGOT
Start date: October 1, 2014
Phase:
Study type: Observational

Falls after stroke are common. Previous research has shown that almost every other, 48%, of patients with a first-ever stroke fell at least once during the first year after stroke (1). Moreover, most of the patients fell during the first three months after stroke onset. However, the exact time-point for the falls was not analyzed (1). In addition, many patients are falling already during hospital stay (2-5). Reducing the number of falls during inpatient rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the factors that best predict falls is eligible. The aim of the study is to analyze the significance of different physiological, psychological and medical factors for predicting the risk of falling in patients with stroke per day of care at a stroke unit.

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.