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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: NCT02263807 Completed - Joint Instability Clinical Trials

Knee Function in Patients With Two or More Episodes of Patella Dislocations

MPFL
Start date: May 2010
Phase: N/A
Study type: Interventional

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

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: NCT02262104 Completed - Dementia Clinical Trials

Effects of an Exercise Program for Nursing Home Patients With Dementia

EXDEM
Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.

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: NCT02261714 Completed - Clinical trials for Pancreatic Cancer, Resected

Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer

Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and - Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine - Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response - Investigate if the treatment can delay or reduce recurrence of the disease

NCT ID: NCT02261402 Completed - Clinical trials for Cardiovascular Diseases

Effectiveness of "Medisinstart"

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

"Medisinstart" is a new service developed for use in Norwegian pharmacies. It is intended for patients that are about to start a new medicine for a chronic or long-term condition. It is based on research showing that problems with newly prescribed medicines appear rapidly and that a significant portion of patients quickly becomes non-adherent. The service consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine. The main purpose of this study is to investigate whether "Medisinstart" increases patients' adherence to the prescribed medication. Patients' beliefs about their medicines and their motivation for adherence will also be examined. The study also aims at revealing if "Medisinstart" has additional benefits for the patient, the society and the pharmacies.

NCT ID: NCT02261272 Completed - Clinical trials for Psychophysiologic Insomnia

Internet-based Treatment for Insomnia

SHUTiNorse
Start date: November 2013
Phase: N/A
Study type: Interventional

The study will test an internet-based treatment for insomnia.

NCT ID: NCT02259075 Completed - Migraine Disorders Clinical Trials

Botox Injection in Treatment of Chronic Migraine

Start date: February 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect. The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion. The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail. The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.

NCT ID: NCT02258646 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial

iTrain
Start date: October 2014
Phase: N/A
Study type: Interventional

This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.