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NCT ID: NCT02411084 Terminated - Clinical trials for Graft vs Host Disease

Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD

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

The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.

NCT ID: NCT02410876 Completed - Clinical trials for Disorder of the Lower Urinary Tract

Changes of microRNA Expression in Obstructive and Neurogenic Bladder Dysfunction

MoVe
Start date: June 2015
Phase:
Study type: Observational

Patients with obstructive or neurogenic lower urinary tract disease will be invited to participate. Upon agreement they will undergo an assessment of bladder function (questionnaires) and bladder biopsies at 2 time-points. Bladder biopsies will be evaluated for molecular changes in the laboratory and compared to the functional findings.By uncovering the molecular similarities and differences between BLUTD and NLUTD, the investigators will elucidate some of the causative factors in the development of these disorders and highlight the impact of myogenic and neurogenic components postulated to be involved. The project involves close collaboration between clinical and basic research.

NCT ID: NCT02410616 Completed - Clinical trials for Depressive Disorder, Major

E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial

E-COMPARED_CH
Start date: March 2015
Phase: N/A
Study type: Interventional

To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss patients in secondary care

NCT ID: NCT02410148 Recruiting - Open-angle Glaucoma Clinical Trials

aICP in Glaucoma and Papilledema

aICP Ophtha
Start date: April 2015
Phase: N/A
Study type: Interventional

Glaucoma remains a disease with an unclear and complex underlying pathophysiology. Recently, researchers have emphasized not only intraocular pressure (IOP) or vascular dysregulation, but also translaminar pressure's (TPG) role in glaucoma (TPG=IOP-ICP). A higher TPG may lead to abnormal function and optic nerve damage due to changes in axonal transportation, deformation of the lamina cribrosa, altered blood flow, or a combination thereof leading to glaucomatous damage. However only invasive ICP measurements are available within the contemporary medicine. The ideas for non-invasive ICP measurement have been approached since about 1980. Most of the proposed technologies were based on ultrasound and were capable of monitoring blood flow in intracranial or intraocular vessels, cranium diameter, or acoustic properties of the cranium. Broad research has extended into sonography of optic nerve sheath and its relation with elevated ICP. However, most of these correlation-based methods had the same problem—the need of individual patient specific calibration. Seeking to measure absolute ICP values, researchers from Kaunas University of Technology created a non-invasive method, which does not need a patient specific calibration. The method is based on direct comparison of ICP value with the value of pressure Pe that is externally applied to the tissues surrounding the eyeball. Intracranial segment of ophthalmic artery (OA) is used as a natural sensor of ICP and extracranial segment of OA is used as a sensor of Pe. The special two depth transcranial Doppler (TCD) device is used as a pressure balance indicator when ICP = Pe. The aim of our study is to assess TPG in patients with primary open open-angle glaucoma (POAG). In addition the investigators want to measure ICP in patients with papilledema (PE) in order to compare them with glaucoma patients.

NCT ID: NCT02409667 Completed - Plaque Psoriasis Clinical Trials

Plaque Psoriasis Efficacy and Safety With Secukinumab

OPTIMISE
Start date: May 7, 2015
Phase: Phase 3
Study type: Interventional

To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.

NCT ID: NCT02408757 Terminated - Hydrocephalus Clinical Trials

Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

Start date: September 2015
Phase:
Study type: Observational

As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable. No firm data exists about the change of the width of the third ventricle, the diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the width of these structures has been shown to depend on intracranial pressure. Ultrasonographic measurements of changes of the width of the third ventricle or the diameter of the optic nerve would have some advantages compared to the ultrasonographic assessments of the lateral ventricles. First, the width of the third ventricle can be measured easier and more reliable than the width of the lateral ventricles (better defined insonation plane and therefore higher repeatability of measurements) 3. Second, whereas assessments of the width of the side and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of patients have insufficient temporal bone windows), the measurement of the diameter of the optic nerve does not have this limitation and can therefore be performed in almost all patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one major limitation of transcranial ultrasound. The latter limitation for transcranial ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but this was also not yet studied. The use of an ultrasound contrast agent would in addition allow to study changes of brain perfusion during clamping of EVD/LD.

NCT ID: NCT02408367 Unknown status - Multiple Sclerosis Clinical Trials

Intensity Depended Impacts on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study

Start date: February 2015
Phase: N/A
Study type: Observational

Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in pwMS have become important aspects of standardized rehabilitation programs. Recent findings show that the achieved adaptations through exercise are associated with the intensity dependent lactate increases during exercise. This dose-response relationship between the mode and the exercise intensity implicates the relevance of the exercise protocol as higher exercise intensities seem to facilitate greater benefits, also in pwMS. This pilot study evaluates the influences of acute bout of moderate physical exercise (cycling) and relaxation on cognitive functions at three time points. Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised (BVMT-R) T1-3 of the BICAMS battery. Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive functions.

NCT ID: NCT02407938 Completed - Healthy Clinical Trials

Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal

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

Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal and a postprandial observational period will be determined.

NCT ID: NCT02407886 Completed - Ganglion Cells Clinical Trials

Retinal Ganglion Cell Layer in Patients With Intracerebral Processes

Start date: March 2015
Phase: N/A
Study type: Observational

Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.' Purpose: To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion. To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities. To correlate GCL with visual field defects and electrophysiological parameters.

NCT ID: NCT02407626 Terminated - Myocardial Ischemia Clinical Trials

Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

OPT
Start date: September 2015
Phase: N/A
Study type: Interventional

This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.