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NCT ID: NCT01318785 Recruiting - Lymphedema Clinical Trials

Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

BF09-PH-01
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase 1. thesis: - all types should be equal regarding volume reduction 2. thesis: armsleeves manufactured with microfibre yarn are expected to be - better in wearing comfort and - better in handling features.

NCT ID: NCT01299168 Recruiting - Clinical trials for Incorporate Molecular Diagnosis Into Diagnostic Standards

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Start date: May 2011
Phase:
Study type: Observational

The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.

NCT ID: NCT01285479 Recruiting - Multiple Sclerosis Clinical Trials

The Gilenya Pregnancy Registry

Start date: October 15, 2011
Phase:
Study type: Observational [Patient Registry]

The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.

NCT ID: NCT01281735 Recruiting - Clinical trials for Chronic Myeloid Leukemia

International Chronic Myeloid Leukemia Pediatric Study

ICMLPed
Start date: January 2011
Phase:
Study type: Observational

The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

NCT ID: NCT01281410 Recruiting - Clinical trials for Stem Cell Transplantation

Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Start date: January 2011
Phase: N/A
Study type: Interventional

The study is a monocentric, controlled randomized trial. Its an interventional method study. There is a control and an interventional group. The interventional group is receiving a specific inspiratory muscle training with "Respifit" (special device for inspiratory muscle training) during the first 30 days after allogenic stem cell transplantation. The investigators want to show that the training group gets stronger inspiratory muscles. The investigators measure the change of PIMAX values and MVV values.

NCT ID: NCT01265186 Recruiting - Sedation Clinical Trials

Evaluation of Sedation in Newborns

Start date: December 2010
Phase: N/A
Study type: Observational

Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team. The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.

NCT ID: NCT01257269 Recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura

Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)

TTP registry
Start date: October 2006
Phase:
Study type: Observational

Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder characterized by thrombocytopenia as a result of platelet consumption, microangiopathic hemolytic anemia, occlusion of the microvasculature with von Willebrand factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1 motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13 gene mutations. Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman syndrome patients varies considerably without an apparent genotype-phenotype correlation. In 2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their family members to identify possible triggers of acute bouts of TTP, to document individual clinical courses and treatment requirements as well as possible side effects of long standing plasma substitution, e.g. alloantibody formation or viral infections.

NCT ID: NCT01252485 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project

AMLSG BiO
Start date: July 2010
Phase:
Study type: Observational

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 60-70 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives - To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness) - To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations) - To assess patient and family history, clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS]) - To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers) - To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue, e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum) - To assess quality of life

NCT ID: NCT01247402 Recruiting - Clinical trials for Peripheral Arterial Disease

Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)

PACUBA 1
Start date: November 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms: 1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) 2. Control Arm: standard percutaneous transluminal angioplasty (sPTA). Purpose: To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).

NCT ID: NCT01233141 Recruiting - Clinical trials for Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs

Viennese Registry on Patients With Chronic Critical Limb Ischemia

Start date: January 2011
Phase: N/A
Study type: Observational

The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.