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NCT ID: NCT03206671 Recruiting - Clinical trials for Mature B-cell Non-Hodgkin Lymphoma

Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

B-NHL 2013
Start date: August 3, 2017
Phase: Phase 3
Study type: Interventional

The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents. The following primary study questions are going to be analyzed: - the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. - the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. - the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab. Secondary study questions will address - additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates - kinetics of immune reconstitution after treatment - adverse event and severe adverse event profile - inter-individual variability of rituximab response - role of different mechanisms of action of rituximab in advanced B-NHL/B-AL

NCT ID: NCT03206190 Recruiting - Clinical trials for Hereditary Spastic Paraplegia

The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Study goals 1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease 2. Biomarkers providing objective measures of disease activity

NCT ID: NCT03205267 Recruiting - Clinical trials for Chronic Myelogenous Leukaemia

Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients

BODO
Start date: March 2016
Phase: Phase 2
Study type: Interventional

Bosutinib is a 2nd generation tyrosine kinase inhibitor that has shown promising results from first up to fourth line treatment in patients with in chronic phase of chronic myelogenous leukaemia. Most patients discontinuing the treatment with Bosutinib do so because of side effects occuring early after starting the treatment. A step in dosing scheme could improve these early toxicities. The aim of this study therefore is to demonstrate that temporary lowering of the Bosutinib dose during early treatment may help to reduce or prevent side effects while preserving efficacy.

NCT ID: NCT03202329 Recruiting - Clinical trials for Heart Failure,Congestive

Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)

NCT ID: NCT03199833 Recruiting - Stroke Clinical Trials

Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients ( RETRAINER-S2 )

RETRAINER-S2
Start date: November 10, 2016
Phase: N/A
Study type: Interventional

Stroke is the third most common cause of death and the main cause of acquired adult disability in high-income countries. The most common deficit after stroke is motor impairment of the contralateral arm, with more than 80% of stroke survivors experiencing this condition in the acute phase, and only half regaining some useful upper limb function after six months. Within the European project RETRAINER (grant agreement No 644721), the consortium developed a platform for the rehabilitation of the upper limb after stroke, which combines a passive forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand flexor muscles and of the extrinsic hand extensor muscles, interactive objects, and voluntary effort. The system also provides a graphical user interface which helps the therapist set the training session and save the training data and parameters, and provides the subject a visual feedback about his/her active involvement in the exercise. The training consists of the execution of a series of exercises involving the affected arm during daily life activities. Typical exercises include controlled wrist flexion and extension, controlled fingers flexion and extension, anterior reaching and grasping on a plane or in the space, moving an object on a plane or in the space. The aim of this clinical study it to evaluate the efficacy of this novel training platform on patients between two weeks and nine months after their first stroke, who preserved at least a visible muscle contraction for the arm and shoulder muscles. Participants are randomized in an experimental and a control group. The control group is trained with an advanced rehabilitative program, including physical training, occupational therapy, FES, and virtual reality, while the experimental group is trained with the RETRAINER system for about 30 minutes, in addition to the same program of the control group. The daily training time is the same for the two groups. The intervention consists of three sessions a week for nine weeks. Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which supports task-oriented repetitive training, a close temporal association between motor intention and stimulated motor response, and an intensive and frequent training paradigm, the study's hypothesis is that the experimental group shows a greater treatment effect than the control group.

NCT ID: NCT03196960 Recruiting - Critical Illness Clinical Trials

Effects of Mobility Dose in Surgical Intensive Care Unit Patients

MQS
Start date: May 22, 2017
Phase:
Study type: Observational

The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

NCT ID: NCT03192774 Recruiting - Clinical trials for Aortic Valve Stenosis

The Prospective Segeberg TAVI Registry

POST-TAVI
Start date: September 2007
Phase:
Study type: Observational [Patient Registry]

A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

NCT ID: NCT03191656 Recruiting - Heart Failure Clinical Trials

REDUCE LAP-HF III Corvia Protocol 1701

REDUCELAPHFIII
Start date: July 12, 2017
Phase:
Study type: Observational

This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.

NCT ID: NCT03190876 Recruiting - Clinical trials for Complication of Surgical Procedure

Seroma Prevention After Body Contouring Procedures

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.

NCT ID: NCT03188874 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

Start date: September 2010
Phase:
Study type: Observational [Patient Registry]

This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 51 sites in Germany. Primary objectives: - Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry. - Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS) - Documentation of treatment strategy