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NCT ID: NCT01423747 Active, not recruiting - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood;

Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia

Start date: July 2003
Phase: Phase 3
Study type: Interventional

With this protocol the ALL-SZT BFM international study group wants to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor (MSD) and matched donor (MD). to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment options during haematopoietic stem cell transplantation (HSCT) from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. to prospectively evaluate and compare the incidence of acute and chronic graft- versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

NCT ID: NCT01423500 Active, not recruiting - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood;

ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

ALL-SCT-BFMi
Start date: January 2007
Phase: Phase 3
Study type: Interventional

With this protocol the ALL-SCT BFM international study group wants - to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). - to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors. - to determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. - to prospectively evaluate and compare the incidence of acute and chronic Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

NCT ID: NCT01396993 Active, not recruiting - Quality of Life Clinical Trials

Prospective Non-randomized Evaluation of Oncoplastic Surgery

iTOP
Start date: July 2011
Phase: N/A
Study type: Observational

Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.

NCT ID: NCT01376908 Active, not recruiting - Phenylketonuria Clinical Trials

Kuvan® in Phenylketonuria Patients Less Than 4 Years Old

SPARK
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with Phenylketonuria (PKU).

NCT ID: NCT01368757 Active, not recruiting - Clinical trials for Chronic Myelomonocytic Leukemia

Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.

NCT ID: NCT01363102 Active, not recruiting - Critical Illness Clinical Trials

Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients

mSOMS
Start date: June 2011
Phase: N/A
Study type: Interventional

The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.

NCT ID: NCT01358877 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

APHINITY
Start date: November 8, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

NCT ID: NCT01356888 Active, not recruiting - Clinical trials for Coronary Artery Disease

Study of the Orsiro Drug Eluting Stent System

BIOFLOW-II
Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Primeā„¢ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

NCT ID: NCT01350089 Active, not recruiting - Clinical trials for Perceived Alcohol Intoxication

Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

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

The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.

NCT ID: NCT01344317 Active, not recruiting - Clinical trials for Apneas of Prematurity

The Effect of Stimulating Substances on Brain Activity of Preterm Infants

Start date: June 2009
Phase: N/A
Study type: Observational

Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas of prematurity. Both substances have effects on the central nervous system. While there are data available concerning the use of caffeine (the methylxanthine used at our NICU) even proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are data which suggest a negative effect of the central stimulants doxapram on longterm outcome in this group of infants. Nevertheless concerning both medications only few studies have been published and only scarce data are available concerning the effect of these medications on brain activity of very preterm infants until now. The aim of this study: is the assessment of the effect of stimulating substances on brain activity of preterm infants born below 30 weeks of gestation and their longterm neurodevelopmental follow-up. Methods: This study is a prospective study including preterm infants born below 30 weeks of gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG). The first aEEG measurement is performed without caffeine and/or doxapram medication. At least one hour of brain activity is registrated. The second measurement is done at least 24 hours after the start of caffeine and/ or doxapram treatment. The percentage of different background patterns, the occurrence and duration of sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed. Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of the Bayley Scales of Infant Development II and standardized clinical neurological examination.