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NCT ID: NCT00844441 Completed - Leukemia Clinical Trials

Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Start date: December 2008
Phase: N/A
Study type: Interventional

RATIONALE: Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about a patient's quality of life, use of medical services, and the cost of these services. PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.

NCT ID: NCT00843804 Recruiting - Clinical trials for Invasive Aspergillosis

Surveillance for Nosocomial Infections in Pediatric Cancer Patients

Oncoped2006
Start date: March 2007
Phase: N/A
Study type: Observational

The Oncoped 2006 study implements a multicenter prospective surveillance module for nosocomial infections in pediatric cancer patients.

NCT ID: NCT00840086 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

guardian™1
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

NCT ID: NCT00839371 Completed - Bronchoscopy Clinical Trials

Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

Start date: January 2005
Phase: Phase 4
Study type: Interventional

Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This procedure may cause anxiety and discomfort requiring the use of sedative drugs. In this study the investigators titrate the administration of sedatives using bispectral analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.

NCT ID: NCT00839163 Completed - Clinical trials for Deep Vein Thrombosis

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

NCT ID: NCT00837642 Recruiting - Infertility Clinical Trials

Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

Start date: October 2008
Phase:
Study type: Observational

The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use of assisted reproductive technologies (ART) has allowed millions of infertile couples to have children. These children make up for 1 to 4% of the population in developed countries. ART involves the manipulation of early embryos at a time when they may be particularly vulnerable to external disturbances. In line with this concept, studies in mice suggest that ART alters the activity of enzymes involved in the regulation of metabolic and cardiovascular homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring. The safety of ART for long-term health is, therefore, of utmost importance. Among the potential long-term consequences of ART, cardiovascular disease may represent an important candidate, but there is no information. Investigators show that, children born after in vitro fertilization (IVF) present systemic and pulmonary vascular dysfunction at high-altitude when compared to age- and sex-matched control subjects. A 5 years follow-up study shows that premature vascular aegieng persist and evolve to arterial hypertension. Arterial hypertension may induce cardiac dysfunction. Therefore, the major goal of this proposal is to assess cardiac function in apparently healthy participants born after ART.

NCT ID: NCT00837356 Completed - Clinical trials for Congenital Bleeding Disorder

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Start date: March 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

NCT ID: NCT00836212 Recruiting - HIV Infections Clinical Trials

Adjusting Antiretroviral Therapy Dosage Using Therapeutic Drug Monitoring

TDM
Start date: March 2008
Phase: Phase 4
Study type: Interventional

Background Low concentrations of protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) are associated with an increased risk of virological failure. Likewise, excessive antiretroviral drug concentrations increase the risk of toxicity. Therapeutic drug monitoring (TDM) may identify and correct excessively high or low PI and/or NNRTI concentrations, and thus minimize toxicity and risk of treatment failure. Treatment guidelines only recommend using TDM to help optimize ARV therapy in selected patients, and there are no clear recommendations to guide the clinician who decides to adjust drug doses. Prospective studies have demonstrated the relationship between EFV plasma concentration and neuropsychiatric symptoms. Moreover, EFV is metabolized mainly by cytochrome P450 2B6 and its concentration was reported to be associated with the CYP2B6 516GrT genetic polymorphism. For drugs such as EFV or LPV/r, lower doses than the ones validated for standard clinical use have demonstrated efficacy in dose-ranging studies. The investigators will use a standardised algorithm to reduce doses in patients with plasma EFV or LPV/r concentration above percentile 75. This algorithm is based on a Bayesian approach from the pharmacology unit in Lausanne. The investigators hypothesize that a dosage individualisation is feasible and safe. 2.2 Study Aims The investigators aim at testing a simplified algorithm for dose reduction in patients with documented virological efficacy, treated by a stable LPV/r or EFV based regimen with elevated plasma concentration of these drugs. Study Design Prospective open label study in which all eligible patients screened with a plasma drug concentration of either EFV or LPV/r above percentile 75 will be included. After confirmation of the results at baseline, patients will be offered to decrease drug dosage by a third or a half according to a standardised algorithm. All patients will undergo HIVRNA, biochemistry and validated questionnaires after 3 and 6 months to assess the safety and the benefit of this strategy.

NCT ID: NCT00835770 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

ENDORSE
Start date: February 3, 2009
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

NCT ID: NCT00835055 Withdrawn - Rectal Cancer Clinical Trials

Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer

Start date: April 2005
Phase:
Study type: Observational

The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.