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NCT ID: NCT01481207 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

Start date: September 2011
Phase:
Study type: Observational

Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is thought to affect approximately 0.2% of live births, and is associated with a high risk of mortality or long-term neurological disability. Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely important both for clinical management and the evaluation of therapeutic approaches. According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome following HIE. However, for various technical reasons standard MRS methods do not offer optimal sensitivity for detecting lactate, which may potentially be improved with a custom lactate editing MRS sequence. In addition, while perfusion has also been suggested as a potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has not been evaluated in comparison with more established MR biomarkers. The aims of this study are: 1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence (specialist software) relative to the standard point resolved (PRESS) MRS sequence for detecting lactate in neonates with suspected HIE. 2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to MRS measures as predictors of neuro-developmental outcome at 2 years.

NCT ID: NCT01480479 Completed - Glioblastoma Clinical Trials

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

ACT IV
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

NCT ID: NCT01480180 Completed - Clinical trials for Congenital Bleeding Disorder

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

pathfinderâ„¢2
Start date: January 30, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

NCT ID: NCT01477502 Completed - Spinal Cord Injury Clinical Trials

Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

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

recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life. - until today, there is no effective prophylaxis for UTI for patients with spinal cord injury. - homeopathy has been shown to be an effective treatment option in several chronic diseases - study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone

NCT ID: NCT01477307 Completed - Obesity Clinical Trials

Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver

Start date: July 1, 2013
Phase: N/A
Study type: Observational

In patients with NAFLD/NASH, changes in liver lipid composition and function tests following a short dietary intervention are associated with changes in gut microbiota

NCT ID: NCT01476514 Terminated - Hyperekplexia Clinical Trials

Effects of Mutations of the Glycine Gene Associated With Hyperekplexia on Central Pain Processing

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

Mutations in genes affecting pain transmission start to be known, the investigators are investigating a mutation in a glycine channel, which has an influence on pain modulation. Pain modulation is the ability of the central nervous system to enhance or diminish the sensation of pain. The investigators therefore will test patients and healthy volunteers with quantitative sensory tests, basically determining the point at which a stimulation just starts to induce pain. These tests are reliable and permit a direct comparison between healthy volunteers and patients with the affected glycine gene.

NCT ID: NCT01476423 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Start date: January 2004
Phase: N/A
Study type: Observational

This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.

NCT ID: NCT01475838 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

NCT ID: NCT01474694 Completed - Adult Liver Cancer Clinical Trials

Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver

CALS
Start date: October 2011
Phase: N/A
Study type: Observational

Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for improved accuracy during complete oncological resection / ablation. In the short- and long-term this possibly results in better patient outcome.

NCT ID: NCT01474070 Completed - Glaucoma Clinical Trials

GAT-DCT-Discordance Due to Corneal Properties

Start date: November 2011
Phase: Phase 4
Study type: Observational

IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)).