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NCT ID: NCT01359891 Completed - Sepsis Clinical Trials

Clinical Evaluation of Novel Biomarkers in Patients With Septicemia

NOBIS
Start date: November 2010
Phase:
Study type: Observational

The protein ST2 is a member of the interleukin-1 receptor family. Blood concentrations of the soluble isoform of ST2 (sST2) are increased in inflammatory and heart diseases and are considered a prognostic marker in both. The Presageā„¢ST2 assay was recently shown to meet the needs of quality specifications of laboratory medicine. Soluble urokinase plasminogen activator receptor (suPAR) levels reflect inflammation and elevated suPAR levels are found in several infectious diseases and cancer. Both sST2 and suPAR have recently been introduced as sensitive biomarkers for patients with septicemia. Both may be promising or even superior alternatives to currently established sepsis markers leading to an improvement of outcome in patients with septicemia. However, a clinical study which clarifies kinetics of values over time/possible correlation with causative pathogen/progress/deterioration of septic patients is urgently needed before these biomarkers can be established in clinical routine. Primary study objectives To clinically evaluate sST2 and suPAR in patients with bacteremia /septicemia. To correlate results with causative bacterial organisms, response to or failure of antiinfective treatment, severity of clinical status as well as outcome. To study the kinetics of the test results and to correlate the sST2/suPAR results with other well established infection markers (e.g. C-reactive protein, procalcitonin, blood counts). Natural endpoints of the study will be patient's death or complete recovery. This is an explorative study. To meet the objectives both novel biomarkers will be clinically evaluated in a cohort of 500 in-patients with septicemia at the University Hospital Graz. Starting the day a patient's blood culture turned positive the investigators will collect samples every 12h within the first two days and then every 24h.Measurement of sST2 and suPAR values will be done retrospectively. To analyze clinical sensitivity/specificity of the novel biomarkers sST2 and suPAR as prognostic factors for development of bacteremia/septicemia, a second cohort consisting of 250 in-patients will be investigated in a longitudinal matter. Patients without a previous positive blood culture test during the current episode of disease for which blood cultures are ordered by a physician will be included and sST2 and suPAR levels will be determined from samples taken simultaneously with this first blood cultures.

NCT ID: NCT01358864 Completed - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

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

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

NCT ID: NCT01358266 Completed - Clinical trials for Uveitis; Posterior, Disorder

Study Assessing Double-masked Uveitis Treatment

SAKURA
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

NCT ID: NCT01357837 Completed - Clinical trials for Osteoarthritis of the Knee

Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

NCT ID: NCT01356537 Completed - Gaucher Disease Clinical Trials

Home Therapy With VPRIV in Gaucher's Disease

Start date: May 20, 2011
Phase:
Study type: Observational

The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at the clinic or at doctor's practice.

NCT ID: NCT01355627 Completed - Clinical trials for Cerebrospinal Fluid Leaks

TASALL - TachoSil® Against Liquor Leak

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

The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater. The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

NCT ID: NCT01355146 Completed - Fabry Disease Clinical Trials

Home Therapy With Replagal in Fabry Disease

Start date: March 15, 2011
Phase:
Study type: Observational

The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the clinic or at doctor's practice.

NCT ID: NCT01354691 Completed - Dementia Clinical Trials

Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease

Start date: February 2011
Phase: Phase 2
Study type: Interventional

For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease

NCT ID: NCT01353534 Completed - Healthy Clinical Trials

Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine

Start date: May 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site. The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

NCT ID: NCT01353417 Completed - Clinical trials for Chronic Kidney Insufficiency

Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

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

This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.