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NCT ID: NCT01802762 Completed - Clinical trials for Subarachnoid Hemorrhage

A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Start date: January 2013
Phase: N/A
Study type: Interventional

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

NCT ID: NCT01802749 Active, not recruiting - Clinical trials for Recurrent Ovarian Cancer

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer

MITO16MANGO2b
Start date: November 2013
Phase: Phase 3
Study type: Interventional

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

NCT ID: NCT01802164 Terminated - Surgery Clinical Trials

Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia

PerProMe
Start date: March 2013
Phase: N/A
Study type: Interventional

In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence. The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia. In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.

NCT ID: NCT01801397 Recruiting - Clinical trials for Low Bone Mass in Anorexia Nervosa Patients

A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa Patients With Low Bone Mineral Density and Increased Bone Fagility (FAN-Trial)

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Study Title: A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia Nervosa patients with low mineral density and increased bone fragility (FAN-Trial) Short Title/Study ID: FAN-Trial / Psy-Rheu_2011/1 Indication: Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available) without fragility fractures in Anorexia Nervosa patients Trial Design: Open-label, single-centre pilot study with study drug treatment duration of 24 months. Study Center: Single-centre (University Hospital of Zürich) Investigator(s)/Authors: PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091 Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg Objective(s)/Outcome(s): Primary endpoint: •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone density at months 12 and 24. Secondary endpoints: - To assess the changes in blood biomarkers - To assess changes in whole body composition - To assess the incidence of new fragility fractures - To assess changes in bone structure - To assess the changes in EDE-Q - Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN Assessments for primary endpoint: •BMD at lumbar spine, total hip and femoral neck, measured by DXA Assessments for secondary endpoints: - bone resorption and bone formation markers measured in urine and serum - whole body composition measured by DXA - New clinical peripheral and vertebral fractures - HRqCT of tibia and forearm - EDE-Q Score at months 12 and 24 Safety measurements: - Safety lab (blood and urine) - Clinical adverse event monitoring at all visits Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: - Women, aged > 18 to < 35 years - Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening - Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score < -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) without any previous fragility fracture - or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) and at least one previous fragility fracture - In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and Psychotherapy of the University Hospital of Zurich. Main Exclusion Criteria: - Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV positive patients, pregnancy, open epiphyses - Incapacity to understand the aims of the study or patients not willing to collaborate. Study Product, Dose, Route, Regimen: Teriparatide (Forsteo®), 20µg s.c. daily for 24 months. Duration of study: 24 months. Reference therapy, Dose, Route, Regimen: - Trial with medicinal product

NCT ID: NCT01799954 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults

Start date: August 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.

NCT ID: NCT01798043 Terminated - Clinical trials for Ventricular Dysfunction

Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

Start date: January 2013
Phase: N/A
Study type: Interventional

The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).

NCT ID: NCT01797965 Terminated - Multiple Sclerosis Clinical Trials

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

EXTEND
Start date: February 15, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

NCT ID: NCT01797757 Completed - Obesity Clinical Trials

Comparison of MAG and Fish Oil Efficacy

Start date: January 2012
Phase: N/A
Study type: Interventional

A potential application for unstructured monoacylglycerol (MAG) containing long chain polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed, it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other type of maldigestion/malabsorption. Potential applications of such concept are therefore related to disease conditions comprising low lipid digestion due to lipase activity insufficiency. In the present study, in order to see the response information for eicosapentanoic acid (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under Orlistat® consumption will be analyzed.

NCT ID: NCT01797653 Completed - Clinical trials for Obstructive Sleep Apnoea

Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA

Start date: February 2013
Phase: N/A
Study type: Interventional

Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.

NCT ID: NCT01796587 Completed - Clinical trials for Intermittent Catheterization

Non-Interventional Study Among Users Of LoFric Origo

Start date: January 2013
Phase: N/A
Study type: Observational

Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale Secondary objectives: - To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale - To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale - To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes. Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users. Medical Device: LoFric Origo Study Variable(s): - Primary variable: Use or No use of LoFric Origo after 8 weeks. - Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.