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NCT ID: NCT01498523 Completed - Healthy Clinical Trials

The Glycaemic and Insulinaemic Responses of Camel Milk

GLUCAM
Start date: December 2011
Phase: N/A
Study type: Interventional

Rationale: Recently, human, animal and epidemiological studies suggested that camel milk has a hypoglycaemic activity. However, a mechanism and reasons for this activity have not been sufficiently studied. Therefore, a study on a glycaemic and insulinaemic responses of regular camel milk and camel milk powder is needed. Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and camel milk powder in healthy adults. Study design: In a randomised, single-blind and cross over design, two hour post prandial glucose and insulin responses of 4 treatments (regular camel milk, camel milk powder, regular cow milk and glucose) will be measured . Those treatments will be consumed in a portion that contained 25g available carbohydrate. Finger-prick capillary blood samples will be taken at fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test product. Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the test product. The measurements will be conducted on 4 separate days with at least 2 days wash out. Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25 kg/m2. Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and glucose. These are standardized to 600ml containing 25g available carbohydrate. Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin responses. Secondary parameters: amino acid composition and glycemic index. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This intervention is non-therapeutic to the subjects. The risk associated with participation is negligible and the burden can be considered low. Before subjects are able to participate in this study they will have to fill out a brief questionnaire, and have their fasting blood glucose measured, in order to ensure they fit the inclusion criteria of the study. Once entering the study, each subject will have to visit the research centre 4 times for the postprandial tests. On each measurement day, each subject will be required to have fasted for at least ten hours before (an overnight fast). Each subject will have 7 finger-prick blood samples and 3 venapunctures taken during each visit. A maximum amount of 50 ml blood is drawn per day.

NCT ID: NCT01497366 Completed - Hepatitis C Clinical Trials

Phase 3 Study of Sofosbuvir and Ribavirin

FISSION
Start date: December 2011
Phase: Phase 3
Study type: Interventional

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

NCT ID: NCT01496911 Completed - Healthy Volunteers Clinical Trials

Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving

Start date: April 2012
Phase: Phase 4
Study type: Interventional

Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. However, the effects of these drugs on cognitive performance have not been investigated during diving.The objective of this study is to investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a hyperbaric chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that hydroxyzine will produce significant impairment, and that the magnitude of impairment is related to hyperbaric pressure.

NCT ID: NCT01494883 Completed - Lung Cancer Clinical Trials

Mindfulness for Lung Cancer Patients and Partners

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

The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.

NCT ID: NCT01493843 Completed - Clinical trials for Non-Small Cell Lung Cancer

Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

Start date: January 20, 2012
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

NCT ID: NCT01493284 Completed - Clinical trials for Symptomatic Aortic Stenosis

Portico TAVI Implant With Transfemoral Delivery System

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

The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).

NCT ID: NCT01493037 Completed - Clinical trials for ST Elevation (STEMI) Myocardial Infarction

PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

pRAMSES
Start date: December 2011
Phase: N/A
Study type: Interventional

A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.

NCT ID: NCT01492400 Completed - Macular Edema Clinical Trials

Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

Start date: March 9, 2012
Phase: Phase 2
Study type: Interventional

This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

NCT ID: NCT01492361 Completed - Clinical trials for Cardiovascular Diseases

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

REDUCE-IT
Start date: November 2011
Phase: Phase 3
Study type: Interventional

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.

NCT ID: NCT01492101 Completed - Clinical trials for Metastatic Breast Cancer

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

BEACON
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens. The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.