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NCT ID: NCT01499290 Completed - Clinical trials for Complicated Intra-Abdominal Infection

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

NCT ID: NCT01499082 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

EDITION I
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

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: NCT01496313 Active, not recruiting - Thyroid Cancer Clinical Trials

To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

Start date: August 28, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

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: NCT01493505 Terminated - Ovarian Cancer Clinical Trials

TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

NCT ID: NCT01493349 Not yet recruiting - Diverticulitis Clinical Trials

Pathophysiology of Diverticular Disease

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

Colonic diverticular disease is a highly prevalent condition in Western populations. The prevalence increases age-dependently from 5% at 40 years to 65% by the age of 85 years (1-3). The majority remain asymptomatic. However, a significant proportion of the patient population develops complications, such as diverticulitis with or without symptoms (10-20%) (1, 4-10). Perforated diverticulitis is rare with an estimated incidence of 4 per 100.000 per year, but the associated mortality rate is 22% to 39% (9, 11, 12). In the United States, the complications related to diverticular disease account for 130.000 hospitalizations each year, resulting in substantial health care costs (13). In Europe, it is estimated that approximately 23.600 deaths per year can be attributed to complicated diverticular disease, and the mortality will probably increase in the future due to the aging population (15-17). Several case studies report an overall increase in the incidence of diverticulitis, based on the increase in hospitalizations (18). Kang et al, reported a 16% increased male admission rate and 12% female admission rate for diverticulitis, between 1989/1990 and 1999/2000 (19). Aging and the Western diet, low in fiber and high in fat, in combination with increased intraluminal pressure and alterations in colonic motility are considered important etiological factors. A disturbance in large bowel motility is suggested to be a common pathophysiological feature in IBS and diverticular disease (20, 21). Based on observations that IBD, subgroups of IBS and (symptomatic) diverticular disease share clinical symptoms, the hypothesis is derived that they might also share pathophysiological factors like low grade inflammation, changed microbiota composition and activity, and increased intestinal permeability. The identification of clinical and pathophysiological factors associated with an increased risk for complicated diverticular disease may help to identify patients with diverticular disease, prevent complications, develop strategies to improve quality of life and reduce the related health care costs. Therefore we aim to investigate the composition of luminal and mucosal intestinal microbiota and the intestinal permeability in the development of diverticular disease and complicated diverticular disease. We hypothesize that both the intestinal microbiota and intestinal permeability are altered in patients with (current- or previous history of complicated) diverticular disease.