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NCT ID: NCT01740947 Terminated - Colorectal Cancer Clinical Trials

Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?

SELECT
Start date: January 2013
Phase: Phase 4
Study type: Interventional

The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.

NCT ID: NCT01740895 Completed - Clinical trials for Cardiovascular Disease

ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

ADVISEII
Start date: December 2012
Phase: N/A
Study type: Observational

To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)

NCT ID: NCT01740050 Not yet recruiting - Obesity Clinical Trials

Weight-loss and Gut-brain Interactions

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

While exposure to an obesogenic environment has increased for almost every individual in western society, not everyone is equally susceptible to overeating and not everyone becomes obese. Teasing apart the physiological underpinnings of those individual seemingly protective- differences may contribute to the development of successful preventive measures and treatment. Neuroimaging studies started to deliver important insights into the neuroanatomical determination of individual eating behavior. However, food intake is not only determined by the brain, but is orchestrated by an interaction of peripheral hormones with neural circuits and decision-making processes. This interactive axis is also referred to as the gut-brain axis. While individual aspects of the axis have been studied extensively, detailed insight in the interaction of gut and brain in the regulation of food intake is lacking. Objective: The current study aims to investigate the effect of a) caloric restriction (very low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on gut-brain interactions to find an optimal balance for weight loss and long-term sustained weight maintenance.

NCT ID: NCT01740037 Completed - Atrial Fibrillation Clinical Trials

IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4

RACE4
Start date: December 2012
Phase: N/A
Study type: Interventional

Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence. Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations and mortality. Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized AF clinic (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. Data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study. Study population: Patients older than 18 year with newly diagnosed AF. Intervention: The intervention is delivered through the specialized outpatient AF clinic. The multidisciplinary team at the AF clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable ESC guideline recommendations. The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP.

NCT ID: NCT01739764 Completed - Neoplasms Clinical Trials

An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

Start date: February 19, 2013
Phase: Phase 4
Study type: Interventional

This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.

NCT ID: NCT01738906 Completed - Obesity Clinical Trials

The Effect of Alcohol on Food Reward

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

Rationale It has been shown in several studies that alcohol increases subsequent food intake. However, moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the Western world, where palatable food is highly available, food reward may play an important role in food intake. Alcohol consumption is known to stimulate neurotransmitters important for food reward and may therefore stimulate the reward response on a subsequent meal. This may lead to higher food consumption than when no alcohol is consumed. It is hypothesized that the reward response of food or beverages can already be generated when food or beverages are sensed in the mouth, because oral nutrient sensing is known to induce a satiety response (i.e. the cephalic phase response). Moreover, taste buds directly signal brain areas closely connected to the reward areas in the brain. Primary objective - To determine whether moderate alcohol consumption influences subsequent food reward, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to reward. Secondary objectives - To determine whether food reward is different when food is consumed than when food is sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to food reward. - To determine whether moderate alcohol consumption influences subsequent food reward differently when food is consumed than when food is sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters related to food reward.

NCT ID: NCT01738828 Active, not recruiting - Clinical trials for Coronary Artery Disease

GLOBAL Clinical Study

GLOBAL
Start date: December 2012
Phase: N/A
Study type: Observational

The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD). The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.

NCT ID: NCT01738490 Completed - Hearing Loss Clinical Trials

Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

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

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed. More specifically the primary objective of this clinical study is to test the hypothesis - The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant. And the secondary objective is to - Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

NCT ID: NCT01738035 Completed - Clinical trials for Primary IgA Nephropathy

The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

NEFIGAN
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).

NCT ID: NCT01736475 Completed - Hemophilia A Clinical Trials

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Start date: January 31, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.