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NCT ID: NCT01397409 Completed - Clinical trials for Age-related Macular Degeneration

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

Start date: September 1, 2011
Phase: Phase 2
Study type: Interventional

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

NCT ID: NCT01396551 Completed - Lung Cancer Clinical Trials

Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Start date: October 2010
Phase: N/A
Study type: Interventional

Clinical study investigating the feasibility and safety of using an anchored Calypso transponder in the airways of the lung for real-time monitoring of tumor location during radiotherapy

NCT ID: NCT01396330 Completed - Diabetes Mellitus Clinical Trials

Effect of Mental Stress on Glucose Control in Patients With Diabetes Mellitus

EMSOD
Start date: September 2011
Phase: N/A
Study type: Interventional

Introduction Stress is part of the investigators daily life, and means to cope with it allow adaptation and survival. To this end, physiological pathways are activated, including neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of consequences are beneficial, in the long run, however, chronic psychosocial stress may constitute an increased risk for coronary heart disease, type 2 diabetes, and disability. Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but also to increase blood glucose levels. In clinical practice, patients and health care providers are often confronted with questions concerning psychological stress as a possible reason for glucose fluctuations. Whether stress itself or poor treatment adherence is responsible for the altered glucose control remains often controversial. Differences in the inter- and intraindividual response to stress have been suggested, but only a few small studies have addressed the effect of acute psychological stress on glucose control in patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute psychological stress on glucose control but further studies are clearly needed to definitely exclude or confirm a relevant effect of stress on the glucose control in diabetic patients. For example, effects of longer lasting or repetitive events of psychological stress on glucose concentrations still remain elusive. The aim of the present study was therefore to investigate the effect of prolonged psychological stress by means of repetitive safe driving training courses on glucose control in patients with diabetes. Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for regular visits are invited to participate. Included are patients on any oral glucose-lowering treatment and at least one daily injection of insulin, a valid driver license and written informed consent given. Exclusion criteria are diabetes duration <2 years, pregnancy, unstable coronary artery disease, limited visual acuity or unstable proliferative diabetic retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary or adrenal disease. The Ethics committee of the Kanton Thurgau approved the protocol and the study conform to the principles outlined in the Declaration of Helsinki. Study protocol Each patient completes a control and a stress testing day which takes place consecutively in a randomized order. Randomization is performed by an uninvolved third person. The study is carried out at the driving training area of the Touring Club Switzerland at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain from food thenceforth. Drinking mineral water remains allowed during the entire study days, and the patients have to take their basal insulin and other medication as usual. Patients are advised to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a capillary glucose measurement is carried out, and glucose concentrations ≥10mmol/l are corrected with short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no additional adjustment with insulin is allowed during the study. Glucose concentrations ≤4mmol/l are always corrected with administration of 10g carbohydrate (DextroEnergy® or orange juice). On both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min before the driving training). Immediately after the meal, short-acting insulin is injected in knowledge of the carbohydrate content (same dose on both days) or oral antidiabetics are ingested as usual. Measurements of capillary and plasma glucose concentration, blood pressure, heart rate, stress perception and salivary cortisol concentration are carried out in regular intervals between 4 and 9 p.m. on both study days. On the control day, patients are placed in a quiet room and are permitted to read. They also have the possibility to leave the room and stay on a balcony. On the stress testing day, patients complete a driving training with their car between 5 and 7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on dry and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the car is hurled around by a mechanical plate and the patients has to regain control over it.

NCT ID: NCT01394380 Completed - Obesity Clinical Trials

Reduction of Sweetened Beverages and Intrahepatic Fat

REDUCS
Start date: October 2011
Phase: N/A
Study type: Interventional

The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period - intrahepatic fat concentration - visceral fat volume - changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations) - changes in food intake and daily energy, carbohydrate and sugars intake from baseline

NCT ID: NCT01394237 Completed - Clinical trials for Vaginal Vault Prolapse

Laparoscopic Sacrocolpopexy: Long Term Follow-up

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

The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.

NCT ID: NCT01393353 Completed - Mental Competence Clinical Trials

Cognitive Training in Parkinson's Disease

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

The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.

NCT ID: NCT01392573 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

DUAL™ II
Start date: November 28, 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

NCT ID: NCT01390155 Completed - Clinical trials for Coronary Artery Disease

Characterization of Ischemia Related Changes in Esophageal Electrocardiography

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

Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings. Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary angiography.

NCT ID: NCT01389921 Completed - Healthy Clinical Trials

Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract

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

The purpose of this study is to investigate afferent and cortical activities during bladder filling under different stimulations of the lower urinary tract. The participants of the study are healthy test persons and patients with overactive bladder.

NCT ID: NCT01389856 Terminated - Clinical trials for Persistent Pulmonary Hypertension of the Newborn

Persistent Pulmonary Hypertension of the Newborn

FUTURE 4
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.