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NCT ID: NCT01053585 Completed - Clinical trials for Gastroesophageal Reflux Disease

Structure and Function of the Gastro-esophageal Junction

Start date: February 2007
Phase: N/A
Study type: Interventional

Aims of research project: To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging. Hypothesis: 1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however 2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux'). 3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .

NCT ID: NCT01053481 Completed - Osteopenia Clinical Trials

Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health

Start date: March 2010
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D as achieved by oral supplementation higher than the current recommendations are associated with a less negative bone calcium balance in post-menopausal Swiss women.

NCT ID: NCT01053442 Completed - Iron Deficiency Clinical Trials

Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate

SIA
Start date: January 2010
Phase: N/A
Study type: Interventional

Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile. The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.

NCT ID: NCT01052935 Completed - Clinical trials for Group B Streptococcus (GBS) Disease

A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine

Start date: January 2010
Phase: Phase 1
Study type: Interventional

This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.

NCT ID: NCT01046448 Recruiting - Clinical trials for Cardiovascular Disease

The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study

4C
Start date: July 2009
Phase: N/A
Study type: Observational

Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.

NCT ID: NCT01046292 Completed - Clinical trials for Mild Cognitive Impairment

Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking alone as well as under differing dual-task conditions. The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint is cycle time variability under dual-task conditions.

NCT ID: NCT01046279 Terminated - Glioma Patients Clinical Trials

Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Start date: January 2010
Phase: N/A
Study type: Observational

Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension. - Trial with medicinal product

NCT ID: NCT01044043 Completed - Clinical trials for Dermatologic Disease of Inpatients in Internal Medicine

Prevalence and Subjective Impairment of Quality of Life (QoL) Due to Dermatologic Diseases in Internal Medicine Patients

Start date: November 2009
Phase: N/A
Study type: Observational

This is a 3 months single centre clinical patient-oriented study to evaluate the prevalence and impairment in QOL of dermatologic diseases in patients hospitalised in internal medicine. Up to 200 patients hospitalised at the division of internal medicine for any reason are going to be offered participation by a patient information form given to patients at the time of admission, as well as oral information about the study. Written informed consent will be obtained by the investigators after patients have had adequate time to consider their participation in the study. Participating patients will be examined clinically for dermatologic pathologies at a single visit. In the case of signs of dermatologic disease, investigators are going to recommend further diagnostic procedures to the physician in charge and/or the referring physician, depending on the urgency of the suspected diagnosis. This procedure is meant to avoid giving referring physicians the impression that active patient acquisition for the department of Dermatology is an aim of this study. Diagnostic procedures that are performed upon suspicion of a specific dermatologic disease at the Division of Internal Medicine are going to be performed during the hospitalisation period. All other diagnostic or operative procedures are going to be advised to the referring physician. Study participants are going to be interviewed by the investigators about impairment in QOL of their illnesses. Two separate questionnaires are going to be filled in by each participant. For measurement of general QOL, the widely used SF-12 questionnaire (8 questions) is going to be used. To measure specific impairment in QOL by dermatologic disease, participants are going to be asked to fill in the DLQI (Dermatology life quality index, 10 questions). Photographic documentation of specific identified lesions will be made and pictures stored exclusively in the secured electronic patient file (KISIM). Medication and all identified diseases will be noted. All diagnostically useful information is going to be recorded in the patient file and transmitted to the referring physician in the discharge letter.

NCT ID: NCT01043848 Withdrawn - Spinal Cord Injury Clinical Trials

Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients

Start date: December 2009
Phase: N/A
Study type: Interventional

Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic dysreflexia with life threatening increases in blood pressure and there is still no concept for an early rehabilitation of bladder function after SCI. Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for spastic bladder dysfunction and vegetative dysregulation and that this can be positively influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as autonomic dysreflexia will be positively affected. Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more effective compared to late initiation (after spinal shock). Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects, 12 control subjects). EPS will be started either within 10 days after SCI (early stim group) or after cessation of spinal shock (late stim group). Effects on spastic bladder function and autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by electrophysiological techniques. Expected value: If early EPS is effective and complete SCI patients benefit from this intervention; and if early onset of EPS has better and longer lasting effects than late onset stimulation, the findings will be of utmost relevance not only for bladder function but also to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective modulation and promotion of neuroplasticity, thus opening up new treatment options in the field of paraplegiology.

NCT ID: NCT01043731 Completed - Clinical trials for Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis

Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Start date: September 2008
Phase: N/A
Study type: Observational

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine. Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.