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NCT ID: NCT00944593 Withdrawn - Clinical trials for Diabetic Gastroparesis

Gastric vs Jejunal Feeding in Diabetic Gastroparesis

Start date: n/a
Phase: Phase 4
Study type: Interventional

Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur in the absence of any structural abnormality of the stomach, rather abnormal gastric function underlies the condition. Up to one in five patients with type I diabetes experience symptoms consistent with this diagnosis. The effects on diabetic control, physical health and emotional quality of life are severe. Patients do not respond reliably to general supportive management or conventional medications. Surgical options have disappointing results. The need for more effective treatment is acknowledged universally. Feeding into the small bowel beyond the stomach (jejunal feeding) is established management in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake. The benefits have been assumed secondary to improved nutrition and diabetic control; however this assertion has never been studied. Recently we observed that patients with severe gastroenteropathy recovered promptly and could eat normally during and for a few hours after jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological' effects in patients with gastroenteropathy. One attractive explanation for these observations is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the normal fed state by bypassing the dysfunctional stomach. This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without symptoms will also be investigated. Studies will assess: 1. Effects on GI symptoms and function to gastric distension in fasted and fed states 2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal 3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to assess complex gastric response to feeding. In addition the effects of feeding on symptoms and gastric function will be related to alterations in GI hormones and autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response of the GI tract to feeding fails in patients with diabetic gastroenteropathy. The primary aim of this project is to assess the effectiveness of jejunal feeding in the management of diabetic gastroenteropathy. However, by defining the processes that 'switch' gastric function between the fasted and the fed states and control gastric emptying, we hope also to identify candidate targets for more effective pharmacologic treatment of this severe disease. - Trial with medical device

NCT ID: NCT00944567 Completed - Clinical trials for Primary Mediastinal B-Cell Lymphoma

A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

Start date: January 2007
Phase: N/A
Study type: Observational

A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.

NCT ID: NCT00943826 Completed - Glioblastoma Clinical Trials

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

Start date: June 29, 2009
Phase: Phase 3
Study type: Interventional

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.

NCT ID: NCT00943696 Completed - Clinical trials for Healthy Participants

Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers

Start date: August 2009
Phase: Phase 4
Study type: Interventional

Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract. In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design. The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.

NCT ID: NCT00942591 Completed - Multiple Sclerosis Clinical Trials

Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b

SWABIMS
Start date: May 2005
Phase: Phase 2
Study type: Interventional

Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis Short title: "SWABIMS" Study phase: Phase IIb study Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta Reference product: Interferon-beta-1b 250mg given Indication: Relapsing-remitting multiple sclerosis (RR-MS) Study objectives: Comparison of efficacy, safety and tolerability of combination of Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d. Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.

NCT ID: NCT00941733 Completed - Clinical trials for Critical Lower Limb Ischemia

Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

INPACT-DEEP
Start date: September 2009
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.

NCT ID: NCT00941460 Completed - Glioblastoma Clinical Trials

Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

DIRECTOR
Start date: September 2009
Phase: Phase 2
Study type: Interventional

For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.

NCT ID: NCT00941265 Completed - Aphasia Clinical Trials

Effect of Dopaminergic Medication on Recovery of Aphasia

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

The investigators have been offering computer assisted therapy of aphasia (CAT) as a complement to traditional treatments to aphasia patients of the "Service of Neurorehabilitation" for some years. The investigators have shown its efficacy in hospitalised patients with recently acquired aphasia. In addition to studies stressing the importance of treatment intensity, several studies suggest that pharmacological treatment can also improve recovery after a cerebral lesion. The underlying idea is that the administration of medication influencing the system of neurotransmitters can play a role in functional recovery. Studies have assessed mainly substances acting on the dopaminergic (amphetamine and bromocriptine) and GABAergic system (piracetam). The main objective of the present study concerns the evaluation of the effects of levodopa on recovery of anomia in patients with aphasia. In particular, the investigators use CAT to control intensity and quality of therapy and they will assess whether the administration of levodopa promotes recovery. In each patient, two periods of anomia therapy with CAT, each performed with a different word list, will be compared. In addition to speech therapy, each period will be associated with the administration of either levodopa and benserazide (Madopar ®), or placebo. Evaluations at baseline and after each treatment period will be performed with the material and denomination battery

NCT ID: NCT00941044 Completed - Healthy Clinical Trials

Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

Start date: July 2009
Phase: Phase 1
Study type: Interventional

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in respiratory muscle unloading in healthy volunteers.

NCT ID: NCT00940602 Completed - Clinical trials for Myelodysplastic Syndromes

Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

TELESTO
Start date: March 22, 2010
Phase: Phase 2
Study type: Interventional

This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.