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NCT ID: NCT00006068 Not yet recruiting - Diabetes Mellitus Clinical Trials

Does Islet Transplantation Eliminate Hypoglycemia?

Start date: n/a
Phase: N/A
Study type: Interventional

Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.

NCT ID: NCT00062530 Not yet recruiting - HIV Infections Clinical Trials

Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers

Start date: n/a
Phase: Phase 1
Study type: Interventional

This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.

NCT ID: NCT00067977 Not yet recruiting - Clinical trials for Kidney, Polycystic, Autosomal Dominant

Clinical Trial to Slow the Progression of ADPKD

Start date: n/a
Phase: N/A
Study type: Interventional

This study will determine whether certain blood pressure medications will slow cyst growth or keep kidneys functioning longer in patients with autosomal dominant polycystic kidney disease (ADPKD). The study will take place at several sites in the United States. The start date of the study has not yet been determined.

NCT ID: NCT00163813 Not yet recruiting - Critical Illness Clinical Trials

The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study

ENTERIC
Start date: n/a
Phase: N/A
Study type: Interventional

This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal [NJ] tube) and standard feeding in critical illness.

NCT ID: NCT00164086 Not yet recruiting - Myeloma Clinical Trials

Atorvastatin in Myeloma

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.

NCT ID: NCT00172341 Not yet recruiting - Asthma Clinical Trials

Sublingual Immunotherapy With House Dust Mite Extract in Asthmatic Children

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

Asthma, the airway inflammatory disorder, is an important chronic disease in children. About 10~15% children are bothered with this. Allergens, such as house-dust mites (HDM), animal dander (i.e. cats and dogs), and seasonal pollens, are often implicated as causative and triggering factors of respiratory attacks in children with asthma. Among them, mites are the most common indoor allergen associated with asthma worldwide. It appears that SLIT is somewhat effective and safe. However, on the current evidence, further studies are needed to define the indications, the duration of treatment and therapeutic optimal dose of standardized allergen extracts in relation to efficacy and side effects before it is recommended for routine clinical use. The objective of the present study was to investigate the effects and safety of StaloralTM, the standardized extracts of D. pt. and D. f., in asthmatic children allergic to HDM.

NCT ID: NCT00173667 Not yet recruiting - Hypertension Clinical Trials

A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension

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

Objective: - To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients with hypertension. - To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in patients with hypertension. - To study flow-mediated dilatation and oxidative stress in nonsmoker with essential hypertension but without diabetes mellitus or dyslipidemia. Study Design: - Head-to-head, randomized and parallel design. - A total of 60 patients with a clinically confirmed diagnosis of hypertension will provide 30 available patients in each treatment group. - The drugs and dosage will be as follows: Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer) Method: After washout period, the eligible patients will randomly be allocated to receive two brands of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood pressure measurement (ABPM) at both entrance and final stages of the study. The patients will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure measurement will be set to take reading at 1-hour intervals during the 24 hours assessment. Physical examination included the measurement of heart rate and blood pressure. The value will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood chemistry test will be measured immediately before the start of treatment and after 8 weeks’ treatment or at time of discontinuation. Thiobarbituric acid–reactive substances (TBARS) in patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated vasodilation will also be evaluated. Possible concomitant medication will remain constant throughout the study. The physician will question the patients as to their compliance at each visit. If compliance dose not reach 80%, the subject will be dropped out.

NCT ID: NCT00176020 Not yet recruiting - Healthy Clinical Trials

Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

Start date: n/a
Phase: Phase 1
Study type: Interventional

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3-­way crossover. Subjects will be randomly allocated to a treatment sequence – AAB, ABA or BAA. The two treatments will be: - Treatment A: 500 mg nicotinic acid (Niacor(R)) - Treatment B: Niacor(R) Placebo Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.

NCT ID: NCT00190021 Not yet recruiting - Clinical trials for Dementia of Alzheimer Type

Donepezil Treatment of Psychotic Symptoms in Dementia Patients

Start date: n/a
Phase: Phase 3
Study type: Interventional

Conventional psychotropic medications may be used to treat behavioral disturbances and psychotic symptoms in patients with dementia and they are the drugs of choice for treating delusions and hallucinations. However the sensitivity to side effects in these patients often restricts the use of these agents (2, 3). Although, atypical antipsychotics have some advantages compared with conventional neuroleptics, they also are associated with side effects (5, 6). Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of some researchers ChEIs have psychotropic effects and may play an important role in controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease (7-10). These agents may also contribute to the management of other disorders with cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations (11). Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the management of patients with Alzheimer's disease of mild to moderate severity (12-14). Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies and patients suffering from Parkinson's disease (11-18). The results of our study (18) indicate that the addition of donepezil to perphenazine resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic therapy without donepezil. The finding of the pilot study although impressive, stem from data regarding a rather small sample. The present (second) phase of the study will include a larger sample of patients. We now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.

NCT ID: NCT00190112 Not yet recruiting - Atrial Fibrillation Clinical Trials

Change of Heart Rate Variability and Baroreflex Sensitivity After Ventral Cardiac Denervation

Start date: n/a
Phase: N/A
Study type: Interventional

Atrial fibrillation (Af) is the most common morbid event after open heart surgery. Its incidence ranges from 19% to 27%, as reported by the Society of Thoracic Surgeons database. Many groups have tried to understand and treat this difficult problem and have formulated different hypotheses to explain its origin. An imbalance of the autonomic nervous system after surgical intervention has been accepted as a major determinant for this morbidity. Ventral cardiac denervation is a fast and low-risk procedure. This intervention has shown significantly reduction of the incidence and severity of Af after routine coronary artery bypass surgery. This technique could be applied both on-pump or off-pump and used as an adjunctive procedure to achieve Af prophylaxis. However, the detailed mechanism remains unclear. Theoretically, heart receives its innervation from the autonomic nervous system (ANS) via the great vessels and pericardial attachment. The propensity and distribution of ANS nerve fibers are different in location. In this study, we would like to evaluate the ANS function after ventral cardiac denervation by using heart rate variability (HRV) and baroreflex (BRS) sensitivity. 30 patients proposed to have elective off-pump coronary artery bypass surgery are enrolled. After induction of anesthesia, the depth of anesthesia is controlled by inhalation agents and monitored by bispectral index. After the major cardiac operation, ventral cardiac denervation is performed by using electrocautery. The digital signals of heart rate and blood pressure are acquired before and after the surgical procedures under the same range of bispectral index (50~60). The paired HRV and BRS are analyzed. This will provide us more information to justify the procedure.