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NCT ID: NCT00781612 Recruiting - Neoplasm Metastasis Clinical Trials

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Start date: October 16, 2008
Phase: Phase 2
Study type: Interventional

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

NCT ID: NCT00781547 Completed - Obesity Clinical Trials

Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus

GHDM
Start date: January 1999
Phase: Phase 3
Study type: Interventional

The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM. Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months. The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given. The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious. The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator. Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.

NCT ID: NCT00781391 Completed - Stroke Clinical Trials

Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

EngageAFTIMI48
Start date: November 2008
Phase: Phase 3
Study type: Interventional

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

NCT ID: NCT00779298 Completed - Healthy Clinical Trials

Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects

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

Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.

NCT ID: NCT00778921 Completed - Hypertension Clinical Trials

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Start date: October 2008
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

NCT ID: NCT00778479 Terminated - Clinical trials for Adhesion Prevention (Abdominal)

Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Start date: October 2008
Phase: N/A
Study type: Interventional

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

NCT ID: NCT00777166 Completed - Myocardial Ischemia Clinical Trials

Cardiac Effects of Oxytocin Administrated During Cesarean Section, Signs of Myocardial Ischemia

Start date: December 2005
Phase: Phase 4
Study type: Interventional

Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm. The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this outcome has not been investigated to any extent. In the current study, we tested the hypothesis that there was no difference in occurrence of ECG changes (ST segment depression) between two doses of oxytocin. Participants were randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion. Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest.

NCT ID: NCT00776321 Completed - Clinical trials for Primary Hypercholesterolemia

Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Start date: September 2006
Phase: Phase 2
Study type: Interventional

Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases. The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.

NCT ID: NCT00775333 Completed - Clinical trials for Carpal Tunnel Syndrome

Nerve Entrapment in Diabetic Patients

Start date: December 2003
Phase: N/A
Study type: Observational

The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

NCT ID: NCT00774514 Completed - Clinical trials for Endothelial Dysfunction

The Cardiovascular Effects of Nitrogen Dioxide Exposure

Start date: October 2008
Phase: N/A
Study type: Interventional

Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. It has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. Recent studies using an inline retrofit particle trap to reduce the particulate component of exhaust have shown that filtering particles leads to a reversal of the endothelial dysfunction seen after diesel exhaust exposure, and have even suggested an augmentation of vascular function. This raises the question of the cardiovascular effects of the gaseous pollutants, the most abundant of which is nitrogen dioxide. In this study we plan to investigate the cardiovascular effects of nitrogen dioxide exposure.