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NCT ID: NCT01620684 Recruiting - Obesity Clinical Trials

Cortisol and Nutritional Sympathetic Responsiveness

Start date: February 2013
Phase: Phase 4
Study type: Interventional

This project will examine whether short-term (over a 12-hour period) pharmacological lowering of the stress hormone 'cortisol' improves the nervous system response to food intake in overweight or obese individuals who have metabolic syndrome. The investigators know from our previous research that overweight/obese persons who are insulin resistant, have a blunted sympathetic nervous response to carbohydrate ingestion. This means that they are less able to dissipate energy from caloric intake, which would favour the maintenance of the obese state. Cortisol adversely impacts on insulin action and transport into the brain and cortisol levels are often elevated in persons with central (abdominal) obesity. A randomized, double-blind, placebo controlled, cross-over design will be used to compare the effects of overnight treatment with metyrapone (15 mg/kg at midnight and 15 mg/kg at 6 am) versus placebo on sympathetic nervous system activity in response to a standard 75-g oral sugar (glucose) tolerance test. A 2 week washout will separate treatments. Metyrapone is a drug that reversibly inhibits the enzyme 11beta-hydroxylase, and therefore the production of cortisol. It is used clinically to test the activity of the adrenal gland (the key site of cortisol production) and the pituitary gland. The investigators anticipate that at the dosage used, it will lower blood cortisol concentration by 44 to 64% during the experimental morning. The study protocol comprises two screening visits and two experimental mornings. Key procedures will include: - Assessment of insulin action (sensitivity) using the gold standard 'clamp' method. - Measurement of sympathetic nervous system activity by both biochemical methods (isotope dilution which provides a measure of the apparent rate of release of 'noradrenaline'-the key neurotransmitter in the sympathetic nervous system) and direct intra-neuronal nerve recordings from the peroneal nerve in the lower leg. - Indirect calorimetry to assess resting metabolic rate and the response to sugar ingestion. - DEXA scan to quantify fat and lean mass. - Assessment of arterial elasticity and calf blood flow by non-invasive methods. - A standard 75g oral sugar tolerance test. The results will provide important new information regarding the role of cortisol on nervous system function in overweight/obese individuals.

NCT ID: NCT01620255 Completed - Ulcerative Colitis Clinical Trials

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

TURANDOT
Start date: November 2, 2012
Phase: Phase 2
Study type: Interventional

To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

NCT ID: NCT01619085 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Start date: June 6, 2012
Phase: Phase 3
Study type: Interventional

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

NCT ID: NCT01618695 Completed - Clinical trials for Partial-onset Seizures

A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Start date: May 15, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures

NCT ID: NCT01617668 Completed - Breast Cancer Clinical Trials

A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With LCL161 in Patients With Triple Negative Breast Cancer

Start date: August 2012
Phase: Phase 2
Study type: Interventional

To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression

NCT ID: NCT01617629 Completed - Clinical trials for Epithelial Ovarian Cancer

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study

CAN-003X
Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.

NCT ID: NCT01616732 Completed - Obesity in Men Clinical Trials

Testosterone and Weight Loss

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.

NCT ID: NCT01616524 Completed - Clinical trials for Hepatitis C Virus (HCV)

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

PRINCIPAL
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

NCT ID: NCT01615796 Completed - Clinical trials for Infections, Respiratory Tract

Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses

Start date: June 4, 2012
Phase: Phase 1
Study type: Interventional

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

NCT ID: NCT01614197 Completed - Clinical trials for Peripheral T-cell Lymphoma

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Start date: July 3, 2015
Phase: Phase 1
Study type: Interventional

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).