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NCT ID: NCT01072175 Completed - Cancer Clinical Trials

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212

Start date: March 26, 2010
Phase: Phase 2
Study type: Interventional

This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.

NCT ID: NCT01071954 Completed - Clinical trials for Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP

A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura

Start date: December 30, 2009
Phase: Phase 3
Study type: Interventional

This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura. This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.

NCT ID: NCT01068912 Completed - Influenza Clinical Trials

Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

NCT ID: NCT01068860 Completed - Clinical trials for Type 2 Diabetes Mellitus

To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.

NCT ID: NCT01068509 Completed - Clinical trials for Epithelial Ovarian Cancer

Ovarian Cancer Vaccine for Patients in Remission

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac)in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.

NCT ID: NCT01066936 Completed - Osteoarthritis, Hip Clinical Trials

Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

MISDexa
Start date: September 14, 2009
Phase:
Study type: Observational

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

NCT ID: NCT01066208 Recruiting - Clinical trials for Giant Cell Arteritis

American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis

DCVAS
Start date: January 2011
Phase: N/A
Study type: Observational

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'. We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.

NCT ID: NCT01065935 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Start date: February 2010
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

NCT ID: NCT01065454 Active, not recruiting - Clinical trials for Hypertension, Pulmonary

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

LEPHT
Start date: April 14, 2010
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

NCT ID: NCT01065090 Completed - Exercise Clinical Trials

A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis

ACTIMS
Start date: June 2010
Phase: N/A
Study type: Observational

The primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.