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NCT ID: NCT01876784 Completed - Clinical trials for Differentiated Thyroid Cancer

Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer

VERIFY
Start date: September 17, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: - To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). - To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. - To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. - To evaluate the safety and tolerability of vandetanib treatment in this participant population.

NCT ID: NCT01876654 Completed - Clinical trials for Osteoarthritis, Knee

Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Start date: June 2013
Phase: N/A
Study type: Interventional

Patient specific instrumentation is an alternative to conventional intra- and extra-medullary guides to perform the femoral and tibial cuts in total knee replacement (TKR). This instrumentation could provide a better alignment of a TKR, reduce blood losses and operative time, and improve clinical outcomes. The primary goal of this study is to compare the femorotibial mismatch angle of two groups of patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional Attune® instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient undergoing TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.

NCT ID: NCT01875029 Completed - Chronic Pain Clinical Trials

tDCS Effects on Chronic Low Back Pain

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

Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back pain. Up to date clinical research studies have shown that transcranial direct current stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain and facilitating the mechanisms inhibitors descendants of pain control. The aim of this study is to test the feasibility of combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back pain.

NCT ID: NCT01875003 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: August 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

NCT ID: NCT01874431 Completed - Clinical trials for Diabetic Nephropathies

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

ARTS-DN
Start date: June 12, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

NCT ID: NCT01873391 Completed - Clinical trials for Pain in Diagnostic Hysteroscopy

Pain in Diagnostic Hysteroscopy

Start date: May 2013
Phase: N/A
Study type: Interventional

The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.

NCT ID: NCT01873378 Completed - Uterine Myoma Clinical Trials

GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Start date: January 2013
Phase: N/A
Study type: Interventional

The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.

NCT ID: NCT01872689 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: October 13, 2013
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.

NCT ID: NCT01872455 Completed - Clinical trials for Kidney Transplantation

Diet Rich in N-3 Polyunsaturated Fatty Acids in Renal Transplant Recipients

Start date: January 2010
Phase: Phase 4
Study type: Interventional

n-3 Polyunsaturated fatty acids (PUFAs) supplementation reduces systemic inflammation and improves renal and cardiovascular prognosis in kidney transplant recipients. A good patient compliance is often difficult to obtain because bad tasting fish oils are used as n-3 PUFA source. Therefore, we explored whether n-3 beneficial effects can be obtained by administering a diet based on n-3 rich foods.

NCT ID: NCT01872299 Completed - Heart Failure Clinical Trials

Studies Investigating Co-morbidities Aggravating Heart Failure

SICA-HF
Start date: March 2010
Phase: N/A
Study type: Observational [Patient Registry]

SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological evaluation study, which is being conducted in 11 centres across six countries. SICA-HF receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and Education within the file transfer protocol "R&D in priority fields of the S&T complex of Russia 2007-2012" under state contract number 02.527.11.0007. The aim of SICA-HF is to provide detailed characteristics of co-morbidities of heart failure at baseline and over time, particularly with regards to obesity, cachexia, and type 2 diabetes.