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NCT ID: NCT01676077 Active, not recruiting - Dysferlinopathy Clinical Trials

Clinical Outcome Study for Dysferlinopathy

Jain COS
Start date: September 2012
Phase:
Study type: Observational

The "Clinical Outcome Study for Dysferlinopathy" is being performed in centres in Europe (UK- Newcastle; Spain- Barcelona, Sevilla; San Sebastian;Denmark, Copenhagen, Italy- Padova; France- Paris,), USA (Charlotte, NC; Columbus, OH; St.Louis, MO, Stanford CA, Irvine CA and Columbia NY), Chile (Santiago) Japan (Tokyo) and South Korea (Pusan). Oversight is provided by Newcastle upon Tyne Hospitals Trust. Funding for this study is being provided by the Jain Foundation, a non-profit foundation dedicated to finding therapies for dysferlinopathies(LGMD2b/Miyoshi). The aim of this "Clinical Outcome Study" is to determine the clinical outcome measures required for future clinical trials, characterize the disease progression of dysferlinopathy and collect biological samples for the identification of disease markers that are needed to non-invasively monitor the disease during clinical trials. Without this information, effective clinical trials cannot be performed. This study is recruiting a large number of genetically confirmed dysferlinopathy patients aged 10 years or older, who are ambulant or non-ambulant. The study has reopened for a further two years (COS2). Participants will be assessed at 4 further visits over 2 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard blood tests. Optionally, the participants can donate blood samples and a skin sample for use in the identification of disease markers and other approved research. There is a sub-study running in MRI at selected sites.

NCT ID: NCT01675518 Completed - Healthy Clinical Trials

A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

NCT ID: NCT01674777 Completed - Healthy Clinical Trials

A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941

Start date: October 2010
Phase: Phase 1
Study type: Interventional

This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

NCT ID: NCT01674023 Completed - Clinical trials for MicroRNA Expression Profile in Human Vitreous of Various Vitreoretinal Diseases

MicroRNA Expression Profile in Human Vitreous of Patients With Various Vitreoretinal Diseases Requiring Vitrectomy

Start date: August 2012
Phase: N/A
Study type: Observational

MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare with that of patients with macular holes which are suggested to be similar to that of healthy subjects.

NCT ID: NCT01673646 Completed - Acromegaly Clinical Trials

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

Start date: October 16, 2012
Phase: Phase 2
Study type: Interventional

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.

NCT ID: NCT01672762 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients

Start date: May 25, 2012
Phase: Phase 3
Study type: Interventional

This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

NCT ID: NCT01670435 Completed - Infection Clinical Trials

Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Start date: May 2007
Phase: N/A
Study type: Observational

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

NCT ID: NCT01670318 Recruiting - Clinical trials for Coronary Artery Disease

Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

SPECIALIST
Start date: August 2012
Phase: N/A
Study type: Interventional

Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

NCT ID: NCT01669811 Completed - Clinical trials for Refractory Reflux Esophagitis

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

NCT ID: NCT01668784 Completed - Clinical trials for Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Start date: October 9, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy