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NCT ID: NCT01722526 Completed - Clinical trials for Human Acid Sphingomyelinase Deficiency

Tolerability and Safety Study of Recombinant Human Acid Sphingomyelinase in Acid Sphingomyelinase Deficiency Patients

Start date: March 2013
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose administration.

NCT ID: NCT01722500 Completed - Childhood Obesity Clinical Trials

International Study of Childhood Obesity, Lifestyle and the Environment

ISCOLE
Start date: December 2010
Phase: N/A
Study type: Observational

The primary aim of the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and obesity in a large multi-national study of 10 year-old children, and to investigate the influence of behavioral settings and physical, social and policy environments on the observed relationships within each country.

NCT ID: NCT01722487 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

Start date: March 2013
Phase: Phase 3
Study type: Interventional

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

NCT ID: NCT01722396 Completed - Tuberculosis Clinical Trials

Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Start date: March 2011
Phase: Phase 3
Study type: Interventional

Previous studies of vitamin D supplementation have suggested there may be differences in response between individuals. This study is an open label study of vitamin D supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin D response. Latent patients will only be studied for vitamin D response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells will be related to polymorphisms in the DBP gene, and that this may relate to clinical response in terms of post supplementation vitamin D level.

NCT ID: NCT01722370 Completed - COPD Clinical Trials

Ambulatory Oxygen Effects on Muscles in COPD

OM-COPD
Start date: August 2012
Phase: Phase 4
Study type: Interventional

Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.

NCT ID: NCT01721746 Completed - Clinical trials for Unresectable or Metastatic Melanoma

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Start date: December 21, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

NCT ID: NCT01721681 Completed - Factor X Deficiency Clinical Trials

A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years

Start date: April 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months. The secondary objectives of the study are: 1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg. 2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks).

NCT ID: NCT01721291 Completed - ASTHMA Clinical Trials

Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)

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

Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to provide relief from breathlessness. However, current inhalers are inefficient as they deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways. In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in our patients. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD.

NCT ID: NCT01721161 Completed - Clinical trials for Acute Optic Neuritis

215ON201 BIIB033 In Acute Optic Neuritis (AON)

RENEW
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral Acute Optic Neuritis (AON). The secondary objective of this study in this study population is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033.

NCT ID: NCT01721057 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Moderate to Severe Rheumatoid Arthritis Participants

RA-BUILD
Start date: December 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate response] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).