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NCT ID: NCT01597739 Completed - Clinical trials for Arthritis, Rheumatoid

A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

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

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.

NCT ID: NCT01591005 Completed - Clinical trials for Internal Carotid Artery Stenosis

SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy

SONOBUSTER
Start date: October 2010
Phase: Phase 3
Study type: Interventional

The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 60minute non-diagnostic TCD monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second aim is to compare number of brain infarctions detected using MRI between CEA and CS patients. Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA or CS can be treated using these methods in the future. In the Substudy "Risk of brain infarction after carotid endarterectomy and stenting" the the risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic severe ICA stenoses undergoing elective CEA and CAS will be compared. The sample size of the Substudy was based on an expected 80% difference of new ischemic lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study calculations showed that a minimum of 73 patients in each group was needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 15% of subjects would be lost to follow-up or refuse to participate in the study.

NCT ID: NCT01590459 Completed - Clinical trials for Rheumatoid Arthritis

24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

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

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

NCT ID: NCT01586559 Completed - Diastasis Recti Clinical Trials

Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

Start date: October 2010
Phase: N/A
Study type: Observational

A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

NCT ID: NCT01585649 Completed - Clinical trials for Ewing Family of Tumors, Rhabdomyosarcoma

PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma

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

This is a Phase I, open label study aimed at assessing the pharmacokinetics, pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy (CTX)

NCT ID: NCT01585324 Completed - Clinical trials for Hepatitis C, Chronic

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

Start date: January 2012
Phase: Phase 4
Study type: Interventional

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

NCT ID: NCT01583738 Completed - Acute Vertigo Clinical Trials

Effect of V0251 in Acute Vertigo

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

Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

NCT ID: NCT01582347 Completed - Clinical trials for Opioid Related Disorder

Transfer of Subjects From Subutex/Suboxone to RBP-6300

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

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone

NCT ID: NCT01582178 Completed - Colorectal Cancer Clinical Trials

Warm Water Versus Room Temperature Water Immersion Colonoscopy

Start date: June 2012
Phase: N/A
Study type: Interventional

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials. The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice. The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.

NCT ID: NCT01578850 Completed - Clinical trials for Rheumatoid Arthritis

Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Start date: July 2012
Phase: Phase 4
Study type: Interventional

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.