Clinical Trials Logo

Filter by:
NCT ID: NCT01121536 Terminated - Depression Clinical Trials

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Start date: April 30, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

NCT ID: NCT01118728 Terminated - Clinical trials for Ankylosing Spondylitis

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

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

Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in patients with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in patients with AS

NCT ID: NCT01117987 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

IMPRES Extn
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

NCT ID: NCT01116557 Terminated - Atrial Fibrillation Clinical Trials

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

CLARITY-AF
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

NCT ID: NCT01116349 Terminated - Clinical trials for Humeral Diaphysis Fracture

Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Start date: January 2010
Phase: N/A
Study type: Interventional

The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The conservative treatment of diaphyseal fractures of the humerus has long been considered the only option and the surgical treatment was primarily reserved for displaced fractures with no contact of bone ends. However, for a few years there has been an upsurge of indications for the surgical treatment of diaphyseal fractures. The purpose of this study is to compare the functional outcomes and the quality of life of surgically treated patients versus those who undergo a conservative treatment.

NCT ID: NCT01116037 Terminated - Clinical trials for Heart Valve Diseases

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

PAS
Start date: September 2009
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

NCT ID: NCT01113541 Terminated - Bipolar Disorder Clinical Trials

One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

NCT ID: NCT01111565 Terminated - Clinical trials for Major Depressive Disorder (MDD)

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start date: October 4, 2010
Phase: Phase 3
Study type: Interventional

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

NCT ID: NCT01106443 Terminated - Clinical trials for Indeterminate Thyroid Nodules

Central Compartment Neck Dissection With Thyroidectomy

Start date: February 2010
Phase: N/A
Study type: Interventional

When a patient presents with a thyroid mass, part of the work-up may include a fine needle aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results are benign, the management will typically be to follow the nodule. If the results demonstrate or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a total thyroidectomy (total thyroid removal). The latest American thyroid association guidelines for PTC (2009) suggest that in many instances a central lymph node dissection (CLND) should be performed in conjunction with the total thyroidectomy. This procedure consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as this tissue may have a propensity for cancer spread. The procedure's necessity has met much controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery. When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted with surgical management for an "indeterminate" lesion, while in others, it is standard protocol. The argument of performing CLND is largely based on the tenet that it adds little surgical time, cost or risks to the patient. Because the evidence of the prognostic role of lymph node metastases is limited many would argue that the risk of not performing CLND is greater than performing CLND. Furthermore, in the event of finding cancer on final pathology, and thus, having to re-operate in the thyroid/central compartment bed, post-operative complications may increase. Opponents of CLND argue that there is a paucity of strong evidence supporting CLND in the improvement of oncologic outcomes and can potentially increase post-operative low calcium levels or vocal nerve damage However, these recommendations are based on retrospective level III evidence. Thus the debate continues: is CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid pathology? The hypothesis is: CLND in hem- or total thyroidectomy for "indeterminate" thyroid nodules will not increase post-operative complications.

NCT ID: NCT01104831 Terminated - Clinical trials for Proximal Tibia Fracture

The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

ARCTIC CAT
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored. Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement