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NCT ID: NCT01026376 No longer available - Clinical trials for Myelodysplastic Syndromes

An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

Start date: June 2008
Phase: Phase 3
Study type: Expanded Access

The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients.

NCT ID: NCT01026207 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Portable Monitoring Device for the Diagnosis of Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease

Start date: August 2009
Phase: N/A
Study type: Observational

Introduction: The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important issue because is related to nocturnal desaturation and its complications. The use of portable monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an alternative to full-night polysomnography (PSG). However, there are not studies evaluating the PM recording in COPD patients to detect or exclude OSAS. Objective: To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.

NCT ID: NCT01026142 Completed - Breast Cancer Clinical Trials

A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

Start date: January 26, 2010
Phase: Phase 3
Study type: Interventional

This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.

NCT ID: NCT01025908 Completed - Panic Disorder Clinical Trials

Cognitive Behavior Psychotherapy in Panic Disorder

Start date: May 2006
Phase: N/A
Study type: Interventional

The objective of this study in cognitive-behavioural therapy (CBT) was to demonstrate the preparation of the patient with panic disorder for agoraphobic exposures. The focus of the work consisted of interoceptive exposures, in vivo, of body sensations themselves, to feared places and situations. The sample consisted of 50 individuals. Group 1 undertook 10 weekly, individual sessions of CBT of one hour duration. Group 2, control, was just follow-up with supportive therapy. The procedures used for the exposures, especially for induction symptom exercises, were considered essential in the preparation of patients with panic disorder, to be able to face up to panic attacks and subsequent agoraphobic situations.

NCT ID: NCT01024985 Recruiting - Multiple Sclerosis Clinical Trials

Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.

NCT ID: NCT01024257 Completed - Pterygium Clinical Trials

Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

Start date: n/a
Phase: Phase 3
Study type: Interventional

PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.

NCT ID: NCT01024036 Completed - Clinical trials for Multicentric Castleman's Disease

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Start date: March 18, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

NCT ID: NCT01023932 Completed - Cochlear Implants Clinical Trials

Auditory Neuropathy and Cochlear Implants

Start date: September 2006
Phase: N/A
Study type: Observational

The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP's characteristics, the threshold and amplitude of neural response together with the amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. The auditory perception benefits as well as the possibility to measure the ECAP showed that the electrical stimulation could compensate the neural dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending the Cochlear Implant is advised

NCT ID: NCT01023841 Completed - Alopecia Areata Clinical Trials

Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

Start date: June 1, 2010
Phase: Phase 4
Study type: Interventional

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

NCT ID: NCT01023789 Completed - Clinical trials for Coronary Artery Disease

ABSORB EXTEND Clinical Investigation

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

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.