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Discover 21,047 clinical trials near Pittsburgh, Pennsylvania. Find research studies in your area.
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NCT00521534
Background and Introduction: SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart failure. The disorder is prevalent among males, estimated to affect upto 24% of the general population. Its prevalence increases with age, and it is particularly prevalent among patients with congestive heart failure with the prevalence rising to 51% in that group. Interestingly, recent evidence points to a potential impact for treating sleep disordered breathing, on heart failure patients. At the same time, recent reports of a beneficial impact of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs further exploration. The interdependence of potential positive impact on each entity needs to be elucidated for further research and refinement of therapeutic tools. Furthermore, this study aims to explore potential neurohormonal influence on and affection by each of these disorders. Specific Aims and Hypotheses: Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after implementation of therapy. Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT. Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation to its effects on CHF and SDB. Hypothesis #2: CRT neuro-hormonal modulation is a common path in its effects on SDB and CHF. Specific Aim #3: To assess prevalence of sleep disordered breathing (SDB) in patients with advanced congestive heart failure (CHF). Hypothesis #3: SDB is prevalent yet under recognized in this patient population. Research Design: This is an observational study with a built in double blinded prospective randomized interventional substudy of a potential confounder i.e. atrial pacing. All patients will receive CRT with defibrillator for clinical indications (CRT-D). Investigators other than the EP physicians as well as patients will be blinded to the pacing mode. After screening and a run in period of back up pacing a baseline polysomnogram (PSG) will be performed. Patients will be randomized between atrial overdrive or atrial tracking pacing modes for six months, all patients receiving CRT. Sleep studies will be performed at baseline and at three month intervals. Subjects: Patients referred for implantation of CRT -D will be recruited for this trial. Patients are included only if they are indicated for such a device on clinical grounds. Outcome Measures: 1.Sleep quality related Parameters:The following will be collected at times of each PSG: MAP-PSQI, PSG parameters of sleep quality and architecture, apnea hypopnea index, and oxygen saturation as well as biochemical markers of sleep efficiency. 2.Heart Failure Parameters: The following will be obtained at times of each PSG: Minnesota Living with Heart Failure Questionnaire, Clinical and echocardiographic measures of heart failure progression and biochemical markers of heart failure severity. Power Analysis: An improvement in SDB in both initial randomization arms is assumed, however we further assume the atrial overdrive arm will offer improvement over the atrial tracking arm of equal magnitude. An arbitrary estimate would be twenty percent improvement in atrial overdrive arm. The corresponding estimate is 40% improvement due to CRT. To achieve 0.80 power thirty four data sets need to be collected.
NCT00938236
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
NCT00003293
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether SU-101 is more effective than procarbazine in treating patients with glioblastoma multiforme. PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of procarbazine in treating patients with glioblastoma multiforme that has recurred.
NCT00292903
This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.
NCT00373256
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
NCT00058747
This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec. The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).
NCT00079950
The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.
NCT00820196
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
NCT01229137
Assessment of sensor parameter in patients with heart failure.
NCT00366834
This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.
NCT00946985
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
NCT00990964
The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
NCT01016964
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
NCT00033904
Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.
NCT00337493
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
NCT01281657
The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.
NCT00553787
The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.
NCT00350233
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
NCT01009593
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
NCT00392769
The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer. Primary Objective: 1\. To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer. Secondary Objectives: 1. To determine the duration of disease control, time to disease progression, and survival of this cohort of patients. 2. To determine the nature and degree of toxicity of cetuximab in this cohort of patients. 3. To correlate biologic markers with response to therapy if tissue is available.
