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Discover 21,047 clinical trials near Pittsburgh, Pennsylvania. Find research studies in your area.
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NCT00156390
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the deaths will be attributed to worsening pump function while the remainder will be attributable to sudden cardiac death. Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF with dramatic benefits to some patients. Current candidates include those with ventricular conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated that BIV pacing improves myocardial function, functional capacity, quality of life, as well as reduces the incidence of hospitalization and even prolongs life. Despite all this, about one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'. Our group and others have shown that there are direct genetic effects of BiV pacing in an animal model, however, there are gaps in existing knowledge about the effects of left ventricular (LV) pacing site or genetic influences on the degree of response to this novel therapy. This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with the goal of optimizing the degree of benefit and increasing the proportion of patients who respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect scan testing. In the empiric group, the LV lead position will be chosen by the masked operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria, or other as per standard of care. Blood would be collected from all patients at the time of the procedure for analysis of genetic polymorphisms.
NCT00547651
This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
NCT02277990
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.
NCT03178071
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
NCT00326209
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets \[MP\]) in participants with ulcerative colitis currently in remission.
NCT00528983
The purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. This Phase I study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease MDS, AML and CMML.
NCT00505414
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT03859986
This is a Phase 2, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of ALX-101 Gel 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 56 days in adult and adolescent subjects with moderate atopic dermatitis
NCT02271503
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
NCT00038129
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
NCT01096186
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
NCT00548184
We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors. The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.
NCT00915083
The purpose of the study is to determine whether amrubicin is safe and effective in the treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics of the amrubicin and if it has an effect on the heart.
NCT01905787
The purpose of this study is to take advance of the presence of two different cohorts of SCA patients in one country, the first group included SCA patients from Bedouin Arab origin that lives in Israel for more than one century and originally comes from African countries or Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology Unit of the Emek Medical Center, the second group are SCA patients from African origin that come to Israel in the last decades and belong to original African population, this group receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov Medical Center. A third group is a cohort of SCA patients treated at Schneider Children's Hospital Hematology Unit. Those patients belong also to the Israel Arab population and patients from a village that African Muslims live for many years. The characteristics of the three groups will be compared to the characteristics of a fourth group, a cohort of Afro-American SCA patients that are followed up and treated at the Pediatric Hematology Unit, Detroit Children's Medical Center, Detroit, Michigan, USA.
NCT02423434
Through the multinational pooled dataset approach, this trial will aim to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk. Results of the study will permit application in clinical practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification. The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes with and without neuropathy, who had CCM performed in the past as a part of their neurological examination, to assess concurrent and predictive validity of different CCM parameters in individuals . These subjects will be invited to the study to be re-examined by CCM along with other neurological tests (physical exam, nerve conduction studies, quantitative sensory testing, blood test and in some centres also skin biopsy) during the single study visit. Additionally CCM data will be analyzed both manually and by recently developed automated analytical software to evaluate accuracy of the automated method. Evaluation of automated image analysis will influence likelihood of successful knowledge translation of this surrogate biomarker for DPN into clinical practice - in which the procedure could be harmonized with annual retinal examinations - and into intervention trials. Secondary aim of the study is to determine the factors associated with CCM parameters and their longitudinal change and collect bio-samples for future research in this field.
NCT02867371
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.
NCT01413087
This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administration of BC-819 and intravenously administered gemcitabine. Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS). Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival. Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on: Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life, Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival
NCT01899053
The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117. It also evaluated the single- and multiple-dose plasma pharmacokinetics (PK) of TAK-228+TAK-117 in participants with advanced nonhematologic malignancies.
NCT04123210
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.
NCT02829489
The purpose of this study is to evaluate the current state of nutrition care and patient related outcomes in patients with head, neck and esophageal cancers in North America, Europe and Australia.
