There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will enroll patients with locally advanced or metastatic non-EGFR mutated Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than two prior approved treatment regimens. Patients will be randomized to receive one of two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and patients will also receive erlotinib 150mg taken orally once daily for the duration of the trial. The study will examine the immune effects, safety and efficacy of two different doses of HS110 vaccine in combination with erlotinib versus erlotinib alone.
The study will test whether the Proteus Sustained Behavior Change (SBC) System will help Type 2 diabetics feel more able to perform self-care activities, feel less distressed about diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest.
The overall objective of this project is to conduct a feasibility study using data proved by Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate goal of establishing a mechanism by which VA clinicians could access data on Veterans regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as documented in the Department of Defense Suicide Event Report (DoDSER).
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Autism.
Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can lead to multiple complications including fever that is not infectious. Identifying the cause of fever can help physicians choose the best care for the patient to try and prevent further damage to the already injured brain. Bacterial infection is one possible cause of fever in the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary antibiotic use. Better screening tools for infection are being developed to help fight the problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of antibiotics in patients increases the risk of adverse events and overall healthcare costs. Procalcitonin (PCT) is one such screening tool which has been used previously to help tell apart bacterial and nonbacterial causes of infection in other disease states; however, PCT has not been studied in hemorrhagic stroke patients. The purpose of this study is to understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can be a useful marker for infection in these patients.
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.
The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 male and female subjects participating at 4-5 military sites who suffer from injury with loss of skeletal muscle tissue. The University of Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating Center for this multi-site study.
Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding outcomes, many previous studies feature major design limitations that preclude widespread applicability of findings. Some fail to control for the precise pharmacologic composition of the epidural infusion, including whether or not an opioid, such as fentanyl, is even used at all in addition to local anesthetic or whether a combined spinal/epidural or purely epidural technique is used. The drugs used in epidural infusions not only have different mechanisms of action and lipophilicities but are also transferred across the placenta in varying proportions, with one study identifying an umbilical vein/maternal vein ratio of 0.94 for epidural fentanyl and 0.30 for bupivacaine, and another finding significantly different umbilical cord fentanyl concentrations among neonates whose mothers' epidural infusions contained >150 micrograms fentanyl, <150 micrograms, or none at all. It is also possible that the same total dose of epidural fentanyl could affect neonates differently depending upon the time course over which it was administered - namely, whether fentanyl is included in both the initial epidural bolus and the subsequent infusion or solely in the infusion. In two studies, mean umbilical vein concentrations of fentanyl did not correlate with total epidural infusion time, but both of these featured sample sizes fewer than 30, necessitating further research. Another limitation of some previous studies is defining success solely as the time to cessation of breast-feeding. Questionnaires mailed to mothers months or even years postpartum may generate unreliable data. If epidural medications truly mediate some physiologic effect upon breast-feeding, then the optimal study period is immediately post-delivery, specifically before the drugs are cleared from the maternal and neonatal circulations. After hospital discharge, many new factors - such as a mother's need to return to work or lack of social support - begin to confound the picture of breast-feeding success. Full-time employment outside the home has been significantly associated with decreased likelihood of breast-feeding at 6 months postpartum. Some studies also fail to control for intent to breast-feed at the time of hospital admission, number of infants previously breast-fed, or labor duration. Failure to account for oxytocin augmentation of labor is also problematic, as intravenous intrapartum oxytocin infusion has been shown to decrease a woman's endogenous serum oxytocin concentration on the second day postpartum in a dose-dependent fashion, which can subsequently impair milk release and, thus, decrease breast-feeding success. Epidural analgesia may worsen breast-feeding outcomes by attenuating neonatal exhibition of neurobehaviors tied to feeding, such as sucking, rooting, and swallowing, during the immediate postpartum period. This critical period is when mother and baby make their first attempts at breast-feeding and set a precedent for subsequent interactions. Neonatal feeding behavior in the early postpartum period is an important predictor of long-term breast-feeding success; those babies who feed most vigorously during their first days of life are significantly more likely to still be breast-feeding at 3 or 6 months than those who exhibit any lesser degree of breast-feeding enthusiasm. Radzyminski et al. found no significant dose-response relationship for either epidural bupivacaine or fentanyl regarding neonatal feeding behaviors, and Porter et al. found no significant effect of epidural fentanyl, mean dose 184 micrograms, upon neonatal APGAR scores, incidence of respiratory depression, or NACS scores (Neurologic and Adaptive Capacity Scores) at 2 or 24 hours post-delivery. Beilin et al. found that neonatal NACS scores were significantly lower when mothers' epidural infusions contained greater than 150 micrograms total epidural fentanyl than when they contained only bupivacaine. In this randomized, controlled, double-blinded study, we investigate whether intrapartum epidural fentanyl significantly decreases the likelihood of breast-feeding at hospital discharge and increases the incidence of neonatal deficits in latching on to the breast and audibly swallowing during the first three hours of life. We hypothesize that these effects will be dose-dependent but will have no relation to the time course over which the epidural fentanyl is administered. We also investigate whether oxytocin augmentation of labor and decreased amount of skin-to-skin contact during the first hour of life are associated with significantly decreased breast-feeding rates at hospital discharge.
Postoperative pain is a major problem in patients who either donate a kidney or undergo kidney transplantation. This pain is commonly treated with opioids, which can cause several side effects, ranging from pruritus, impaired vigilance, and most concerning to severe respiratory depression. This can be aggravated in the recipient by accumulation of opioid metabolites secondary to renal impairment and secretion. Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP) block after surgery in the lower abdomen. In the proposed study, we plan to compare the impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a ultrasound guided sham block with normal saline (placebo) on postoperative pain scores, postoperative opioid consumption, as well as patient's satisfaction. The investigators hypothesize, that patients who receive a TAP block will have lower postoperative pain scores, lower postoperative opioid consumption as well as higher satisfaction scores.
A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.