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.
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
This trial will see if extended abatacept administration (combined with a standard regimen of tacrolimus and mycophenolate mofetil) will prevent acute and chronic graft-versus-host disease (GVHD) in children and adolescents receiving unrelated donor (URD) hematopoietic stem cell transplantation (HSCT), without compromising their engraftment or reconstitution of protective immunity to infection. The study will enroll 30 pediatric patients with serious non-malignant hematologic diseases (NMHD) undergoing URD HSCT. The trial will include patients with 7/8 donors and those with 8/8 (matched) donors. All participants will receive 8 doses of abatacept. Recruitment is expected to last for about 2 years and participants will be followed for up to 3 years.
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).
Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among Native Americans (NA), making the long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse and violence in NA families by testing an efficacious, sustainable, culturally-relevant and family-centered intervention for cross-national dissemination. The central hypothesis is that the sustainable and community-based Weaving Healthy Families program, will reduce and postpone AOD use among NA adults and youth, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. The expected outcomes of the proposed research are an efficacious, culturally relevant, and sustainable community based program to promote health and wellness that will address the factors that drive health disparities and promote individual, family, and community resilience.
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
This is a randomized multi-arm trial evaluating the safety and efficacy of thoracic radiation therapy followed by either durvalumab as monotherapy or in combination with tremelimumab or olaparib in participants with Extensive-Stage Disease Small Cell Lung Cancer (ES-SCLC) who have completed a first-line platinum-based chemotherapy regimen and achieved ongoing complete response (CR), partial response (PR) or stable disease (SD).
Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical underuse of cardiac rehabilitation in older adults with a coaching model that addresses issues related to aging as a means to better facilitate cardiac rehabilitation (CR). MACRO is a randomized controlled trial (RCT) in which older adults with a CVD event are randomized between a MACRO intervention (MACRO-I) versus usual care. The MACRO-I is designed to facilitate CR as a means to augment functional recovery.
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings. The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff. For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) < 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine). Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is < 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value. Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement. We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. < 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. < 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.