Rochester, NY Paid Clinical Trials

Congenital heart defects (CHD) are the most common major human birth malformation, affecting ~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and are second only to infectious diseases in contributing to the infant mortality rate. Current understanding of the etiology of pediatric cardiovascular disorders is limited. The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective observational cohort study. Participants will be recruited from the Pediatric Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program. Biological specimens will be obtained for genetic analyses, and phenotype data will be collected by interview and from medical records. State-of-the-art genomic technologies will be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome. To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and genetic data, along with detailed, phenotypic and clinical outcomes data in order to investigate relationships between genetic factors and phenotypic and clinical outcomes in congenital heart disease. Read Less

The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. Read Less

To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses. Patients with COPD and humoral dysfunction will be offered treatment with Subcutaneous Immune Globulin Replacement Therapy (SCIgR) in an attempt to decrease future AECOPD. Read Less

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT). Read Less

The number of students aged 6-21 years with an educational classification of autism spectrum disorder (ASD) in the United States grew by about 19 times over a 19-year period-from 29,076 in 1995-6 to 545,198 in 2014-2015 (IDEA Data Center, 2018). Meeting the needs of this growing population of students is a significant concern for schools (Bowen, 2014). Investigators have described as many as 27 efficacious intervention strategies for teaching new skills to children with ASD (Wong et al., 2015). However, these strategies are only rarely implemented in schools. In a survey of 185 teachers across the state of Georgia working with at least one student with ASD, fewer than 5% reported using an evidence-based intervention (Hess, Morrier, Heflin, & Ivey, 2008). To address gaps in current practice for students with ASD, there is a need for (1) a process for selecting and implementing interventions that can address the multi-faceted needs of students with ASD and (2) a service-delivery system that is feasible, flexible, durable, effective, and sustainable in schools. The investigators hypothesize that The Modular Approach for Autism Programs in Schools (MAAPS), an individualized, comprehensive modular intervention system, will address this gap. MAAPS integrates evidence-based strategies to address core and associated features of autism spectrum disorders (ASD) to enhance the success of elementary students with ASD in schools. The primary aim is to evaluate whether, compared to services as usual, MAAPS improves teacher outcomes and subsequent student educational outcomes. Read Less

This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing. Read Less

This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered. Read Less

Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. The objective of the study is to develop and implement perioperative strategies to eliminate PPCs in abdominal surgery, the field with the largest absolute number of PPCs. We will conduct a randomized controlled pragmatic trial in 750 studied participants. The effectiveness of an individualized perioperative anesthesia-centered bundle will be compared to the usual anesthetic care in patients receiving open abdominal surgery. At the end of this project, the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity. The research will be conducted across 14 US academic centers, and will be funded by the National Institute of Health. Read Less

The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC) Read Less

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period. Read Less

Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA. Read Less

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Condition or disease: Breast Cancer Intervention/treatment: Drug: Gedatolisib Drug: Palbociclib Drug: Fulvestrant Drug: Alpelisib Phase 3 Read Less