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281. M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC)

and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent and any locally-required authorization (e.g., HIPAA) obtained from the subject

2018 Clinical Trials

282. A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 1. Subject has capacity; is willing and able to provide written consent for use and disclosure of protected health information per requirements of 45CFR164.508 (Health Insurance Portability and Accountability Act; HIPAA) prior to initiating any study procedure after

2018 Clinical Trials

283. Effects of Metformin During Nicotine Withdrawal

in English. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form. Exclusion Criteria Smoking Behavior: Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months. Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes. Alcohol/Drugs: Self-report current alcohol consumption that exceeds 25

2018 Clinical Trials

284. Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

, in any 2 weeks period. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the area(s) to be treated

2018 Clinical Trials

285. Prospective Evaluation of the Incidence of PICS

) Sharing Statement: Plan to Share IPD: No Plan Description: Data will be entered and stored in in a de-identified/HIPAA compliant manner using a password protected web-based database that has securities to protect confidentiality and data integrity. The database will be constructed in REDCap. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Nutrition Disorders

2018 Clinical Trials

286. An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity

inpatient and outpatient care, the investigators now propose to complete a 360 degree approach by developing and rigorously assessing an integrated telemedicine-home-visitation program (THVP) to augment care for CMC in their homes to reduce the need for clinic visits as well hospitalizations. Building on prior experience in using telemedicine for children at UTH and evidence of benefits in other populations, 4,5 the providers will use a convenient, inexpensive, HIPAA-compliant telemedicine platform

2018 Clinical Trials

287. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia

-up visit. Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA). Exclusion Criteria: Have a clinically significant unstable medical condition or chronic disease, or malignancy. Had a medically significant illness within 30 days of screening. Have a known or suspected differential diagnosis of any of the other known forms of classic CAH. Have a history that includes bilateral adrenalectomy

2018 Clinical Trials

288. Genius System for Neck Treatment

of physical or psychological conditions unacceptable to the investigator. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe

2018 Clinical Trials

289. Peds SM-THINk: Nursing Interventions to Improve Discharge Outcomes

yet, the nurse will check back periodically until they have left. This design will ensure that nursing discharge time is not affected. The research team will pick up the list of patient codes on the next working day. There is a waiver for documentation of informed consent and assent. If the parent and child are interested, participation will serve as implied consent. A HIPAA waiver will be requested by the study team to abstract data from the patient's medical record to look for outcomes over time

2018 Clinical Trials

290. The Epigenetics of Exercise and Physical Activity in COPD

to Share IPD: Yes Plan Description: Individual level data will be entered into an approved research repository behind the VA firewall. Data will be shared with qualified researchers (see below) Time Frame: 3 years Access Criteria: Prospective researchers must complete VA-required trainings in HIPAA, information security, and CITI training. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Emily S

2018 Clinical Trials

291. Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).

2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Plan Description: RedCap database, central to primary center, online, web based and HIPAA compliant. Password protected and encrypted database. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No Keywords provided by Christopher Ellis, Vanderbilt University Medical Center: DRT Device

2018 Clinical Trials

292. Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and NHL

) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria - Unless otherwise noted, subjects must meet all of the following criteria to participate in this study: Written informed consent and HIPAA authorization for release of personal health information. Subjects must sign a consent to undergo cell procurement. Written informed consent to enroll in the CAR T-cell therapy trial must be obtained prior to lymphodepletion. Adults ≥18 years of age. Diagnosis of recurrent

2018 Clinical Trials

293. Video Games to Track Cognitive Health

on servers with HIPAA-level security. No participants will be asked to modify their normal behavior in any way. No feedback or results will be given to participants. The tests will not be distressing in any way. To meet the objective of detecting cognitive impairment, investigators will test a broad array of participants from ages 10 through 99 in several different settings in parallel. The targeted cognitive stressors of advanced age, head injuries, physical strain, sleep deprivation, alcohol ingestion

2018 Clinical Trials

294. Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA

care provider within 12 months of enrollment Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, and follow-up visits and assessments Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure Exclusion Criteria To be eligible for inclusion in this study, the subjects must not meet any

2018 Clinical Trials

296. Registry Study to Evaluate the Clinical Outcome of Cancer Patients and Benign Diseases Treated With Radiation

in the spreadsheet supplied with the IRB submission. The data will be disclosed only for analytical purposes.Confidentiality will be maintained by adhering to HIPAA guidelines. Only the PI and other study team members will have access to that data. Criteria Inclusion Criteria: Any patient who received or was potentially evaluated for radiotherapy since 2000 for benign or malignant etiologies in the definitive or palliative setting. Patients with comparatively similar diagnosis and disease status at UTSW

2018 Clinical Trials

297. TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative

Sexes Eligible for Study: All Sampling Method: Probability Sample Study Population Any age population with a diagnosis of a TFE Renal Cell Carcinoma Criteria Inclusion Criteria: All patients of any age with a diagnosis of a TFE Renal Cell Carcinoma. Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent. Exclusion Criteria: Any patient that has not been diagnosed with TFE Renal Cell

2018 Clinical Trials

298. Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma

therapy, and do not refuse surgery Written informed consent and HIPAA authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations Age > 18 years at time of study entry ECOG performance status ≤ 1 Life expectancy ≥ 24 weeks Body weight >30kg Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) 1.0 x 109/L (> 1000 per mm3) Platelet count ≥75 x 109/L (>75,000 per mm3) Serum

2018 Clinical Trials

299. Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

to the data. Data will be entered into a REDcap database by a member of the study team. All data and records generated during this study will be kept confidential in accordance with Institutional and HIPAA policies on subject privacy. The study team will not use such data and records for any purpose other than conducting the study. In order to keep protected health information from disclosure, each patient will be given a unique identification number. The key to this code will be kept in a locked file

2018 Clinical Trials

300. Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings

Accepts Healthy Volunteers: No Criteria Inclusion Criteria: In good general health Between 22 and 95 years of age and diagnosed with cataract(s) Able to comprehend and sign a written statement of informed consent for participation in the study, including HIPAA Undergoing cataract extraction surgery with an Alcon SN6 platform intraocular lens implantation into the posterior chamber Clear intraocular media, other than cataract Potential postoperative best-corrected visual acuity (BSCVA) of 20/30

2018 Clinical Trials

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