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281. We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples

prospective RCT in which 160 YMSM and their partners (320 participants) will complete a Baseline assessment and then complete assessments every 3 months for 9 months. Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platform, VSee. Specific Aims: Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition

2018 Clinical Trials

282. Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers

from participation with urine dipstick tests used to rule out pregnancy (pregnancy test performed before each treatment session, days one, five) All non-English speaking/writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study. If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well. Allergy to any

2018 Clinical Trials

283. Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease

in all clinic visits. Patients living at home or in the community (assisted living acceptable). Able to swallow CT1812 capsules. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening. Subjects must be capable of providing either written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. Written informed consent also shall

2018 Clinical Trials

284. sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

instillations and at least one maintenance (two of three instillations) in a 6 month period Eastern Cooperative Oncology Group performance status 0 to 2 Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information NOTE: HIPAA authorization may be included in the informed consent or obtained separately Females must not be breastfeeding Patients must be willing to undergo additional radiologic imaging while on study

2018 Clinical Trials

285. Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

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 HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time

2018 Clinical Trials

286. Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

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 Recipients and donors must meet all of the following applicable inclusion criteria to participate in this study: Informed consent and HIPAA authorization for release of personal health information signed by the subject. Age ≥ 18 years at the time of consent

2018 Clinical Trials

287. Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma

days before study registration, and the measurable disease must be outside of the radiation port. Pemetrexed-containing chemotherapy must be completed > 28 days before study registration. Must provide written informed consent and HIPAA authorization approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately. All previous toxicity resolved to Grade 1 or less. Exclusion Criteria: Any Grade 3-4 GI bleeding within 3 months

2018 Clinical Trials

288. A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients

. 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: Subject must meet all of the following applicable inclusion criteria to participate in this study: Written informed consent and HIPAA authorization for release

2018 Clinical Trials

289. Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP

2018 Clinical Trials

290. Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

subjects seeking repair of modest (approx. 5-30cc) soft tissue defects of the trunk (n=15). All participants will be treated via permanent injection of the study intervention (AAT injection) to restore the defect's contour. All study data will be collected in Case Report Forms (CRFs) and entered into a customized study database, created and maintained in HIPAA-compliant Research Electronic Data Capture (REDCap) software (14). Drug: Acellular Adipose Tissue (AAT) Participants (n=15) will be administered

2018 Clinical Trials

291. The Volumetric Analysis of Fat Grafting

. 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 to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Females or Males in good general health age 18 - 65 years of age Must be willing to give and sign a HIPAA form and informed consent form Must be willing

2018 Clinical Trials

292. Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Open wounds or lesions in the area(s) to be treated. Severe or cystic acne on the area(s) to be treated. Presence of an active systemic or local skin disease that may affect wound healing. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.). Subcutaneous fillers Keloid scar

2018 Clinical Trials

293. Safer Use of Antipsychotics in Youth

by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Analytic Code Time Frame

2018 Clinical Trials

294. Palbociclib and Cetuximab in Metastatic Colorectal Cancer

the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 4.1.1 Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 4.1.2 Age ≥ 18 years at the time of consent. 4.1.3 ECOG Performance Status of 0-2 4.1.4 Histologically-confirmed metastatic

2018 Clinical Trials

295. Relationship of Skin Related SNP to Topical Skin Care Product

products, acetyl glucosamine or other effective anti-aging topical products on the face 2 weeks prior to the start of the study and throughout the duration of the study. Completion and signing of a Informed Consent and Enrollment form, HIPAA form, photo release form, medical intake, skin habits survey. Willingness to complete all study assessments. Exclusion Criteria: Individuals who currently or in the last month have regularly used certain topical or oral medications which, in the opinion

2018 Clinical Trials

296. Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

Physically and mentally willing and able to comply with study protocol Lives in the immediate area and has no plans to relocate Provides informed consent and HIPAA release of medical information Exclusion Criteria: Active infection Any return or ongoing clinical recovery of distal motor function within 6 months after injury Physically/mentally compromised Systemic disease that would affect the patient's welfare or the research study Immunologically suppressed or immunocompromised Currently undergoing

2018 Clinical Trials

297. Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer

and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subject must meet all the following applicable inclusion criteria to participate in this study: Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent. Eastern Cooperative Oncology Group (ECOG

2018 Clinical Trials

298. The DCISionRT Registry

-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of a yearly follow-up form. All study data will be stored in an encrypted, HIPAA-compliant database maintained by the coordinating center. Each consented patient will be assigned a unique Study ID number. Study personnel at each institution will maintain an electronic key to link the Study IDs of its own patients to the patients' local medical record number. All personal health information (PHI

2018 Clinical Trials

299. Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

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 HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent. ECOG Performance Status of ≤ 1 within 14 days prior to registration

2018 Clinical Trials

300. The Genetic Basis for Atrial Fibrillation

setting at the Jesse Brown VA Medical Center and approached for informed consent and HIPAA authorization. Criteria Inclusion Criteria: Subjects must be at least 18 years of age, and up to 100. Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder. Subjects must be willing to give written, informed consent. Exclusion Criteria: Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from

2018 Clinical Trials

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