221. Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men
the study period. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form. Subjects will be advised to refrain from major changes in their level of exercise during the study period. Men who meet any of the following criteria are NOT eligible for enrollment in the trial: Men participating in another clinical trial involving an investigational drug within the 30 days prior to the first screening visit. Men not living
222. Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
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 of consent (no upper age limit) Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 (see Section 10.1 Appendix A) Tumor Eligibility: Dose escalation cohorts: Histologically confirmed advanced solid tumor
223. Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
have no known allergy to riluzole or inactive ingredients* in ROSF. Subjects or subject's legally authorized representative must be willing and able to complete informed consent/assent and HIPAA authorization. Ability to comprehend and be informed of the nature of the study, as assessed by the Primary or Sub-Investigator. Subjects prescribed to take riluzole at or before the time of first dose. (The study is open to subjects currently taking riluzole at screening, subjects who are not currently
224. The Use of Oracea and Epiduo Forte in Severe Acne Patients
will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.] ii. Facial acne IGA score of 4 iii. Minimum of 20 or more inflammatory lesions and 20 or more non-inflammatory lesions and not more than 4 nodules iv. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization
225. Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.
. Parent/LAR Is 18 years of age or older and willing/able to present proof of guardianship for the infant subject (i.e., birth certificate, hospital records, adoption record, insurance card, other ID along with valid ID of parent/LAR). Parent/LAR has signed the ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure in English, for the infant to participate in the study. Parent/LAR agrees not to introduce any new products or fragrances on his/her person, on his/her infant
226. Tobacco Use Treatment in Cancer Patients
(CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling. Drug: Nicotine Replacement Therapy Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants
227. ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer
formula Life expectancy at least 3 months. Ability to understand and willingness to sign a written informed consent and HIPAA consent document. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Exclusion Criteria: No prior treatment with ONC201. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have
228. Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer
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 obtained from the subject and documented according to local regulatory requirements prior to beginning any protocol-specific procedures, including screening procedures The subject is willing and able to comply
229. LaseMD System for the Treatment of Melasma
to enrollment and during the entire course of the study. Absence 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: Inability to understand the protocol or to give
230. Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514. Time Frame: 6 months after publication for a 2 year duration Access Criteria: upon request to NCORP@wakehealth.edu 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
231. [Trial of device that is not approved or cleared by the U.S. FDA]
information Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Adults; Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement; Subjects must be considered dependable and able to follow directions Exclusion Criteria: Subjects who are in ill health; Subjects who are taking medications other than birth control; Female subjects who are pregnant (return positive
232. Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
Fitzpatrick Wrinkle Scale evaluating the nasolabial folds (Appendix A1 and A2). Subjects must be willing to provide written informed consent, HIPAA authorization, and photographic release. Subjects must be willing to follow study instructions and complete all required visits. Negative urine pregnancy test results at the time of study entry (if applicable). The subject is healthy as judged by medical history and investigator's assessment of current health Female subjects will be either of non-childbearing
233. Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
hour before each visit. Whose parent or legal representative agrees to not soak the tape during a sponge bath. If the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing). Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization. Exclusion Criteria: Who are known to be developmentally delayed Who have any known allergy or sensitivity to tapes Who have sunburn, skin infection or scars
234. A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging
that work in the respective urology clinics Providers may be any gender or race/ethnicity Qualitative portion only: Urology Chiefs and/or frontline staff physicians participating PAs & NPs having cared for at least 5 men with incident prostate cancer within the previous 6 months Patients will not be directly recruited into the study. The investigators have obtained a waiver of HIPAA authorization and informed consent to analyze electronic health records of patients that are diagnosed with ICD-9 code 185
235. Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
baseline period. Note: Each seizure within a cluster may be counted as separate seizures. 5. 12 years of age or older. 6. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control. 7. Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator. Exclusion Criteria
236. Evaluation of Skin Attributes Following Dietary Supplement Consumption
images for use in relation to this clinical study; Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; Subject understands and is willing to sign an Informed Consent in conformance with 21 CFR Part 50: "Protection of Human Subjects." Exclusion Criteria: Subject is pregnant, planning to become pregnant, or nursing; Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light); Subject has scars, tattoos, moles
237. A Randomized Control Trial: Returning to Run After Injury
will be kept in a secure location and access limited to authorized research study personnel. This research study meets the confidentiality requirements of the Health Insurance Portability and Accountability Act (HIPAA). 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 Wounds and Injuries Knee Injuries Leg Injuries
238. 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
239. 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
240. Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
Estimated Primary Completion Date : January 1, 2023 Estimated Study Completion Date : January 1, 2023 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Sleep Parent Training The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (HIPAA compliant video-chat