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201. Comparative Effectiveness Study Telerehab Versus Conventional

or No Choice. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the No Choice group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines

2018 Clinical Trials

202. Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

greater than one hour either for clinical or research purposes within 3 hrs of the proposed PET-MRI examination. Participant will be fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions Exclusion Criteria: Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants) Women who are pregnant. Subjects who

2018 Clinical Trials

203. Brain Injury Rehabilitation Improving the Transition Experience

, although a HIPAA-compliant video conferencing option will also be available. The content of these contacts will include: Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans; Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population. Outcome Measures Go to Primary Outcome Measures

2018 Clinical Trials

204. Post-Exercise Cardiovascular Responses Following Energy Drink Consumption

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. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer

2018 Clinical Trials

205. Mobile Devices as Educational Skin History Tools

or other drug treatment facilities and therefore considered prisoners Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization. If the area being operated on is of the genitals or breasts If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2018 Clinical Trials

206. Three Way Crossover Closed Loop Study With Xeris Glucagon

. Current use of a phone or other device so can be contacted by study staff off-campus. Willingness to follow all study procedures, including attending all clinic visits. Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill/patch/vaginal ring, Depo-Provera, Norplant, an IUD

2018 Clinical Trials

207. Anesthetics and Analgesics in Children

to understand the consent process and provides informed consent/HIPAA Participant provides assent and as required by the institutional review board Receiving one or more drugs of interest (DOI) per local standard of care meeting DOI-specific inclusion criteria Exclusion Criteria: Known pregnancy Extracorporeal life support (i.e., Extracorporeal membrane oxygenation, dialysis, ventricular assist device) Any condition which would make the participant, in the opinion of the investigator, unsuitable

2018 Clinical Trials

208. Post Approval Study of the remedē System

and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial. Criteria Inclusion Criteria: Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial In the investigator's opinion, willing and able to comply with all study requirements Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA

2018 Clinical Trials

209. Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

assessment, and noninvasive blood flow assessments will be performed at baseline, and at completion of 20 and 40 infusions. HIPAA-compliant photographs of the affected lower limbs will be taken at each infusion visit. The specific aims of this open-label pilot study are to: Assess the effect of EDTA-based chelation therapy plus vitamins in diabetic patients with below-the-knee peripheral artery disease presenting with impending amputation and determine if there is an improvement in vascular flow (...) . Additionally, for patients entering the continued treatment phase, the test will be performed during infusion visits 45 and 50. Wound Evaluation [ Time Frame: 1 Year ] HIPAA-compliant pictures of skin integrity including wounds and areas of gangrene will be obtained for each patient at baseline and every 5 infusions. Wound assessment includes ulcer measurements (length, width, depth and undermining) and percentage of epithelialization. Additionally, for patients entering the continued treatment phase

2018 Clinical Trials

210. ViBone in Cervical and Lumbar Spine Fusion

, or 3 contiguous levels between L1-S1 Patient signed Consent Form with HIPAA Authorization Appropriate candidate for surgery Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available). Exclusion Criteria: Long term use of medications that are known

2018 Clinical Trials

211. Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers

-cigarettes: An Evidence Update. A report commissioned by Public Health England. Available at: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_ Public_Health_England_FINAL.pdf (Aug 2015). Other Publications: HIPAA Privacy Rule. Information for Researchers. De-identifying Protected Health Information Under the Privacy Rule. U.S. Department of Health and Human Services. NIH (Feb 2007). Available at: http

2018 Clinical Trials

212. Using the Neuroscience of Fear Extinction for Anxiety Reduction

to and provide HIPAA authorization for this use will have their data uploaded. Time Frame: We anticipate uploading the final research data of all consenting participants no later than 5 years after the completion of the study. 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 Tali Manber Ball, PhD, Stanford University: Exposure therapy Behavioral therapy fMRI Extinction learning Social anxiety Additional

2018 Clinical Trials

213. Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

personal decision. Talk with your doctor 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 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 0-1 within 28 days prior to registration (Appendix 1). Life expectancy of 6 months or greater as determined by the site investigator. Histologically-confirmed diagnosis of unresectable stage IV or metastatic melanoma not amenable to local therapy. Measurable disease, defined as at least 1 tumor

2018 Clinical Trials

214. Topical Collagen Powder for Healing of Acute Full-thickness Wounds

, Layout table for eligibility information Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Outpatient, male or female subjects of any race, 18-75 years of age Able to understand the requirements of the study and understand and sign Informed Consent/HIPAA Authorization forms Patients willing to refrain from using topical medications to punch biopsy sites Patients who are willing to follow

2018 Clinical Trials

215. A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures; participants will be asked to give written or verbal assent according to local requirements Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis of DMD as defined as: Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR Identifiable mutation

2018 Clinical Trials

216. Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

the study.] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days. iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms. Exclusion Criteria: I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while

2018 Clinical Trials

217. Neural Basis of Eating Behavior in Abstinent Smokers

than 100 lifetime cigarettes and not even a puff of a cigarette for a minimum of 2 years. Smoking status of non-smokers will be confirmed by CO less than 5ppm. They will be matched to the smoker group on age, sex, and education. Plan to live in the area for the duration of the study (i.e. ~8 weeks/2 months). Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. Smokers who wish to make a permanent

2018 Clinical Trials

218. Collagen Matrix With and Without Enamel Matrix Derivative

plaque control (>25% of sites) Those with clinically significant systemic disease, which may affect healing (i.e. uncontrolled diabetes or bone metabolic disease) Allergy to chlorhexidine gluconate (Peridex) Does not sign study consent or HIPAA forms Bleeding complications (e.g. hemophilia) Warfarin therapy History of osteoporosis or taking bisphosphonate medications History of radiation therapy in the head and neck area Mobile teeth beyond physiologic mobility Facial restorations at the site

2018 Clinical Trials

219. TracPatch in Total Knee Arthroplasty

that may indicate a fall. A temperature sensor monitors the skin temperature near the joint. The device is attached by the patient to the shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage. The adhesive strip is disposable, allowing the device to be removed or relocated at any time. Data is transferred from the TracPatch to the user's blue-tooth enabled iOS or Android device, which then syncs to an encrypted, HIPAA compliant, database (...) as instructions on its use. Device: Consensus TracPatch The information gained by the TracPatch wearable technology will be readily available via a HIPAA secure system to the surgeon and patient in order to monitor post-operative recovery and signal to both parties if any intervention is indicated. The device also monitors for rapid acceleration events which may indicate a traumatic injury. Additionally, the temperature sensor may help detect sub-clinical infection. No Intervention: Current Standard Patients

2018 Clinical Trials

220. Effect of CT1812 Treatment on Brain Synaptic Density

consent or oral assent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. If the Participant can provide only assent, their legally authorized representative also must provide written informed consent. Written informed consent also shall be obtained from the responsible caregiver. All consent processes must be undertaken in the presence of a witness and prior to any study procedures. Must

2018 Clinical Trials

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