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141. Non-invasive Cervical Electrical Stimulation for SCI

-017 First Posted: January 30, 2018 Last Update Posted: January 30, 2018 Last Verified: January 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: A Limited Dataset (LDS), with individual electrophysiological and physiological outcome measures, will be shared in electronic format pursuant to a VA-approved Data Use Agreement. Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate (...) Agreement. Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated

2018 Clinical Trials

142. Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

at least 3 minutes apart during screening; Schirmer tear test with anesthesia <7 mm/5 min in at least one eye during screening; Willingness and and ability to undergo, and return for, all scheduled study-related visits through Follow-up (Appendix 21.1); Willingness and and ability to provide written Informed Consent consistent with privacy language as per national regulations (e.g., HIPAA authorization) and which signature may be obtained from the patient or legally authorized representative prior

2018 Clinical Trials

143. 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

2018 Clinical Trials

144. Spectroscopic Magnetic Resonance Imaging of Glioma

of Excellence for HIPAA Data intended for storing, sharing and accessing sensitive and private-highly restricted files. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code Time Frame: 2 years Access Criteria: The link to the data will be made available upon request 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

2018 Clinical Trials

145. An Evaluation of Changes in Psychological Health to a Yoga Program for Medical Residents

Khalsa, PhD, Assistant Professor of Medicine, Brigham and Women's Hospital Identifier: Other Study ID Numbers: 2017P002372 First Posted: September 27, 2018 Last Update Posted: March 20, 2019 Last Verified: March 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Plan Description: Kripalu will potentially be receiving data, analyzing data, and publishing. The data will be HIPAA de-identified. A research agreement between Kripalu and Partners

2018 Clinical Trials

146. The Navigator Trial

PDMP manages a database that contains information on all prescriptions for schedule II-IV substances filled in the state. The database is updated daily; all pharmacies are required to report prescriptions within 48-hours of the fill date. All records will be linked deterministically to participant data using identifiable information (e.g., name, social security number) within the Stronghold computing environment, a HIPAA-compliant server maintained by the team at Brown University. The proportion

2018 Clinical Trials

147. A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

, ability and sufficient cognitive awareness to comply with the study protocol including: randomization; examination procedures; completion of planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye treatments. Ability to understand, read and write English to consent to study participation and complete study questionnaires. Willingness to sign informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining

2018 Clinical Trials

148. GrafixPL PRIME Evaluation Case Study

such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients. Condition or disease Intervention/treatment Phase Diabetic Foot Ulcer Biological: GrafixPL PRIME Phase 4 Detailed Description: Screening and Enrollment: Review and sign the Informed Consent and HIPAA Authorization Review

2018 Clinical Trials

149. Simulation RCT of Telemedical Support for Paramedics

resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Telemedicine The telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician. Other: Telemedicine The mobile, HIPAA-compliant, video-conferencing platform, Zoom Pro, will be used on tablet computers as a low-cost telemedicine platform for the intervention group. This platform uses Wi-Fi or cellular data connection for video streaming. The investigators will use the telephone

2018 Clinical Trials

150. Study of Pediatric Migraine: The Pediatric Migraine Registry

Method: Non-Probability Sample Study Population Participants aged 4-17 years old (inclusive) diagnosed with migraine with or without aura will be eligible for participation in this study. Criteria Inclusion Criteria: 4 to 17 years of age inclusive at the time of enrollment visit Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura Guardian provides informed consent/HIPAA Participant provides assent if developmentally appropriate and required

2018 Clinical Trials

151. Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices

of phase II/III and phase III trials to This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II 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

2018 Clinical Trials

152. Adherence to Inpatient Venous Thromboembolism Prophylaxis: A Single Institution's Concurrent Review. (PubMed)

, utilizing a cloud-based, HIPAA-compliant tool, on a convenience sample of hospitalized patients. Adherence and agreement between different assessment modalities were calculated. Seventy-six patients consented for participation. Nurse documented adherence was 66% (29/44), 44% (27/61), and 89% (50/56) for mechanical, ambulatory, and chemoprophylactic prophylaxis, respectively. Patient report and nurse documentation showed moderate agreement for mechanical and no agreement for ambulatory adherence (κ

2018 American Journal of Medical Quality

153. Trial of Atezolizumab Plus Chemotherapy After Progression on Single Agent PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

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 0-2 within 28 days prior to registration. Histological or cytological confirmed metastatic or unresectable locally advanced urothelial carcinoma (primary tumor: renal pelvis

2018 Clinical Trials

154. Patient Modesty: Volume 89

medical facility you will be asked to sign an agreement that you will not share any patient information on social media. Folks, as I recall Hipaa was passed in 1995, those laws were meant to protect patient information and patient privacy with hugh fines and imprisonment. Yet, nurses posting on Allnurses tell others that well don’t tell them you have a Facebook account and/or we’ll always make your settings to private that way you don’t get busted. You see the notion that there is no advocacy (...) the patient's former occupation and possible asbestos exposure. ..Maurice. At , Anonymous said... Maurice Pleural effusion can also be attributable to CHF, renal disease or a fall. I shudder to think people coming to a diagnosis with occupation first in mind. That the diagnosis could be arrived at after some investigation clinically or after a series of diagnostic tests. I might mention that prior to Hipaa laws in 1995 much of patient information from medical offices was placed in dumpsters. With names

2018 Bioethics Discussion Blog

155. The difference between care and service is significant

, this was in the days before HIPAA and caller ID, so scattered charts on the dining table and calling patients from the home phone was just the way he did business. The point of this story is not to bemoan the current state of medicine, where it feels like doctors spend 75 percent of their time battling with the electronic medical record, 15 percent of their time battling with insurance companies for authorizations, 10 percent of their time apologizing to patients for running late, 10 percent documenting patient

2018 KevinMD blog

156. How to create an app as a physician

in the medical world, it seems as if there’s so much room to innovate. Creating an app as a physician Perhaps you’re an OB/GYN and you’re trying to find a HIPAA compliant way to communicate with patients off-hours, then you might create something like Call Simplified. Or perhaps you’re a Urologist and want to help your patients better track their daily urinary tract symptoms, medication, and behavioral patterns, as well as offer personalized tips for UTI prevention, then you might create UTI Tracker. Maybe

2018 KevinMD blog

157. Secure smartphone application-based text messaging in emergency department, a system implementation and review of literature. (PubMed)

inter-hospital communication and patient outcomes.We conducted a systematic literature review in PubMed, MEDLINE using the keywords Health Insurance Portability and Accountability Act (HIPAA) Compliant Group Messaging (HCGM), text paging communication, secure hospital text message, HIPAA text message, and secure hospital communication. The search considered studies published until January 2018. Only English-language studies were included. We reviewed the reference lists of included articles

2018 American Journal of Emergency Medicine

158. How writing fiction can free physicians

— and sometimes required of medical students. This is a commendable trend, though the exercise can be affected by issues with the Health Insurance Portability and Accountability Act (HIPAA), designed to protect patient privacy, and other confidentiality issues. And students may feel too vulnerable to share their deep-seated emotions; some of them have told me that, concerned about “setting off alarms,” they started “dumbing down” their mandatory writing in order to avoid worried calls from advisors who

2018 KevinMD blog

160. How did EHR designers get control of health care?

only get consent from the patient for us to view their records at another hospital that uses the same EHR when the patient is physically in front of us at an appointment? Why can’t this be changed? If my patient tells me over the phone that they went to another hospital with a medical emergency, shouldn’t there be a button that they can click in their secure HIPAA-compliant patient portal that authorizes me to see those records? Why is it they have to come in for me to print out a paper copy

2018 KevinMD blog

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