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121. 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

2018 Clinical Trials

122. 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

123. 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

124. 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

125. 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

126. Cervical Electrical Stimulation for ALS

: Other Study ID Numbers: B2527-P First Posted: January 26, 2018 Last Update Posted: January 16, 2019 Last Verified: January 2019 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 (...) Use 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

2018 Clinical Trials

127. Post Acute Cardiac Event Smoking (PACES) Study

: August 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Plan Description: Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals

2018 Clinical Trials

128. Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)

Research Institute ClinicalTrials.gov Identifier: Other Study ID Numbers: SU2C HRI NPG-001 First Posted: January 30, 2018 Last Update Posted: July 18, 2018 Last Verified: July 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees

2018 Clinical Trials

129. 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

130. 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

131. 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

132. 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

133. 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 ClinicalTrials.gov 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

134. 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

135. 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

136. 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

137. 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

138. 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

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

of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. 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

140. 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

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