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241. 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

242. [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

2018 Clinical Trials

243. Pain Biomarker Study

to provide HIPAA authorization to share prior medical records/imaging Age 18 and older Exclusion Criteria: The following items exclude the subject from all portions of the study: a. Known history of cardiovascular or neurovascular diseases. These diseases may include carotid stenosis of >50%, vertebral stenosis, peripheral vascular disease, angina or myocardial infarction, stroke, or vascular malformations; b. History of brain tumors or epilepsy; c. Active pregnancy or lactation; d. Daily cigarette

2018 Clinical Trials

244. Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

of age) who receive maternal breastmilk. Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines. Exclusion Criteria: Any concomitant condition which, in the opinion of the physicians providing patient care or the principal

2018 Clinical Trials

245. Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

, i.e., oxygen delivered via a POC. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization. Exclusion Criteria: Patient's condition is contraindicated for the use of a POC. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated. Patient is unable to complete the 6-minute walk test. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection

2018 Clinical Trials

246. A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC

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 ≤ 2 and/or sufficient to undergo both perioperative systemic chemotherapy and hepatic surgery as determined by surgical and medical oncology evaluations. Histologically confirmed hepatic-limited metastatic colorectal

2018 Clinical Trials

247. Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)

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. NOTE: HIPAA authorization may

2018 Clinical Trials

248. 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

249. 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

250. Canadian Network for Autoimmune Liver Disease

for research studies. REDCap is designed to comply with HIPAA security regulations. The CaNAL REDCap database (REDCap project CaNAL) has been established at the University of Alberta under the jurisdiction of the Women and Children's Health Research Institute (WCHRI). Individual centres will have access only to their own data and patient identifiers will only be visible to the individual centres. The steering committee will have access to all anonymized data within the REDCap database, that is without any

2018 Clinical Trials

251. Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

clinic visits. Other: Usual Care of IPF standard of care given to patients with IPF Other: Telenursing scheduled phone calls with the patient and care giver Experimental: Telenursing and Remote Monitoring Patients will receive usual care with telenursing and will be given a hand held spirometer and puse oximeter and be asked to take daily measurements and report these via an electronic HIPAA approved secured platform for evaluation by the telenursing team. Other: Usual Care of IPF standard of care

2018 Clinical Trials

252. The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol

and cysts). Investigator's Global Assessment (IGA) of acne severity grade 2 or 3 Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. Subject/Guardian must sign an IRB-approved Informed Consent/Assent/Assent Form including photography consent, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed Exclusion Criteria: Presence of any skin

2018 Clinical Trials

253. Assessing the Mechanism of Change of Functional Analytic Psychotherapy

data. Data that contain HIPAA protected information (e.g., video records) won't be shared to other researchers. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code Time Frame: It is planned that IPD and additional supporting information will become available by June 2019 for 5-year (June 2024). Access Criteria: IPD and additional supporting information will be shared for publication and replication purposes. They will be only available

2018 Clinical Trials

254. Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Eligible for Study: 18 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients undergoing primary total knee arthroplasty Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures. Exclusion Criteria: Patients with a current diagnosis of chronic pain Patients requiring narcotics for greater than one week prior to surgery Patients with chronic

2018 Clinical Trials

255. Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma

and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures. 2. Male or female patients who are 18 years of age or older. 3. Patients with a diagnosis of histologically confirmed advanced (defined as unresectable stage III or IV) melanoma with the NRAS Q61 mutation or BRAF/NRAS WT for which there is no remaining standard therapy with curative potential or patients are ineligible or unable to tolerate

2018 Clinical Trials

256. 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

257. Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)

, Layout table for eligibility information Ages Eligible for Study: 30 Years to 83 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any

2018 Clinical Trials

258. Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

informed consent. Up to 2 repeat doses of aerosolized Infasurf can be administered. Aerosolized Infasurf must be administered as described in the protocol. Adverse events at administration (if any) and all serious adverse events related or possibly related the aerosolized Infasurf therapy will be extracted from the medical record and reported to the sponsor, ONY Biotech. A copy of the discharge summary of patients will be collected by the sponsor using HIPAA compliant methodology for generation

2018 Clinical Trials

259. Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer

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. ECOG

2018 Clinical Trials

260. 4D Cone Beam CT Reconstruction for Radiotherapy Via Motion Vector Optimization

research subjects training and HIPAA training. Criteria Inclusion Criteria: Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW. Patients are greater than 18 years of age. Patients understand a written informed consent document and are willing to sign the consent form. Exclusion Criteria: Women who are pregnant or trying to get pregnant Children (under age of 18) Contacts and Locations Go to Information from the National Library of Medicine

2018 Clinical Trials

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