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141. Rural Asthma Effectiveness Study

ClinicalTrials.gov Identifier: Other Study ID Numbers: AAAR4130 First Posted: May 23, 2018 Last Update Posted: February 28, 2019 Last Verified: February 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: All data shared between sites will be de-identified by HIPAA standards using the "safe-harbor" method (i.e., all 18 identifiers will be stripped) prior to being scanned and stored on a password-protected webserver. Supporting Materials: Study Protocol Statistical

2018 Clinical Trials

142. Palbociclib and Cetuximab in Metastatic Colorectal Cancer

the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 4.1.1 Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 4.1.2 Age ≥ 18 years at the time of consent. 4.1.3 ECOG Performance Status of 0-2 4.1.4 Histologically-confirmed metastatic

2018 Clinical Trials

143. Relationship of Skin Related SNP to Topical Skin Care Product

products, acetyl glucosamine or other effective anti-aging topical products on the face 2 weeks prior to the start of the study and throughout the duration of the study. Completion and signing of a Informed Consent and Enrollment form, HIPAA form, photo release form, medical intake, skin habits survey. Willingness to complete all study assessments. Exclusion Criteria: Individuals who currently or in the last month have regularly used certain topical or oral medications which, in the opinion

2018 Clinical Trials

144. Safer Use of Antipsychotics in Youth

by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Analytic Code Time Frame

2018 Clinical Trials

145. Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

Physically and mentally willing and able to comply with study protocol Lives in the immediate area and has no plans to relocate Provides informed consent and HIPAA release of medical information Exclusion Criteria: Active infection Any return or ongoing clinical recovery of distal motor function within 6 months after injury Physically/mentally compromised Systemic disease that would affect the patient's welfare or the research study Immunologically suppressed or immunocompromised Currently undergoing

2018 Clinical Trials

146. The Genetic Basis for Atrial Fibrillation

setting at the Jesse Brown VA Medical Center and approached for informed consent and HIPAA authorization. Criteria Inclusion Criteria: Subjects must be at least 18 years of age, and up to 100. Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder. Subjects must be willing to give written, informed consent. Exclusion Criteria: Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from

2018 Clinical Trials

147. Connecting Alaska Native People to Quit Smoking

2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Plan Description: All data elements and data transfer activities will be strictly compliant with HIPAA privacy regulatory requirements. 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 Christi Patten, Mayo Clinic: Social Media Alaska Native

2018 Clinical Trials

148. Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

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 be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent. ECOG Performance Status of 0 or 1. Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory

2018 Clinical Trials

149. Feasibility of Individualized Therapy for Recurrent GBM

Patients must understand and provide written informed consent and HIPAA authorization authorization prior to initiation of any study-specific procedures Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma, WHO grade IV that is surgically resectable. The patient's surgeon thinks that they can resect at least 500 mg of tumor. Patient must have KPS score ≥ 70 Patient must have an estimated life expectancy ≥ 3 months Patients may enroll independent of number of prior

2018 Clinical Trials

150. Topical Treatment for Sexual Pain, Vulvar Pain, in Postmenopausal Women Not Taking Estrogens or Similiar Hormones

with the gynecologist. In addition, 2 short questionnaires will be filled out online on a HIPAA compliant web based survey at the end of week 1,2,4 and 5. Other: Placebo Aquaphor Active Comparator: 5% Topical sinecatechins ointment 30 postmenopausal women not using estrogen will apply one 0.5cm strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 6 weeks. They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip (...) will be filled out online on a HIPAA compliant web based survey at the end of week 1,2,4 and 5. Drug: Sinecatechins Topical Topical sinecatechins ointment will be applied daily. Other Name: Veregen Outcome Measures Go to Primary Outcome Measures : Numerical Rating Scale for pain [ Time Frame: Change in the Numerical Rating Scale for pain will be assessed weekly for 6 weeks and then finally at the end of week 8 ] Subjects will be asked to rate their pain 0=no pain, 1-3= mild pain, 4-6 =moderate pain; 7-9

2018 Clinical Trials

151. Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.

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: Males or females at least 18 years of age. Provided written HIPAA Informed Consent

2018 Clinical Trials

152. Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals

of defined metrics for all TIA patients admitted to the participating ASRH after implementation of an inpatient telestroke service. Other: Telestroke Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST-TIA, inpatient telestroke rounding will be used to oversee the urgent diagnostic TIA evaluation, secondary

2018 Clinical Trials

153. Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma

of normal institutional limits OR Creatinine clearance > 30 ml/min/1.73 m2 for patients with creatinine levels above 1.5x upper institutional normal Serum lipase/amylase ≤1.5 × ULN Hemoglobin ≥10 g/dL (can be transfused to achieve Hgb ≥10 g/dL) Ability to understand and willingness to sign a written informed consent and HIPAA consent document. LARs are allowed to sign on patient's behalf with proper documentation. Female patients who are postmenopausal for at least 1 year before the screening visit

2018 Clinical Trials

154. First in Human Study to Assess Safety of VIS649 in Healthy Subjects

and Accountability Act (HIPAA) authorization form or subject privacy form, if appropriate. Male and female subjects between 18 to 55 years of age, inclusive, at the Screening Visit. For Japanese subjects: Subject is of Japanese descent as evidenced by verbal confirmation of familial heritage (a subject has all four Japanese grandparents born in Japan). For non-Japanese subjects: Subjects must be of non-Asian descent, as evidenced by verbal confirmation that all four grandparents are non-Asian. The following

2018 Clinical Trials

155. United States Pre-Market Tobacco Application Pharmacokinetics

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). 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://privacyruleandresearch.nih.gov/pr_08.asp#8a. Last accessed 31-Jul-2017

2018 Clinical Trials

156. 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

2018 Clinical Trials

157. Implementation and Evaluations of Sepsis Watch

Clinical Research Institute Information provided by (Responsible Party): Duke University Study Details Study Description Go to Brief Summary: The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording & transcripts, and survey responses) will be stored on HIPAA-compliant

2018 Clinical Trials

158. Electrical Stimulation of Human Myocytes in Microgravity

Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Participant is 20-40 or 60-80 years of age, inclusive Participant BMI <30 kg/m2 Participant states willingness to follow protocol

2018 Clinical Trials

159. Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)

for at least the next 6 weeks; Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form; Able to communicate fluently in English (speaking, writing, and reading). Exclusion Criteria: Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study: Alcohol/Drugs: History or current diagnosis or treatment for alcohol

2018 Clinical Trials

160. Circadian Misalignment and Energy Balance

should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data. Supporting Materials: Study Protocol Informed Consent Form (ICF) Time Frame: Data will become available after results of the main aims from the final dataset

2018 Clinical Trials

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