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241. Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

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. Men and women ≥ 18 years of age at the time of informed consent. ECOG Performance Status of 0 or 1 within 28 days prior to registration. Histologic or cytologic diagnosis of metastatic breast cancer (unless metastatic disease is definitive

2018 Clinical Trials

242. Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)

More Information Go to Layout table for additonal information Responsible Party: HonorHealth Research Institute ClinicalTrials.gov Identifier: Other Study ID Numbers: SU2C HRI NPG-002 First Posted: January 25, 2018 Last Update Posted: February 21, 2019 Last Verified: February 2019 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

2018 Clinical Trials

243. Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations

Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. Males aged 18 years of age and above Histological or cytologic proof of adenocarcinoma of the prostate Germline mutation in one or more homologous recombination DNA-repair genes (BRCA1, BRCA2, ATM, CHEK2, NBN, RAD50, RAD51C, RAD51D, PALB2, MRE11, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM

2018 Clinical Trials

244. Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride

Portability and Accountability Act (HIPAA) documentation. Female subjects of childbearing potential must have a negative serum pregnancy test at screening. human chorionic gonadotropin levels will be assessed for all women of childbearing years prior to the procedure. Exclusion Criteria: Severe septicemia or severe infection in the 4 weeks prior to study entry; The subject has a baseline NIHSS > 1 or modified Rankin Scale > 1. Active participation in other research therapy for cardiovascular repair

2018 Clinical Trials

245. Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease

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: Yes Criteria Inclusion Criteria: Able to understand and sign an informed consent and HIPAA privacy document Greater than 18 years of age at time of informed consent Able and willing to follow protocol instructions Capable of performing at-home eye wash Must be willing

2018 Clinical Trials

246. 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

247. 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

248. 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

249. 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

250. 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

251. M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC)

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 any locally-required authorization (e.g., HIPAA) obtained from the subject

2018 Clinical Trials

252. Denosumab + Pembrolizumab in Patients With Stage IV Melanoma

staff using 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: Signed written informed consent and HIPAA authorization for release of personal health information. Age ≥ 18 years at the time of consent. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Histologically confirmed

2018 Clinical Trials

253. Autoantibodies in Breast Cancer Detection

or women who have recently had a normal screening mammogram. The study team will enroll approximately 1,550 participants at Sanford Health in Sioux Falls, SD and Fargo, ND. Cohort A= 300 participants, Cohort B= 250 participants, Cohort C= 500 participants and Cohort D= 500 participants. Criteria Inclusion Criteria: Inclusion Criteria: All Cohorts: Women age 18 and older Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures Cohort A: Recent

2018 Clinical Trials

254. A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients

of their medication, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to perform a pilot trial examining the rates of medication adherence in adolescent kidney transplant recipients who use a novel mHealth system, and to understand the acceptability/satisfaction with using this technology. Study Design Go to Layout (...) , and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. Outcome Measures Go to Primary Outcome Measures : 12-week immunosuppression medication adherence [ Time Frame: 12 weeks ] After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence

2018 Clinical Trials

255. A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

provide written informed consent to participate in the study. Subjects living at home or in the community (assisted living acceptable). Ability to swallow CT1812 capsules. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening. Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA), if applicable]. Written informed

2018 Clinical Trials

256. 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

257. 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

258. Genius System for Neck Treatment

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: Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe

2018 Clinical Trials

259. Peds SM-THINk: Nursing Interventions to Improve Discharge Outcomes

yet, the nurse will check back periodically until they have left. This design will ensure that nursing discharge time is not affected. The research team will pick up the list of patient codes on the next working day. There is a waiver for documentation of informed consent and assent. If the parent and child are interested, participation will serve as implied consent. A HIPAA waiver will be requested by the study team to abstract data from the patient's medical record to look for outcomes over time

2018 Clinical Trials

260. The Epigenetics of Exercise and Physical Activity in COPD

to Share IPD: Yes Plan Description: Individual level data will be entered into an approved research repository behind the VA firewall. Data will be shared with qualified researchers (see below) Time Frame: 3 years Access Criteria: Prospective researchers must complete VA-required trainings in HIPAA, information security, and CITI training. 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 Emily S

2018 Clinical Trials

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