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181. Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: provides written informed consent and HIPAA authorization before any study procedures are conducted; has a body mass index (BMI) < 37 kg/m2 is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause; subjects with hysterectomy only must have a serum FSH > 40 mIU/mL; has vulvovaginal atrophy with moderate to severe dyspareunia; has at least one

2018 Clinical Trials

182. Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC

therapy. Provision of written informed consent including HIPAA according to institutional guidelines prior to any study-specific procedures Patients must agree to research blood sampling to participate in study; Adequate organ and marrow function as defined by the following: Creatinine clearance ≥ 50 cc/min or serum Cr < 1.5 x institutional ULN Total bilirubin ≤ 1.5 x upper limit of normal (ULN) AST/ALT ≤ 2 x ULN without liver metastasis; ≤ 5 x ULN with liver metastasis Absolute neutrophil count (ANC

2018 Clinical Trials

183. Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Age>=19 years at time of study entry Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of >= 3months Histologically proven pancreatic ductal adenocarcinoma Resectable or borderline resectable based on AJCC Cancer staging system (8th ed) Chemotherapy -naïve for their pancreatic cancer Body weight

2018 Clinical Trials

184. Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic

monitoring Device: Home INR Monitoring The self-monitoring group will monitor INR at home using the AlereTM Home Monitoring Service. They will call in the weekly results to Alere or submit online via the patient portal, which is the standard protocol among home monitoring patients. Alere will then upload the information to a password-protected HIPAA compliant website that only study investigators will be able to access. Pharmacists will have real-time access to the test results via the web interface

2018 Clinical Trials

185. Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).

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: Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures

2018 Clinical Trials

186. Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease

in all clinic visits. Patients living at home or in the community (assisted living acceptable). Able 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 either written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. Written informed consent also shall

2018 Clinical Trials

187. 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

188. Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography

and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. Patient information will be protected according to HIPAA. The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression

2018 Clinical Trials

189. 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

190. 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

191. Multiparametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer

data collection. The information will be given only to faculty members and statisticians involved in the research project. The information will include the parameters attached in the spreadsheet supplied with the IRB submission. The data will be disclosed only for analytical purposes. Confidentiality will be maintained by adhering to HIPAA guidelines. The location of the data will be maintained at the worksite of the PI and the research coordinator in the Moncrief Radiation Oncology Department

2018 Clinical Trials

192. Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

, in any 2 weeks period. 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 systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the area(s) to be treated

2018 Clinical Trials

193. Randomized Controlled Trial of Standard ERP and OC-Go

, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for OCD, a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments (...) . Behavioral: Exposure and Response Prevention Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies. Experimental: OC-Go Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application. Behavioral: OC-Go OC-Go is a HIPAA-compliant web-based clinician portal and patient-side mobile

2018 Clinical Trials

195. Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA

care provider within 12 months of enrollment Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, and follow-up visits and assessments Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure Exclusion Criteria To be eligible for inclusion in this study, the subjects must not meet any

2018 Clinical Trials

196. Video Games to Track Cognitive Health

on servers with HIPAA-level security. No participants will be asked to modify their normal behavior in any way. No feedback or results will be given to participants. The tests will not be distressing in any way. To meet the objective of detecting cognitive impairment, investigators will test a broad array of participants from ages 10 through 99 in several different settings in parallel. The targeted cognitive stressors of advanced age, head injuries, physical strain, sleep deprivation, alcohol ingestion

2018 Clinical Trials

197. A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 1. Subject has capacity; is willing and able to provide written consent for use and disclosure of protected health information per requirements of 45CFR164.508 (Health Insurance Portability and Accountability Act; HIPAA) prior to initiating any study procedure after

2018 Clinical Trials

198. Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

to the data. Data will be entered into a REDcap database by a member of the study team. All data and records generated during this study will be kept confidential in accordance with Institutional and HIPAA policies on subject privacy. The study team will not use such data and records for any purpose other than conducting the study. In order to keep protected health information from disclosure, each patient will be given a unique identification number. The key to this code will be kept in a locked file

2018 Clinical Trials

199. Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma

therapy, and do not refuse surgery Written informed consent and HIPAA authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations Age > 18 years at time of study entry ECOG performance status ≤ 1 Life expectancy ≥ 24 weeks Body weight >30kg Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) 1.0 x 109/L (> 1000 per mm3) Platelet count ≥75 x 109/L (>75,000 per mm3) Serum

2018 Clinical Trials

200. Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

personal decision. Talk 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: 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 0-1 within 28 days prior to registration (Appendix 1). Life expectancy of 6 months or greater as determined by the site investigator. Histologically-confirmed diagnosis of unresectable stage IV or metastatic melanoma not amenable to local therapy. Measurable disease, defined as at least 1 tumor

2018 Clinical Trials

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