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261. Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

subjects seeking repair of modest (approx. 5-30cc) soft tissue defects of the trunk (n=15). All participants will be treated via permanent injection of the study intervention (AAT injection) to restore the defect's contour. All study data will be collected in Case Report Forms (CRFs) and entered into a customized study database, created and maintained in HIPAA-compliant Research Electronic Data Capture (REDCap) software (14). Drug: Acellular Adipose Tissue (AAT) Participants (n=15) will be administered

2018 Clinical Trials

262. The Volumetric Analysis of Fat Grafting

. 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 to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Females or Males in good general health age 18 - 65 years of age Must be willing to give and sign a HIPAA form and informed consent form Must be willing

2018 Clinical Trials

263. Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

, Center for Health Care Delivery Science, Nemours Children's Clinic ClinicalTrials.gov Identifier: Other Study ID Numbers: First Posted: June 14, 2018 Last Update Posted: March 15, 2019 Last Verified: March 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: A redacted data set stripped of all HIPAA-defined identifiers will be made available to interested and qualified researchers once all of the analyses of the study hypotheses have been completed

2018 Clinical Trials

264. A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

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: Male Gender Based Eligibility: Yes Gender Eligibility Description: Prostate Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening (...) procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Males 18 years of age and above Histological or cytological proof of prostate cancer Documented progressive mCRPC based on at least one of the following criteria: PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng

2018 Clinical Trials

265. Organ Preservation in Early Rectal Cancer Patients

institutional normal Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria: Patients with contraindication to use FOLFOX chemotherapy and pelvic radiation. Low risk T1 tumors that fulfill all of the following - size<4 cm, lack of lymphovascular invasion and well differentiated histology, are excluded High risk T3 tumors that fulfill any of the following - circumferential tumor, extension into mesorectal fascia > 5mm, prediction of positive

2018 Clinical Trials

266. Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

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 Recipients and donors must meet all of the following applicable inclusion criteria to participate in this study: Informed consent and HIPAA authorization for release of personal health information signed by the subject. Age ≥ 18 years at the time of consent

2018 Clinical Trials

267. Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

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 be included in the informed consent or obtained separately. Age ≥ 18 years at the time

2018 Clinical Trials

268. 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

269. Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life

participation, only the subject must sign a provision of informed consent and HIPAA compliant research authorization. Exclusion Criteria: Age less than10 years and greater than 21 years at study entry Greater than 2 diagnosed UTIs within last 12 months or symptomatic UTI at trial onset (UTI defined as the presence or ≥104 cfu/ml of a single bacterial strain in the presence of identified symptoms including but not limited to fever, flank or abdominal pain, change in urinary pattern or dysuria). Potential

2018 Clinical Trials

270. 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

271. SurvivorLink Scalability

related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: SurvivorLink Participants receiving treatment at a pediatric cancer survivor clinic randomized to this study arm will receive education on how to use SurvivorLink, late effects of treatment, and survivorship care through the system. Behavioral: SurvivorLink SurvivorLink (www.cancersurvivorlink.org) was developed in 2010 as a HIPAA compliant web-based communication tool to enable survivors to learn about survivorship

2018 Clinical Trials

272. 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

273. 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

274. 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

275. 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

276. 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

277. 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

278. Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing. Supporting Materials: Clinical Study Report (CSR) Time Frame: Available as requested. Data will be archived indefinitely for research purposes. Access Criteria: Individuals seeking use of these data should contact the study chair. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies

2018 Clinical Trials

279. 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

280. 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

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