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101. Impact of Coronary Computerized Tomography Angiography-Derived Plaque Quantification and Machine-Learning Computerized Tomography Fractional Flow Reserve on Adverse Cardiac Outcome. (Abstract)

in this single-center retrospective, institutional review board-approved, HIPAA-compliant study. Follow-up was performed to record major adverse cardiac events (MACE). Plaque quantification of lesions responsible for MACE and control lesions was retrospectively performed semiautomatically from cCTA together with machine-learning based CT-FFR. The discriminatory value of plaque markers and CT-FFR to predict MACE was evaluated. After a median follow-up of 18.5 months (interquartile range 11.5 to 26.6 months

2019 American Journal of Cardiology

102. Quantitative Ultrasound Spectroscopy for Differentiation of Hepatocellular Carcinoma from At-Risk and Normal Liver Parenchyma. (Abstract)

Insurance Portability and Accountability Act (HIPAA)-compliant study was approved by the Institutional Review Board. Fifteen patients with HCC, 15 non-HCC patients with chronic liver disease, and 15 healthy volunteers were included (31.1% women; 68.9% men). Ultrasound radiofrequency data were acquired in each patient in both liver lobes at two focal depths (3/9 cm). Region of interests (ROIs) were drawn on HCC and liver parenchyma. The average normalized power spectrum for each ROI was extracted

2019 Clinical Cancer Research

103. Impact of computed tomography (CT)-derived fractional flow reserve on reader confidence for interpretation of coronary CT angiography. (Abstract)

Impact of computed tomography (CT)-derived fractional flow reserve on reader confidence for interpretation of coronary CT angiography. To assess the impact of computed tomography-derived fractional flow reserve (FFRCT) on reader confidence and reader time for interpretation of coronary computed tomography angiography (CCTA).This IRB-approved, HIPAA-compliant, consent waivered, quality-improvement study included 50 patients (23 women, age 67 ± 12years, body mass index 28.7 ± 5.3 kg/m2). CCTA

2019 European journal of radiology Controlled trial quality: uncertain

104. Hearing Loss in Pediatric Septo-Optic Dysplasia. (Abstract)

Hearing Loss in Pediatric Septo-Optic Dysplasia. To identify and characterize hearing loss (HL) in children with septo-optic dysplasia (SOD).Otologic and audiometric data for patients less than 18 years of age identified as having SOD who were seen in the Children's Healthcare of Atlanta-Scottish Rite Hospital clinic between 2013 and 2017 were collected and reviewed through a HIPAA-compliant medical record search. Relevant literature was also reviewed with the assistance of Medline.Sixty-four

2019 Rhinology and Laryngology

105. Feasibility of remote administration of the fundamentals of laparoscopic surgery (FLS) skills test using Google wearable device. (Abstract)

) is referred to as a wearable computer containing a heads-up display and front-facing camera allowing point-of-view video transmission. The objective of this study was to evaluate the feasibility of GG in scoring the technical skills component of the FLS exam.Twenty-eight participants were asked to complete the peg transfer and intracorporeal knot tasks of FLS using both GG and Skype™ setups. GG employed a third-party HIPAA-compliant video software (Pristine; Austin, TX) for video transmission

2019 Surgical endoscopy

106. Digital Mammography in Breast Cancer: Additive Value of Radiomics of Breast Parenchyma. (Abstract)

the addition of radiomic analysis of contralateral breast parenchyma to the characterization of breast lesions with digital mammography improves lesion classification over that with radiomic tumor features alone. Materials and Methods This HIPAA-compliant, retrospective study included 182 patients (age range, 25-90 years; mean age, 55.9 years ± 14.9) who underwent mammography between June 2002 and July 2009. There were 106 malignant and 76 benign lesions. Automatic lesion segmentation and radiomic analysis

2019 Radiology

108. Three-Dimensional Ultrasound for Screening and Diagnosis of Breast Cancer: Clinical and Cost Effectiveness

/pmc/articles/PMC265786 PubMed: PM18936310 PURPOSE: To assess the diagnostic performance of various Doppler ultrasonographic (US) vascularity measures in conjunction with grayscale (GS) criteria in differentiating benign from malignant breast masses, by using histologic findings as the reference standard. MATERIALS AND METHODS: Institutional Review Board and HIPAA standards were followed. Seventy-eight women (average age, 49 years; range, 26-70 years) scheduled for breast biopsy were included

2012 Canadian Agency for Drugs and Technologies in Health - Rapid Review

109. Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism

at the time of screening who are capable of providing informed consent prior to screening and any protocol-related procedures. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act (HIPAA) in the USA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Ability to complete and meet all eligibility requirements for randomization within 28 days of informed consent (56 days

2018 Clinical Trials

110. A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

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: For inclusion in the study patients must fulfil all of the following criteria: Written informed consent and any locally-required authorization (e.g. HIPAA) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations Age > 18 years at time of study entry Eastern Cooperative

2018 Clinical Trials

111. A prospective, randomized, single-blinded trial for improving health outcomes in rhinology by the use of personalized video recordings. (Abstract)

outcomes.Patients in a tertiary rhinology clinic were enrolled into a single-blinded prospective study after obtaining institutional review board (IRB) approval and informed consent. All enrollees had a short summary of their clinical encounter video-recorded with a tablet using Medical Memory, a Health Insurance Portability and Accountability Act (HIPAA)-compliant software system. Patients were randomized to receive access to their videos by our research coordinator, and outcomes included questionnaires

2018 International forum of allergy & rhinology Controlled trial quality: uncertain

112. Durvalumab and Tremelimumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

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 obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment. Age ≥ 18 years of age on day of signing informed consent Eastern Cooperative Oncology Group

2018 Clinical Trials

113. Orange Juice And Sugar Intervention Study

and prepared in accordance with all HIPAA regulations prior to release for sharing. Study outcome results will be submitted to no later than one year after the trial's primary completion date. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code Time Frame: One year after the end of study--March 31, 2024 Access Criteria: We will make data and demographic information available to investigators who submit

2018 Clinical Trials

114. Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC

duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices). Ability to understand and willingness to sign a written informed consent and HIPAA consent document

2018 Clinical Trials

115. Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

. 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: Yes Criteria Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included

2018 Clinical Trials

116. Single Hormone Closed Loop Study With PDT Sensor

pump for at least 3 months with stable insulin pump settings for > 2 weeks. HbA1c ≤ 10% at screening. Body Mass Index ≥ 22. Total daily insulin requirement is less than 200 units/day. Willingness to follow all study procedures, including attending all clinic visits. Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable

2018 Clinical Trials

117. Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults

the approved informed consent document and HIPAA Authorization. Have in their charts: medical history (including concomitant medications) within 60 days of planned first administration of vaccine physical examination and laboratory tests within 1 year previous chest radiograph results and electrocardiogram Be medically cleared for participation by an investigator (Examinations and/or tests may be repeated at the discretion of the PI). Be willing to return for all follow-up visits. Agree to report any

2018 Clinical Trials

118. Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

the study period. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form. Subjects will be advised to refrain from major changes in their level of exercise during the study period. Men who meet any of the following criteria are NOT eligible for enrollment in the trial: Men participating in another clinical trial involving an investigational drug within the 30 days prior to the first screening visit. Men not living

2018 Clinical Trials

119. Comparative Effectiveness Study Telerehab Versus Conventional

or No Choice. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the No Choice group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines

2018 Clinical Trials

120. Collagen Matrix With and Without Enamel Matrix Derivative

plaque control (>25% of sites) Those with clinically significant systemic disease, which may affect healing (i.e. uncontrolled diabetes or bone metabolic disease) Allergy to chlorhexidine gluconate (Peridex) Does not sign study consent or HIPAA forms Bleeding complications (e.g. hemophilia) Warfarin therapy History of osteoporosis or taking bisphosphonate medications History of radiation therapy in the head and neck area Mobile teeth beyond physiologic mobility Facial restorations at the site

2018 Clinical Trials

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