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121. Lutronic LaseMD for Treatment of Benign Pigmented Lesions

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. History of keloids or poor wound healing. Significant scarring in the area(s) to be treated that would interfere with assessing results. Open wounds or lesions in the area(s) to be treated. Inability to understand the protocol or to give informed consent. Microdermabrasion

2018 Clinical Trials

122. 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

123. Mobile Devices as Educational Skin History Tools

or other drug treatment facilities and therefore considered prisoners Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization. If the area being operated on is of the genitals or breasts If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2018 Clinical Trials

124. Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

baseline period. Note: Each seizure within a cluster may be counted as separate seizures. 5. 12 years of age or older. 6. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control. 7. Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator. Exclusion Criteria

2018 Clinical Trials

125. 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

126. 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

127. Post-Exercise Cardiovascular Responses Following Energy Drink Consumption

the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study. If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer

2018 Clinical Trials

128. A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures; participants will be asked to give written or verbal assent according to local requirements Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis of DMD as defined as: Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR Identifiable mutation

2018 Clinical Trials

129. Neural Basis of Eating Behavior in Abstinent Smokers

than 100 lifetime cigarettes and not even a puff of a cigarette for a minimum of 2 years. Smoking status of non-smokers will be confirmed by CO less than 5ppm. They will be matched to the smoker group on age, sex, and education. Plan to live in the area for the duration of the study (i.e. ~8 weeks/2 months). Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. Smokers who wish to make a permanent

2018 Clinical Trials

130. Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

the study.] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days. iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms. Exclusion Criteria: I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while

2018 Clinical Trials

131. 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

132. 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

133. Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM

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 (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related

2018 Clinical Trials

134. Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer

and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subject must meet all the following applicable inclusion criteria to participate in this study: 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. Eastern Cooperative Oncology Group (ECOG

2018 Clinical Trials

135. LaseMD System for the Treatment of Melasma

to enrollment and during the entire course of the study. Absence 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: Inability to understand the protocol or to give

2018 Clinical Trials

136. Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

assessment, and noninvasive blood flow assessments will be performed at baseline, and at completion of 20 and 40 infusions. HIPAA-compliant photographs of the affected lower limbs will be taken at each infusion visit. The specific aims of this open-label pilot study are to: Assess the effect of EDTA-based chelation therapy plus vitamins in diabetic patients with below-the-knee peripheral artery disease presenting with impending amputation and determine if there is an improvement in vascular flow (...) . Additionally, for patients entering the continued treatment phase, the test will be performed during infusion visits 45 and 50. Wound Evaluation [ Time Frame: 1 Year ] HIPAA-compliant pictures of skin integrity including wounds and areas of gangrene will be obtained for each patient at baseline and every 5 infusions. Wound assessment includes ulcer measurements (length, width, depth and undermining) and percentage of epithelialization. Additionally, for patients entering the continued treatment phase

2018 Clinical Trials

137. ViBone in Cervical and Lumbar Spine Fusion

, or 3 contiguous levels between L1-S1 Patient signed Consent Form with HIPAA Authorization Appropriate candidate for surgery Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available). Exclusion Criteria: Long term use of medications that are known

2018 Clinical Trials

138. Brain Injury Rehabilitation Improving the Transition Experience

, although a HIPAA-compliant video conferencing option will also be available. The content of these contacts will include: Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans; Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population. Outcome Measures Go to Primary Outcome Measures

2018 Clinical Trials

139. Post Approval Study of the remedē System

and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial. Criteria Inclusion Criteria: Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial In the investigator's opinion, willing and able to comply with all study requirements Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA

2018 Clinical Trials

140. 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

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