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121. Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors

consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations AGE ≥ 18 Alkaline phosphatase (ALP) level ≤ upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine amino transferase (ALT) ≤ ULN Bilirubin ≤ ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to evaluate for Gilbert's Syndrome (if direct bilirubin is within normal range, subject may

2018 Clinical Trials

122. Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

a HIPAA authorization, if applicable. Study subjects should be literate and willing to complete the subject diary regularly as directed. Study subjects must be in good health and free from any clinically significant disease apart from indication under study. Females of child bearing potential (WOCBP*) must not be pregnant or lactating at baseline visit (as documented by a negative urine pregnancy test with a minimum sensitivity of 25 IU/L or equivalent units of beta-human chorionic gonadotropin (Beta

2018 Clinical Trials

123. 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

124. Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514. Time Frame: 6 months after publication for a 2 year duration Access Criteria: upon request to NCORP@wakehealth.edu Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured

2018 Clinical Trials

125. Pharmacogenomics and Post-Operative Nausea and Vomiting

switch. Patient age 18 or above. Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures. Patient is willing to engage in a medication adjustment as part of their clinical visit (when needed). Exclusion Criteria Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent

2018 Clinical Trials

126. Endotracheal Tube Placement Using Totaltrack Video Laryngeal Mask Use Versus Macintosh Laryngoscope in Low Risk Patients

of a breathing tube through the mouth into the airway) that will occur at the beginning of general anesthesia (i.e. combination of drugs to sedate and put you to sleep during surgery) with TotalTrack Video Laryngeal Mask (VLM) versus conventional intubation with Macintosh curved laryngoscope in adult patients. Both devices are approved by the US Food & Drug Administration (FDA) for clinical use in patients. Pending partial HIPAA waiver approval, potential subjects will be identified via review of surgery

2018 Clinical Trials

127. Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma

days before study registration, and the measurable disease must be outside of the radiation port. Pemetrexed-containing chemotherapy must be completed > 28 days before study registration. Must provide written informed consent and HIPAA authorization approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately. All previous toxicity resolved to Grade 1 or less. Exclusion Criteria: Any Grade 3-4 GI bleeding within 3 months

2018 Clinical Trials

128. A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients

. 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: Subject must meet all of the following applicable inclusion criteria to participate in this study: Written informed consent and HIPAA authorization for release

2018 Clinical Trials

129. Using the Neuroscience of Fear Extinction for Anxiety Reduction

to and provide HIPAA authorization for this use will have their data uploaded. Time Frame: We anticipate uploading the final research data of all consenting participants no later than 5 years after the completion of the study. 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 Tali Manber Ball, PhD, Stanford University: Exposure therapy Behavioral therapy fMRI Extinction learning Social anxiety Additional

2018 Clinical Trials

130. Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP

2018 Clinical Trials

131. 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

132. 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

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. The DCISionRT Registry

-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of a yearly follow-up form. All study data will be stored in an encrypted, HIPAA-compliant database maintained by the coordinating center. Each consented patient will be assigned a unique Study ID number. Study personnel at each institution will maintain an electronic key to link the Study IDs of its own patients to the patients' local medical record number. All personal health information (PHI

2018 Clinical Trials

135. Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

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 ≤ 1 within 14 days prior to registration

2018 Clinical Trials

136. Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects

hour before each visit. Whose parent or legal representative agrees to not soak the tape during a sponge bath. If the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing). Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization. Exclusion Criteria: Who are known to be developmentally delayed Who have any known allergy or sensitivity to tapes Who have sunburn, skin infection or scars

2018 Clinical Trials

137. ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer

formula Life expectancy at least 3 months. Ability to understand and willingness to sign a written informed consent and HIPAA consent document. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Exclusion Criteria: No prior treatment with ONC201. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have

2018 Clinical Trials

138. Tobacco Use Treatment in Cancer Patients

(CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling. Drug: Nicotine Replacement Therapy Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants

2018 Clinical Trials

139. A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients

and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth application against controls who do not. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 50 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is a single center, prospective (...) to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. 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

2018 Clinical Trials

140. 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

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