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261. Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).

2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Plan Description: RedCap database, central to primary center, online, web based and HIPAA compliant. Password protected and encrypted database. 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 in and Exported from the U.S.: No Keywords provided by Christopher Ellis, Vanderbilt University Medical Center: DRT Device

2018 Clinical Trials

262. Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

in accordance with the HIPAA Privacy Rule (45 C.F.R. § 164.514(b)). Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Analytic Code Time Frame: The dataset will be available after completion of the study and publication of results. Access Criteria: Third party data requests will be reviewed by a committee, and approved requests will require a DUA. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product

2018 Clinical Trials

263. Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma

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 Eligibility Criteria: Written informed consent and HIPAA authorization for release of personal health information. Patients must sign a consent to undergo cell procurement. Written informed consent to enroll in the CAR T-cell therapy trial must be obtained prior to lymphodepletion. Age ≥ 18

2018 Clinical Trials

264. Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment

Subjects with child bearing or fathering potential must agree to use adequate contraception during the study and for 3 months after last treatment of investigational drug. Agree to study specific informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Adequate baseline complete blood count (CBC), renal and hepatic function Parameters described as WBC > 3000 cells/mm3, ANC > 1,000 cells/mm3, hemoglobin > 8.5 g/dL

2018 Clinical Trials

265. Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals

ischemic stroke patients admitted to the participating ASRH after implementation of an inpatient telestroke service. Other: Telestroke Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST, inpatient telestroke rounding will be used to oversee the urgent diagnostic stroke evaluation, secondary stroke prevention

2018 Clinical Trials

266. REcycled CartiLage Auto/Allo IMplantation

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 1.2 Exclusion Criteria To be eligible for inclusion in this study, the subjects must not meet any of the following criteria: Pregnant or nursing, or planning on becoming pregnant during the study period Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study

2018 Clinical Trials

267. Registry Study to Evaluate the Clinical Outcome of Cancer Patients and Benign Diseases Treated With Radiation

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. Only the PI and other study team members will have access to that data. Criteria Inclusion Criteria: Any patient who received or was potentially evaluated for radiotherapy since 2000 for benign or malignant etiologies in the definitive or palliative setting. Patients with comparatively similar diagnosis and disease status at UTSW

2018 Clinical Trials

268. 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

269. 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

270. Circadian Misalignment and Energy Balance

should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data. Supporting Materials: Study Protocol Informed Consent Form (ICF) Time Frame: Data will become available after results of the main aims from the final dataset

2018 Clinical Trials

271. Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)

for at least the next 6 weeks; Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form; Able to communicate fluently in English (speaking, writing, and reading). Exclusion Criteria: Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study: Alcohol/Drugs: History or current diagnosis or treatment for alcohol

2018 Clinical Trials

272. Electrical Stimulation of Human Myocytes in Microgravity

Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Participant is 20-40 or 60-80 years of age, inclusive Participant BMI <30 kg/m2 Participant states willingness to follow protocol

2018 Clinical Trials

273. DPCP for the Treatment of Alopecia Areata

Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I). Written informed consent and HIPAA authorization have been obtained. Subject is > 18 to years of age. Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year

2018 Clinical Trials

274. Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

ages 12 to 17 years of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization. Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions

2018 Clinical Trials

275. Connecting Alaska Native People to Quit Smoking

2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Plan Description: All data elements and data transfer activities will be strictly compliant with HIPAA privacy regulatory requirements. 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 Christi Patten, Mayo Clinic: Social Media Alaska Native

2018 Clinical Trials

276. NR in Chemo-induced Peripheral Neuropathy

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 to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Be able to give written informed consent and HIPAA authorization Be 18 to 80 years old Have been diagnosed with stage IV breast cancer of any type

2018 Clinical Trials

277. Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial

Verified: August 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: Information about study subjects will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require a signed subject authorization informing the subject of the following: What protected health information (PHI) will be collected from subjects in this study Who will have access

2018 Clinical Trials

278. Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

, i.e., oxygen delivered via a POC. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization. Exclusion Criteria: Patient's condition is contraindicated for the use of a POC. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated. Patient is unable to complete the 6-minute walk test. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection

2018 Clinical Trials

279. 4D Cone Beam CT Reconstruction for Radiotherapy Via Motion Vector Optimization

research subjects training and HIPAA training. Criteria Inclusion Criteria: Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW. Patients are greater than 18 years of age. Patients understand a written informed consent document and are willing to sign the consent form. Exclusion Criteria: Women who are pregnant or trying to get pregnant Children (under age of 18) Contacts and Locations Go to Information from the National Library of Medicine

2018 Clinical Trials

280. 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

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