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2941. fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis (MS) Patients to Controls

Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Sampling Method: Non-Probability Sample Study Population ProHealth Care, Waukesha Memorial Hospital Neuroscience Center Criteria Inclusion Criteria MS Subjects: Written informed consent and HIPAA authorization. Age between 18 and 65 years Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis in accordance with the refined McDonald • Diagnosed with Relapsing

2006 Clinical Trials

2942. AS703569 Phase I in Patients With Solid Tumours

therapy for the disease or for which standard of care therapy is not reliably effective or has a cancer for which no standard therapy exists Age greater than or equal to 18 years Has read and understands the informed consent form and is willing and able to give informed consent, and subject authorization under Health Insurance Portability and Accountability Act (HIPAA). Fully understands requirements of the study and willing to comply with all study visits and assessments Subjects and their partners

2006 Clinical Trials

2943. Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. Exclusion Criteria: History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening. Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study

2006 Clinical Trials

2944. A Randomized Trial of Unruptured Brain AVMs

, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms Exclusion Criteria: Patient has BAVM presenting with evidence of recent or prior hemorrhage Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery

2006 Clinical Trials

2945. Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health Insurance Portability and Accountability Act ) and guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process

2006 Clinical Trials

2946. Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

with consultation with clinical nutritionists, as indicated. Hemoglobin must be greater than or equal to 10 g/dL. At least one parotid should keep a mean RT dose of < 24-26 Gy. If this cannot be achieved on one side, then the contralateral parotid dosing goal is to keep the mean dose as low as possible, typically <15 Gy. It is anticipated that at least one submandibular gland will receive a mean dose >24-26 Gy. Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any

2006 Clinical Trials

2947. Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

from all acute effects of treatment. Adequate organ and marrow function Negative pregnancy test. Agree to use birth control during and for 3 months after last dose of study drug. At least 18 years of age. Sign an informed consent and HIPAA consent. Must be able to take and absorb enteral medication. Exclusion Criteria: Serious concomitant systemic disorder that would compromise safety or ability to complete study. Prior treatment with gemcitabine or pemetrexed within the previous year, unless used

2006 Clinical Trials

2948. A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women

for eligibility information Ages Eligible for Study: 18 Years to 45 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy adult males and females, 18 - 45 years of age, inclusive. Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial. Subjects must give written informed consent and sign Health Insurance Portability and Accountability Act (HIPAA

2006 Clinical Trials

2949. An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis

) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent and HIPAA authorization. Age between 18 and 65 years Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis A minimum disease level according to the McDonald criteria for the definition of MS based on results of an MRI scan; acquired within 1 year (Subjects with other significant abnormal findings will be excluded

2006 Clinical Trials

2950. Treatment of Childhood Obesity in Primary Care

, and playing video games) will be described, as will any changes in BMI. Experienced behavioral interventionists will be trained in behavioral theory principles fundamental to the intervention that involve helping children and their parents to change behavior and maintain the changes by Dr. Ewing (Co-Investigator). Dr Ewing, who has completed Human Subjects and HIPAA training at the University of Pittsburgh will come to Madison, Wisconsin to do a training session for the behavioral interventionists

2006 Clinical Trials

2951. Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer

and older (Adult, Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent and HIPAA authorization for release of protected health information. Have histologically-confirmed: epithelial ovarian cancer or primary peritoneal carcinomatosis or fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged. Have measurable disease according to RECIST or detectable disease by 1) CA-125 at least twice the ULN

2006 Clinical Trials

2952. A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation

study will enroll 20 patients over 6 months after which statistical analysis will be performed to evaluate the merit of continuing the study. Patients will be randomized in a 1:1 ratio. If a study participant has been randomized to receive open lumbar microdiscectomy a referral to a neurosurgeon will be made for the patient. All patients participating in study must be screened, meet all study inclusion/exclusion criteria and sign informed consent and HIPAA forms prior to any research participation

2006 Clinical Trials

2953. Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test Admitted to the clinical center at the time of study entry Listed with UNOS for cardiac transplantation Clinical indication

2006 Clinical Trials

2954. Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile) Life expectancy > 3 months Adequate laboratory results: ANC => 1.5 x 109/L. Platelets => 100 x 109/L Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery Exclusion Criteria: Prior use of temozolomide Presence or history of severe hepatic or renal impairment Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea

2006 Clinical Trials

2955. Computer applications in clinical practice. (PubMed)

, and elsewhere are at various stages in the implementation of national health information infrastructures. US officials are playing a greater role in prompting physicians to use EMRs and in setting standards for EMR systems. A study by the American College of Rheumatology observed, 'Increasing requirements for provider compliance with quality and outcomes reporting, HIPAA regulations, medical error reduction, including Medicare e-prescribing mandates, and downward pressure on practice revenues

2005 Current Opinion in Rheumatology

2956. Use of a wireless local area network in an orthodontic clinic. (PubMed)

hardware devices that are used by the orthodontist, office staff, and patients. This article details the standards and choices in wireless technology that can be implemented in an orthodontic clinic and suggests how to select suitable mobile hardware for accessing or adding data to a preexisting network. The network security protocols discussed comply with HIPAA regulations and boost the efficiency of a modern orthodontic clinic.

2005 American journal of orthodontics and dentofacial orthopedics

2957. Development and evaluation of an open source software tool for deidentification of pathology reports. (PubMed)

Development and evaluation of an open source software tool for deidentification of pathology reports. Electronic medical records, including pathology reports, are often used for research purposes. Currently, there are few programs freely available to remove identifiers while leaving the remainder of the pathology report text intact. Our goal was to produce an open source, Health Insurance Portability and Accountability Act (HIPAA) compliant, deidentification tool tailored for pathology reports (...) in the test set were removed. Only 19 HIPAA-specified identifiers (mainly consult accession numbers and misspelled names) were missed. Of 41 non-HIPAA identifiers missed, the majority were partial institutional addresses and ages. Outside consultation case reports typically contain numerous identifiers and were the most challenging to deidentify comprehensively. There was variation in performance among reports from the three institutions, highlighting the need for site-specific customization, which

Full Text available with Trip Pro

2006 Medical Informatics and Decision Making

2958. Protecting medical record information: start your research registries today. (PubMed)

Protecting medical record information: start your research registries today. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted with the long-term goal of improving the efficiency and effectiveness of health care. It has created sweeping changes for clinical medicine and research. Generally, the standards for privacy of individual, identifiable health information (the privacy rule) require patient consent before their protected health information (PHI) can (...) Department of Otolaryngology, a clinical tumor registry was established in 1982. These data have served as the basis for over 200 publications reflecting practice-based learning. The present study quantifies the cost of HIPAA compliance to maintain access to our faculty's career-long clinical activities and to stress to all physicians the importance of research registries as a means of protecting their own career's work.Compliance with the privacy rule required that written, informed consents be mailed

2005 Laryngoscope

2960. Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer

), or measurable prostate cancer by CT or MRI scans (PSA level must have shown two consecutive increases [at >= 14 day intervals] since the previous nadir) Ability to take oral medication (dasatinib must be swallowed whole) Subjects of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped Signed informed consent documents including Health Insurance Portability and Accountability Act (HIPAA) according

2007 Clinical Trials

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