Inclusion and Exclusion Criteria. Neither OPKO nor any of its Representatives will provide a waiver for any exclusion or inclusion criteria related to a Trial as specified in the Development Plan. Any changes to the exclusion or inclusion criteria will be subject to an amendment to the Development Plan to be approved by the JDC pursuant to the terms of this Agreement.
Inclusion and Exclusion Criteria. CRO will not waive any exclusion or inclusion criteria specified in the Protocol, and shall require that no Clinical Investigator or Site do so.
Inclusion and Exclusion Criteria. This review was conducted in line with the Preferred Reporting Items for Systematic reviews and Meta Analyses (PRISMA) standard (Moher et al. 2009) where applicable. Risk bias was not considered in this review. The initial search carried out in 2018 used Medline, a bibliographic database of life sciences and biomedical information from academic journals covering medicine, nursing, pharmacy, dentistry, veterinary medicine, and health care. Medline provides an advanced search capacity covering over 23 million article references. It also uses Medical Subject Heading (MeSH) terms and spans over 50 years. This initial search extracted articles published within the preceding five years (2013-2018) in order to cover the most up-to-date evidence in the area. The following inclusion criteria were applied in the search:
Inclusion and Exclusion Criteria. 3.5.1 Opportunistic screening of asymptomatic young people for chlamydia and gonorrhoea (Component A) (See separate specification – ‘Participation in the Ruclear chlamydia and gonorrhoea screening programme (Pharmacies) Component A’)
Inclusion and Exclusion Criteria. Eligible participants will be recruited using electronic medical records from Northwestern Medicine Enterprise Data Warehouse (NMEDW) using the below inclusion/exclusion criteria for search criteria. No special populations will be targeted for the enrollment in this study. Additional patient referrals will be made by the physicians who are participating as investigators on this study. The referring physicians of patients to the study will make an assessment if a potential study subject can provide informed consent and will not refer patients unlikely to understand what is being asked of them. All potential subjects will be evaluated by research staff to match them to the inclusion and exclusion criteria that has been established.
Inclusion and Exclusion Criteria. We will use data collected in near real time, data that we collected on previous IRBs, and data from collaborators. All data sets will include records from children and pregnant women. We will exclude any data that we know to be from prisoners. NEW DATA COLLECTION (new IRB) Development and implementation EHR NLP and IR technology uses prospective and retrospective EHR records. It is prospective in that we will periodically collect new data which may include data subsequent to the IRB approval date. However, we are not tracking patients going forward in time or watching for an outcome. Furthermore, all data exists at the time of collection. Data collection will include records from children and pregnant women. We will exclude any data that we know to be from prisoners. Use of UMASS identified data: NLP and IR: All UMMHC prospective and retrospective patients EHR data to generate a sufficiently large dataset for development of NLP and IR. For example, we will collect HL7 messages to collect unstructured clinical narratives not currently found in the UMMS Clinical Data Repository. HL7 (Health Level Seven) is a standard for the exchange, integration, sharing, and retrieval of electronic health information. These standards define how information is packaged and communicated from one party to another, setting the language, structure and data types required for seamless integration between systems. Information sent using the HL7 standard is sent as a collection of one or more messages, each of which transmits one record or item of health-related information.
Inclusion and Exclusion Criteria. All patients have a baseline stress perfusion CMR scan and further management will depend on whether they have been randomised to the MR-INFORMED or the FFR-INFORMED arm of the trial. In addition, all patients receive optimal medical therapy.
Inclusion and Exclusion Criteria. Research and Instrument Design This study utilized a cross-sectional research design, and the same protocol was used in all five villages. The survey was administered by the research team to all randomly selected households that were eligible and gave consent, asking questions related to wealth, socioeconomic factors, health, education, and WASH practices. Emory IRB was not required for this thesis, as ethical considerations involving human subjects’ research was obtained by Children of the Nations. As stated previously, the original research question asked whether household’s had access to a sanitation facility and/or protected water source. The purpose of this thesis was to use the secondary data to better understand diarrhea and its potential contributing factors. The United States researcher, with the help of the Sierra Leone Country Liaison and Country Director from Children of the Nations, developed the survey instrument in English. The survey was translated orally into Krio and Mende, depending on the household, by the local researchers. The United States researcher read the questions aloud in English, and they were then translated by one of the local researchers at the household to ensure that the survey was administered the same way every time. The survey instrument was divided into four main sections including demographics and household characteristics, WASH practices, religion, and general health questions. The full survey can be found in Appendix A. The demographics and household characteristics section asked questions about the head and female head of household, number of household members, education, household wall and floor materials, number of rooms, main source of lighting and fuel used, and number of radios in the house. The WASH practices section asked question about what kind of toilet and drinking water source are used (how far it is, how many people use it, barriers to using it), diarrhea, materials used for washing hands, reasoning for washing hands, key times for washing hands, primary water collector for the household, and where the household learned about WASH. The religion section asked questions about primary religion in the home, owning a bible, and attending church. The general health questions section asked questions about immunizations, common sicknesses, common medications taken, clinics/hospitals visited by the household, food staples, meals per day, mosquito nets, and income. In addition to the survey, observations were m...
Inclusion and Exclusion Criteria. The BoFEP study includes an assessment of all new cases of psychosis at their first contact with CMHC and after 3 and 12 months.. Patients between 18 and 64 years old with a first episode of psychosis (psychotic coding F10–F29 and F30–F33 in ICD-10) were identified among those presenting for the first time to the three CMHCs within tightly defined catchment areas in West –Bologna, Italy over 9 years period (Jenuary 2002 – December 2010). The inclusion criteria are based on those used in the WHO study (Xxxxxxxxx et al, 1992): i.e., presence of hallucinations, delusions, thought disorder, bizarre or disturbed behaviour, negative symptoms, mania, or clinical suspicion of psychosis; absence of an organic cause or profound learning disability; and no previous contact with psychiatric services for psychotic symptoms.
Inclusion and Exclusion Criteria. Inclusion criteria: All admissions to adolescent inpatient units across the trust were eligible for the study. Inclusion criteria therefore matched those of the inpatient service, which were young people aged between 12 and 18, in need of acute mental health care. Exclusion criteria: Adolescents thought by the clinical and/or research team to be unable to give consent due to severity of symptoms or other unrelated difficulties such as severe learning difficulties were excluded from the study. Adolescents under 16 with extremely difficult family circumstances, where it was thought that contact with the family to obtain parental consent would exacerbate the young person’s social difficulties were also excluded. Young people who were not able to converse in English were able to take part providing the xxxx could access an interpreter. Excluded participants were kept under review with the clinical team in case the situation changed and participation became possible.
