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. 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:
1) Studies of people with psychosis, SMI, schizophrenia, bipolar and major depressive disorder) defined using structured interviews or clinical diagnostic schedules (e.g., DSM, ICD criteria)
2) Studies that were prospective or cohort study designs
3) Studies that measured diabetes (known diagnosis or an HbA1c of 48mmol/mol (6.5%)) or glucose dysregulation (42–47 mmol/mol (6.0–6.4%) (Diabetes UK 2020). Diabetes ‘known diagnosis’ included recorded ICD codes, self-report, records in medical notes/insurance databases or defined by use of diabetic medication (from medical notes or interview).
4) English-language articles.
5) Studies defining mental disorder by diagnosis – i.e., not including studies which defined or characterised cohorts on medication receipt (e.g. antipsychotics) alone.
6) Studies could include diabetes medication
7) Diabetes outcomes of interest could include diabetes management and any subsequent health outcome such as cardiovascular disease or resulting in hospital admission. Systematic reviews and meta-analyses that report outcome of interest were also extracted, although primarily as sources of references to original research, and to illustrate other relevant reviews in the field. All age groups were included. The following exclusion criteria were applied in the search and extraction:
1) Duplicates.
2) Studies of GDM specifically.
3) Studies of T1DM only (studies were included if they were looking at both types or did not distinguish them).
4) Studies of other mental disorders in isolation or if not mentioned alongside the disorders specified.
Inclusion and Exclusion Criteria. All patients with chronic angioedema, i.e. recurrent swelling attacks for longer than 6 weeks, can be enrolled/recorded in the registry, if a written, dated and signed informed consent is available. The data for CARE are collected from the real-life management situation in clinical practice (observational approach). As children and adolescents (minors) can also be affected by chronic angioedema, it makes sense to not exclude these patient groups from participation. Before including patient data into the registry, a dated and signed written informed consent by the patient or the parent / legal guardian (i.e. the legal authorized representative - LAR) must be available.
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. 3.5.1 Opportunistic screening of asymptomatic young people for chlamydia and gonorrhoea (Component A)
Inclusion and Exclusion Criteria. Criteria Included Excluded Rationale
Inclusion and Exclusion Criteria. Inclusion criteria were developed to identify studies relevant to the research question. These focused on studies related to collaborations between two or more agencies or organizations, collaborations involving the health sector and non-health sector at the national and global levels, and collaborations focused on public health preparedness and response. Also, studies that reported collaboration frameworks, mechanisms, and processes were included. Studies examining similar phenomena without focusing on collaboration at an organizational level (e.g., interprofessional or multidisciplinary collaboration at hospital levels) were excluded. The criteria also focused on excluding studying examining collaboration between organizations within the health care system only or between agencies focused on academic research.
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.
Inclusion and Exclusion Criteria. Rural Malawian residents of Mulanje district over 15 years of age from areas of high unintended pregnancy occurrence were eligible to participate in the study.
Inclusion and Exclusion Criteria. The inclusion and exclusion criteria are assessed during Screening (within 28 days before the first dose of MIRV on Cycle 1, Day 1). All screening evaluations must be completed and reviewed to confirm that potential patients meet all eligibility criteria. The Investigator will maintain a screening log to record details of all participants screened and to confirm eligibility or record reasons for screening failure, as applicable. Procedures conducted as part of the patient’s routine clinical management and obtained before signing an ICF may be utilized for screening or baseline purposes provided the procedure met the protocol-specified criteria and were performed within the timeframe defined in the Schedule of Assessments (Table 2). A patient is considered enrolled when they have received their first dose of MIRV (Section 5.2.1).
