Study Overview. This chapter will outline the study design, objectives and hypothesis, and methodologies used. The research was conducted on site at Guy’s Hospital, London in the Osteoporosis Unit and the Department of Nuclear Medicine. Ethical approval was obtained from St Xxxxxx’ Hospital Ethics committees for this study.

Study Overview. This is a two-part, multi-center, prospective longitudinal, exploratory study of biomarkers, clinical, and physiological profiles in CF. Part A In Part A, a cohort of non-CF control subjects and two cohorts of CF subjects, grouped by underlying level of CFTR function, will be studied. Importantly, comparison with a non-CF control group will allow examination of CFTR-dependent biomarkers across the spectrum of CFTR activity (absent, partial, complete). Part A will consist of the Part A CORE Study and one optional sub-study (pH Pill). Refer to Study Schematics below and Schedule of Events in Appendices 1 and 2 for the specific visit schedule and procedures for each cohort. A subset of patients will undergo nasal cell procurement and storage. • Cohort 1 subjects (Controls) will be on study for up to 14 days with up to two visits. • Cohort 2 and 3 subjects (CF) will be on study for up to 3 months with up to three visits. Part B In Part B, Cohort 3 subjects who are homozygous for the F508del mutation and who are prescribed lumacaftor/ivacaftor will be further studied. Part B will also be expanded to allow for the enrollment of additional CF subjects homozygous for the F508del mutation who did not participate in Part A. (Refer to Study Schematics and Schedule of Events in Appendices 2 and 3). • Subjects who enroll in Part B of the study will be on study for up to 12 additional months with up to five visits during Part B. Part B will consist of the Part B CORE Study and several optional exploratory outcome measure studies including: • Multiple Breath Washout (MBW) • Fractional Exhaled Nitric Oxide (FENO) • Mucociliary Clearance (MCC) • Gastro-intestinal Functional Testing • Glucose/Insulin Functional Testing • Small intestinal pH profile (pH Pill) Most study subjects will be asked to participate in an optional sub-study that includes a combination of these outcome measures as noted below (refer to Study Schematics for Part B and Schedule of Events in Appendix 3): • MBW/FENO with or without MCC • Gastro-intestinal and Glucose/Insulin Functional Testing (GIFT) with or without pH Pill The sub-study available to the study participant will depend on the site where they are enrolled. Up to 10 sites will be trained on the MBW and FENO procedures and a sub-set of 4 of these sites will also have the capacity to perform the MCC test. Other sites will be trained on the GIFT and pH pill procedures. In addition, a small subset of subjects will undergo nasal cell procurement a...

Study Overview. The purpose of this study is to conduct an evaluation of key components of the GHBS surveillance project. Additionally, this study proposes to determine what key components have contributed to the efficacy of the GHBS surveillance project.

Study Overview. Estimated time commitment: 1 to 2 hours or more either a bi-weekly or monthly cycle for a three year period • We generally estimate 1 hour of sampling time per site, per lake • This does not include travel time to or from the site, nor between sites on lakes with • Frequency of sampling for a Level 3 study varies from bi-weekly to monthly depending on the lake Detailed Responsibilities: The primary Level 3 Study responsibilities volunteers are to: • Collect bi-weekly or monthly water samples and submit to an accredited laboratory for analysis • Record data on water clarity (using a Secchi disk), lake profile readings using a water meter, as well as general weather and site information • Maintain and store sampling equipment provided by the Ministry • Submit a photo or copy of the completed lab requisition form and field form to the Ministry following each sampling event • Volunteers also commit to entering the field data into the standardized digital format provided using online field data submission form or ministry provided standardized excel spreadsheet available here and sending to the Ministry monthly • Return sampling equipment to Ministry for maintenance and storage within 30 days of the final sampling event for the season, unless otherwise arranged Location Level 3 studies can be conducted on any lake of interest. Each volunteer group will be provided with coordinates to a predetermined station site from which to collect samples. Frequency Undertake at least 12 evenly spaced samples during ice-off season. Timing When possible, samples should be taken between 10 am and 2 pm (best time to collect Secchi disk readings) and on the same day of the week. Do not sample on Thursday late, Friday, or Saturday as the lab is not available to receive samples within holding times. Equipment: Provided by Ministry: • Secchi disk for measuring lake water clarity data and depth • Handheld thermometer • Field meter (such as a YSI) for lake profile data • Water sampling equipment and bottles • Forms, instructions, shipping labels, and shipping waybills Monitoring program may require watercrafts, fuel and other equipment required for safe watercraft operation, including personal flotation devices. These items must be supplied by volunteers.

Study Overview. The primary aim of this qualitative study is to identify the barriers and facilitators to self- efficacy for primary care providers as they address the healthcare needs of women survivors of sex trafficking. Furthermore, this study seeks to share findings and offer recommendations which may contribute to policy or program development to strengthen primary care response to sex trafficking. This study interviewed providers (N=11) who offer primary care services in 11 distinct care healthcare settings across seven U.S. states. Responses from semi-structured interviews were analyzed for common themes that indicate barriers and facilitators to self- efficacy for providers to identify and treat women survivors of sex trafficking. The providers engaged in this study currently address in practice the healthcare needs of adult women who are survivors of sex trafficking. Providers who are experienced in this area were interviewed because their experiences can provide insight that may be applicable to the broader population of primary care providers. To frame the language throughout this thesis, the term survivor refers to currently and formerly trafficked individuals; this term was selected to represent more empowering language when referring to those currently or formerly in trafficking and also is a more inclusive term given the patient mix primary care providers may encounter (Xxxxxxxx, H., XxxXxxxxx, & Xxxxxxxx, J., 2017).

Study Overview. Power Up for 30 (PU30) is a state-wide joint initiative through the Georgia Department of Public Health and Department of Education to encourage 30 minutes of physical activity each day among elementary school students. Some Georgia elementary schools have participated in PU30 and some have not. The purpose of this study is to identify and explore the barriers and facilitators to uptake and implementation of PU30 among Georgia elementary schools. Procedures Participation in this study includes a 30-45 minute in-person interview.

Study Overview. ‌ This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five-day infusion of IV gallium nitrate. Approximately one hundred twenty eligible subjects will be randomized in equal allocation to receive either a single 5-day infusion of IV gallium or volume-matched placebo. Subjects will be randomized using an adaptive randomization scheme to prevent imbalances in treatment allocation within baseline FEV1 strata. Five study visits will occur at Screening/Baseline (Day 1; Visit 1), Day 6 (Visit 2), Day 14 (Visit 3), Day 28 (Visit 4), and Day 56 (Visit 5). On Day 3, subject will be contacted by phone. Screening data will be reviewed to determine subject eligibility. Screening can occur on Day 1 prior to the start of study drug or within seven (7) days prior to Day 1. If Screening takes place prior to Day 1, then on Day 1, in order to reconfirm eligibility, an abbreviated physical exam, spirometry and a urine pregnancy test for females must be completed prior to dosing on Day 1. Subjects who meet all inclusion criteria and none of the exclusion criteria will be eligible for the study. Subjects will be permitted to remain in the clinical research center for the full five (5) days of continuous infusion at the discretion of the investigator. During each day of the infusion and for two subsequent days (Day 1 to Day 8), the subject will be instructed to consume at least two (2) liters of fluid. Calcium, BUN and creatinine may be checked more frequently at the discretion of the investigator. All subjects who had the study drug infusions started will be considered evaluable for safety and efficacy analyses. Incidence of AEs will be monitored during the trial. Total duration of subject participation will be up to 63 days. Additional data regarding long-term health impact may be ascertained through the CF Foundation National Patient Registry with optional patient consent. 5 CRITERIA FOR EVALUATION‌

Study Overview. The purpose of this study is to examine undergraduates’ experiences that influence continuing or discontinuing a pursuit of the pre-medical educational track.

Study Overview. ‌ This will be a multi-center, placebo-controlled, double-blind, randomized, Phase II clinical trial. Approximately sixty pancreatic insufficient (PI) subjects with CF, ≥ 2 and < 11 years of age, will be enrolled to participate in this study. Each subject will come to clinic for four study visits (see Figure 1). Screening: Visit 1 (Screening, Day -42), Visit 2 (Baseline, Day 0), Visit 3 (Week 12, Day 84) and Visit 4 (Week 24, Day 168). At Visit 2 (Baseline), subjects will be randomized to receive GSH 65 mg/kg/day or placebo (lactose 65mg/kg/day) for 24 weeks. Visit 1 and Visit 2 may be combined if subject meets eligibility requirements and a fecal specimen is collected prior to dosing. Safety and clinical outcomes will be assessed throughout the study. Assessment of inflammatory markers in blood and fecal samples will be performed at Visit 2 and Visit 4. Subjects will be contacted by phone 4 and 8 weeks after Visit 2, as well as 4 and 8 weeks after Visit 3 and 2 weeks after Visit 4, to assess safety. If a subject had a clinically significant abnormal lab result or on-going treatment-related AE at Visit 4, the subject will be asked to return for a follow-up visit two weeks after Visit 4 instead of the call (Visit 5). Subjects will be on study for up to 32 weeks: Screening: up to 42 days Treatment: 24 weeks Follow-up: Phone call/visit 2 weeks after end of treatment Figure 1. Study Schematic 5 CRITERIA FOR EVALUATION‌

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