Study Procedures. Upon receipt of the interconnection proposal and a written guarantee by the Eligible Customer to pay all costs incurred by the ISO and Transmission Owner(s) conducting the technical studies, the ISO, in cooperation with the Transmission Owner with whose system the Eligible Customer proposes to interconnect, shall perform the technical studies of the proposed interconnection. The ISO shall evaluate each Large Facility using the Interconnection Studies specified in the Large Facility Interconnection Procedures in Attachment X. The technical studies shall address the following:
Study Procedures. After giving written informed consent, prospective participants will be screened for eligibility, and 12 subjects meeting study criteria will be enrolled. In consultation with their prescribing physician, any individuals taking psychiatric medications will taper off these medications, allowing for a washout period of 5 times the medication half life before the first MDMA administration. During the study, benzodiazepines or zolpidem may be used as rescue medications if needed as approved by the medical doctor responsible for the study. Any subjects who are in psychotherapy with an outside therapist at the time of enrollment may continue that therapy during the study without increasing the number or type of sessions or changing psychotherapists or type of psychotherapy. Symptoms of PTSD, depression, general psychological function, and sleep quality will be assessed at baseline in all participants. The CAPS interviews may be recorded to video to assess reliability of CAPS ratings. The first experimental session will be preceded by three preparatory sessions and followed by three integrative psychotherapy sessions. During preparatory sessions, subjects will learn what to expect during experimental sessions, and during integrative sessions they will receive support in integrating their experiences and insights from the experimental sessions. Preparatory, experimental and integrative sessions will be video recorded for research purposes. Video data will be evaluated for adherence to the therapy manual using adherence criteria ratings and for therapeutic alliance. Seven subjects will be randomized to receive a full dose of MDMA and five will be randomized to receive a low dose of MDMA during two experimental psychotherapy sessions scheduled three to five weeks apart. After each experimental session, subjects will spend the night at the treatment facility with an attendant on duty. Subjects will complete the SOCQ in the time between an experimental session and the integrative session following it. The first integrative session will take place the day after the experimental session. Subjects and therapists will report their beliefs on their condition assignment on the day after each experimental session. There will be daily phone contact with one of the therapists for 7 days after each experimental session. Symptoms of PTSD, depression, sleep quality and general psychological function will be repeated for each subject at the primary endpoint, after which the blind ...
Study Procedures. No study procedures are allowed to be conducted until the parent’s written informed consent has been obtained (please also refer to chapter 9.1). The investigator is responsible for obtaining the parent’s written informed consent after adequate explanation of the aim, study assessments, potential risks and benefits and consequences of the study as well as alternative treatment options.
Study Procedures. Primary Endpoint • Change in DENV viral load (DENV RNA as measured by RT-qPCR) from baseline Secondary Endpoints: PK Endpoints Pharmacokinetic endpoints will be characterized as subject numbers and PK data permit. • Plasma concentrations of AT-281 (and metabolites AT-551, AT-229, AT-219 and AT- 273) for each cohort at: o Day 1 at time 0 (pre-dose; before the first dose on Day 1)
Study Procedures. 3.1 SCHEDULE OF ASSESSMENTS AT EACH STUDY VISIT Table 3.1-1 provides an overview of the subject screening procedure, baseline evaluation, treatment plan, and follow-up requirements.
Study Procedures. 3.8.1 Enrollment/Preoperative Visit Patients who meet all the inclusion criteria and who do not meet any of the exclusion criteria specified on the eligibility form will be asked to enroll in the study. Information on screening failures will be collected in a screening log. Patients agreeing to participate in this study must then sign the informed consent.
Study Procedures. 7.1.1 Demographic Data Subject demographic data will be collected at the Screening Visit. These data include age, gender, and Xxxxxxxxxxx type.
Study Procedures. All potential eligible patients for this study will be informed by their treating medical specialist (e.g., medical oncologist, surgeon, nurse practitioner) about this study and the study procedures before the start of systemic treatment. Furthermore, the medical specialist will provide patients an information letter, which outlines the study objectives, study procedures, and includes an informed consent. Moreover, the medical specialist will provide contact details of the eligible patient to the coordinating researcher (after the patient agrees on that), and consequently the coordinating researcher will contact the eligible patient to provide more information and if available to answer questions. Written informed consent will be asked and obtained if the patient wants to participate in this study. The research team will keep track on this procedure. We plan to dedicate the entire last year of the project to the clinical study, starting the enrolment procedures of first patients at the end of the 3rd year (M36), and having the last patients enrolled observed for at least six months (M42). The study protocols will be prepared in advance (by month M28) and submitted to the Medical Ethics Review Committee (MERC) of the two hospitals, to have time to manage possible additional requests from MERC themselves.
Study Procedures. All subjects must sign a written informed consent before participating in any study-related activity. Enrollment will occur at Baseline Visit (Day 0) after a subject meets all eligibility requirements at Screening Visit and Baseline Visit (Day 0). Each enrolled subject will be assigned a unique subject number. If a subject is discontinued from the study for any reason, the subject number will remain in effect and will not be reused. A Schedule of Events can be found below and detailed procedures for examinations can be found in Appendix 4. Table 2: Schedule of Events Visit Number Screening Visit Baseline Visit Visit Day 1 Visit Day 7 Visit Day 28 Visit Day 56 Visit Schedule (Time window; days) Day 0 Day 1 Day 7 (±1) Day 28 (±2) Day 56 (±3) RBM-007 injection Pre Post Informed consenta X Demographics/Eligibility X AMD Treatment history review X X Medical/surgical history, Concomitant medication X Physical exam X X Xxxxx xxxxx X X X X X X EKG X BCVA (ETDRS) X X X X X X Slit-lamp exam and biomicroscopyb X X X X X X X Intraocular pressurec X X X X X X X Indirect ophthalmoscopyb X X X X X X X SD-OCT X X X X X X Fundus photography X X X Fluorescein angiography X X X OCT-angiography X X X Serum pregnancy testd X Hematology, serum chemistrye X X Plasma RBM-007 levelf X X X X RBM-007 i.vt. Injection X Anti-VEGF rescue treatmentg X Option Anti-VEGF Injectionh X X Adverse events X X X X X a Informed Consent Form - obtain prior to conducting any study-related activities. b Slit-lamp exam and biomicroscopy and indirect ophthalmoscopy at Baseline Visit (Day 0) will be performed prior to RBM-007 injection and within 30 minutes after injection. c IOP measurement will be performed before RBM-007 Intravitreal injection and 30±10 minutes after injection. If IOP is increased ≥10 mmHg above pre-injection baseline, repeat IOP measurement is to be done 60±10 minutes after the injection. d Serum pregnancy tests are to be performed on all women of child-bearing potential. e Order blood tests at local laboratory; review results. f Collect blood specimen for RBM-007 plasma drug level 1 hour after RBM-007 injection; document time of both RBM-007 injection and post-injection blood draw. g Visit Day 7 anti-VEGF rescue based on rescue criteria: compared to Baseline Visit (Day 0) there is: 1) worsening of BCVA from Baseline Visit (Day 0) of more than 10 ETDRS letters, or 2) increased thickness in the central subfield of more than 100 µm. Clinical Investigator may also rescue if it is req...
