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 subjects will be screened for eligibility, and twelve 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 at least five times the medication half-life plus one week for stabilization before the first experimental session. Subjects taking psychostimulants for ADHD or gabapentin for pain management may continue to take these medications so long as they discontinue use for five half lives prior to each experimental session and resume use of psychostimulants ten days after an experimental session. During the study, benzodiazepines or zolpidem or other anxiolytic or sedative may be used as rescue medications if needed as approved by the qualified investigator 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, perceived positive changes or growth after trauma, general psychological function, depression, sleep quality and dissociative experiences will be assessed at baseline in all subjects. The RBANS and PASAT will be administered to all subjects at baseline. The CAPS interviews may be recorded to audio and 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 audio and video recorded for research purposes. Video data will be evaluated for adherence to the therapy manual using adherence criteria ratings. Seven subjects will be randomized to receive a full dose of MDMA and five will be randomized to receive comparator dose 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 sessi...
Study Procedures. No study procedures are allowed to be conducted until 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. 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. 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. The Informed Consent form must be signed by the patient or his/her legal representative prior to any study-related procedures, with the assent of patients who are legally capable of providing it, at the latest at the Baseline visit. Analyses done on blood samples will favor as much as possible the use of micro-sampling techniques. When limiting blood drawing is needed, laboratory safety parameters (which would have been done as normal disease monitoring) will be prioritized. Please refer to the schedule of assessments in Table 1 and Table 2 for an overview of the procedures to be performed during this long-term follow-up study. If conditioning and/or transplantation have occurred before entry in this follow-up protocol, the corresponding visits will not be performed in the NI-0501-05 protocol. In this case when a patient enters the NI-0501-05 study, he/she will start to be monitored according to the NI-0501-05 remaining visits to be performed in the SOA. During the study, the following time-windows are allowed around visits: - Weekly visits pre-HSCT: ±2 days - Pre-conditioning: if this visit is no more than 48 hrs apart from one of the weekly visit pre-HSCT, then these visits may be combined following the most demanding SoA - Wk 1-2-3, D+30 post-HSCT: ±2 days - D+60, D+100 post-HSCT: ±1 week - 6-mo, 1-yr post-HSCT: ±4 weeks If HSCT is not performed, the above described time windows apply to the follow-up visits required to occur after the last NI-0501 infusion. The following assessments will be performed in all patients: Clinical assessments: at each visit ▪ Xxxxx xxxxx: body temperature, heart rate, blood pressure and respiratory rate ▪ Physical examination with particular attention being paid to: - height (at pre-Transplant visit, 100-days, 6- month and 12-month post-Transplant visits), weight - occurrence of skin rashes, jaundice, purpura, bleeding, edema - signs of infections - neurological examination - liver and spleen size (in cm from costal grill) Laboratory: at each visit ▪ CBC ▪ Coagulation tests: aPTT, PT, D-dimers and fibrinogen ▪ Biochemistry: glucose, ferritin, CRP, AST, ALT, γGT, ALP, LDH, bilirubin, albumin, creatinine, urea, triglycerides ▪ Urinalysis: glucose, blood, protein, leucocytes, ketones, pH and specific gravity (only at Baseline, D+30, D+60, D+100 visit, 6 months and 1 year/WD visits) Imaging: ▪ Chest X-ray if clinically indicated Search for infections: every 2 weeks, as long as NI-0501 is detectable in serum Pharmacokinetics: at...
Study Procedures. Initially, only patients who completed Study RP103-03 will be enrolled into this long-term study. Additional patients who did not complete Study RP103-03 but qualify for RP103-04 based on current inclusion and exclusion criteria may be enrolled after completion of the analysis of the RP103-03 Study where the non-inferior efficacious and safe dose of RP103 versus Cystagon® has been determined. For patients who completed Study RP103-03, study procedures include: Screening The RP103-04 Screening visit occurs simultaneously with the RP103- 03 Period 2 Day 7 (End of Study) visit. These patients will continue RP103 Q12H treatment at the last dose level prescribed during their participation in Study RP103-03. Monthly Study Visits Study assessments will be made monthly (± 7 days) after study entry according to the Schedule of Events. A minimum of six (6) consecutive Monthly visits will be completed for each patient. Clinical laboratory assessments (hematology, chemistry, urinalysis), physical examination (including basic neurological and skin assessments) and xxxxx xxxxx, ECG, body weight, body mass index (BMI), body surface area (BSA), an Investigator administered will be made according to the Schedule of Events. During these visits, blood samples for PK (cysteamine) and PD (WBC cystine) will be collected 0.5 hour post RP103 dose administered at the clinic. Patients or parents will continue to maintain a daily diary, recording the dose and time, of cysteamine medications, proton pump inhibitors (PPI) and other gastric acid reducing drugs (prescription and over the counter medications). Patients or their parents will return their completed daily diary at each scheduled study visit and will receive a new or re- dispensed daily diary. Concomitant medications and adverse events will be collected. At or before each Monthly Visit, the Investigator will review available safety and PK/PD data and if a patient does not achieve an appropriate level of WBC cystine reduction or does not tolerate the dose, the patient may have their RP103 dose adjusted or may be terminated from the Study. This review will be documented in source and in the CRF as appropriate, with the action(s) taken and reasons for such action(s).
Study Procedures. For patients who completed Study RP103-03, study procedures include: Screening The RP103-04 Screening visit occurs simultaneously with the RP103-03 Period 2 Day 7 (End of Study) visit. These patients will continue RP103 Q12H treatment at the last dose level prescribed during their participation in RP103-03.
Study Procedures. Before any Study-specific procedures are performed, the patient and legal guardian (if appropriate) must receive an explanation of all Study procedures and must sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved written informed consent and assent (if applicable) form.
