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. The following sections describe each assessment. The timing of these assessments is noted in Table 3. All Day 1 procedures, except AE assessments, should be completed prior to administration of first dose of study drug.
Study Procedures. [*] *Confidential Treatment Requested 101 SCH 00066 PAGE 5 STUDY NO. B96-364 SECTION 6 11/26/96 [*] [*] [*]
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. Consultations with the National Malaria Control Programme, Machinga District Health Office, the District Development Committee and Sitola TA were undertaken during study development, and the study was launched with their approval. A series of community meetings explained the study purpose, procedures and eligibility criteria to people living in the study area. Initially, a bed net census was taken on all households in the study area to determine ownership, type, age, condition and use of ITN at baseline. Regardless of previous ownership of ITNs, new LLIN (Permanet®2 Xxxxxxxxxxx-Xxxxxxxx, Switzerland, which are treated with deltamethrin 0.05%) were distributed to all households in the study area with a minimum of one LLIN for each sleeping space or one LLIN for every two household members plus an extra bed net for households with odd numbers of inhabitants. Twice during the initial study period, a validation exercise compared caregivers’ responses about bed net use with observations about bed net use during home visits. Mosquitoes were collected for insecticide resistance testing to deltamethrin and permethrin at intervals during the study, using pyrethrum spray catches and WHO tube assays. Deltamethrin was the insecticide found on bed nets distributed by the study protocol. Permethrin was the insecticide present on most bed nets in the study area at the time the study began. Cohort children were instructed to attend the study clinic at Machinga District Hospital if they fell ill. Transportation to and from the facility was reimbursed for study participants, although after December 2012 this was limited to one visit per month. Weights and heights were measured twice, and if the results indicated a greater than 10% disparity, a third ‘tiebreaker’ measurement of weight and height was done. Each enrollee had a fingerstick blood sample drawn for malaria polymerase chain reaction (PCR) with species differentiation for P. falciparum, P. malariae, P. ovale and P. vivax at the beginning of the study period. During each sick visit, updated information about bed net use and condition was collected, and children were examined. Blood was collected by fingerstick for thick and thin blood film malaria testing and SD Bioline® RDT for P. falciparum. All final results in the analyses presented here were based on the results of SD Bioline® RDT. Hemoglobins were determined using Hemocue® Hb201+ Analyzers (Hemocue Inc., Cypress, CA, USA). Children with anemia were prescribed i...
Study Procedures. There will be 5 visits during the course of the study:
Study Procedures. Upon being discharged to home from the hospital, the investigator, Xx. Xxxx X Rippetoe, PT, DPT, will perform the initial visit within 48 hours to collect initial data and to demonstrate proper use of the app to the participant • The participant is to use the app 3 to 5 times daily as able according to the instructions in the app • The investigator, Xx. Xxxx X Rippetoe, will be available by phone or e-mail to address questions or concerns related to the participant’s recovery or the use of the app • The investigator will check-in periodically with the participant to ensure proper participant compliance with the app and the app’s instructions. • If the participant does not engage with the app over any 24-hour period, the investigator, who is a licensed physical therapist, will obtain orders from the participant’s physician for the participant’s care to be transferred to a home health provider. The participant may choose their home health provider. Once the participant’s care has been transferred to a home health provider, the participant will no longer be under the care of Xx. Xxxx X Rippetoe, PT, DPT. Any costs associated with receiving home health services will be billed directly to the participant or their insurance company. • Once the participant is ready to begin outpatient physical therapy, usually 2 to 4 weeks following hospital discharge, Xx. Xxxx X Rippetoe, PT, DPT will perform a follow-up visit for the final data collection. POSSIBLE RISKS If you do not understand what any of these risks mean, please ask the investigator or study staff to explain these terms to you. Because this smartphone app is investigational, all of the risks may not be known. Some risks may be life threatening. You must tell the investigator or study staff about all negative events that occur. If you are not honest about negative events, you may harm yourself by staying in this study. Such events may include: falls, suspected blood clots, suspected infection, or worsening overall condition of post-operative knee.
Study Procedures a. Recruitment, Randomization, treatment allocation, and blinding A standardized, IRB approved email will be sent to department chairs describing the study. A research coordinator will reach out to interested participants via phone with the help of an IRB-approved verbal script to introduce the study, confirm eligibility and provide further instructions on how to access and sign the IRB-approved ICD via REDCap using their own electronic devices. It is important that we obtain the consent via REDCAp to a) avoid direct person-to-person contact and comply with social distancing imposed recommendations, and b) minimize the waste of reconstituted BCG by allowing the research personnel to schedule vaccinations in a controlled fashion. Patient registration into the trial will happen immediately after consent has been provided and will involve entering of baseline information into an electronic data capture system (RedCap). Once the eligibility is confirmed and the ICD signed by the participant and stored in REDCap, the research coordinator will randomize the participant and communicate the treatment assignment to the nurse administering the vaccination. The nurse will subsequently assign an appointment and communicate date and time of vaccination with the participant. All eligible participants will receive intradermal injections of BCG:placebo in a 1:1 ratio. Both, participants and investigators will be blinded to the treatment assignments during the study. However, in case of an emergency where it is important to know the treatment received, the investigator and/or participant can reach out to the unblinded study personnel who will provide the unblinded data. All participants will receive their treatment allocation at the end of the study, after the data analysis is finalized. Unblinded personnel will not be involved in the collection and analysis of study data other than the baseline eligibility criteria. The end of the study is defined as the last patient’s last entry in the electronic data capture system.
