Study Schedule. (A) Study Completion Date The Parties’ estimated completion date for the Study is set forth in Clause K(1) of the Mandatory Contract Clauses.
Study Schedule. (1) Study Completion Date The Contract Parties’ estimated completion date for the Study is [date].
Study Schedule. The required study schedule for study participants is shown in Section 14.0 and
Study Schedule. Initial Year: 1988 Final year: Ongoing
Study Schedule. (A) Study Completion Date
Study Schedule. The schedule of procedures and assessments during the study is summarised in Table 4 for Screening and Treatment 1 follow-up and in Table 5 for retreatment assessment and follow-up. Informed consent X Demographic data X Medical/surgical/NDO history X Prior medications and therapies X Inclusion/exclusion criteria X X X Concomitant medications and therapies X X X X X X X X X X Prior and concomitant treatments for NDO [a] X X X X X X X X X X Adverse events X X X X X X X X X X Physical examination (symptom-based) X X X Xxxxx xxxxx X [f] X [l] X X X X Urinary tract ultrasound X [g] Urine pregnancy test [b] X X Laboratory urinalysis/microscopy [c] X X X X Urine culture [c] X X Dispense antibiotics X [i] X [n] Haematology and serum chemistry X X X Anti BTX-A antibodies X X X Dispense bladder diary & training [d] X Bladder diary review X [j] X[j] X[j] X [j] X [j] X [j] I-QoL and EQ-5D-5L X X X X mPGI-I [e] X X X X X Urodynamics (filling cystometry) X [k] X Randomisation X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. Concomitant medications and therapies X X X X X X X X X Concomitant treatments for NDO X X X X X X X X X Retreatment criteria X [e] X [e] Adverse events X X X X X X X X X Physical examination (symptom based) X X X Urine pregnancy test [a] X Laboratory urinalysis/microscopy [b] X X X X Urine culture [b] X Dispense antibiotics X [f] Haematology and serum chemistry X X X Anti BTX-A antibodies X X Bladder diary review X [g] X [g] X [g] X [g] X [g] X [g] I-QoL and EQ-5D-5L X X X X mPGI-I [c] X X X X X X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. a Pregnancy test to be performed only in females of childbearing potential. Must be performed prior to retreatment administration on the day of retreatment. b Laboratory urinalysis/microscopy and urine culture to be performed at any follow-up visit if there is a suspicion of urinary tract infection based on subject symptoms. See Section
Study Schedule. Study assessments During the study periods all pauents were asked to conunuously wear a Withings® Steel hR Smartwatch (Withings, Issy-les-Molineux, France), which collects step count, hR, and sleep paчern. Furthermore, subjects were asked to complete a daily quesuonnaire. An exisung respiratory symptom quesuonnaire was adapted for a pediatric populauon, and subjects and their parents of the cap and pw cohorts were asked to complete the ques- uonnaire at the end of each day to determine a respiratory symptom score (Supplemen- tary Text S1).16 in addiuon, these pauents performed daily temperature measurements with the Withings Thermo (Withings, Issy-les-Molineux, France). Pauents with ae com- pleted the Modified Asthma Control Diary (acd)17 and spirometry measurements with the Air Next spirometer (NuvoAir, Stockholm, Sweden) every day. The spirometer registers the forced vital capacity (Fvc), the forced expiratory volume in the 1st second (Fev1) and the Fev1/Fvc rauo.18 All devices were connected to a c6 smartphone (Motorola, Chicago, iL, usa)) with the HealthMate, Thermo and chdR MORe® applicauons pre-installed. The devices used during the study have previously been used in an iniual validauon study in healthy children.19 Addiuonally, the smartphone calendar was filled with a personal- ized study schedule. At the end of the study, parucipants were asked to complete a ques- uonnaire regarding the study experience. Baseline and admission characterisucs were obtained from pauent charts. Analysis and Statistics MoDellinG analysis seT The primary endpoint in this study was physical acuv- ity (step count). However, individual exploratory plots of physical acuvity over the enure study period (Supplementary Figure S2) showed a large amount of inter-individual vari- ability between subjects. To define a common point of recovery (return to ‘healthy’ physical acuvity levels), subject data was normalized based on data gathered during the 10-day ‘healthy’ period (day 15-2щ), since a true baseline period was obviously not possible within the study design. For each individual subject, the mean step count in the healthy period (minimum of 2 days) was used as their “baseline” physical acuvity (100%). If no data of the healthy period was available, the mean steps of the last щ days of the recovery period (minimum of 2 days) were used as reference. Thus, only subjects who performed PySpark version 2.щ.6 was used for data aggregauon and tabulauon. measurements for at least 2 d...
Study Schedule. Projected Open to Accrual Date: Projected Enrollment Period: Projected Total Study Accrual:
Study Schedule. During the semester, students on F-1 visas are permitted to work a maximum of 20 hours per week, including campus work/assistantships and CPT-eligible internships. There is no limit during summer, winter or spring breaks. Only part- time CPT can be authorized in a student’s final term. Graduate assistants should consult with their supervisors before accepting any co-op assignment that might conflict with their obligations to the University of Maryland.
Study Schedule. A proposal for an ISP shall be submitted by a doctoral student and his/her supervisor no later than one month after the commencement of studies. All doctoral students shall have an approved ISP within three months of the commencement of studies.
