louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05739396: Core Stabalization and Rebound Therapy and CP
Official title: Effect of Core Stabalization Versus Rebound Therapy on Balance in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whole Body Vibration
Rebound Therapy
Balance
cp
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy

Detailed description: PURPOSE:

To compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy

BACKGROUND:

Cerebral palsy is primarily a disorder of movement and posture

HYPOTHESES:

There is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy.

RESEARCH QUESTION:

Is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?

Eligibility criteria: Inclusion Criteria:

* children diagnosed with spastic hemiplegic CP.
* Their chronological age ranged from 5 to 8 years,
* able to follow verbal commands or instructions during testing procedures,
* degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
* they are able to understand and follow instructions given to them,

Exclusion Criteria:

* Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
* children who were suffering from cardiopulmonary problems or epilepsy.

Primary outcomes:
measure: balance
timeFrame: 12 week
Secondary outcomes:
measure: gross motor function measure-88
timeFrame: 12 week
measure: lafayette hand held dynamometer
timeFrame: 12 week
measure: 6 minute walk test
timeFrame: 12 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Physical Therapy
Study officials:
affiliation: Cairo University
name: Faculty OP Therapy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375296: China Made Sirolimus Eluting Stent for Intermediate Lesion
Official title: China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(\> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.


Eligibility criteria: Inclusion Criteria:

* age 18-80 years old
* both gender
* native coronary lesion
* narrowing 50-70%
* vessel size 2.5-4.0 in diameter

Exclusion Criteria:

* without informed consent,
* ST elevation myocardial infarction within 7 days,
* left main lesion,
* by-pass graft,
* restenosis
* abnormal liver function before randomization,
* active hepatitis or muscular disease,
* impaired renal function with serum creatinine level \> 3mg/dl ,
* impaired left ventricular function with LVEF \< 30%,
* participate in other studies.

Primary outcomes:
measure: target vessel failure
timeFrame: 12 months
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ruijin hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02861196: Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Official title: Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.


Eligibility criteria: Inclusion Criteria:

1. bladder urothelium carcinoma
2. cT2-4aN0M0
3. life expectancy≥1 year
4. ECOG PS 0-1
5. have no previously received radiotherapy or chemotherapy
6. have no major organ dysfunction
7. have been provided informed written consent

Exclusion Criteria:

1. extensive carcinoma in situ or ureter invaded
2. distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis
3. have severe major organ dysfunction
4. cannot finish treatments because of other severe diseases or life expectance≤6 months
5. exist other malignant tumors
6. have severe coagulation disorders
7. no other trails participated in 4 weeks

Primary outcomes:
measure: bladder preservation rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianzhong Shou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03392116: Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM120 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cachexia
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Normal ECG findings

Exclusion Criteria:

* Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

Primary outcomes:
measure: Part A Arm-Single Dose: Treatment Emergent Adverse events
timeFrame: 28 days
measure: Part B Arm-Multiple Dose: Treatment Emergent Adverse events
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Limited
Study officials:
References:
Clinical trial NCT05850416: mGlide-Care: A Partnership With Caregivers
Official title: mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HTN
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertension (HTN) is the most significant stroke, cardiovascular disease and dementia risk factor and is substantially under-treated especially in older persons. In this study the investigators will develop mGlide-Care to address uncontrolled HTN in people with mild cognitive impairment (MCI) and early stage Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD). mGlide-Care is adapted from mGlide which is a mHealth (mobile health technology) mediated care model for HTN care. Aim 1 will engage stakeholders to study the acceptability of mHealth mediated HTN care and will use their input to develop mGlide-Care. Stakeholders are persons with early stage AD/ADRD and MCI, unpaid family caregivers, primary care providers, geriatricians and clinical pharmacists. Aim 2 is a feasibility pilot to test mGlide-Care vs. usual care in 75 participants with uncontrolled HTN and early stage AD/ADRD or MCI. Caregivers will assist participants. Outcomes will include HTN control and participant and caregiver reported measures.


Eligibility criteria: Inclusion Criteria: Must meet all criteria

* Diagnosed with early stage AD/ADRD or MCI
* Have uncontrolled hypertension (HTN)
* Have an unpaid, family caregiver
* Have established medical diagnosis of hypertension (HTN)
* English speaking
* Participant or caregiver must have a smartphone or mobile device (e.g. iPad) that can transmit blood pressure (BP) from the BP monitor
* Participant and caregiver capable and willing to comply with the entire study protocol
* Able to give voluntary written informed consent.

Exclusion Criteria: Any of the following will be an exclusion.

* Severe comorbid illness including end-stage kidney disease, end-stage liver disease, and life expectancy \<1 year, or if medical complexity of the patient precludes clinical trial participation
* Active illicit drug use (e.g. cocaine, methamphetamines, opioids, phencyclidine) since this will interfere with HTN management
* Participant and caregiver unable to complete study tasks, including are homeless, will leave the country, or will relocate in the next 12 months
* Serious psychiatric illness that could interfere with treatment, assessment, or compliance including significant delusional disorders such as schizophrenia and bipolar illness
* Unable or unwilling to give consent.

Primary outcomes:
measure: HTN control
timeFrame: 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04863716: Erector Spinae Plane Block in Renal Transplantation Donors
Official title: Effects of Erector Spinae Plane Block on Opioid Consumption in Renal Transplantation Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Laparoscopic Nephrectomy
Erector Spinae Plane Block
Keywords: Laparoscopic Nephrectomy
Erector Spinae Plane Block
Lead sponsor: Koc University Hospital
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively.

The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.


Eligibility criteria: Inclusion Criteria:

* Donor patients scheduled for elective nephrectomy in renal transplantation surgery
* ASA I-II
* Patients who are aged between 18-75

Exclusion Criteria:

* Skin infection at the Erector Spina Plan Block area
* Coagulation disorder or using anticoagulant drugs
* End-stage organ and system failure
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage

Primary outcomes:
measure: Fentanyl consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
measure: Modified Aldrete Score
timeFrame: Postoperative 1 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT00133016: The Efficacy of Early Amniotomy for Induction of Labor
Official title: The Efficacy of Early Amniotomy for Induction of Labor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Labor, Induced
Keywords: Induction of labor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-08-22
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this clinical trial is to investigate the efficacy of early amniotomy on reducing both the duration of labor and the frequency of dystocia in nulliparous women undergoing an induction of labor. This research project is a prospective, parallel clinical trial, in which subjects are randomized into one of two treatment groups: those who undergo early amniotomy and those who do not undergo early artificial rupture of the amniotic membranes.


Eligibility criteria: Inclusion Criteria:

* Gestational age \> 37 weeks (using established National Institute of Child Health and Human Development \[NICHD\] dating criteria)
* Nulliparous (i.e., first term pregnancy)
* Admitted to the hospital for induction of labor
* Singleton pregnancy
* Fetal head applied to the cervix
* The ability to understand the requirements of the study, as determined by the study nurse

Exclusion Criteria:

* Premature rupture of amniotic membranes
* Cervical dilation \> 4 cm
* Vaginal bleeding
* Major fetal abnormalities that are known at time of admission

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: George A. Macones, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169416: Evaluation Of Valaciclovir In Patients With Chickenpox
Official title: Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Keywords: chicken pox
varicella
VZV
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.


Eligibility criteria: Inclusion criteria:

* Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.

Exclusion criteria:

* History of hypersensitivity reactions.
* Impaired hepatic or renal function.
* Gastrointestinal dysfunction.
* Serious underlying disease.
* Weigh over 40kg.
* Vaccinated for chickenpox.

Primary outcomes:
measure: Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Secondary outcomes:
measure: Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05884216: Entarik Feeding Tube System Placement in Adult ICU
Official title: Entarik Feeding Tube System Placement in Adult ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasogastric Tube
Lead sponsor: Gravitas Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.


Eligibility criteria: Inclusion Criteria:

* Must be able to swallow tabletsAt least 18 years old
* Able to provide informed consent or ability to have a legally authorized representative provide informed consent
* Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
* Suitable to start enteral (gastric but no post-pyloric) feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion Criteria:

* inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
* Known major upper airway malformation
* Known major GI abnormality, upper GI malignancy, or partial gastric resection
* History of gastroparesis
* Currently pregnant
* NPO status - expected to remain NPO for the following 72 hours.
* Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
* Critically ill, facing imminent death
* Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

Primary outcomes:
measure: Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Nova Clinical Research at HCA Florida Blake Hospital
state: Florida
city: Richmond
country: United States
facility: HCA Chippenham and Johnston-Willis Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT05667116: eVusheld Assessment reaL wORld Effectiveness at UPMC
Official title: An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care at UPMC in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2, COVID-19
Keywords: EVUSHELD, AZD7442, SARS-CoV-2, COVID-19, Immunocompromise
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
First posted: 2022-12-28
Enrollment: 4232
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All EVUSHELD EUA-eligible patient population in the UMPC health system.

Brief summary: An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the University of Pittsburgh Medical Center (UPMC) Health System.

Detailed description: This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in UPMC health system

Eligibility criteria: Inclusion Criteria:

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD
2. Eligibility for assess Evusheld use under the EUA. -

Exclusion Criteria:

* None

Primary outcomes:
measure: COVID-19 hospitalisation
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
Secondary outcomes:
measure: SARS-CoV-2 infection
timeFrame: 6 & 12 months
measure: Medically attended COVID-19
timeFrame: 6 & 12 months
measure: Medically attended acute COVID-19
timeFrame: 6 & 12 months
measure: COVID-19 hospitalisation
timeFrame: 12 months
measure: COVID-19 intensive care unit (ICU) admission
timeFrame: 6 & 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Donald M Yealy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801016: Virtual Reality and Autobiographical Recall in Anorexia Nervosa: a Preliminary Study
Official title: Esplorare l'Effetto di un Protocollo Combinato di Realtà Virtuale e Autobiographical Recall su Memoria, Percezione, Affetto in Pazienti Con Anoressia Nervosa: Uno Studio Preliminare
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception


Eligibility criteria: Inclusion Criteria:

* Anorexia Nervosa
* Body mass index equal or superior to 15 kg/m2
* Mother tongue Italian
* Semiresidential rehabilitation program

Exclusion Criteria:

* Other eating disorders
* Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders

Primary outcomes:
measure: Change in estimation of body weight
timeFrame: At baseline and after 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: università cattolica Milano
name: Giuseppe Riva, prof
role: STUDY_DIRECTOR
References: