louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01240395: Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chemical Sensitivity
Keywords: Multiple chemical sensitivities
MCS
Mindfulness-based cognitive therapy
MBCT
Lead sponsor: The Danish Research Centre for Chemical Sensitivities
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness worry, quality of life, and illness perceptions in patients suffering from multiple chemical sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible symptom reduction is mediated by an increased level of mindfulness.

The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to which chemical exposures causes symptoms and the impact on daily life will be significantly improved in the MBCT treatment group as compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Fulfil Lacour's criteria for Multiple Chemical Sensitivity
* Sign a written informed consent form

Exclusion Criteria:

* A psychotic or bipolar disorder
* An acute psychiatric disorder requiring other treatment
* Suicidal ideations
* Current alcohol or drug abuse
* Previously engaged in a mindfulness programme

Primary outcomes:
measure: The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
timeFrame: 8 weeks, 1 year follow up
Secondary outcomes:
measure: The brief illness perception questionnaire (Brief IPQ)
timeFrame: 8 weeks, 1 year follow up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 8 weeks, 1 year follow up
measure: Symptom Check List 92 (SCL-92)
timeFrame: 8 weeks, 1 year follow up
measure: The Perceived Stress Scale (PSS-10)
timeFrame: 8 weeks, 1 year follow up
measure: The World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: 8 weeks, 1 year follow-up
measure: Rumination-reflection questionnaire (RRQ)
timeFrame: 8 weeks, 1 year follow-up
measure: Self compassion scale short form
timeFrame: 8 weeks, 1 year follow up
measure: The role work functioning index
timeFrame: 8 weeks, 1 year follow-up
Other outcomes:
Locations:
city: Ledreborg Allé 40, 2.
country: Denmark
facility: The Danish Research Centre for Chemical Sensitivities
state: Gentofte
Study officials:
References:
citation: Hauge CR, Bonde PJ, Rasmussen A, Skovbjerg S. Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial. Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.
Clinical trial NCT01785095: Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Official title: Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oocyte Donation
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:
* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
* \>=18 and \<35 years old;
* Regular menstrual cycle (26 - 35 days);
* BMI between 18 and 30 kg/m2;
* First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
* basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l);
* Normal TSH levels;
* Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).

Exclusion Criteria:

* Age \<18 and \>=35 years;
* PCOS;
* Endometriosis;
* Subjects with evidences of autoimmune or rheumatic diseases;
* Hypersensitivity to the active substance or to any of the excipients (lactose);
* Abnormal bleeding of undetermined origin;
* Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
* Uncontrolled adrenal dysfunction;
* Neoplasia;
* Severe impairment of renal and/or hepatic function;
* Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone...).

Primary outcomes:
measure: Number of Patients Producing Anti-FSH Antibodies.
timeFrame: 4 months.
Secondary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: after 2 weeks of treatment
measure: Total Dose of FSH Units Used.
timeFrame: after 2 weeks of treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus
Study officials:
References:
Clinical trial NCT00616395: Study of Early Infant Diet on Growth and Development
Official title: Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Keywords: Infant Nutrition
Soy Phytochemicals
Infant Body Composition
Brain Function
Cognition and Development
Healthy Infants
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants

Brief summary: The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.


Eligibility criteria: Inclusion Criteria:

* Healthy Infants
* Birth weight = 6 to 9 lbs
* Mostly fed breast milk, milk-based formula, soy-based formula
* Mother over 18 years of age

Exclusion Criteria:

* Unhealthy pregnancy
* Illness during pregnancy or for the child that could interfere with the study parameters

Primary outcomes:
measure: Growth and development
timeFrame: yearly, 1-6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Aline Andres, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sobik S, Sims CR, McCorkle G, Bellando J, Sorensen ST, Badger TM, Casey PH, Williams DK, Andres A. Early infant feeding effect on growth and body composition during the first 6 years and neurodevelopment at age 72 months. Pediatr Res. 2021 Jul;90(1):140-147. doi: 10.1038/s41390-020-01157-z. Epub 2020 Sep 22.
citation: Brink LR, Mercer KE, Piccolo BD, Chintapalli SV, Elolimy A, Bowlin AK, Matazel KS, Pack L, Adams SH, Shankar K, Badger TM, Andres A, Yeruva L. Neonatal diet alters fecal microbiota and metabolome profiles at different ages in infants fed breast milk or formula. Am J Clin Nutr. 2020 Jun 1;111(6):1190-1202. doi: 10.1093/ajcn/nqaa076.
citation: Andres A, Moore MB, Linam LE, Casey PH, Cleves MA, Badger TM. Compared with feeding infants breast milk or cow-milk formula, soy formula feeding does not affect subsequent reproductive organ size at 5 years of age. J Nutr. 2015 May;145(5):871-5. doi: 10.3945/jn.114.206201. Epub 2015 Mar 11.
citation: Andres A, Casey PH, Cleves MA, Badger TM. Body fat and bone mineral content of infants fed breast milk, cow's milk formula, or soy formula during the first year of life. J Pediatr. 2013 Jul;163(1):49-54. doi: 10.1016/j.jpeds.2012.12.067. Epub 2013 Feb 1.
Clinical trial NCT03100695: Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
Official title: A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unilateral Tibial Diaphyseal Fracture
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.


Eligibility criteria: Inclusion Criteria:

* Aged 18-65, skeletally mature adults.
* Acute unilateral closed tibia diaphyseal fractures as the primary injury.
* Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
* Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.

Exclusion Criteria:

* Open/compound tibial fracture.
* Fracture Type 42-C2 according to Muller AO classification.
* Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
* Polytrauma (defined as injury severity score of 17 or more.)
* Prior or concomitant illnesses that may affect healing.
* Exposure to drugs that can affect the bone metabolic state within the past three months.
* Receiving chemotherapy, radiation treatment or immunosuppression drugs.
* Currently enrolled in any other study which may impact on the results of the present study.
* If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.

Primary outcomes:
measure: Time to healing
timeFrame: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
References:
Clinical trial NCT01383395: Effect of Cilostazol on the Pharmacokinetics of Simvastatin
Official title: Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Inje University
First posted: 2011-06-28
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.

Detailed description: Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 20 - 48 years
* A body mass index (BMI) in the range 19-27 kg/m2
* Provide written informed consent after being fully informed about the study procedures
* Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
* Determined eligible in the ECG, clinical laboratory tests and urinalysis

Exclusion Criteria:

* Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
* Use of medication within 10 days before first dose
* Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
* Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
* Whole blood donation during 60 days before the study
* Participation in other clinical trial within 90 days prior to scheduled study drug administration
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Plasma concentration of simvastatin
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center Clinical Trial Center
Study officials:
affiliation: Samsung Medical Center
name: JaeWook Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741595: Visual Stimulus Competition
Official title: Visual Stimulus Competition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visual Pathway Disorder
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, we will use behavioral methods to investigate several types of interactions that occur when visual stimuli conflict, such as when objects are presented nearby to each other, or to separate eyes. We will target purely sensory aspects by using simple geometric shapes: letters and lines. Our outcome measure will be performance thresholds.

Detailed description: Participants will be shown visual stimuli on displays and be asked to identify some aspect of the stimuli: their orientation and/or color, the existence of binocular suppression, etc.

In different blocks, stimuli will be manipulated in different ways to characterize basic aspects of visual processing. For example, the contrast, color, and/or spatial layout of stimuli will be varied.

Eligibility criteria: Inclusion Criteria:

* Normal Vision
* English language

Exclusion Criteria:

* Less than 20/20 in either eye
* Vision-affecting abnormalities (amblyopia, keratoconus, etc.)
* Ortho-K lenses

Primary outcomes:
measure: Detection probability
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
Study officials:
References:
Clinical trial NCT00397995: Undislocated Distal Both-Bone Forearm Fractures in Children
Official title: Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Forearm
Distal
Child
Treatment
Keywords: Fracture
Forearm
Distal
Child
Treatment
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-11-10
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

Detailed description: children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of cast will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* both-bone forearm fracture
* distal
* undislocated
* age \< 16 years

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures type torus

Primary outcomes:
measure: pronation and supination
Secondary outcomes:
measure: complications, function, esthetics, complains in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, location Juliana Children's Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre location Sophia Children's hospital
state: Zuid Holland
Study officials:
name: joost w Colaris, drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384695: A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Official title: A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: GERD
Barrett's Esophagus
Keywords: Barrett's esophagus
confocal microendoscopy
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
First posted: 2011-06-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.


Eligibility criteria: Inclusion Criteria:

* patient 18 years or older
* colonoscopy for screening or surveillance of polyps or disease of colon
* anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

* patient unable to provide informed consent
* patient found unfit for standard colonoscopy or anoscopy with biopsies

Primary outcomes:
measure: to determine whether tissue is neoplastic or non-neoplastic
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Mt. Sinai School of Medicine
name: Sharmila Anandasabapathy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04392895: Para Aortic Lymphadenectomy : Always ?
Official title: Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Locally advanced cervical cancer, more than IB3 stage FIGO 2018
Para aortic lymphadenectomy
Laparoscopy
PET/CT
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019

Brief summary: Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.


Eligibility criteria: Inclusion criteria:

- Patients with :

* locally advanced cervical cancer,
* who undergone PAL
* with pre operative PET CT, between January 2015 and december 2019

Exclusion criteria:

- patients aged under 18

Primary outcomes:
measure: negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
timeFrame: 1 day
Secondary outcomes:
measure: morbidity of PAL
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Martha DURAES, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00405795: Envision® Surface Evaluation
Official title: Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.

Detailed description: This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.

Eligibility criteria: Inclusion Criteria:

* Subject Weight \< 400 lbs. Subject has Stage II, III, or IV pressure ulcer on weight bearing aspect of the body Subject estimated length of stay at least 7 days Subject Ability to provide informed consent

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Levindale Hebrew Geriatric Center and Hospital
state: Maryland
Study officials:
affiliation: Levindale hebrew Geriatric Center and Hospital
name: Susan Levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Levindale Hebrew Geriatric Center and Hospital
name: Cathie Papantonio, RN,BSN,CWCN
role: STUDY_DIRECTOR
References: