louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02184104: Caffeine Disposition After Inhalation
Official title: Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: caffeine
pharmacokinetics
pharmacodynamics
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how fast caffeine gets into your body with a product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your blood. You will also be asked to fill out some scales to measure the effects you feel after the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster than after an energy drink.


Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* non-smoker

Exclusion Criteria:

* Take chronic medication
* Co-existing diseases
* Platelet count less than 100,000/uL (per microliter)
* Acute or chronic psychiatric condition
* Consume more than 300 mg of caffeine per day
* Participated in another study within last 30 days or donated blood in last 6 weeks

Primary outcomes:
measure: Caffeine plasma concentration
timeFrame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours
Secondary outcomes:
measure: Caffeine effects
timeFrame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Other outcomes:
measure: Cardiovascular effects
timeFrame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Steven C. Laizure, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239304: Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Official title: A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Neoplasms
Keywords: Stage III Head and Neck Cancer
Stage IV Head and Neck Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed head and neck cancer
* Lymph node negative or positive
* Metastasis negative
* Chemo- and radiotherapy naïve
* WHO 0-2
* Measurable disease by RECIST
* Written informed consent

Exclusion Criteria:

* Severe alcohol abuse
* Active ILD
* Co-existing chronic gastrointestinal disease(s)
* Brain metastasis

Primary outcomes:
measure: Parts 1 and 2: Safety (Incidence of DLTs)
measure: Part 3: Safety and tolerability
Secondary outcomes:
measure: Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
measure: Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Research Centre
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Finland Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00599404: PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
Official title: An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics study
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.


Eligibility criteria: Inclusion Criteria:

Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

Standard inclusion criteria for a study of this nature

Primary outcomes:
measure: Pharmacokinetic profile following dosing with PN400
timeFrame: 24-hour PK on Day 1 & Day 10 of each treatment period
Secondary outcomes:
measure: To evaluate the safety of PN400
timeFrame: Day 1-10 of each treatment period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01665404: A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
Official title: A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, 18-65 years of age inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 30 mg/m2 inclusive
* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

* Evidence of any active or chronic disease
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer History or presence of clinically significant psychiatric condition
* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration time curve
timeFrame: Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00959504: Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA
Official title: VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detection and Genotyping of Factor V and Factor II Point Mutations
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Brief summary: As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.


Eligibility criteria: Inclusion Criteria:

* Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Exclusion Criteria:

* There are no applicable exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01653704: Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
Official title: Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Teaching Crisis Resource Management
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.

Detailed description: This will be a prospective randomized controlled study. Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group. Each participant of the active group will be paired with one of the participants from the observer group. The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system. Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles. The same active and observer participants will then individually manage another simulated crisis scenario (post-test). Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).

Eligibility criteria: Inclusion Criteria:

* emergency medicine residents from the University of Ottawa

Primary outcomes:
measure: Total Ottawa GRS Score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Skills and Simulation Centre
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Anita Lai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Sylvain Boet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai A, Haligua A, Dylan Bould M, Everett T, Gale M, Pigford AA, Boet S. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial. Anaesth Crit Care Pain Med. 2016 Aug;35(4):275-81. doi: 10.1016/j.accpm.2015.10.010. Epub 2016 Mar 14.
Clinical trial NCT05998304: ADME Study of [14C] Yiqibuvir in Healthy Male Subjects
Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Yiqibuvir.


Eligibility criteria: Inclusion Criteria:

* signing of informed consent
* Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Exclusion Criteria:

* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
* Positive results from urine drug screen test
* Donate blood or lose blood 400 mL or more within 3 month prior to dosing
* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection

Primary outcomes:
measure: Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
timeFrame: up to 18 days
Secondary outcomes:
measure: Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir
timeFrame: up to 18 days
measure: Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
timeFrame: up to 18 days
measure: Number of adverse events (AE) experienced by subjects
timeFrame: up to 18 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai xuhui central hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00520104: Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
Official title: A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Detailed description: To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Patients with Allergic Rhinitis

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: Pharmacokinetics
timeFrame: multiple
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Javelin Pharmaceuticals
state: Massachusetts
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02181504: A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.


Eligibility criteria: Inclusion Criteria:

* Ethnically Japanese
* Diagnosis of wet age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Week 20
measure: Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
timeFrame: Baseline, 20 Weeks
measure: Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale
timeFrame: Baseline, 20 Weeks
measure: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 16, Week 20
Other outcomes:
Locations:
city: Chiyoda-ku,Tokyo
country: Japan
facility: Nihon University Hospital
city: Fukushima-shi
country: Japan
facility: 1 Fukushima Medical University
city: Kita-ku, Fukuoka-shi Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kita-ku, Okayama-shi Okayama
country: Japan
facility: Okayama University Hospital
city: Otsu-shi
country: Japan
facility: Shiga University
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University
city: Showa-ku, Nagoya-shi Aichi
country: Japan
facility: Nagoya University Hospital
city: Taito Ku Tokyo
country: Japan
facility: Takeuchi Eye Clinic
city: Tennoji-ku Osaka
country: Japan
facility: Musashi Dream Clinic
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayas
city: Yamato Kanagawa
country: Japan
facility: Otakeganka Tsukimino Clinic
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01370304: Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Depression
Keywords: repetitive Transcranial Magnetic Stimulation (rTMS)
Depression
Venlafaxine
fMRI
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Clinical diagnosis of major depressive disorder (DSM-IV)
* HDRS-17 items \> 20
* Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)

Exclusion Criteria:

* Psychotic features
* Failure of one previous venlafaxine treatment
* Addiction comorbidity or schizophrenia comorbidity
* Involuntary hospitalization
* Seizures history
* Pregnancy or breastfeeding
* Somatic comorbidity able to impact on cognitive functions

Primary outcomes:
measure: The primary outcome measure is remission
timeFrame: 1-6 weeks
Secondary outcomes:
measure: fMRI
timeFrame: 0,6 weeks
measure: CGI
timeFrame: 1-6 weeks
measure: QIDS-C30
timeFrame: 1-6 weeks
measure: UKU Scale
timeFrame: 1-6 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yun chun Chen
state: Shaanxi
Study officials:
affiliation: Department of Psychiatry, Xi Jing hospital, Xi'an, China
name: Qingrong Tan, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00904904: Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Inflammation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
* Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.

Exclusion Criteria:

* Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
* Subjects who take acetylsalicylic acid at doses \> 100 mg daily and cannot discontinue usage during the study.
* Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
* Subjects with immunodepression.
* Subjects with a history of intolerance to the study drug or to any NSAI drug.
* Subjects who are monocular for any reason other than cataract.
* Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.

Primary outcomes:
measure: Aqueous flare
timeFrame: Post-operative day 1 & day 7
Secondary outcomes:
measure: Aqueous flare
timeFrame: Postoperative day 30 and day 90
measure: Change from baseline of retinal thickness
timeFrame: Postoperative day 30 & day 90
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Bausch & Lomb
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gabriele Brenger
role: STUDY_DIRECTOR
References: