louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03996486: Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Official title: A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hemophilia
Keywords: Coagulation Factor VIII (FVIII)
Coagulation Factor IX (FIX)
Anti-tissue factor pathway inhibitor (aTFPI)
Human monoclonal immunoglobulin G2 antibody
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

Detailed description: The primary objective is to assess the safety of multiple doses of BAY1093884.

Eligibility criteria: Inclusion Criteria:

* Participants with hemophilia A and FVIII activity \<1% or hemophilia B with FIX activity \<2%
* Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer \< 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified)

Exclusion Criteria:

* History or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis)
* History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder
* History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension
* History or at risk for thrombotic microangiopathy

Primary outcomes:
measure: Frequency of drug-related adverse events
timeFrame: Up to 3 months
measure: Frequency of drug-related serious adverse events
timeFrame: Up to 3 months
measure: Frequency of adverse events of special interest
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01505686: MRI Findings in Inguinal Hernia
Official title: MRI Findings in Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Pain
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The aim of the present study is to determine, whether similar inflammatory changes can be detected with MRI scan in inguinal hernia. Also, patient questionaires are used preoperatively and postoperatively to determine, if preoperative pain scores can be used as a predictive value for postoperative prolonged pain/neuralgia.


Eligibility criteria: Inclusion Criteria:

* age \< 50 years
* painful inguinal hernia

Exclusion Criteria:

* conditions that do not allow the use of MRI
* conditions that prevent general anesthesia

Primary outcomes:
measure: Inflammatory changes in MRI scan
timeFrame: 7 months
Secondary outcomes:
measure: Pain scores
timeFrame: 7 months
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital, department of surgery
Study officials:
References:
Clinical trial NCT03662386: Prospective Analysis of "genotype-phenotype" Correlations Observed in a Large Cohort of Patients with Hereditary Retinal Dystrophies - GEPHIRD
Official title: Prospective Analysis of "genotype-phenotype" Correlations Observed in a Large Cohort of Patients with Hereditary Retinal Dystrophies - GEPHIRD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Retinal Dystrophies
Keywords: hereditary retinal dystrophies
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for suspicion of hereditary retinal distrophy

Brief summary: This study will carry out a detailed descriptive analysis of a large population of patients with hereditary retinal dystrophies (HRD): clinical, paraclinical and genetic data.

The information drawn from these analyzes will provide a better understanding of the pathophysiology of these rare diseases and this may ultimately impact the medical management of patients (targeted therapy).


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for suspicion of hereditary retinal dystrophy
* Benefiting as part of the care of a genetic analysis

Exclusion Criteria:

- Patient under a measure of legal protection

Primary outcomes:
measure: Description of the phenotypic characteristics of patients with hereditary retinal dystrophies.
timeFrame: Baseline
measure: Description of the genotypic characteristics of patients with hereditary retinal dystrophies.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Elise BOULANGER SCEMAMA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00533286: Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
Official title: Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Disability
Paresis
Keywords: physiotherapy
Tuebingen concept
benzodiazepines
muscle relaxants
disc herniation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-09-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse


Eligibility criteria: Inclusion Criteria:

* sciatica without or with neurological deficit attributable to lumbar disc prolapse
* CT or MRI confirmation of lumbar disc prolapse
* informed consent

Exclusion Criteria:

* bladder or bowel disturbance
* acute (\< 24 h) development of paresis grade 1 or plegia
* taken benzodiazepines for more than 2 weeks
* history of benzodiazepine intolerance
* prior surgery for disc prolapse, or prior trauma to the vertrebral column

Primary outcomes:
measure: (i) median extent of reduction of referred pain
timeFrame: 7 days
Secondary outcomes:
measure: median duration of inability to work after discharge
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
name: Michael Weller, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04637386: TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT
Official title: the Efficacy of Transversus Abdominis Plane Block for Analgesia in Comparison With Local Anesthetic Wound Infiltration Post-cesarean Section: A Randomized Comparative Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Pain
Obstetric Anesthesia Problems
Keywords: transversus abdominis plane
VAS; visual analogue score
wound infiltration
cesarean section
postoperative pain
analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility criteria: Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.
2. Aged ≥19 years and less than 40 years.
3. Gestational age ≥ 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) ≥40 kg/m2.
2. History of recent opioid exposure
3. Hypersensitivity to any of the drugs used in the study.
4. Significant cardiovascular, renal, or hepatic disease

Primary outcomes:
measure: degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively
timeFrame: 24 hours
Secondary outcomes:
measure: measures the time to the first postoperative opioid dose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine - Cairo university
state: Kasr El Ainy
Study officials:
affiliation: Cairo University
name: Mohammed A Taymour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080386: UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
Official title: UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Alcoholic Fatty Liver Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-10-12
Enrollment: 100
Sex: ALL
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 followed by the department of hepato gastroenterology of the CHU d'Angers for liver disease (NAFLD)

Brief summary: The purpose of this study is to assess UDFF performance (compared to MRI)


Eligibility criteria: Inclusion Criteria:

* All patients who had hepatic ultrasound with available UDFF measurements and hepatic MRI (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included.

Exclusion Criteria:

* chronic liver disease with a different etiology other than NAFL/NASH or mixed (hepatitis B or C, hemochromatosis, autoimmune hepatitis, Wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency),
* decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices),
* hepatocellular carcinoma.
* opposition to the use of its data

Primary outcomes:
measure: To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte.
timeFrame: 3 months maximum between the 2 measurements (UDFF and MRi)
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers university hospital
Study officials:
References:
Clinical trial NCT00525486: Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
Official title: Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Labor
Keywords: Nifedipine
Tocolysis
Maintenance
Preterm delivery
extended release nifedipine
PTL
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2007-09-05
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group.

The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.


Eligibility criteria: Inclusion Criteria:

* pregnancy week 24-33
* Singleton pregnancy
* After successful treatment to stop PTL

Exclusion Criteria:

* Contraindications for Nifedipine extended release treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Baruch Padeh Medical Center, Poria, Israel.
name: Yuri Perlitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT02467686: Breast Cancer, Sexuality and Black Cohosh
Official title: Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sexuality
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.

Detailed description: For the study will be recruited 60 women treated with breast cancer, using tamoxifen or aromatase inhibitor, are in menopause, hot flashes and has with or without sexual life. They will answer the questionnaires: Kupperman, World Health Organization Quality of Life (WHOQOL) and those sexually active will have Female Sexual Function Index (FSFI). The control group will have 30 patients using tamoxifen alone or inhibitor. The other group will have 30 patients receiving tamoxifen or inhibitor and will start with 2 tablets per day of dry extract of Cimicifuga racemosa. They will be followed for 6 months and answer questionnaires at the first visit, 3-month and 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.
* With hot flashes and with or without active sexual life.

Exclusion Criteria:

* Women did not have breast cancer
* do not use tamoxifen or aromatase inhibitor
* not in menopause and not have hot flashes

Primary outcomes:
measure: Hot flashes (score of hot flashes)
timeFrame: 6 months
Secondary outcomes:
measure: Sexual function (score of sexual function questionnaire (FSFI)
timeFrame: 3 months
measure: Sexual function (score of sexual function questionnaire (FSFI)
timeFrame: 6 months
Other outcomes:
measure: Quality of life (questionnaire scores of quality of life (WHOQOL)
timeFrame: 3 months
measure: Quality of life (questionnaire scores of quality of life (WHOQOL)
timeFrame: 6 months
Locations:
city: Sao Paulo
country: Brazil
facility: Carolina Furtado Macruz
Study officials:
affiliation: Irmandade da Santa Casa Misericordia Sao Paulo
name: Black cohosh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00119886: Botox on Vulvar Vestibulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vulvar Vestibulitis
Vulvar Diseases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-07-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.

Detailed description: Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings.

The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation.

Injection of Botulinum Toxin is tested as a therapeutic option for this condition.

A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.

Eligibility criteria: Inclusion Criteria:

* Vulvar vestibulitis
* Safe birth control

Exclusion Criteria:

* Treated earlier with Botulinum toxin
* Ongoing vulvar infection
* Age\<18
* Skin disease
* Pregnancy
* Myasthenia gravis
* Amyotrophic lateral sclerosis (ALS)
* Diabetes
* Using:

  * Calcium antagonists;
  * Aminoglycosides;
  * Magnesium sulfate;
  * Systemic steroid treatment

Primary outcomes:
measure: Reduce vulvar pain on a visual analogue scale (VAS).
Secondary outcomes:
measure: Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christina Damsted Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40. doi: 10.1016/j.jpain.2004.02.575.
Clinical trial NCT03090386: Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients
Official title: Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults diagnosed with a malignant brain tumor either as a primary diagnosis or recurrent

Brief summary: This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.


Eligibility criteria: Inclusion Criteria:

* be between18 to 89 years old;
* have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery)
* have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study;
* be native speakers of American English;
* have obtained a minimum of a high school education;
* self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; and
* must demonstrate capacity to sign informed consent based on Informed Consent for Research: A Guide to Assessing a Participant's Understanding tool.

Exclusion Criteria:

* are younger than 18 years old or older than 89 years old;
* have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery)
* have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment;
* are not native speakers of American English;
* have not obtained a minimum of a high school education;
* do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; or
* do not demonstrate the capacity to sign informed consent

Primary outcomes:
measure: Cognitive Communication Survey
timeFrame: 1 day at time of consent
Secondary outcomes:
measure: Cognitive-linguistic Standardized Testing
timeFrame: within 3 months of cognitive communication survey
measure: Follow-up Survey
timeFrame: within 6 months after completion of standardized testing
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
References:
Clinical trial NCT00333086: A Study of Letrozole in the Treatment of Endometrial Cancer
Official title: A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent and Metastatic Endometrial Cancer
Keywords: Endometrial Cancer
Aromatase inhibitor
Letrozole
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Canadian Cancer Trials Group
First posted: 2006-06-02
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.


Eligibility criteria: Inclusion criteria

* Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
* No adjuvant therapy
* Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
* No chemotherapy for recurrence (adjuvant permitted)
* Unidimensionally measurable disease
* Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
* No prior tamoxifen or aromatase inhibitor therapy
* No other concurrent anti-cancer treatment
* No metastases in the central nervous system

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks
Secondary outcomes:
measure: Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: