louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00658983: Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Official title: Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Leg Ulcer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Johnson & Johnson
First posted: 2008-04-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.


Eligibility criteria: Inclusion Criteria:

* 18 year or older
* A non-healing chronic lower leg ulcer
* Platelet ranges of 150000 per ml circulating blood

Exclusion Criteria:

* Presence of a tumor or metastatic disease
* Hypersensitive to collagen regenerated cellulose
* Hemodynamic unstable patient
* Hypercoagulability
* Heart decompensation or angina pectoris

Primary outcomes:
measure: Wound healing
timeFrame: 6 weeks
Secondary outcomes:
measure: Wound healing
timeFrame: 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wim Bongaerts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Wouter De Moor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868683: The Glycemic Effect of Added Sugar on Bake Beans
Official title: The Glycemic Effect of Added Sugar on Bake Beans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
PreDiabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2019-03-11
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover randomized controlled Trials
Primary purpose: OTHER

Brief summary: To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.

Detailed description: There will be a total of 7 test session. Each session will last for 3 hours. At each test session, volunteers will be served with 7 test meals and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerpick. Following the fasting samples, volunteers will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

Eligibility criteria: Inclusion Criteria:

* Chinese ethnicity
* Age ≥21 and ≤ 60 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure \<140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current Smoker
* have any metabolic diseases (such as diabetes, hypertension etc)
* have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* have intolerances or allergies to any foods
* partake in sports at the competitive and/or endurance levels
* intentionally restrict food intake

Primary outcomes:
measure: Glucose [
timeFrame: Up to 180 minutes
Secondary outcomes:
measure: Insulin
timeFrame: Up to 180 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
Clinical trial NCT00168883: Study for Patients With Non Small Cell Lung Cancer (NSCLC)
Official title: Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
curative non-treatable NSCLC UICC stage IIIB and IV
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Pierre Fabre Pharma GmbH
First posted: 2005-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Detailed description: Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Eligibility criteria: Inclusion Criteria:

* Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion Criteria:

* New York Heart Association (NYHA) III or IV
* Brain metastases
* Neurotoxicity Grade 2 or greater

Primary outcomes:
measure: Determination of response rate (stable disease [SD] or better)
measure: Determination of safety of the combination and life quality
Secondary outcomes:
measure: Determination of remission rate
measure: Determination of time to progression
measure: Determination of 1-year survival rate
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hematology & Oncology Charité CBF Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363583: Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
Official title: Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 48
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of \> 10 mm Hg, and arrival within 24 hours after trauma.

Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.

A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.


Eligibility criteria: Inclusion Criteria:

* traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

* pregnant or lactating women

Primary outcomes:
measure: Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
timeFrame: 24 hours
Secondary outcomes:
measure: Levels of systemic inflammatory markers
timeFrame: 4 days
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: Umea university
Study officials:
affiliation: Umea university
name: Lars-Owe Koskinen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olivecrona M, Rodling-Wahlstrom M, Naredi S, Koskinen LO. Prostacyclin treatment in severe traumatic brain injury: a microdialysis and outcome study. J Neurotrauma. 2009 Aug;26(8):1251-62. doi: 10.1089/neu.2008.0605.
citation: Hagglund L, Olivecrona M, Koskinen LD. Correlation of Cerebral and Subcutaneous Glycerol in Severe Traumatic Brain Injury and Association with Tissue Damage. Neurocrit Care. 2022 Jun;36(3):993-1001. doi: 10.1007/s12028-021-01412-z. Epub 2021 Dec 16.
citation: Olivecrona Z, Bobinski L, Koskinen LO. Association of ICP, CPP, CT findings and S-100B and NSE in severe traumatic head injury. Prognostic value of the biomarkers. Brain Inj. 2015;29(4):446-54. doi: 10.3109/02699052.2014.989403. Epub 2014 Dec 18.
citation: Wahlstrom MR, Olivecrona M, Ahlm C, Bengtsson A, Koskinen LO, Naredi S, Hultin M. Effects of prostacyclin on the early inflammatory response in patients with traumatic brain injury-a randomised clinical study. Springerplus. 2014 Feb 18;3:98. doi: 10.1186/2193-1801-3-98. eCollection 2014.
Clinical trial NCT01345383: Impact of Current Smoking in the Tolerance of Bronchoscopy
Official title: Impact of Current Smoking in the Tolerance of Bronchoscopy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Smokers
Keywords: smoking
bronchoscopy
cough
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current and regular smokers needing a bronchoscopy as determined by their own physician

Brief summary: The purpose of this study is to study the impact of smoking in the preceding hours before a bronchoscopy on the tolerance of this exam.

Detailed description: Tolerance evaluation of the bronchoscopy on current and regular smokers. The investigators assess episodes of cough, dyspnea, volume of lidocain (liquid 1% and in spray 10%), duration of the procedure, episodes of desaturation and completion of the bronchoscopy.

The investigators compare patients who did not smoke in the 6 hours before the bronchoscopy and those who have smoked.

Eligibility criteria: Inclusion Criteria:

* current and regular smoker
* bronchoscopy under local anesthesia

Exclusion Criteria:

* patients needing EBUS or fluoroscopy
* intravenous sedative

Primary outcomes:
measure: cough
timeFrame: Day 1
Secondary outcomes:
measure: dyspnea
timeFrame: day 1
measure: Lidocaine volume
timeFrame: day 1
measure: length of bronchoscopy
timeFrame: Day 1
measure: desaturation episodes
timeFrame: day 1
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Isabelle De Meulder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01832883: Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Official title: Pediatric Vision Scanner 4 (PVS4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Strabismus
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
First posted: 2013-04-16
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting for ophthalmic exam at eye clinic.

Brief summary: The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.


Eligibility criteria: Inclusion Criteria:

* Children aged 3-8 years
* Signed Informed consent by parent or guardian
* Meet all inclusion criteria.

Exclusion Criteria:

* Children with a history of developmental delay or cognitive deficit
* Children unable to complete the GSE (including visual acuity testing)

Primary outcomes:
measure: Binocularity score
timeFrame: Day 1
Secondary outcomes:
measure: Presence of amblyopia risk factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Sean Donahue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
Clinical trial NCT01701583: Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Official title: Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Urticaria
Keywords: Chronic Idiopathic Urticaria
CIU
Urticaria
Chronic Hives
Xolair
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2012-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Detailed description: The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.

Eligibility criteria: Inclusion Criteria:

* Chronic urticaria (hives) for more than 6 weeks.
* No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)

Exclusion Criteria:

* Taken any oral steroids for 1 month prior to beginning the study.
* Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.
* Physical urticaria as a primary diagnosis.
* Known allergic precipitant of urticaria such as foods.
* Urticarial Vasculitis.
* Anemia.
* Asthma.
* Serum Immunoglobulin E (IgE) \>700 IU/ml.
* Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.
* Known sensitivity to omalizumab or this class of drug.
* Use of any other investigational agent in the last 1 month.
* Untreated intercurrent illness.

Primary outcomes:
measure: Change in the Basophil Proteome
timeFrame: Baseline through week 13
Secondary outcomes:
measure: Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.
timeFrame: Baseline through week 13
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stephen Dreskin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. Epub 2018 May 20. No abstract available.
Clinical trial NCT01120483: Prevalence of Malnutrition in Oncologic Patients
Official title: Prevalence and Impact of Malnutrition in Hospitalised Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Malnutrition
Keywords: mortality
functional status
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected in primary care clinics.

Brief summary: Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is associated with poor clinical outcome. The purpose of this study is to determine the prevalence of hospital malnutrition and its impact on functionality, quality of life and mortality in cancer patients and to test the reference percentiles of phase angle values (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.

Hypothesis:

The fifth reference percentile of the phase angle norm values is a prognostically relevant cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired functional status, as well as predictive of 6-month mortality


Eligibility criteria: Inclusion Criteria:

* Patients suffering from cancer.
* Patients who have signed a written Informed Consent.

Exclusion Criteria:

* Patients with implanted pacemaker or defibrillator
* Patients with neuromuscular disease or hemiplegia.

Primary outcomes:
measure: Prevalence of malnutrition
timeFrame: 1 day
Secondary outcomes:
measure: Quality of life
timeFrame: 1 day
measure: Mortality
timeFrame: 6 months
measure: Depression
timeFrame: 1 day
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Matthias Pirlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03066583: Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
Official title: Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meniscus Lesion
Keywords: meniscus repair
platelet rich plasma
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.

Detailed description: The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.

Eligibility criteria: Inclusion Criteria:

* Complete horizontal 10 mm in length
* Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
* Single tear of the medial and/or lateral meniscus
* Skeletally mature patients 18-70 years of age

Exclusion Criteria:

* discoid meniscus
* arthritic changes (Kellgren Lawrence scale \>2) or axial leg deformity (valgus \> 6 deg)
* inflammatory diseases (i.e. rheumatoid arthritis)
* concominant chondral defects (\> 2 ICRS)

Primary outcomes:
measure: Assessment of meniscal healing by MR scanning
timeFrame: by 1 year
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 12 weeks, 6months, 1year post procedure
measure: Knee injury and Osteoarthritis Outcome Score scale
timeFrame: 12 weeks, 6months, 1year post procedure
measure: International Knee Documentation Committee - Subjective Knee Evaluation Form
timeFrame: 12 weeks, 6months, 1year post procedure
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: PCME, Otwock, Poland
name: Rafal Kaminski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04993183: Promoting an incLUsive Society Towards Older Adults With Physical Disabilities
Official title: Promoting an incLUsive Society Towards Older Adults With Physical Disabilities Through Disability Simulation Education (PLUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Social Acceptance
Respect
Keywords: Physical disability
Social inclusion
Disability simulation
Education
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 1111
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All recruited participants will receive the intervention.
Primary purpose: OTHER

Brief summary: To improve secondary school students' positive attitudes towards older adults with physical disabilities via a Promoting an incLUsive Society towards older adults with physical disabilities through disability simulation education (PLUS) project.

Detailed description: A pretest-posttest and qualitative study design will be adopted. 1,000 junior secondary students will be recruited from six secondary schools in Hong Kong by convenience sampling to participate in a 3-day PLUS Convention. Changes in students' attitudes towards older adults with physical disabilities and satisfaction with life, and their satisfaction with the disability simulation experience will be assessed. Semi-structured interviews will be conducted with students, facilitators, teachers, and older adults with physical disabilities to gain further feedback.

Eligibility criteria: Inclusion Criteria:

1. currently a secondary 1 to secondary 3 student
2. studying in a secondary school in Hong Kong
3. communicable in Cantonese
4. willing to attend all of the activities of the 3-day PLUS Convention

Exclusion Criteria:

1. have a physical or learning disability
2. diagnosed with a severe psychiatric illness

Primary outcomes:
measure: Change in the participants' attitudes towards older adults with physical disabilities
timeFrame: Change from baseline to immediately after completion of the intervention (2 months)
Secondary outcomes:
measure: Change in the participants' level of life satisfaction
timeFrame: Change from baseline to immediately after completion of the intervention (2 months)
measure: The participants' level of satisfaction with the disability simulation workshop
timeFrame: Immediately after completion of the disability simulation workshop (within 1 day)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Secondary Schools
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References: