louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02714491: Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Consciousness Disorders
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 15
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: SUPPORTIVE_CARE

Brief summary: Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.


Eligibility criteria: Inclusion Criteria:

* Vegetative State or Minimally Conscious State diagnosis
* \>3 months from acute brain injury

Exclusion Criteria:

* No clinical stability
* Sepsis
* Orthopaedic contraindications for verticalization
* Deep Vein Thrombosis
* weight \>130 Kg
* height \>210 cm

Primary outcomes:
measure: change in Coma Recovery Scale revised score
timeFrame: 0 and 35 days
Secondary outcomes:
measure: change in Levels of Cognitive Functioning score
timeFrame: 0 and 35 days
measure: change in Disability Rating Scale score
timeFrame: 0 and 35 days
measure: change in quantitative EEG parameters
timeFrame: 0 and 35 days
measure: change in Glasgow Coma Scale score
timeFrame: 0 and 35 days
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: CO
Study officials:
References:
Clinical trial NCT06111391: Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium
Official title: Patient Satisfaction , Prosthetic Complication and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium Maxillary Fixed Full Arch Prosthetic Opposing Mandibular Distal Extension Partial Denture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Prosthetic Complication
Clinical Outcomes
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 58
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture.

Detailed description: thirty patients were selected for this study from a previous study who have already received previous implants in the maxillary arch. The patients were divided into two groups: Group1 received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture, Group 2 received maxillary PEEK composite full arch fixed prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated using visual analogue scale (VAS) after one year months , Prosthetic complications were measured on the patient and implant levels after one year

Eligibility criteria: Inclusion Criteria:

Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space in order to have sufficient restoration space to construct FP3 prosthesis.

Exclusion Criteria:

Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.

Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).

Primary outcomes:
measure: implant stability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Mansoura University
name: Marwa Aboelez, Phd
role: STUDY_DIRECTOR
References:
citation: Wang J, Wu P, Liu HL, Zhang L, Liu LP, Ma CF, Chen JH. Polyetheretherketone versus titanium CAD-CAM framework for implant-supported fixed complete dentures: a retrospective study with up to 5-year follow-up. J Prosthodont Res. 2022 Apr 27;66(2):279-287. doi: 10.2186/jpr.JPR_D_20_00142. Epub 2021 Sep 30.
Clinical trial NCT00599391: Far Infrared Treatment for Kidney Diseases
Official title: Phase 1 Study to Examine the Use of Far Infrared Radiation for Renal Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Kidney Failure
Keywords: KIDNEY FAILURE, ACUTE
KIDNEY FAILURE, CHRONIC
RENAL INSUFFICIENCY
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal failure or kidney failure is a situation in which the kidneys fail to function adequately. It is divided into acute and chronic forms; either form may be due to a large number of other medical problems.

Detailed description: There are many causes of chronic kidney disease. The most common cause is diabetes mellitus. Acute renal failure is a rapidly progressive loss of renal function, generally characterized by body fluids disturbances and electrolyte derangement.

It is believed that far infrared radiation of the central nervous system, the endocrine system and the kidneys will help in the management of renal failure and a possible cure.

Eligibility criteria: Inclusion Criteria:

* People with kidney diseases

Exclusion Criteria:

* None

Primary outcomes:
measure: Kidney Function Improvement
timeFrame: 1 year
Secondary outcomes:
measure: Causes of Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_CHAIR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00884494: Ghrelin and Insulin Resistance
Official title: Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Insulin Resistance
Normal Weight,Healthy Controls
Keywords: Obesity
Insulin resistance
Ghrelin
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.


Eligibility criteria: Inclusion Criteria for RYGB group:

* Age 18-65
* BMI \> 35 kg/m2
* Scheduled for bariatric surgery at Vanderbilt University Medical Center

Inclusion Criteria for Lean group:

* Age 18-65
* BMI \< 30kg/m2

Exclusion Criteria:

* Prior bariatric surgery
* Serum creatinine \> 1.5 mg/dl
* Hepatic enzyme elevations \> 2x upper limits of normal
* Current use of warfarin or clopidogrel
* Intercurrent infections
* Females with positive pregnancy test
* Abnormal ECG

Primary outcomes:
measure: Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Robyn Tamboli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: STUDY_DIRECTOR
References:
citation: Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
Clinical trial NCT06135194: Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
Official title: Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib

Brief summary: To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib


Eligibility criteria: Inclusion Criteria:

(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records

Exclusion Criteria:

* Has uncontrolled or significant cardiovascular disease
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Primary outcomes:
measure: Central neryous system Progression Free Survival，CNS-PFS
timeFrame: 3years
Secondary outcomes:
measure: Overall Response Rate (ORR)for intracranial and extracranial lesions
timeFrame: 3years
measure: Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions
timeFrame: 3years
measure: Overall survival (Oversall Survival, OS) and security
timeFrame: 5years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: tao wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02519894: Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Official title: Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction :

Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.

The study hypothesis :

Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate

Objectives :

To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.

Study design :

Multicenter, open labeled, parallel, randomized controlled trial

Sample size : 600

Primary outcome : GFR reduction (CKD-EPI)

Secondary outcome :

* Achievement rate of Na intake \< 2 g/day (Urine Na \< 90 mEq/day)
* Blood pressure difference
* Proportions of patients with BP reached the target (130/80 mmHg)
* Number of anti-hypertensive drugs use to achieve BP target
* Urine albumin/creatinine ratio
* Major Adverse Cardiac Events (MACE)
* Cardio-ankle vascular index (CAVI)
* ankle-brachial index (ABI)

Documentary Proof of Ethical Clearance :

This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki


Eligibility criteria: Inclusion Criteria:

* CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
* Microalbuminuria
* Any blood pressure level

Exclusion Criteria:

* Salt - losing conditions
* Hyponatremia (Na \< 135 mg/dL) or Hypernatremia (Na \> 145 mg/dL)
* Bilateral renal artery stenosis
* Severe comorbid disease or life expectancy \<1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
* Immunosuppressant used

Primary outcomes:
measure: The declination of glomerular infiltration rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00439894: Ancillary Study to Protocol 20060104
Official title: Protein Phosphorylation Ancillary Study to Amgen Protocol 20060104: Open Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
etanercept
Enbrel
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who enrolled in to Etanercept SFP 20060104 study and signed the 20060364 informed consent.

Brief summary: Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.


Eligibility criteria: Inclusion Criteria:

* Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104

Exclusion Criteria:

* Meet exclusion criteria outlined in Amgen Protocol 20060104

Primary outcomes:
measure: To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity.
timeFrame: week 24
Secondary outcomes:
measure: Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored.
timeFrame: week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05964894: An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
Official title: Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to examine the effectiveness of the 12-week ergonomic intervention developed by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and muscle strength for hemodialysis nurses. The maintenance effects of the intervention were also evaluated after another 12-week follow-up.

Detailed description: Methods A cluster experimental design was used to conduct this study. Participants were recruited from hemodialysis units at two medical centers in Taiwan and had complaints of work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the 12-week intervention including ergonomic education and exercise program was designed based on the job contents of hemodialysis nurses. In the study period, we used a mobile massager app to reminder them and monitor their implementation of exercises. The outcome indicators were measured before and after intervention as well as the follow-up after another 12 weeks. A generalized estimating equations model was adopted to analyze the repeated measurements.

Eligibility criteria: Inclusion Criteria:

* 20 to 65 years old, which is the legal age range of adult for work in Taiwan
* registered nurses to work full time in the hemodialysis unit more than 6 months,
* having complaint of WMSDs within previous 6 months before this study.

Exclusion Criteria:

* having no musculoskeletal disorder related to the job
* to care less than 4 patients in 4 hours, which was below the Taiwan workload reference for nurse in hemodialysis job
* to have any other consideration to keep from 12- week physical exercise program (such as pregnancy, injury, disease, leave..., etc.).

Primary outcomes:
measure: severity degree of muscular discomfort
timeFrame: week 0
measure: muscle strength
timeFrame: week 0
measure: severity degree of muscular discomfort
timeFrame: week 12
measure: muscle strength
timeFrame: week 12
measure: severity degree of muscular discomfort
timeFrame: week 24
measure: muscle strength
timeFrame: week 24
Secondary outcomes:
measure: Subjective quality of life
timeFrame: week 0
measure: Subjective quality of life
timeFrame: week 24
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University, College of Medicine
name: JER-HAO CHANG, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03840694: Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
Official title: Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cigarette Smoking
Nicotine Withdrawal
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
First posted: 2019-02-15
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Right-handed
* Smoke \>= 10 cigarettes per day
* Smoking regularly for \>= 1 year
* Carbon Monoxide (CO) \> 8 at screening (or urinary cotinine \> 100)
* Own a compatible smartphone
* Able to read and understand English
* Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking

Exclusion Criteria:

* Regular use of "roll your own" cigarettes
* Planning to quit smoking within the next 60 days
* Current or planned smoking cessation treatment
* Regular use of smokeless tobacco or other nicotine products
* Expired CO \> 80 parts per million
* Breath alcohol \> .000 at screening (re-attempts are allowed)
* Positive toxicology screen for exclusionary drugs
* Use of exclusionary medications
* Significant medical problems
* Currently breastfeeding, pregnant, or planning to become pregnant
* Enrollment in another study utilizing Spectrum cigarettes within the last 3 months
* Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) Activation
timeFrame: Approximately 1-3 weeks
measure: Ecological Momentary Assessment (EMA) Pleasure Ratings
timeFrame: 2-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason A Oliver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915494: Intermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function
Official title: Intermittent Pneumatic Compression in Inhalation Injury: Effects on Diaphragm Mobility and Pulmonary Function in Children Sufferers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inhalation Injury
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: inhalation injury is very common in infants, young, children. complications of this problems are low pulmonary functions and limited mobility of main inspiratory muscle.

Detailed description: inhalation injury patients (children, n = 40) will be included in intermittent pneumatic compression group (n = 20, this device, intermittent pneumatic compression, will be used a resistive inspiratory muscle training for diaphragm muscle and the 10-set training will be done five session per the week, for 12 weeks. besides this training, traditional physical therapy program will be handled). In other inhalation group, n =20, traditional physical therapy program will be handled only)

Eligibility criteria: Inclusion Criteria:

* inhalation injury

Exclusion Criteria:

* brain injury
* fractures of any body part
* cardiac or chest disorders

Primary outcomes:
measure: forced vital capacity
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: forced expiatory volume at the first second of expiration
timeFrame: it will be measured after 12 weeks
measure: right-side diaphragmatic excursion
timeFrame: it will be measured after 12 weeks
measure: left-side diaphragmatic excursion
timeFrame: it will be measured after 12 weeks
measure: upper chest expansion
timeFrame: it will be measured after12 weeks
measure: lower chest expansion
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali MA Ismail
role: PRINCIPAL_INVESTIGATOR
References: