louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02868333: Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood
Official title: Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Immune Deficiency
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 1780
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with primary immune deficiency diagnosed during childhood and followed in refereries center for this desease

Brief summary: Background: Most children with primary immune deficiency (PID) now reach adulthood. However, few studies have evaluated their health status and health related quality of life (HRQoL).

Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term Cohort). The data collected will be used to assess the physical health condition of patients who reached adulthood and the impact on their quality of life.

Methods: Patients are asked to complete health status questionnaires. A severity score (grade1 \["mild"\] to grade 4 \["life-threatening"\]) is assigned to each health condition. The HRQoL of patients is compared to age- and sex-matched French normal values using the SF36 HRQoL questionnaire.

Capsule summary. This will be the first study of adult survivors of childhood PID describing how the burden of health conditions affect their quality of life.


Eligibility criteria: Inclusion Criteria:

* Patient with primary immune deficiency diagnosed during childhood

Exclusion Criteria:

* Patients not willing to answer to quality of life questionnaires

Primary outcomes:
measure: Numbers of patient with PID diagnosed during childhood experiencing a heavy burden of health conditions affecting their quality of life
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Vincent BARLOGIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barlogis V, Mahlaoui N, Auquier P, Fouyssac F, Pellier I, Vercasson C, Allouche M, De Azevedo CB, Moshous D, Neven B, Pasquet M, Jeziorski E, Aladjidi N, Thomas C, Gandemer V, Mazingue F, Picard C, Blanche S, Michel G, Fischer A. Burden of Poor Health Conditions and Quality of Life in 656 Children with Primary Immunodeficiency. J Pediatr. 2018 Mar;194:211-217.e5. doi: 10.1016/j.jpeds.2017.10.029. Epub 2017 Dec 6.
Clinical trial NCT02872233: Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
Official title: Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female of an age of 18 to 70 years inclusive;
* Fitzpatrick Skin Type I, II and/or III for SPF testing;
* Good health as determined from the CRO Subject History Form (SHF);
* Signed and dated Informed Consent Form;
* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
* An unambiguous minimal erythema dose (MED).

Primary outcomes:
measure: Evaluation of 2 hours water resistant SPF
timeFrame: 16-24 h post exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03273933: DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Official title: DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate persistent asthma
* Uncontrolled symptoms (C-ACT≤ 19)
* Treated for at least 3 months
* FEV1 between 60% and 90% of predicted value

Exclusion Criteria:

* Symptoms of acute respiratory infection
* Immunological or metabolic systemic disease
* Major malformations of the upper airways
* Active smoker

Primary outcomes:
measure: Acquisition and maintenance of the control status
timeFrame: Once every 4 weeks, for 12 weeks
Secondary outcomes:
measure: Quality of life in asthma children
timeFrame: 12 weeks
measure: Adherence to asthma treatment
timeFrame: 12 weeks
measure: Lung function: FEV1
timeFrame: 12 weeks
measure: Lung function: FVC
timeFrame: 12 weeks
measure: Lung function: FEF 25-75
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Study officials:
References:
Clinical trial NCT02993133: Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Official title: Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autoimmune Bullous Dermatose
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years.
* Patient treated by Mycophénolate Mofétil (MMF) per os (Cellcept®) for an autoimmune bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according to the recommendations (PNDS Pemphigus and cicatricial pemphigoid HAS 2011)
* Patient able to understand the nature, purpose and methodology of the study
* Patient affiliated to the French social security system or equivalent
* Patient who have signed an informed consent form

Exclusion Criteria:

* Pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration)
* Patient under legal protection.
* Patient deprived of freedom
* Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.

Primary outcomes:
measure: Evaluation of the Bayesian estimator performance
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Paris
country: France
facility: Hôpital Avicenne - AP-HP
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References:
Clinical trial NCT03354533: Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II
Official title: Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukocyte Adhesion Deficiency, Type II
Lead sponsor: Orpha Labs
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 4
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of ORL-1F in Patients With Leukocyte Adhesion Deficiency Type II


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Leukocyte Adhesion Deficiency Type II.
* Less than 18 years old.

Exclusion Criteria:

* Diagnosis of any other disease that is not a manifestation of Leukocyte Adhesion Deficiency Type II.

Primary outcomes:
measure: Decrease in infection frequency
timeFrame: 12 months after treatment started
Secondary outcomes:
measure: Decrease in neutrophil count
timeFrame: 30 days after treatment started
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03429933: A Study of Experimental Medication BMS-986278 Given to Healthy Participants
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
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 investigate experimental medication BMS-986278 given to healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must be in good general health in the opinion of the investigator
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
* Body weight between 55 and 105 kg, inclusive, at screening
* Female participants must have documented proof that they are not of childbearing potential
* Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any major surgery within 6 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
timeFrame: Up to 30 days
measure: Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02262533: Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Official title: Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: N/A - Healthy Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2014-10-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
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 assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

Exclusion Criteria:

* Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Primary outcomes:
measure: Apixaban and Atenolol plasma concentration
timeFrame: Days 1-13
Secondary outcomes:
measure: Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests
timeFrame: Days 1-13
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Bms Clinical Research Center
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03609333: Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation
Official title: Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation in Hypoxic Ischemic Brain Injury After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. The mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. In patients with traumatic brain injury (similar to HIBI), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. This strategy is associated with improved outcomes. The investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal MAP is associated with improved brain oxygenation and blood flow .


Eligibility criteria: Inclusion Criteria:

* Confirmed cardiac arrest with return of spontaneous circulation \> 10 minutes
* post resuscitation GCS \< 9

Exclusion Criteria:

* concurrent coagulopathy
* prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage
* anticipated cardiac catheterization within next 7 days
* anticipated or current use of anticoagulants or anit-platelets

Primary outcomes:
measure: Cerberal blood flow
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: UBC
name: Mypinder Sekhon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sekhon MS, Ainslie PN, Menon DK, Thiara SS, Cardim D, Gupta AK, Hoiland RL, Gooderham P, Griesdale DE. Brain Hypoxia Secondary to Diffusion Limitation in Hypoxic Ischemic Brain Injury Postcardiac Arrest. Crit Care Med. 2020 Mar;48(3):378-384. doi: 10.1097/CCM.0000000000004138.
citation: Sekhon MS, Griesdale DE, Ainslie PN, Gooderham P, Foster D, Czosnyka M, Robba C, Cardim D. Intracranial pressure and compliance in hypoxic ischemic brain injury patients after cardiac arrest. Resuscitation. 2019 Aug;141:96-103. doi: 10.1016/j.resuscitation.2019.05.036. Epub 2019 Jun 8.
Clinical trial NCT04918433: Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery
Official title: Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Local Infiltration
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy

Detailed description: Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.

Eligibility criteria: Inclusion Criteria:

* either sex, aged 2-12 years, undergoing

elective cardiac surgery via median sternotomy

Exclusion Criteria:

* refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension

Primary outcomes:
measure: Weight, height , BMI
timeFrame: 1 year
measure: Postoperative pain score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT02443233: Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B Infection
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 750
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: Maternal and paternal hepatitis B carrier

Brief summary: Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis. There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to answer the following questions:

1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure
2. the prevalence of immunoprophylaxis failure in Hong Kong


Eligibility criteria: Inclusion Criteria:

* All women age ≥ 18 years
* Maternal or paternal hepatitis B carrier

Exclusion Criteria:

* Couples will be excluded if female partners of paternal hepatitis B carrier were occult carrier
* Plan to deliver in other units

Primary outcomes:
measure: The effect of high maternal viral load on immunoprophylaxis failure, using 10^6 copies/ml as cut-off
timeFrame: Infants' blood for HbsAg at 9-12 months old
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics and Gynaecology
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka Wang Cheung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00467233: Study of Acid Peel and Laser for the Treatment of Melasma
Official title: A Randomized, Rater-blinded, Split-face Comparison of the Efficacy of 30 % Salicylic Acid Peel vs. Q-switched Nd:Yag Laser for the Treatment of Melasma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-04-30
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: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid peel for the treatment of melasma.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of melasma lesion measuring at least 4 square centimeters.
* Age 18-75 years.
* Good health.
* Willingness and ability to understand and provide informed consent for participation in the study.
* Ability to communicate with the investigator.
* Must be willing to forgo other treatment options for melasma during the course of the study.

Exclusion Criteria:

* Inability to understand the protocol or to give informed consent.
* Mental illness.
* Under 18 years of age and over 75 years of age.
* Laser treatment in the last 6 months before enrollment.
* Isotretinoin within the past year.
* Lidocaine allergy.
* History of herpes simplex viral infection.
* Concurrent active disease to facial area (i.e acne).
* Bleeding disorder.
* History of abnormal wound healing.
* History of abnormal scarring.

Primary outcomes:
measure: MASI
timeFrame: 20 weeks
Secondary outcomes:
measure: Safety
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: