louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987428: Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis
Official title: Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatitis Acute Biliary
Keywords: ERCP
EUS
Pancreatitis biliary
Severe
Interventional endoscopy
Choledocolithiasis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 27
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: The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

Detailed description: The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.

Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Eligibility criteria: Inclusion criteria :

* age \> 18
* predicted severe acute biliary pancreatitis (including age \> 80, BMI \>30, pre-existing organ failure, Modified Glasgow score \> 3)
* timespan between onset and randomization \< 48 hrs
* informed consent signed by patient or liable person in case of emergency

Exclusion criteria :

* non biliary pancreatitis
* non severe pancreatitis
* age \< 18
* timespan between onset and randomization \> 48 hrs
* absence of consent
* ongoing pregnancy
* no social security insurance

Primary outcomes:
measure: The difference between the SOFA score measured at entry in the study (day 0) and at day 8
timeFrame: Day 8
Secondary outcomes:
measure: Differences in SOFA score as measured at entry in the study and at day 15
timeFrame: Day 15
measure: Procedure-related morbidity
timeFrame: at Day 15 to 3 months
measure: Overall morbidity
timeFrame: at day 15
measure: Overall mortality
timeFrame: at day 15
measure: Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15
timeFrame: at day 8 and day 15
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederic Prat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790528: Statin Therapy In Patients With Vasospastic Angina
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Angina Pectoris, Variant
Statins, HMG-CoA
Keywords: statin
vasospastic angina
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Vasospastic angina
* LDL less than 160mg/dl
* Written consent

Exclusion Criteria:

* Coronary artery stenosis more than 50% or ischemic coronary disease
* History of percutaneous coronary intervention
* Cerebrovascular diseases or peripheral
* Dyslipidemia required statin therapy
* Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
* NYHA III and IV
* Arrhythmia
* Primary cardiac electrical diseases
* Cardiac pacemaker or implantable defibrillator
* Pregnancy or breast feeding
* Life expectancy less than 2 years

Primary outcomes:
measure: The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
timeFrame: 3 years
Secondary outcomes:
measure: all-cause death
timeFrame: 3 years
measure: cardiac death
timeFrame: 3 years
measure: cardiac arrest
timeFrame: 3 years
measure: myocardial infarction
timeFrame: 3 years
measure: angina-related hospitalization
timeFrame: 3 years
measure: Composite event of death or myocardial infarction
timeFrame: 3 years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 3 years
measure: statin-related complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References:
Clinical trial NCT07003828: Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss
Official title: Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: End-Stage Renal Disease Requiring Haemodialysis
Keywords: hemodialysis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of thirty patients from the First Medical Center of Chinese PLA General Hospital were consecutively enrolled in the study (as detailed in the Study Design section) after providing written informed consent.

Brief summary: Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. The aim of this study was to characterize the changes in renal perfusion in incident HD patients with preserved RRF during dialysis sessions and to provide new strategies for RRF preservation.


Eligibility criteria: Inclusion Criteria:

* (1) adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD; (2) preserved RRF defined as urinary output \>500 mL/24 h or eGFR ≥3 mL/min/1.73 m²

Exclusion Criteria:

* (1) known allergy to sulfur hexafluoride microbubbles (SonoVue®) microbubbles; (2) vascular access dysfunction; (3) combined peritoneal dialysis; (4)severe cardiopulmonary disease; (5) active infection or malignancy; (6) communicable diseases; (7) pregnancy or breastfeeding; (8) participation in other clinical trials.

Primary outcomes:
measure: Renal perfusion
timeFrame: at three time points during the HD session: pre-dialysis baseline, intradialytic phase (3 hours post-initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: the First Medical Center of Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT02161328: Electric Impedance Tomography Before and After Dilatative Tracheotomy
Official title: EIT: Changes of Pulmonary Ventilation Before and After Tracheotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Patients
Tracheotomy Required
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients undergoing an elective dilatative tracheotomy. Before and after tracheotomy the results of EIT will be compared.

Brief summary: The changes of local pulmonary ventilation should be registered with an electric impedance tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT cannot show changes in local ventilation due to the tracheotomy.


Eligibility criteria: Inclusion Criteria:

* treatment on ICU
* indication for tracheotomy
* age between 18 and 85 years
* written to consent

Exclusion Criteria:

* severe chronic pulmonary disease
* cardio pulmonary unstable situation

Primary outcomes:
measure: volume of ventilation, regional compliance.
timeFrame: Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
Study officials:
References:
citation: Eichler L, Mueller J, Grensemann J, Frerichs I, Zollner C, Kluge S. Lung aeration and ventilation after percutaneous tracheotomy measured by electrical impedance tomography in non-hypoxemic critically ill patients: a prospective observational study. Ann Intensive Care. 2018 Nov 15;8(1):110. doi: 10.1186/s13613-018-0454-y.
Clinical trial NCT01355328: Evaluating Light-tissue Reaction and Transdermal Drug Delivery by Multiphoton Microscopy
Official title: Evaluating Light-tissue Reaction and Transdermal Drug Delivery by Multiphoton Microscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: light
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-05-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: In this study, the investigators will evaluate the potential of multiphoton microscopy as a non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue reaction. The investigators will also investigate drug delivery using multiphoton microscopy.


Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* younger than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT06121128: The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study
Official title: The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxia, Altitude
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT): with a Female Control Group (FCON), a Male Control Group (MCON), a Female Training Group (FTRAIN), a Male Training Group (MTRAIN)
Primary purpose: TREATMENT

Brief summary: The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance.

Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening.

Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.

Four laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions.

Measurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

Detailed description: The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance.

Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening.

Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.

Four laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions.

Measurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

Eligibility criteria: Inclusion Criteria:

* Inclusion: endurance trained athletes between 18 and 44 years old

Exclusion Criteria:

cardiovascular, metabolic and respiratory diseases, smoking history, prescription medication (Two medication families are known to interfere with FC:

* Calcium channel blockers
* Beta-blockers

Two families are known to interfere during spirometry measurements:

* Inhaled beta-agonists
* Inhaled glucocorticoids)

Primary outcomes:
measure: sex-differences
timeFrame: One week prior and in the week immediately following the intervention
measure: Effect in hypoxia
timeFrame: One week prior and in the week immediately following the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01987128: Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
Official title: Blocco Del Nervo Sciatico al Poplite, Intraneurale o Extraneurale? Confronto Prospettico, Randomizzato in Cieco Tra la modalità di Iniezione di Anestetico Locale Per il Blocco Eco Guidato Del Nervo Sciatico al Poplite Nella Chirurgia Dell'Alluce Valgo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hallux Valgus
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 88
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: Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.


Eligibility criteria: Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* Neurological diseases
* Diabetes
* Allergies to used drugs
* Chronic pain in treatment
* Electrophysiological alterations at time zero analysis

Primary outcomes:
measure: onset time
timeFrame: every 2 minutes for a maximum of 30 minutes
Secondary outcomes:
measure: success rate in each group
timeFrame: at 30 minutes
measure: Nerve injuries
timeFrame: 1, 5 weeks and at 6 months after surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Ortopedico G. Pini
state: Milano
Study officials:
affiliation: ASST Gaetano Pini-CTO
name: Gianluca Cappelleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cappelleri G, Cedrati VL, Fedele LL, Gemma M, Camici L, Loiero M, Gallazzi MB, Cornaggia G. Effects of the Intraneural and Subparaneural Ultrasound-Guided Popliteal Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Clinical and Electrophysiological Comparison. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):430-7. doi: 10.1097/AAP.0000000000000413.
Clinical trial NCT02340728: Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Official title: A Randomized Trial of Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Unresectable Biliary-pancreatic Malignancies
Keywords: Stent Placement
Biliary Obstruction
14-260
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 24
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: The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. The investigators will also look at the safety of the combination treatment, and see which treatment is better. In either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.


Eligibility criteria: Inclusion Criteria:

* Patients with any tumor obstructing the distal bile duct and causing an indwelling biliary SEMS
* Patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia)
* Age ≥ 18 years

Exclusion Criteria:

* Have altered gastro-duodenal or hepatobiliary anatomy such that ERCP is felt to be unacceptably technically difficult or unsafe
* Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP stenting is felt to be unlikely to provide adequate clinical benefit
* Have cardiac pacemakers
* Have Child B/C cirrhosis
* Are pregnant
* Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory distress or unsafe hematological parameters such as refractory anemia \<7g/dL, thrombocytopenia \<50K/mcL, or coagulopathy with INR \>2.0)
* Have biliary strictures not technically amenable to endoscopic therapy

Primary outcomes:
measure: Rate of Failure
timeFrame: 180 days
Secondary outcomes:
measure: Rate of Stent Patency
timeFrame: 1 and 3 months post procedure
measure: Incidence of Procedure Related Complications
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Schattner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03725228: Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
Official title: Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Pain
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.

Detailed description: Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.

The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.

Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.

Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.

Eligibility criteria: Inclusion Criteria:

* Will receive spinal anesthesia for TURP por Histerectomy

Exclusion Criteria:

* Protocol violation;
* Severe adverse events;
* Change to general anesthesia or addition of epidural anesthesia;
* Complete or partial spinal block failure;
* Mental status alteration (agitation, confusion, loss of conciousness).

Primary outcomes:
measure: Sensitive block duration
timeFrame: 9 hours
Secondary outcomes:
measure: Motor block duration
timeFrame: 9 hours
measure: Two levels regression
timeFrame: 9 hours
measure: Pain at postanesthesia care unit
timeFrame: 1-3 hours
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitário de Brasilia
state: Distrito Federal
Study officials:
References:
Clinical trial NCT00915928: Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
Official title: Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematoma, Subdural, Chronic
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Alice Brenaa Foundation
name: The Hede Nielsen Family Foundation
name: Overlægerådets legatudvalg
name: University of Southern Denmark
First posted: 2009-06-08
Enrollment: 47
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: The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.

Detailed description: Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic subdural hematoma that needs surgical evacuation
2. Age \> 18 year

Exclusion Criteria:

1. Lack of compliance
2. Kidney artery stenosis
3. Stenosis of the aorta
4. Severely decreased kidney function
5. Allergy or intolerance/contraindications toward ACE inhibitors
6. Already in ACE inhibitor treatment
7. Coagulopathies
8. Malignant disorders
9. Fertile women
10. Other neurological disorders
11. Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors

Primary outcomes:
measure: Size of Chronic Subdural Hematoma (CSDH)
timeFrame: 3 months
Secondary outcomes:
measure: Composition of Chronic Subdural Hematoma Fluid
timeFrame: years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurosurgery, Odense University Hospital
name: Frantz R Poulsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: