louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748162: Management of Recurrent Croup
Official title: Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Croup
Keywords: croup
recurrent croup
barky cough
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.


Eligibility criteria: Inclusion Criteria:

* Pediatric population: 6 months to 15 years of age
* 2 or more episodes of croup in 12 month period

  * croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

Exclusion Criteria:

* Grade 3 or 4 subglottic stenosis
* Subglottic hemangioma
* Posterior laryngeal cleft
* Recurrent respiratory papillomatosis
* External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
* Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body
* Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress
* Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.
* Other medical conditions necessitating chronic steroid utilization

Primary outcomes:
measure: Quantity of Recurrent Episodes
timeFrame: 1 year
Secondary outcomes:
measure: Severity of Croup Episodes
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Department of Otolaryngology-Head & Neck Surgery
name: David J Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817062: Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen
Official title: Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Low Birth Weight
Keywords: Capillary leakage
Acute Abdomen
Low birth weight
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 89
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates with very low birth weight and surgery therapy of acute abdomen

Brief summary: Objective:

Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy.

Question:

Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?


Eligibility criteria: Inclusion criteria:

* All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on "Campus Charité Mitte" or "Charité Virchow - Klinikum".
* Neonates (calculated date of birth + 4 weeks)

Exclusion criteria:

* Birth weight \> 1500g

Primary outcomes:
measure: Postoperative Capillary Leakage
timeFrame: 48 hours from Baseline (Operation)
Secondary outcomes:
measure: Amount of transfusions during surgery
timeFrame: Up to 5 hours
measure: Re-surgery rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: Length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: Mortality
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - University Berlin
Study officials:
References:
Clinical trial NCT06935162: Teclistamab in Previously Treated AL Amyloidosis
Official title: Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: AL Amyloidosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 30
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: This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed AL amyloidosis
* Patients must have received at least one line of treatment, including daratumumab and bortezomib
* Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
* dFLC \> 50mg/L

Exclusion Criteria:

* Previous anti-BCMA targeted therapy
* Co-morbidity of uncontrolled infection
* Co-morbidity of other active malignancy
* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
* Seropositive for human immunodeficiency virus
* Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
* Seropositive for hepatitis C (except in the setting of a sustained virologic response)
* Neutrophil \<1×10E9/L, hemoglobin \< 8g/dL, or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, eGFR \< 20 mL/min, or receiving renal replacement therapy

Primary outcomes:
measure: Hematologic complete response (CR) at 3 months after treatment initiation
timeFrame: at 3 months after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01714362: Autonomic Nervous System Activity and Oculocardiac Reflex.
Official title: Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia During Pulling of Eyeball
Keywords: oculocardiac effect
bradycardia
HRV
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients operated bacause of retinal pathology

Brief summary: Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac features of this reflex include hypotension, dysrhythmias, atrioventricular block. These cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs. Patients with existing cardiovascular disease are in risk of complications. Cardiovascular system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5 minutes electrocardiography has been found useful for prediction of hypotension and bradycardia during induction of general anaesthesia and during spinal block. The aim of this study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV analysis for ANS activity assessment, measured prior to the ophthalmic surgery.


Eligibility criteria: Inclusion Criteria:

* planned surgery
* over 18 years of age
* surgery under general anaesthesia

Exclusion Criteria:

* urgent surgery
* under 18 years of age and over 65
* patients with generalised, nontreated disease
* patients receiving beta blockers or calcium channel blocker
* diabetic patients
* patients operated under peri or retrobulbar anaesthesia

Primary outcomes:
measure: oculocardiac reflex occurence in relation to autonomic system activity
timeFrame: perioperatively - about 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
name: Magdalena A Wujtewicz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wujtewicz M, Twardowski P, Jasinski T, Raczynska D, Owczuk R. Prediction of the Occurrence of the Oculocardiac Reflex Based on the Assessment of Heart Rate Variability. An Observational Study. Ophthalmol Ther. 2022 Oct;11(5):1857-1867. doi: 10.1007/s40123-022-00549-0. Epub 2022 Aug 1.
Clinical trial NCT04372862: Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy
Official title: Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block to Control Postmastectomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Postoperative Pain
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective comparative randomized clinical trial
Primary purpose: PREVENTION

Brief summary: In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome


Eligibility criteria: Inclusion Criteria:

* Female patient age 20 to 65
* ASA I, II
* Scheduled for mastectomy

Exclusion Criteria:

* Allergy to local anaesthetics
* Infection at the site of performing the block
* Morbidly obese patient of body mass index more than 40 kg/m2

Primary outcomes:
measure: First time analgesia request
timeFrame: Postoperative up to 24 hours
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: Postoperative up to 24 hours
measure: visual analogue scale
timeFrame: Every two hours for 24 hours postoperative
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT06805162: Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics (I-ReductAI).
Official title: Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics: Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Injury
Keywords: NEURO MUSCULAR
Athletics
injury prevention
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Saint Etienne School of Mine
First posted: 2025-02-03
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In athletics, injuries can affect athletes' participation in athletics, their performance and career, but also their health in physical, psychological and social aspects, in the short, medium and long term.

Detailed description: This justifies the development and implementation of injury risk reduction strategies. These should be developed according to a holistic approach that considers the complex aetiology of injuries in sport. Although many different injury risk reduction strategies have been studied in sport, in general, each has been evaluated in isolation, including for example education, neuromuscular exercises, psychological techniques or individual injury risk assessment. The investigators therefore hypothesized that their combination could improve the overall effectiveness of an intervention aimed at reducing the risk of injuries in athletics.

Eligibility criteria: Inclusion Criteria:

* be licensed at the French Athletics Federation (FFA) for competition (sprints, hurdles, jumps, throws, combined events, and endurance disciplines), without any counter-indications for competitive athletics activity attested by the license at the FFA;
* have daily access to a digital device (smartphone, computer, tablet) with a network connection (public or private).

Exclusion Criteria:

* Any athlete deprived of liberty or subject to legal protection (guardianship, under curatorship, legal protection).

Primary outcomes:
measure: Time (day) until the first Injury-type Complaint related to athletics and resulting in Restricted Participation in athletics (ICRP)
timeFrame: Week 14
Secondary outcomes:
measure: Number of ICRP per 1000 hours of athletics practice
timeFrame: Week 14
measure: Number of days with an ICRP per 1000 hours of athletics practice
timeFrame: Week 14
measure: Percentage of athletes with at least one ICRP
timeFrame: Week 14
measure: The average percentage of athletes with at least one ICRP
timeFrame: Week 14
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CENTRE HOSPITALIER DE SAINT-ETIENNE
name: PASCAL EDOUARD, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471262: Right Hepatectomy in Patients Beyond 70 Years Old
Official title: Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complications
Liver Failure, Acute
Keywords: Complications
Mortality
Liver
Failure
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2011-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that will undergo right or extended right hepatectomy for benign or malignant diseases.

Brief summary: As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Elective right hepatectomy
* Elective extended right hepatectomy

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Other type of hepatectomy
* Emergency hepatectomy

Primary outcomes:
measure: Morbidity
timeFrame: 90 days
Secondary outcomes:
measure: Mortality
timeFrame: 90 days
measure: Liver failure
timeFrame: 90 days
measure: Hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital CHUV
Study officials:
affiliation: Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
name: Emmanuel Melloul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
name: Nicolas Demartines, MD
role: STUDY_CHAIR
References:
citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
citation: Paugam-Burtz C, Janny S, Delefosse D, Dahmani S, Dondero F, Mantz J, Belghiti J. Prospective validation of the "fifty-fifty" criteria as an early and accurate predictor of death after liver resection in intensive care unit patients. Ann Surg. 2009 Jan;249(1):124-8. doi: 10.1097/SLA.0b013e31819279cd.
Clinical trial NCT02894762: Performance Evaluation of In-Vitro Diagnostic Device
Official title: Performance Evaluation of In-Vitro Diagnostic Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Routine Examination
Lead sponsor: Lite-On Technology Corporation H.S.P.B
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults

Brief summary: This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.

Analyte Principle:

Albumin (ALB) - Dye-Binding BCG

Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)

Glucose (GLU) - Hexokinase, Colorimetry

Total Protein (TP) - Biuret


Eligibility criteria: Inclusion Criteria:

* You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.

Exclusion Criteria:

* You may not participate in this study if you do not meet the above inclusion criteria.

Primary outcomes:
measure: Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01163162: The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Official title: The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Vitamin D
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2010-07-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Stage 3 or 4 CKD
* Ability to give informed consent

Exclusion Criteria:

* Serum Calcium \> 10 g/dL
* Serum Phosphorous \> 6 g/dL
* On \> 400 units/d Vitamin D therapy
* Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion
* On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)
* Allergic to radiocontrast dye

Primary outcomes:
measure: 24-hour Urine Creatinine Excretion Rate
timeFrame: 1 Week
Secondary outcomes:
measure: Creatinine Clearance
timeFrame: 1 Week
measure: Serum Creatinine
timeFrame: 1 Week
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Rajiv Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal R, Hynson JE, Hecht TJ, Light RP, Sinha AD. Short-term vitamin D receptor activation increases serum creatinine due to increased production with no effect on the glomerular filtration rate. Kidney Int. 2011 Nov;80(10):1073-9. doi: 10.1038/ki.2011.207. Epub 2011 Jun 29.
Clinical trial NCT02309762: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Ascending Intravenous Doses of FB825
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Fountain Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825


Eligibility criteria: Inclusion Criteria:

1. The subject is male or female between 18 and 55 years of age, inclusive.
2. All female subjects must have a negative serum pregnancy test at screening and on Day -1.
3. The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive.
4. The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
5. The subject has a negative urine drug screen for alcohol, cotinine.

Exclusion Criteria:

1. Female subjects who are pregnant or lactating.
2. The subject has a past history of heart arrhythmias.
3. The subject has history of clinically significant diseases.
4. The subject has any history of a previous anaphylactic reaction.
5. Use of prescribed medication within 6 months of Day -1.

Primary outcomes:
measure: Number of Participants with Adverse events (AE)
timeFrame: Up to day140
measure: Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)
timeFrame: Up to day140
measure: Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)
timeFrame: Up to day140
measure: 12-lead ECG results
timeFrame: Up to day140
measure: Physical examination findings
timeFrame: Up to day140
Secondary outcomes:
measure: Composite of PK parameters
timeFrame: Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose
measure: Total IgE serum concentrations
timeFrame: pre-dose, 5, 14, 29, 85, and 140 day post-dose
measure: Immunogenicity (Anti-FB825 antibody in serum)
timeFrame: pre-dose, 5, 14, 29, 85, and 140 day post-dose
Other outcomes:
Locations:
Study officials:
References: