louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00716092: The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Official title: A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.


Eligibility criteria: Inclusion criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
* Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Exclusion criteria:

* Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
* Impaired hepatic function
* Renal insufficiency with a creatinine clearance \< 50 mL/min
* Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Primary outcomes:
measure: Weighted Mean Glucose (WMG) Change From Baseline at Day 28
timeFrame: Baseline and day 28
measure: GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
timeFrame: Baseline and day 28
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
timeFrame: Baseline and day 28
measure: Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
timeFrame: Baseline and day 28
Other outcomes:
measure: Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28
timeFrame: Baseline and day 28
measure: Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28
timeFrame: Baseline and day 28
measure: Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28
timeFrame: Baseline and day 28
measure: Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28
timeFrame: Baseline and day 28
Locations:
city: Berlin
country: Germany
facility: 1218.37.49003 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1218.37.49002 Boehringer Ingelheim Investigational Site
city: Neuss
country: Germany
facility: 1218.37.49001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00159692: Amlodipine Diabetic Hypertension Efficacy Response Trial
Official title: A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 739
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of \<130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.


Eligibility criteria: Inclusion Criteria:

* Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges).

Exclusion Criteria:

* A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.

Primary outcomes:
measure: The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation).
Secondary outcomes:
measure: Percentage of subjects at SBP goal of <130 mmHg and DBP goal of <80mmHg; change from baseline blood pressures (SBP and DBP); percentage of subjects with SBP >160mmHg and/or DBP >100mmHg at Visits 2, 3, 4, 5, 6.
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01060592: LapBand Adjustment to Improve Early Weight Loss
Official title: Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Gastric Band
LapBand
Bariatric Surgery
Lead sponsor: Crospon
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing gastric band surgery
* Over 18 years of age

Exclusion Criteria:

* Actively bleeding varices

Primary outcomes:
measure: %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
timeFrame: 4-6 weeks post surgery
measure: %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
timeFrame: 4-6 weeks post surgery
measure: % Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
timeFrame: 12m post surgery
measure: % Excess Weight Loss 12 Months After Surgery (Small Bands Only)
timeFrame: 12m post surgery
Secondary outcomes:
measure: Number of Band Adjustments Required in the First Year After Surgery
timeFrame: 12 months
Other outcomes:
Locations:
city: Hurst
country: United States
facility: Specialty Surgery of Fort Worth
state: Texas
Study officials:
affiliation: AIGB
name: Robert G Snow, DO FACOS
role: PRINCIPAL_INVESTIGATOR
affiliation: Crospon
name: John O'Dea, PhD
role: STUDY_DIRECTOR
References:
citation: Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12.
Clinical trial NCT04233892: Clinical Study of in Situ Regeneration of Endometrium
Official title: Clinical Study of in Situ Regeneration of Endometrium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Infertility, Female, of Uterine Origin
Endometrial Fibrosis
Keywords: thin endometrium
infertility
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2020-01-18
Enrollment: 345
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.


Eligibility criteria: Inclusion Criteria:

1.Patients with thin endometrium (4mm≤ EMT \<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up

Exclusion Criteria:

1. Endometrial thickness \<4mm or scarred endometrial area\>70%
2. Uterine cavity out of shape and the cavity depth\<6.5mm
3. Abnormal chromosome karyotype
4. Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
5. Systemic diseases: hypertension, diabetes, and so on
6. Contraindications to pregnancy
7. Contraindications to hormone replacement therapy
8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies

10. Unable to adhere to the follow-up

Primary outcomes:
measure: Endometrial thickness
timeFrame: 6 months
measure: Ongoing pregnancy rate
timeFrame: 24 months
Secondary outcomes:
measure: Endometrial blood flow
timeFrame: 6 months
measure: Pregnancy related complications
timeFrame: 24 months
measure: Histological changes of endometrium
timeFrame: 12 months
measure: Menstrual blood volume
timeFrame: 6 months
Other outcomes:
measure: Adverse event rate
timeFrame: 24 months
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Drum Tower Hospital of Nanjing University
name: Yali Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02248792: Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
Official title: Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Plaque Type Psoriasis
Lead sponsor: Narayana Medical College & Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.


Eligibility criteria: Inclusion Criteria:

Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA \>10% or PASI \>12) -

Exclusion Criteria:

Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past

-

Primary outcomes:
measure: Improvement in health related quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: comparison of improvement in health related quality of life between Group A and Group B
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nellore
country: India
facility: Narayana Med College and Hospital
state: AP
Study officials:
affiliation: Narayana Medical college and hospital
name: C V Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04939792: Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans
Official title: Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin D Deficiency
Keywords: African American;
Vitamin D;
Insulin resistance
Alzheimer's Disease
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two-thirds of the US population, particularly African Americans (AA), is at risk for inadequate or deficient 25-hydroxy-vitamin D (25(OH)VD). Epidemiological studies demonstrate an association between better health outcomes and higher blood levels of 25(OH)VD . Randomized controlled clinical trials have shown that, while supraphysiological high doses of VD are needed to achieve adequate blood levels of 25(OH)VD, not all subjects respond to them. Recent studies have also questioned the therapeutic effects of high-dose VD supplementation. Severe VD deficiency has been associated independently with the future risk of mild cognitive impairment (MCI) and dementia. A reduction in GSH and an increase in the oxidative stress levels of serum, erythrocytes, and circulating lymphocytes has been observed in MCI and Alzheimer disease, findings similar to those in VD deficient persons. Scholarly reviews conclude that excess oxidative stress is one of the major risk factors for AD and support a potential therapeutic role for L-cysteine (LC, a GSH precursor) and vitamin D (VD) supplementation in the treatment of Alzheimer disease symptoms. This application presents the investigators' design for a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that supplementation with VD in combination with L-cysteine (LC) is more successful at optimizing the statuses of 25(OH)VD \[biological signatures\] and simultaneously decreasing TNF-α, IR \[functional or clinical outcomes\], and oxidative stress, suggesting a better therapeutic approach compared with supplementation with VD alone in AA subjects.


Eligibility criteria: Inclusion Criteria:

* African American volunteers only
* Participants between the ages of 18 and 65
* Must be In good general health
* Women with negative pregnancy tests

Exclusion Criteria:

* Subjects with Diabetes, Heart disease, Sickle Cell disease, or Epilepsy
* Subjects with serum positive pregnancy test or breastfeeding

Primary outcomes:
measure: 25-hydroxy-vitamin D
timeFrame: 6 months
Secondary outcomes:
measure: TNF-α
timeFrame: 6 months
measure: HOMA-IR
timeFrame: 6 months
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Shreveport
state: Louisiana
Study officials:
References:
Clinical trial NCT02122692: Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
Official title: Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).


Eligibility criteria: Inclusion Criteria:

Subjects are eligible for inclusion into the study if they meet each of the following criteria:

* Men and women, aged 18 - 45 years.
* Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
* Non-childbearing potential or use of contraception (both sexes).
* Women must not be pregnant or lactating.
* Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .

Other Inclusion and Exclusion Criteria may apply.

Primary outcomes:
measure: Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
timeFrame: Day 5 and Day 11
measure: Maximum observed concentration (Cmax) of Lu AE58054
timeFrame: Day 5 and Day 11
Secondary outcomes:
measure: Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F
timeFrame: Day 5 and Day 11
measure: Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)
timeFrame: Day 5 and Day 11
measure: Plasma pharmacokinetic parameters for itraconazole: CTrough
timeFrame: Day 6 to Day 13
measure: Adverse events
timeFrame: Up to Day 18, including a safety follow-up
measure: Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions
timeFrame: Up to Day 18, including a safety follow-up
Other outcomes:
Locations:
city: Rennes
country: France
facility: FR801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02837744: Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Official title: Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Angiography
Angioplasty
Lead sponsor: Axio Biosolutions Pvt. Ltd.
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients who came to the institution/hospital and provided informed consent.

Brief summary: To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

Detailed description: To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Patient and/or patient's legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provision and has provided written informed consent as approved by the Ethics Committee of the investigative site.
3. Iatrogenic puncture
4. Patient who want to undergo radial intervention.
5. All puncture size must be less than 2.5cm.

Exclusion Criteria:

1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
2. Patients with known sensitivity to chitosan (shellfish) used in this study.
3. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
4. Patient is currently participating in an investigational drug or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this trial.
5. Pregnant women.
6. Patients with hemorrhagic shock.
7. Patient having hemoglobin \< 9 g/dl.

Primary outcomes:
measure: Time to Achieve Hemostasis
timeFrame: 1 Day
Secondary outcomes:
measure: Quantity of Product Used
timeFrame: 1 Day
measure: Number of Patients With Re-bleeding
timeFrame: 1 Day
measure: Number of Participants With Allergy/Skin Irritation and Hematoma Formation
timeFrame: Upto 2 Days
measure: Ease of Use of Product
timeFrame: Upto 2 Days
measure: Patient Comfort Level
timeFrame: 1 day
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola
state: Gujarat
Study officials:
affiliation: Care Institute of Medical Sciences
name: Milan Chag, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533844: To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
Official title: An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Clostridium Difficile
Keywords: CDAD
Neonates
Clostridium difficile
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 1
Sex: ALL
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).

Brief summary: The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.


Eligibility criteria: Inclusion Criteria:

* Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
* Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor

Exclusion Criteria:

Subject will be excluded from participation if any of the following apply:

* Preterm neonates
* Negative C. difficile toxin test

Primary outcomes:
measure: To determine the feasibility of a potential interventional study with fidaxomicin
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: Site: 3301
state: Paris
city: Lyon
country: France
facility: Site: 3302
city: Erlangen
country: Germany
facility: Site: 4902
city: Hanover
country: Germany
facility: Site: 4904
city: Munich
country: Germany
facility: Site: 4901
city: Maastricht
country: Netherlands
facility: Site: 3102
city: Granada
country: Spain
facility: Site: 3403
city: Madrid
country: Spain
facility: Site: 3402
city: Valencia
country: Spain
facility: Site: 3401
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: