louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00301314: A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Hodgkin Lymphoma (HL).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Lymphoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2006-03-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 219 participants aged over 18 with Hodgkin Lymphina who have received an autologous stem cell transplant and written informed consent.

Brief summary: The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or combination chemotherapy. However, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. Treatment results with standard-dose second-line regimens produce low complete remission rates and minimal survival benefit. Single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. In this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long-term outcome of patients with HL who received an autologous stem cell transplant in the past at the Royal Marsden Hospital Eligible patients (those on current-follow-up) identified from the transplant database will be eligible for the study.

Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal.


Eligibility criteria: Inclusion Criteria:

* a) Age over 18 b) Patients with Hodgkin Lymphoma who have received an autologous stem cell transplant c) Informed written consent

Exclusion Criteria:

* a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183414: Right Ventricular Dysfunction in Cardiac Surgery Patients
Official title: Right Ventricular Dysfunction in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Dysfunction
Keywords: cardiac surgery
transoesophageal echocardiography
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 15
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: 15 cardiac surgery patients (elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement) with a significant preoperative aortic valve stenosis (gradient\>40mmHg and/or aortic valve area \<1cm2)

Brief summary: To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

Detailed description: Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process

Eligibility criteria: Inclusion Criteria:

* cardiac surgery patients
* elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement

Exclusion Criteria:

* age \< 18

Primary outcomes:
measure: The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter
timeFrame: during cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: MCL
name: Christiaan Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800614: A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
Official title: An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three Period Crossover
Primary purpose: TREATMENT

Brief summary: An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects


Eligibility criteria: Key Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in
* Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception
* Male subjects must agree to use contraception
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Key Exclusion Criteria:

* History of drug/chemical abuse within 2 years prior to screening.
* History of alcohol abuse within 12 months prior to screening
* Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
* Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period 1.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.
* Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.

Primary outcomes:
measure: Pharmacokinetics - Cmax (sitravatinib)
timeFrame: Up to 72 hours after dosing
measure: Pharmacokinetics - AUC∞ (sitravatinib)
timeFrame: Up to 72 hours after dosing
measure: Pharmacokinetics - AUClast (sitravatinib)
timeFrame: Up to 72 hours after dosing
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to 44 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Texas
Study officials:
affiliation: Mirati Therapeutics
name: Curtis Chin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01190514: Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression - Major Depressive Disorder
Keywords: DVS SR
healthy
Bioequivalence study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Primary outcomes:
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
measure: Terminal Elimination Half-life (t 1/2)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
measure: Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
measure: Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04161014: The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Official title: The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pneumoconiosis Coal
Asbestosis
Silicosis
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2019-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective clinical pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.

Subjects will be treated with Nintedanib 150mg twice daily for 3 years.

Detailed description: 100 Patients with asbestosis, silicosis, coal workers pneumoconiosis and diffuse dust fibrosis will be included. Patients will have an FVC ≥45% predicted (no upper threshold), and a diffusion capacity of the lung for carbon monoxide (TLCO) above 30% predicted. Patients will be randomised to receive Nintedanib 150 mg twice daily, with the dose of the study drug reduced to 100 mg twice daily or interrupted temporarily in the case of adverse events (AEs).The primary end point will be the annual decline in FVC, measured in millilitres per year, calculated from serial measurements over 36 months.

Lung function testing will be performed at baseline; 2, 4, 6, 12, 18, 24, 30, 36, 44 and 52 weeks, and every 4 months thereafter until study cessation or withdrawal at a maximum of 36 months.

In patients who show clinical benefit as per the end points specified access to Nintedanib treatment will be continued.

Eligibility criteria: Inclusion Criteria:

* Pneumoconiosis diagnosis confirmed at the Occupational MDT (Occ-MDT)
* diffuse fibrosing lung disease of extent \>10% on HRCT with protocol criteria for progression
* Asbestosis, silicosis, coal worker's pneumoconiosis and diffuse dust fibrosis
* FVC ≥45% predicted and TLCO above 30% predicted

Exclusion Criteria:

* idiopathic pulmonary fibrosis (IPF) and non-occupational progressive pulmonary fibrosis
* ILD due to connective tissues disorders, hypersensitivity pneumonitis, non-occupational interstitial pneumonia, non-occupational sarcoidosis
* contraindications to Nintedanib (forthcoming surgery, use of anticoagulants, high CVD risk, liver function abnormalities)

Primary outcomes:
measure: annual decline in FVC
timeFrame: 36 months
Secondary outcomes:
measure: K-BILD score
timeFrame: week 52
measure: Time to acute exacerbation
timeFrame: 36 months
measure: Time to referral for Lung transplantation
timeFrame: 36 months
measure: Time to death
timeFrame: 12, 24 and 36 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Holdsworth House Medical Practice
name: Deborah Yates, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844714: Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
Official title: Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Rheumatoid Arthritis
Inflammation
Keywords: endothelial function
rheumatoid arthritis
cardiovascular risk
rituxan therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-02-16
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: TREATMENT

Brief summary: The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function


Eligibility criteria: Inclusion Criteria:

* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Negative serum pregnancy test (for women of child bearing age)
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
* IgG \& IgM levels within normal limits
* Adequate renal function as indicated by serum creatinine measurements.
* No previous biological use (investigational or approved) except for the three approved anti-TNF alpha therapies
* Patients who have been treated with anti-TNF alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
* No use of phosphodiesterase type 5 inhibitors (PDE5) (i.e. Sildenafil, Tadalafil, and Vardenafil) 1 week prior to the study and during the course of the study.
* SBP ≤ 140/90 for two months prior to study enrollment

Exclusion Criteria:

* Prior history of MI, CVA, CABG, PTCA, or peripheral vascular disease
* Any serious concomitant medical condition that could interfere with the study.
* Patients with insulin dependent diabetes
* Failure to provide written consent.
* Individuals with HIV infections
* SBP \> 140/90 at two months prior to study enrollment

Primary outcomes:
measure: Flow-mediated Vasodilation (FMD)
timeFrame: 12 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
citation: Hsue PY, Scherzer R, Grunfeld C, Imboden J, Wu Y, Del Puerto G, Nitta E, Shigenaga J, Schnell Heringer A, Ganz P, Graf J. Depletion of B-cells with rituximab improves endothelial function and reduces inflammation among individuals with rheumatoid arthritis. J Am Heart Assoc. 2014 Oct 21;3(5):e001267. doi: 10.1161/JAHA.114.001267.
Clinical trial NCT02589314: Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
Official title: Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Periodontitis
Diabetes Type 2
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Catholic University of Brasília
name: Brasilia University Hospital
First posted: 2015-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.


Eligibility criteria: Inclusion Criteria:

Periodontitis group:

* Minimum of 15 teeh;
* At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;

Control group:

* Systemically healthy;
* 20 teeth;
* Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.

Exclusion Criteria:

* Periodontal treatment in the last six months;
* Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
* Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity \[BMI 40 kg / m2\] or underweight \[evil nourished BMI \<18.5 kg / m2\], etc.); Pregnant or lactating; smoking; Age \<30 years; Indigenous groups.

Primary outcomes:
measure: Evidence of alteration in periodontal pathogens by PCR
timeFrame: One year
measure: Evidence of alteration of immunocellular response by flowcytometry
timeFrame: one year
measure: Evidence of alteration on pro and anti-inflammatory cytokines by CBA
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Priscilla Farias Naiff
state: Distrito Federal
Study officials:
References:
Clinical trial NCT05616455: Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
Official title: Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anal Fissure Chronic
Anal Fissure
Lead sponsor: Treviso Regional Hospital
Sponsor class: NETWORK
First posted: 2022-11-15
Enrollment: 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Detailed description: Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years

Exclusion Criteria:

* Fecal incontinence
* Inflammatory bowel disease
* Previous history of anal surgery
* Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment
* Current pregnancy or breastfeeding
* Known allergy to one of the agents contained into the evaluating drugs

Primary outcomes:
measure: REALISE score
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
Secondary outcomes:
measure: Burning
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Itching
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Epithelialization
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Physical and mental health
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Physical and mental health
timeFrame: At visit 3 (40 days after the start of the treatment)
measure: Physical and mental health
timeFrame: At visit 3 (40 days after the start of the treatment)
measure: Patients' satisfaction
timeFrame: At visit 3 (40 days after the start of the treatment)
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Regional Hospital Treviso
Study officials:
References:
Clinical trial NCT00679055: A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)
Official title: An Exploratory Double-Blind, Placebo Controlled, Randomized, 12-Week Oral Dose Study to Evaluate the Effects of MK0736 on Atherosclerotic Disease Biomarkers in Lower Extremity Plaque Excised From Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Peripheral Vascular Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: FoxHollow Technologies
First posted: 2008-05-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).


Eligibility criteria: Inclusion Criteria:

* Participants with peripheral arterial disease
* Participants must be 18 to 85 years of age
* Females must be postmenopausal or sterile

Exclusion Criteria:

* Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

Primary outcomes:
measure: Change From Baseline in Cluster of Differentiation 68 (CD68)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Messenger Ribonucleic Acid (mRNA)
timeFrame: Baseline and Week 12
measure: Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)
timeFrame: up to 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: