louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00503828: Derris Scandens Benth Extract VS Naproxen in Knee OA
Official title: The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Derris Scandens Benth extract
Osteoarthritis
WOMAC
6-minute walk
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2007-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age \>=50 yr
* Known case of primary knee osteoarthritis
* WOMAC pain subscale (item1) \>= 5
* signed informed consent

Exclusion Criteria:

* hypersensitive to NSAIDs
* history of peptic ulcer or melena
* unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
* history of intra-articular injection of knee within 3 months
* status post knee replacement

Primary outcomes:
measure: WOMAC score
timeFrame: 2, 4 weeks
Secondary outcomes:
measure: 6-minute walk, Quality of Life, adverse event
timeFrame: 2, 4 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
name: Vilai Kuptniratsaikul, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05242328: Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery
Official title: Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-operative Pain, Acute
Post-operative Pain
Thoracic Diseases
Post-Op Complication
Keywords: Uniportal video-assisted thoracoscopic surgery
Ultrasound-guided erector spinae plane block
surgical thoracoscopic intercostal nerve block
cumulative intravenous morphine consumption
visual analogue scale
Enhanced Recovery After Surgery
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.


Eligibility criteria: Inclusion Criteria:

* adult patients, over 20 years old, u
* undergoing elective uniportal VATS lobectomy.

Exclusion Criteria:

* patient refusal,
* body mass index \> 35 kg/m2,
* American society of anesthesiologists (ASA) grade above 3,
* contraindication to nerve block,
* allergy to analgesic agents,
* regular opioid used for chronic pain prior to this time surgery,
* conversion to thoracotomy or VATS procedure,
* postoperative intubation,
* postoperative intensive care unit admission.

Primary outcomes:
measure: Visual analogue scale
timeFrame: post-op 2 days
measure: accumulated morphine usage dose
timeFrame: post-op 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Shuoying Dai
role: STUDY_CHAIR
References:
Clinical trial NCT04938128: Effect of CPAP vs Control on Nocturnal Dipping in Normotensive Patients With Obstructive Sleep Apnea
Official title: The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Continuous positive airway pressure
Non-dipper
Normotensive
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed moderate-severe OSA (by standard criteria)
* Absence of known hypertension and antihypertensive medication
* Office blood pressure \<140/90mmHg
* Age 18 - 70 years
* Able to provide written, informed consent

Exclusion Criteria:

* Pregnancy
* Previous diagnosis of OSA or previous CPAP treatment
* Diagnosis of Diabetes Mellitus
* Active treatment for malignancy or severe psychiatric disorder
* History of cardiovascular disease or cerebrovascular disease
* Moderate or severe chronic kidney disease (CKD) defined as a eGFR of ≤ 44mL/min/1.73m2
* Dipper on ABPM
* Morbid obesity, defined as BMI ≥40
* Professional drivers or drivers with a history of road-traffic accident due to sleepiness
* Severe excessive daytime sleepiness defined as Epworth sleepiness scale (ESS) \>15

Primary outcomes:
measure: Change in Dipping status
timeFrame: 3 months
Secondary outcomes:
measure: Change in the mean 24-hour ambulatory blood pressure (BP)
timeFrame: 3 months
measure: Change in blood pressure parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
Study officials:
References:
Clinical trial NCT03440528: Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer
Official title: Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcer
Keywords: Skin ulcer, Human amniotic membrane, Treatment
Lead sponsor: Egyptian Atomic Energy Authority
Sponsor class: OTHER_GOV
Collaborators: name: Waleed Nemr,Egyptian Atomic Energy Authority
First posted: 2018-02-22
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is based on randomized selection of 3 types of ulcer ( diabetic foot ulcer, post operative ulcer and ultrasonic ulcer)

Brief summary: To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.

Detailed description: Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.

Eligibility criteria: Inclusion Criteria:

* patients have unhealing ulcer

Exclusion Criteria:

* must stop other line of treatment

Primary outcomes:
measure: Size of ulcer
timeFrame: 2 week
Secondary outcomes:
measure: Reduction of pain
timeFrame: 1 week
Other outcomes:
measure: Complete curring
timeFrame: 4 to 10 weeks
measure: Freedom from scarring
timeFrame: 10 weeks
Locations:
city: Cairo
country: Egypt
facility: Amniotic tissue lab
Study officials:
affiliation: NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
name: Nashwa K Radwan, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06772428: Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.
Official title: A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for Adjuvant Therapy in Patients With High-risk Factor Squamous Cell Carcinoma of the Head and Neck After Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 96
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: This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.


Eligibility criteria: Inclusion Criteria:

* ≥18 years at the time of enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Life expectancy ≥6 months.
* Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, and hypopharynx).
* Patients who have undergone surgery for head and neck squamous cell carcinoma within 6 weeks and are assessed postoperatively as having high-risk factors requiring radiotherapy ± chemotherapy.

Exclusion Criteria:

* Suffering from tumors in areas other than the oral cavity, oropharynx, larynx, and hypopharynx, such as nasopharyngeal carcinoma or other unknown primary head and neck tumors.
* Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting; currently undergoing tube feeding or parenteral nutrition.
* Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
* Suffering from Acquired Immune Deficiency Syndrome (AIDS).

Primary outcomes:
measure: The proportion of subjects with improved appetite based on A/CS-12 assessment
timeFrame: Week 3
measure: The proportion of subjects with a relative increase in body weight of >5% from baseline
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT01556828: Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing
Official title: Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cutaneous Lymphoma
Other Skin Disorders
Mycosis Fungoides
Cutaneous T-cell Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects will be identified and recruited by referral from that individual's treating physician, mainly Stanford-affiliated dermatologists, oncologists, and hematologists.

Brief summary: The goal of this study is to identify genetic changes associated with the initiation, progression, and treatment response of response of cutaneous and hematologic disorders using recently developed high-throughput sequencing technologies. The improved understanding of the genetic changes associated with cutaneous and hematologic disorders may lead to improved diagnostic, prognostic and therapeutic options for these disorders.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patient meets the clinical and/or pathologic criteria for the cutaneous or hematologic disorder being examined.
* Patient is willing to provide skin biopsies and five 10 mL tubes of peripheral blood.

Exclusion Criteria:

- Less than 18 years of age

Primary outcomes:
measure: Number of mutations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Paul Khavari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506128: Human Papillomavirus in Menstrual Blood
Official title: Exploration of Optimal Experimental Settings to Detect Human Papillomavirus From Menstrual Blood in Women With High-grade Squamous Intraepithelial Lesion or High-risk Human Papillomavirus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus
Keywords: HPV
Menstrual blood
HPV detection using menstrual blood
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 19
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women with HSIL at Pap test or high-risk HPV

Brief summary: The investigators tried to know whether a virus causing cervical cancer could be detected in menstrual blood and to set up a experimental setting to detect the virus.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women with HSIL at Pap test or high-risk HPV

Exclusion Criteria:

* Suspicious cancer

Primary outcomes:
measure: HPV detection rate in menstrual blood
timeFrame: First period after enrollment usually within 2 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00821028: Local Paclitaxel Delivery for SFA Disease
Official title: Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Angioplasty
Peripheral Arterial Disease
Keywords: atherosclerosis
angioplasty
peripheral arterial disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.

Detailed description: Treatment of superficial femoral artery atherosclerosis with percutaneous techniques is hindered by high restenosis rates. Paclitaxel inhibits restenosis in coronary arteries, and a few studies suggest it may be effective in reducing restenosis rates in peripheral arteries. The investigators hypothesize that delivering paclitaxel through an irrigating catheter will be superior in preventing restenosis.

Eligibility criteria: Inclusion Criteria:

* All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24).
* Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy.

Exclusion Criteria:

* Life expectancy \<1year
* Acute limb ischemia
* Anatomy not amenable to percutaneous revascularization
* Inability to provide informed consent
* Renal insufficiency (creatinine clearance \<40mL/min calculated using Cockcroft-Gault equation)
* Prisoners
* Pregnant or lactating women

Primary outcomes:
measure: Superficial femoral artery late lumen loss
timeFrame: 12 months
Secondary outcomes:
measure: procedural success, amputation, target segment revascularization (TSR), target vessel revascularization (TVR), surgical revascularization, clinical restenosis defined by increase in Rutherford claudication grade of 1 or more
timeFrame: 12 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Univeristy of Oklahoma
name: Mazen Abu-Fadel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940628: A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Official title: Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adolescent patients, 12-14 years of age
* overweight or obese

Exclusion Criteria:

* age \<12 or \>14 years
* BMI in normal range

Primary outcomes:
measure: Change in BMI
timeFrame: At each clinic visit, every 4 weeks
Secondary outcomes:
measure: Adverse events, laboratory parameters
timeFrame: At each clinic visit, every 4 weeks
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
city: Kazan
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Tumen
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00038428: Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2002-05-31
Enrollment: 40
Sex: FEMALE
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: The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.


Eligibility criteria: Inclusion Criteria

* Histologic diagnosis of ovarian cancer
* Recurrent or persistent disease following primary therapy
* Measurable disease
* Prior treatment with at least one but no more than three prior chemotherapy regimens
* Resistant or refractory to platinum-based chemotherapy
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal and bone marrow function

Exclusion criteria

* Pregnant or currently breast feeding
* Treatment with chemotherapy or immunotherapy within four weeks
* Prior radiation to the whole pelvis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00485628: Safety Study in Outpatient Japanese Children With ADHD
Official title: An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.


Eligibility criteria: Inclusion Criteria:

* Patients must be 6 - 18 years of age
* Patients must meet DSM-IV diagnostic criteria for ADHD
* Patient must be able to swallow capsules
* Patients must be of normal intelligence
* Laboratory results must show no significant abnormalities

Exclusion Criteria:

* Patients who weigh less than 15 kg or more than 75 kg at study entry
* Patients who have a documented history of bipolar disorder or any history of psychosis
* Patients taking any antipsychotic medication within 26 weeks of visit 1
* Patients with a severe history of allergies
* Patients taking methylphenidate

Primary outcomes:
measure: The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.
Secondary outcomes:
measure: To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.
measure: To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: