louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02523430: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
HepaSphere
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 60
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 purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.

Detailed description: By enrolling patients with nasopharyngeal carcinoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography （DSA） for nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of nasopharyngeal carcinoma based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except nasopharyngeal carcinoma
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT01887730: Hand Hygiene Intervention Study in Finnish Garrison
Official title: Can Intensified Hand Hygiene Decrease Morbidity and Lost Service Days in a Garrison
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Infections
Keywords: Hand Hygiene
Communicable Diseases
Prevention
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Finnish Defense Forces
First posted: 2013-06-27
Enrollment: 1120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.


Eligibility criteria: Inclusion Criteria:

* willingness to attend to the study

Exclusion Criteria:

* skin diseases which prevent using hand disinfectants

Primary outcomes:
measure: Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included.
timeFrame: 8 weeks
Secondary outcomes:
measure: Length of distinct infection episodes due to infectious disease
timeFrame: 8 weeks
measure: Length of distinct absence episodes due to infectious disease.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kouvola
country: Finland
facility: Vekaranjärvi garrison
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Carita Savolainen-Kopra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05999630: Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated with Radioactive Iodine for Thyroid Cancer
Official title: The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated with Radioactive Iodine for Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasolacrimal Duct Obstruction
Thyroid Cancer
Keywords: Nasolacrimal Duct Obstruction
Artificial Tears
Thyroid Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal duct obstruction has been well documented in the medical literature. Prior case reports have documented radioactive iodine detection in the tears of patients following radioiodine therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time. A recent study has shown that the administration of artificial tears decreases the level of detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid cancer. The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct obstruction in the two years following radioactive iodine treatment.


Eligibility criteria: Inclusion Criteria:

1. Radio-iodine therapy for thyroid cancer
2. Radioiodine therapy ≥150 mCi
3. Age 18 or older

Exclusion Criteria:

1. Use of eye drops, other than artificial tears
2. History of periocular trauma with tear duct involvement/lacrimal gland trauma
3. History of lacrimal drainage disease: canaliculitis, dacryocystitis
4. Prior radiotherapy
5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
7. Nasolacrimal duct obstruction at baseline

Primary outcomes:
measure: Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT06735430: Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery
Official title: Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Hernia
Laparoscopic Surgery
Appendicitis, Surgery
Keywords: Ciprofol
Propofol
Total Intravenous Anesthesia
Children
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

Detailed description: Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.

Eligibility criteria: Inclusion Criteria:

* laparoscopic surgery under general anesthesia

Exclusion Criteria:

* Known allergies to propofol and ciprofol,
* Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
* uncooperate with peripheral venipuncture and catheterization;
* History of acute upper respiratory tract infection in the past 2 weeks;
* With severe respiratory, circulation, liver and kidney insufficiency;
* Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
* Known long-term use of sedative drugs;
* ASAⅢ grade or above;
* recent participation in other clinical studies.

Primary outcomes:
measure: Extubation time
timeFrame: up to 1 hour
Secondary outcomes:
measure: Aldrete Score
timeFrame: up to 2 hours
measure: Emergence Agitation
timeFrame: up to 2 hours
measure: Postoperative Pain
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: satisfaction degree
timeFrame: 24 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: mujun Chang, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01648530: Chronic Migraine Epidemiology and Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 16789
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with migraine

Brief summary: This is a population internet-based study to characterize migraine clinical course and impact on family.


Eligibility criteria: Inclusion Criteria:

* History of migraine
* U.S. Member of Survey Panel
* Household member of study participant
* Ability to complete internet-based questionnaires

Exclusion Criteria:

* No access to internet

Primary outcomes:
measure: Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)
timeFrame: Baseline
measure: Migraine Disability Assessment (MIDAS)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Schwedt TJ, Buse DC, Argoff CE, Reed ML, Fanning KM, Hussar CR, Adams AM, Lipton RB. Medication Overuse and Headache Burden: Results From the CaMEO Study. Neurol Clin Pract. 2021 Jun;11(3):216-226. doi: 10.1212/CPJ.0000000000001037.
citation: Lipton RB, Fanning KM, Buse DC, Martin VT, Hohaia LB, Adams AM, Reed ML, Goadsby PJ. Migraine progression in subgroups of migraine based on comorbidities: Results of the CaMEO Study. Neurology. 2019 Dec 10;93(24):e2224-e2236. doi: 10.1212/WNL.0000000000008589. Epub 2019 Nov 5.
citation: Buse DC, Fanning KM, Reed ML, Murray S, Dumas PK, Adams AM, Lipton RB. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019 Sep;59(8):1286-1299. doi: 10.1111/head.13613. Epub 2019 Aug 12.
citation: Adams AM, Serrano D, Buse DC, Reed ML, Marske V, Fanning KM, Lipton RB. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015 Jun;35(7):563-78. doi: 10.1177/0333102414552532. Epub 2014 Oct 10.
Clinical trial NCT00699530: Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
Official title: Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hyperprolactinemia
Insulin Resistance
Keywords: Prolactin
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recently diagnosed with hyperprolactinemia

Brief summary: The purpose of this study is to investigate the effects of chronic elevated levels of Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Written consent
* Age between 18 and 70
* At diagnose a serum prolactin \> 200 microgram/l (10 U/l)

Exclusion Criteria:

* Hypothyroidism
* Use of any medication
* Pregnancy

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Before and after treatment
Secondary outcomes:
measure: QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance
timeFrame: Before and after treatment
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital, Department of Endocrinology
name: Jens Otto L. Jørgensen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01096030: Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors
Official title: Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Regorafenib
Advanced
Refractory solid tumors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 33
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: This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.


Eligibility criteria: Inclusion Criteria:

* Male or female Chinese subjects \>/- 18 years
* Advanced, histologically or cytologically confirmed solid tumors
* Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
* Adequate bone marrow, liver and renal function
* Life expectancy of at least 3 months

Exclusion Criteria:

* Unstable/uncontrolled cardiac disease
* History of arterial or venous thrombotic or embolic events
* Malabsorption condition
* Severe renal impairment; persistent proteinuria \>/= Grade 3
* Symptomatic metastatic brain or meningeal tumors
* Clinically significant bleeding \>/=Grade 3 within 30 days before start of study medication.

Primary outcomes:
measure: Pharmacokinetics as measured by cmax and AUC
timeFrame: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
measure: Adverse Event collection
timeFrame: every 1-2 weeks
Secondary outcomes:
measure: Objective tumor response rate
timeFrame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks
Other outcomes:
measure: Exploratory biomarker analysis
timeFrame: Screening, Cycle 0 or 1
Locations:
city: Shatin
country: Hong Kong
state: N.T
city: Hong Kong
country: Hong Kong
city: Singapore
country: Singapore
city: Singapore
country: Singapore
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05899530: Dentoskeletal Changes Expansion Using Invisalign Versus Conventional Expander
Official title: Evaluation of Dentoskeletal Changes After Expansion Using Invisalign Versus Conventional Expander Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Expansion of Maxillary Arch
Maxillary Hypoplasia
Keywords: Expander
Hyrax
Invisalign
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Expansion of maxillary arch by 2 different techniques including conventional expander in one group compared with expansion with clear aligner.
Primary purpose: TREATMENT

Brief summary: Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander

Detailed description: Using cbct for evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander hyrax

Eligibility criteria: Inclusion Criteria:

* Age (12-16)
* Good oral hygiene
* Constricted maxilla or moderate crowding

Exclusion Criteria:

* Patient receive drugs
* Periodontal diseas
* Past Orthodontic treatment

Primary outcomes:
measure: Linear amount of midpalatal Suture opening
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Saleh A Saleh, Professor
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Mohamad A Salem, Professor
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Mohsena A Abdarrazik, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04000230: Teacher Child Interaction Training (TCIT): Randomized Control Trial
Official title: Teacher-Child Interaction Training in Miami-Dade County Early Education Programs: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Keywords: Early Education Program
Developmental Delay
Behavior Management
Social Emotional Development
Special Education
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
First posted: 2019-06-27
Enrollment: 622
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.


Eligibility criteria: Inclusion Criteria:

* UMTCIT will target classrooms of children ages 1-5 enrolled in four participating B-2 Early Education Programs in Miami-Dade County: Debbie School, Easterseals South Florida, Arc of South Florida, and Linda Ray Intervention Center. Participants will also include school staff (teachers, teaching assistants, physical therapists, occupational therapists, speech/language pathologists) and students.

Exclusion Criteria:

* Children will be excluded from the study if they are 6 years of age or older or younger than 12 months of age at the start of each wave of treatment.

Primary outcomes:
measure: Change in teacher use of TCIT skills
timeFrame: Baseline to 8 months
measure: Student social-emotional functioning
timeFrame: 8 months
measure: Child prosocial behaviors
timeFrame: 8 months
measure: Child disruptive/maladaptive behaviors
timeFrame: 8 months
Secondary outcomes:
measure: Child disruptive behaviors
timeFrame: 8 months
measure: Child language development
timeFrame: 8 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Debbie School
state: Florida
city: Miami
country: United States
facility: EasterSeals South Florida
state: Florida
city: Miami
country: United States
facility: Linda Ray Intervention Center
state: Florida
city: Miami
country: United States
facility: Arc of South Florida
state: Florida
Study officials:
affiliation: University of Miami
name: Eileen M Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384330: Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke
Official title: Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Limb Spasticity Post-Stroke
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital ambulatory patients

Brief summary: This study aims to estimate the costs of botulinum toxin A utilization in standard practice for the treatment of upper limb spasticity post-stroke in Portugal.

It will consider the three most used locally available brands of botulinum toxin A which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors.

The study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.

Detailed description: A comparison will be performed between direct costs associated with each therapeutic strategy and cost analysis assuming that quality of life values may be different between patients treated with each treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with post-stroke upper limb spasticity
* Patients currently being treated with Dysport®, Botox® or Xeomin®
* Patients stabilized from a therapeutic point of view - with no switches of treatment in at least the 2 last administrations
* Patients who gave their written informed consent to participate.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Estimate the cost of botulinum toxin utilization
timeFrame: 12 months
Secondary outcomes:
measure: Number of work days missed due to spasticity
timeFrame: 12 months
measure: Carer time needed for patient assistance
timeFrame: 12 months
Other outcomes:
Locations:
city: Alcabideche
country: Portugal
facility: Centro de Medicina de Reabilitação de Alcoitão
city: Faro
country: Portugal
facility: C. H. A. - Hospital de Faro
city: Vila Real
country: Portugal
facility: C. H. T. M. A. D. - Unidade Hospitalar de Vila Real
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: