louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03849079: Validation of the HYPONUT Product
Official title: Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peanut Allergy
Keywords: Peanut Allergy
Skin Prick Test
Oral Food Challenge
Hyponut
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.


Eligibility criteria: Inclusion criteria:

* Patients aged more than 6
* Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)

Exclusion criteria:

* Pregnancy, or patients breast-feeding
* Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
* Patients presenting with dermographism
* Patients not fluent in French

Primary outcomes:
measure: Skin Prick Tests evaluation
timeFrame: day patient enrolled
Secondary outcomes:
measure: Oral food challenge evaluation
timeFrame: day patient enrolled
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
state: Hérault
Study officials:
References:
Clinical trial NCT05607979: Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
Official title: The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: diabetes
diabetic foot ulcer
wound
hydrogel
diabetes mellitus
Lead sponsor: Lavior Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
Primary purpose: TREATMENT

Brief summary: This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.


Eligibility criteria: Inclusion Criteria:

* Foot Wound in the setting of Diabetes Mellitus
* Written informed consent
* Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)

Exclusion Criteria:

* Age \< 18 years
* Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease
* Malignancy of the wound
* Use of any other hydrogels not being studied in this investigation within 1 month of being enrolled
* Dry, uninfected, stable pressure ulcers of the heel
* Dry, stable eschar in arterial wounds
* Simultaneous participation in competing clinical trials
* Pregnancy or Nursing mothers

Primary outcomes:
measure: Primary Endpoint
timeFrame: 60 days
Secondary outcomes:
measure: Incidence of wound closures within 60 days
timeFrame: 60 days
measure: Recurrence
timeFrame: 60 days
measure: Change in wound depth over time (cm)
timeFrame: 60 Days
measure: Change in wound surface area over time (cm)
timeFrame: 60 Days
measure: Change of wound size over time (cm)
timeFrame: 60 days
measure: Change in Pain Scores over time (60 days)
timeFrame: 60 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baefoot Podiatry
state: Florida
Study officials:
affiliation: Baefoot Podiatry
name: Sung-Ho Steve Bae, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03124979: Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility criteria: Inclusion Criteria:

* Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo
state: California
Study officials:
References:
Clinical trial NCT05128279: Adolescent and Young Adulte Scoliosis
Official title: Analysis of Corrections of Adolescent and Young Adulte Scoliosis by Posterior Instrumentation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
Thoracic hyperkyphosis
Cyphosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis

Brief summary: Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis.

The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.


Eligibility criteria: Inclusion criteria:

* Major subjects\> 18 years old
* Subject with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Study of corrections of adolescent and young adult scoliosis by posterior instrumentation
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT06204679: Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir
Official title: A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
timeFrame: Day 1, Day 7, Day 13
measure: Pharmacokinetics (PK) of FDC compared to reference:(AUC)
timeFrame: Day 1, Day 7, Day 13
measure: Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
timeFrame: Day 1, Day 7, Day 13
measure: Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
timeFrame: Day 1, Day 7, Day 13
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Atea Study Site
state: California
Study officials:
References:
Clinical trial NCT05728879: Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Official title: Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cutaneous T Cell Lymphoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.


Eligibility criteria: Inclusion Criteria:

* Adults with early-stage mycosis fungoides (stages IA-IB)
* At least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes
* Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics
* Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.
* Agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study.

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.

Primary outcomes:
measure: Change in microbiome species
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Dermatology CTU
state: Illinois
Study officials:
References:
Clinical trial NCT03699579: Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC
Official title: Patients Characteristics, Treatment Utilization, Costs and Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Who Received at Least One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma Metastatic
Renal Cell Carcinoma
Keywords: advanced or metastatic renal cell carcinoma (RCC)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital chart review study

Brief summary: This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of clear-cell renal cell carcinoma
* Patients with evidence of metastatic disease
* Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
* Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria:

* Patients enrolled in any clinical trial involving anti-cancer therapy
* Pregnant woman

Primary outcomes:
measure: Medication usage
timeFrame: From start point for 2.5 months
measure: Treatment's duration
timeFrame: From start point for 2.5 months
Secondary outcomes:
measure: Cost of medication used
timeFrame: From start point for 2.5 months
measure: Costs of adverse event management
timeFrame: From start point for 2.5 months
measure: Frequency of health resource usage
timeFrame: From start point for 2.5 months
measure: Cost of health resource usage
timeFrame: From start point for 2.5 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01831479: Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics, drug-drug interaction
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only
Secondary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00778479: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Official title: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adhesion Prevention (Abdominal)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

* Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

Primary outcomes:
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clamond
country: France
facility: Chu Hotel Dieu
city: Lille
country: France
facility: CHRU de Lille, Hopital Huriez
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Paris
country: France
facility: Hopital Lariboisiere
city: Linkoping
country: Sweden
facility: University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00964379: Intraperitoneal Versus Extraperitoneal Colostomy
Official title: Prospective Randomized Trial of Intraperitoneal Versus Extraperitoneal Techniques for Construction of Terminal Iliac Fossa Colostomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colostomy
Keywords: Intra versus extraperitoneal colostomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.


Eligibility criteria: Inclusion Criteria:

* permanent colostomy

Exclusion Criteria:

* none

Primary outcomes:
measure: parastomal hernia, stoma dysfunction
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05045079: Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
Official title: Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Tricuspid Valve Regurgitation (Disorder)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 4
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 study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Moderate-severe or severe TR while in atrial fibrillation.
* Ambulatory (not wheelchair/scooter dependent).

Exclusion Criteria:

* Systolic pulmonary artery pressure\>70 mmHg with a fixed pulmonary vascular resistance \>7 Wood units by catheterization.
* Ejection fraction \<40%.
* Obstructive hypertrophic cardiomyopathy.
* Constrictive pericarditis or tamponade.
* Active myocarditis.
* Complex congenital heart disease.
* Other valve disease requiring surgical intervention.
* Terminal illness (other than HF) with expected survival of less than 1 year.
* Pregnancy or breastfeeding mothers.

Primary outcomes:
measure: Change in KCCQ QOL scores
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogesh Reddy, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05259579: ARMA for Postoperative GERD After Sleeve Gastrectomy
Official title: Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy


Eligibility criteria: Inclusion Criteria:

* Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
* Pathological esophageal acid exposure, defined by DeMeester score \>14.7 or acid exposure time (AET) \>4.2% on pH study

Exclusion Criteria:

* Primary esophageal motility disorders
* Sliding hiatal hernia \>3cm
* Narrow gastric sleeve that precludes retroflexion of scope
* Gastric sleeve stricture
* Malignancy
* Pregnancy
* Patients not fit for general anesthesia
* Other cases deemed by the examining physician as unsuitable for safe treatment
* Refusal to participate

Primary outcomes:
measure: Change in GERD symptoms
timeFrame: 3 and 6months
measure: Change in GERD symptoms
timeFrame: 3 and 6months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 day
measure: Change in DeMeester score and AET
timeFrame: 3 months
measure: Dysphagia symptoms
timeFrame: 3 and 6 months
measure: PPI use
timeFrame: 3 and 6 months
measure: Changes in cardia morphology
timeFrame: 3 months
measure: Adverse events rate relating to endoscopic intervention
timeFrame: 7 days, 1, 3 and 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References: