louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03406377: Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Official title: A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 113
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: This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

Detailed description: This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
* BMI ≥27 and ≤45 kg/m2
* HbA1c ≥7.0% and ≤10.5% at screening

Exclusion Criteria:

* Type 1 diabetes mellitus
* Previous treatment with incretin mimetic drugs
* Have used insulin for diabetic control for more than 6 consecutive days within the prior year
* Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
* Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (\>2 x ULN).

Primary outcomes:
measure: Change in HbA1c in Subjects With Type 2 DM
timeFrame: From baseline to 30 weeks
Secondary outcomes:
measure: Mean Percent (%) Body Weight Change
timeFrame: From baseline to 30 weeks
measure: Percent (%) of Subjects With 5% or Greater Body Weight Loss.
timeFrame: 30 weeks.
measure: Change From Baseline of Fasting Plasma Glucose (FPG).
timeFrame: 30 weeks.
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
affiliation: OPKO Health, Inc.
name: Militza Vera De Alba, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01299077: Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar DDD in China
Official title: A Retrospective Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar Disc Degenerative Disease in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Degenerative Disease
Keywords: Lumbar disc degenerative disease
Methycobal
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients visited to the clinics with lumbar disc degenerative disease

Brief summary: The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.

Detailed description: DDD (lumbar disc degenerative disease ) patients who have been prescribed triple therapy (MBL+ MYO+ NSAIDs) over 2 weeks of triple therapy were enrolled in the study. They were asked to assess their overall satisfaction degree on triple therapy.

Eligibility criteria: Inclusion criteria:

1. lumbar degenerative disc disease (DDD)
2. patients who have been prescribed over 2 weeks of triple therapy

Exclusion criteria:

Patients who do not meet inclusion criteria for DDD

Primary outcomes:
measure: Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).
timeFrame: 2 weeks
Secondary outcomes:
measure: Onset Time of Symptom Relief.
timeFrame: 2 weeks
measure: Safety Data During Triple Therapy.
timeFrame: 2 weeks
measure: Japanese Orthopedic Association (JOA) Score
timeFrame: Baseline and 2 weeks
measure: Visual Analogue Scale (VAS) Score
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Dongfang Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Hanzhou
country: China
facility: Shao Yifu Hospital of Zhejiang University
state: Zhejiang
city: Hanzhou
country: China
facility: The 1st Hospital of Zhejiang University
state: Zhejiang
city: Hanzhou
country: China
facility: The 1st People Hospital of Hanzhou
state: Zhejiang
city: Hanzhou
country: China
facility: The 2nd Hospital of Zhejiang University
state: Zhejiang
city: Hanzhou
country: China
facility: Traditional Chinese Medicine Hospital of Zhejiang
state: Zhejiang
Study officials:
affiliation: Eisai China Inc.
name: Haibo Song
role: STUDY_DIRECTOR
References:
Clinical trial NCT01622777: The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
Official title: Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Polyneuropathy
Keywords: Rosuvastatin
Diabetic polyneuropathy
Nerve conduction
Oxidative stress
Nerve growth factor
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Glycated hemoglobin \<12.0%
* Signing of informed consent
* Presence of an abnormality of nerve conduction study
* Symptoms and signs of diabetic polyneuropathy

Exclusion Criteria:

* Pregnancy and lactation
* Foot ulcers
* Treatment with statins
* Antioxidant drug and/or supplements one month previous to enrolment
* Inability to mobilize
* Renal and/or hepatic failure

Primary outcomes:
measure: Stage of diabetic polyneuropathy
timeFrame: 12 weeks
measure: Severity of diabetic polyneuropathy
timeFrame: 12 weeks
measure: Nerve conduction studies
timeFrame: 12 weeks
measure: Neuropathy symptoms and impairment scores
timeFrame: 12 weeks
measure: Lipid peroxidation
timeFrame: 12 weeks
measure: Nerve growth factor
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Cardiovascular Research Unit. University of Guadalajara.
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Ernesto G. Cardona-Muñoz, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: Luis Miguel Roman-Pintos, MD,PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Rogelio Troyo-Sanroman, PhD
role: STUDY_CHAIR
affiliation: Hospital Civil de Guadalajara
name: María del Pilar Alatorre-Carranza, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Alejandra G. Miranda-Diaz, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: Jaime Hernandez-Ojeda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02459977: The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Basiliximab has been a routine induction therapeutic agent even for well-matched living kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is a different drug from cyclosporine, the investigators study the usefulness of tacrolimus-based immunosuppression without basiliximab in well matched living KT.

Detailed description: The investigators omit basiliximab induction therapy in patients who underwent one to three-HLA mismatched living donor renal transplantation. Participants should receive ABO compatible and T-flow negative transplants. The investigators compare the results of intervention group with conventionally treated control group (age and sex matched patient who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy).

Eligibility criteria: Inclusion Criteria:

* ABO compatible and T-flow negative transplants
* Living kidney transplantation
* Tacrolimus based immunosuppression

Exclusion Criteria:

* Multiorgan transplantation
* Zero-mismatch transplantation (we use cyclosporine instead of FK506)

Primary outcomes:
measure: Incidence of rejection
timeFrame: within 3 years
Secondary outcomes:
measure: Incidence of infection
timeFrame: postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Su-Kil Park, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05109377: Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
Official title: Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Endocan
Erectile dysfunction
Tadalafil
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.

Detailed description: The investigators will include at least 90 patients in study. Blood tests will taken before and after tadalafil treatment and will store at -80 celcius degree.

Eligibility criteria: Inclusion Criteria:

• Patients with erectile dysfuction

Exclusion Criteria:

* Psychogenic erectile dysfunction
* Erectile dysfunction associated with hormonal disorders
* Drug related erectile dysfunction

Primary outcomes:
measure: Rates of IIEF Score
timeFrame: 1 month
Secondary outcomes:
measure: Levels of Endocan
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Veysel Bayburtluoğlu
Study officials:
affiliation: Ministry of Health
name: Veysel Bayburtluoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544577: Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Official title: Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+/HER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ESR1 Gene Mutation
Advanced Breast Cancer
Safety
Lead sponsor: SciClone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 350
Sex: FEMALE
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: Advanced breast cancer with ER+/HER2- and ESR1- gene mutation

Brief summary: This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.


Eligibility criteria: Inclusion Criteria:

* 1. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
* 2. female ≥ 18 years of age
* 3. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy.
* 4. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
* 5. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
* 6. have normal organ function (as assessed by the investigator).

Exclusion Criteria:

* 1. women who are pregnant or breastfeeding
* 2. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
* 3. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator

Primary outcomes:
measure: Adverse event rate
timeFrame: 6 months
Secondary outcomes:
measure: Serious adverse event rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)
state: Hainan
Study officials:
affiliation: Ruijin Hospital
name: Qing Qu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665077: Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
Official title: Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)
Breast Cancer
Keywords: Aromatase Inhibitor Induced Musculoskeletal Syndrome
AIMSS
Breast Cancer
Biomarkers
Oxylipin
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

Detailed description: This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers

Eligibility criteria: Inclusion Criteria:

1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines
3. Have a histologically-confirmed diagnosis of breast cancer
4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
5. Age ≥ 21 years
6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
7. Completed definitive therapy (surgery ± radiation)
8. Candidates for adjuvant AI therapy

Exclusion Criteria:

1. Have received adjuvant or neo-adjuvant chemotherapy
2. Prior endocrine therapy (AI or tamoxifen)
3. History of rheumatoid arthritis or other autoimmune arthritis
4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
5. Current use of daily corticosteroids or immunosuppressive therapies

Primary outcomes:
measure: Oxylipin Levels
timeFrame: Baseline, Three months, and Six months
Secondary outcomes:
measure: Tendon Stiffness
timeFrame: Baseline
measure: Pain Levels
timeFrame: Baseline, Six months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198977: Telehealth-Based Exercise Program to Treat Fatigue in MS
Official title: Telehealth-Based Exercise Program to Treat Fatigue in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
Fatigue
exercise
telemedicine
motivational interviewing
counseling
depression
physical activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-09-10
Enrollment: 64
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: This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

Detailed description: This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.

Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis
* Veteran receiving services in VA VISN 20
* Fatigue
* Ability to ambulate
* cell phone or Household phone line
* Individual with multiple sclerosis verified by MS provider
* ambulatory

Exclusion Criteria:

* Current alcohol dependence or other substance dependence
* No working phone

Primary outcomes:
measure: Fatigue
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Depression
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: Physical Activity (Behavioral Target)
timeFrame: baseline, 3 months, 6 months
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Aaron P Turner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner AP, Hartoonian N, Sloan AP, Benich M, Kivlahan DR, Hughes C, Hughes AJ, Haselkorn JK. Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. J Consult Clin Psychol. 2016 Apr;84(4):297-309. doi: 10.1037/ccp0000086. Epub 2016 Feb 25.
citation: Turner AP, Hartoonian N, Hughes AJ, Arewasikporn A, Alschuler KN, Sloan AP, Ehde DM, Haselkorn JK. Physical activity and depression in MS: The mediating role of behavioral activation. Disabil Health J. 2019 Oct;12(4):635-640. doi: 10.1016/j.dhjo.2019.04.004. Epub 2019 Apr 30.
Clinical trial NCT01308177: Efficacy of Ecabet Sodium and Proton Pump Inhibitor Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection
Official title: Efficacy of an Ecabet Sodium and Proton Pump Inhibitor (PPI) Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delayed Bleeding,
Healing Ulcer
Quality of Ulcer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 90
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: * Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens. However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding.
* Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric ulcers. Recently, one study showed the additional benefits of using ES in combination with the PPI after ESD. however, this study did not show the difference of delayed bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated the difference of delayed bleeding and the benefit of ulcer pain control after ESD.


Eligibility criteria: Inclusion Criteria:

* gastric adenomas or differentiated EGC (any size without ulcers or signs of submucosal invasion; intramucosal differentiated-type EGC \< 3 cm with a scar; and no lymph node involvement or metastasis by CT)

Exclusion Criteria:

* recent use of a PPI, H2RA, bismuth, and antibiotics
* current use of aspirin, non-steroidal anti-inflammatory drugs, or corticosteroids
* Helicobacter pylori infection not evaluated appropriately by endoscopic biopsy and serology
* a history of subtotal gastrectomy; patients who underwent surgery due to ESD complications; known hypersensitivity to PPIs
* chronic co-morbid disease, such as chronic liver and renal disease

Primary outcomes:
measure: to determine the difference in delayed bleeding with PPI or PPI+ES
timeFrame: the time of bleeding occured or post 4 weeks after ESD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: