louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01400945: Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease
Official title: Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
endoscopy
LA grade
heartburn
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18\~75) with endoscopically proven GERD treated with AGSPT201 Tablet.

Detailed description: This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.

Eligibility criteria: Inclusion Criteria:

* aged 18\~75 years
* Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
* Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
* Symptoms on at least 2 days of the past 7 days

Exclusion Criteria:

* PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
* Patients whose history of GI tract resection or vagotomy.
* Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
* Acid irrelevant Heartburn and regurgitation.
* Zollinger Ellison syndrome
* Hypersensitive and/or allergy to Pantoprazole and/or other PPI
* Pregnancy and lactation
* peptic ulcer
* serious hepatic
* any other renal, cardiac or haematological disease.
* Patients participated any other clinical studies during the past 3 months.

Primary outcomes:
measure: Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
timeFrame: 4 week
Secondary outcomes:
measure: Absence and/or improvement of typical reflux symptoms
timeFrame: 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea-St. Mary's Hospital
name: MyoungKyu Choi, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Medical Center-Guro
name: YoungTae Park, M.D.
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: PoongRyul Lee, M.D
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: SangKyun Kim, M.D
role: STUDY_DIRECTOR
affiliation: Asan Medical Center
name: HoonYong Jeong, M.D
role: STUDY_DIRECTOR
affiliation: Inje University
name: SangYoung Seol, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01450345: Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Official title: Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Inguinal Hernia
Postoperative Pain
Keywords: Clinical diagnosis of inguinal hernia
Patient undergo operation under daycare basis
ASA I-II
Written consent
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of inguinal hernia
* Patient undergo operation under daycare basis
* ASA I-II
* Written consent

Exclusion Criteria:

* ASA \> II
* Allergic reaction against gabapentin and/or pregabalin
* History of recurrent hernia repair.
* Patient who has taken analgesia prior to the surgery
* Liver failure
* Renal failure
* Pregnancy

Primary outcomes:
measure: Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
timeFrame: 3 days
Secondary outcomes:
measure: Opiod Sparing
timeFrame: 3 days
measure: Side effect of medication
timeFrame: 3 days
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya
Study officials:
affiliation: University of Malaya
name: CharngChee Toh, MBBS, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252445: Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
Official title: Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Site Discomfort
Complications
Anesthesia
Urinary Bladder Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Detailed description: The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for transurethral bladder excision under general anesthesia
* ASA I-III

Exclusion Criteria:

* Foley catheter less than 18 Fr.
* Patients with obstruction of urinary tract
* Patients with neurogenic bladder
* Patients with severe obesity
* Patients with neurologic disorder
* Patients with chronic pain
* Patients with allergic history to propofol or sevoflurane

Primary outcomes:
measure: Catheter-related Bladder Discomfort
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Catheter-related Bladder Discomfort
timeFrame: 0, 6 and 24 hour postoperatively
measure: Hemodynamic Parameters
timeFrame: 0, 1, 5, 10 minute postoperatively
measure: Nausea
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Vomiting
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Dry Mouth
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Flushing
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Blurred Vision
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Dizziness
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Analgesics
timeFrame: 0, 1, 6 and 24 hour postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seolu National University of Hospital
Study officials:
References:
Clinical trial NCT03200145: Person Centered Nursing Homes: Impact Assessment Of Centered Person Care In Nursing Homes
Official title: Residències Centrades en Les Persones (RECENPE): avaluació de l'Impacte d'un Model d'ACP en residències Per Persones Grans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Services for the Aged
Quality of Life
Mood
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
Collaborators: name: SUMAR empresa d'acció social de Catalunya
First posted: 2017-06-27
Enrollment: 170
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: Persons of any age with or without cognitive impairment living indefinitely in a nursing home

Brief summary: Cohort Observational Study. The study will assess differences in quality of life, well-being and mood between persons living in a nursing home following usual care and persons living in nursing homes following a centered person care model.

Initially, the follow up will last 6 months, with the possibility to be extended.


Eligibility criteria: Inclusion Criteria:

* Persons living in nursing homes
* Consent from the person (or legal representative, if the person is not able)

Exclusion Criteria:

* Terminal illness
* Living temporary in a nursing home

Primary outcomes:
measure: Thriving in nursing homes
timeFrame: 0, 6 months
measure: Quality of life
timeFrame: 0, 6 months
measure: Well-being
timeFrame: 0, 6 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 0, 6 months
measure: Neuropsychiatric inventory
timeFrame: 0,6 months
Other outcomes:
Locations:
city: Sant Sadurní d'Anoia
country: Spain
facility: Residència "Casa del Avis"
state: Barcelona
city: Sant Hilari Sacalm
country: Spain
facility: Residència i Centre de dia Sant Hilari
state: Girona
Study officials:
affiliation: Fundació Salut i Envelliment UAB
name: Xavier Rojano Luque, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04324645: Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies
Official title: Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptom Monitoring
Radiation Therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2020-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-site study, which will be open at Siteman Cancer Center at Washington University School of Medicine.

Brief summary: This study seeks to achieve two aims:

* To assess the implementation of Noona software for continuous symptom monitoring for a diverse population of patients with thoracic malignancies who are undergoing radiation and
* To validate remote collection of standardized PRO measures using Noona software.


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed cancer. Radiographically apparent (i.e. not histologically or cytologically confirmed) malignancy of the thorax is allowed.
* Currently planning to receive radiotherapy with or without chemotherapy for greater than one fraction.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
* Age 18 years or older

Exclusion Criteria:

-Unable to reliably access and use a device compatible with Noona software.

Primary outcomes:
measure: Percentage of invited symptom reports completed during the study period
timeFrame: Treatment through 90 days of follow-up (estimated to be 5 months)
measure: Percentage of questions completed within each invited symptom report
timeFrame: Treatment through 90 days of follow-up (estimated to be 5 months)
Secondary outcomes:
measure: Patient reported outcomes as measured by EORTC QLQ-C30
timeFrame: Baseline, within 1 week of completing therapy and at 90-day follow-up
measure: Patient reported outcomes as measured by NCCN Distress Thermometer
timeFrame: Baseline, within 1 week of completing therapy and at 90-day follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Matthew B Spraker, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363345: Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones
Official title: Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Randomized Study
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).


Eligibility criteria: Inclusion Criteria:

* patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
* endoscopic papillary balloon dilation (EPLBD) was performed.

Exclusion Criteria:

* septic shock
* coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control),
* \<platelet count 50,000 / L
* suspected or confirmed malignancy

Primary outcomes:
measure: Percentage of stones cleared
timeFrame: Procedure time
Secondary outcomes:
measure: Total procedural time
timeFrame: Procedure time
measure: the number of adverse events
timeFrame: Procedure time
measure: the numbers of morbidities and mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
References:
Clinical trial NCT04925245: Clinical Reminder to Improve Appropriateness of Echocardiography
Official title: Clinical Reminder to Improve Appropriateness of Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Echocardiography
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 1365
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test a clinical reminder to show recent echocardiograms when a new echocardiogram is ordered. The goal is to avoid unnecessary comprehensive echocardiography.


Eligibility criteria: Inclusion Criteria:

* Echo ordered

Exclusion Criteria:

* None

Primary outcomes:
measure: Comprehensive echo ordered
timeFrame: 24 hours from when when the initial order was placed
Secondary outcomes:
measure: Cost of Echocardiography
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT03321045: Positron Emission Tomography (PET) Imaging with Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Official title: PET Imaging with 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: 89Zr-Trastuzumab, HER2 Imaging
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age.
* Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2
* Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
* Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs., due to the scanner bore size
* Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)

Primary outcomes:
measure: Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Suzanne E Lapi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02498145: Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
Official title: Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.


Eligibility criteria: Inclusion:

* Smoking 1 or more tobacco cigarettes per day.
* Residence within reasonable driving distance to New Haven..

Exclusion:

* Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
* Unstable medical conditions requiring hospitalization.
* Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
* Unstable angina.
* History of allergic reactions to adhesives.
* Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
* Current use of an electronic cigarette.
* Subject unable or unwilling to complete study protocol for any reason.

Primary outcomes:
measure: Change in daily quantitative cigarette smoking
timeFrame: baseline, 8 weeks, and 6 months.
measure: Change in exhaled carbon monoxide (CO) levels
timeFrame: baseline, 8 weeks, and 6 months.
Secondary outcomes:
measure: Short-term impact on lung function (spirometry)
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephen R. Baldassarri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367445: A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
Official title: A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Oral Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 2

Exclusion Criteria:

* Severe Asthma, severe COPD
* Smoking

Primary outcomes:
measure: Variability of blood glucose over a period of 72 hours
Secondary outcomes:
measure: Insulin pharmacokinetics
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00172705: Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique
Official title: Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study is proposed to explore the correlation between fatty content of fatty liver and the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold for diagnosis of fatty liver.

Detailed description: This study is proposed to explore the correlation between fatty content of fatty liver and the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold for diagnosis of fatty liver.

Eligibility criteria: Inclusion Criteria:

* hepatic tumor
* living liver donor

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: province of Taiwan
Study officials:
affiliation: National Taiwan University Hospital
name: HON-MAN LIU, MD
role: STUDY_CHAIR
References: