louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06991348: CLINICAL TRIAL FOR THE COMPARATIVE EVALUATION OF ACID SUPPRESSION AND SYMPTOM MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE WITH THE ADMINISTRATION OF TEGOPRAZAN OR PANTOPRAZOLE
Official title: MULTICENTER, ACTIVE-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, CLINICAL TRIAL FOR THE COMPARATIVE EVALUATION OF ACID SUPPRESSION AND SYMPTOM MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE WITH THE ADMINISTRATION OF TEGOPRAZAN OR PANTOPRAZOLE: TOP-GERD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
pantoprazole
tegoprazan
P-CAB
PPI
Lead sponsor: Carnot Laboratories
Sponsor class: INDUSTRY
First posted: 2025-05-27
Enrollment: 128
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: The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.


Eligibility criteria: Inclusion Criteria:

* With endoscopic diagnosis of GERD or NERD (endoscopy ≤ 15 days old)
* With positive impedance pHmetry results (pHmetry ≤ 15 days old)
* With recurrent symptoms of heartburn and regurgitation for a previous period ≥ 3 months old

Exclusion Criteria:

* With known hypersensitivity to tegoprazan, pantoprazole, or any of the components of each formulation
* Subjects with concomitant administration of atazanavir, nelfinavir or rilpivirine
* Nephropathic and/or hepatopathic subjects (including non-alcoholic hepatitis)
* Subjects with upper gastrointestinal tract bleeding
* Subjects with gastric and/or duodenal ulcer 2 months prior to screening
* Subjects with a history of esophageal or gastric surgery

Primary outcomes:
measure: Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Gastrologen S.A. de C.V.
state: Ciudad De México
city: Boca del Río
country: Mexico
facility: Saluz Investigación, S.C.
state: Veracruz
Study officials:
affiliation: Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México
name: Jose M Remes-Troche, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YK, Kim JH, Kim HS, Kim TO, Oh JH, Choi SC, Moon JS, Lee SK, Jung SW, Kim SS, Jung HK, Lee SP, Cheon GJ, Park MI, Jung HY, Ko KH, Sung IK, Lee SH, Lee JY, Lee ST, Rhee PL, Kim N, Hong SJ, Kim HJ, Kim GH, Lee KJ, Kim SK, Shin WG, Lee OY. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. 2023 Jan;57(1):72-80. doi: 10.1111/apt.17255. Epub 2022 Oct 31.
Clinical trial NCT03669848: Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
Official title: Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Poisoning
Keywords: carbon monoxide poisoning
e-cigarette user
transcutaneous saturation measurements
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 1116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active smoker presenting to adult emergency department

Brief summary: Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO\> 5%) and smokers ( SpCO\> 10%).

Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.

The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.


Eligibility criteria: Inclusion Criteria:

* Patient presenting to adult emergency department
* Age ≥ 18 years

Exclusion Criteria:

* Passive exposure to tobacco
* Mixed exposure (tobacco / e-cigarette)
* Patient having objected to the processing of his data

Primary outcomes:
measure: Blood Carbon Monoxide levels measurements
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Adult Emergency Department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Leila CAMBONI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806948: Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 96
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.


Eligibility criteria: Inclusion Criteria:

* Laparoscopy for benign gynecologic disease

Exclusion Criteria:

* Vomiting within 24 hours before surgery
* Not using patient controlled analgesics postoperatively

Primary outcomes:
measure: Complete Response Rate
timeFrame: Postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi Do
Study officials:
References:
Clinical trial NCT02958748: Change of Immune Cell of ARDS Patients：an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Medicine
ARDS
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosis:ARDS(The Berlin definition），onset within 48hours Without past history which may impact immune function

Brief summary: To evaluate change of different immune cellsduring ARDS and its impact on prognosis.


Eligibility criteria: Inclusion Criteria:

①sign on the acknowledged

②Diagnosis with ARDS(The Berlin definition），onset within 48hours

Exclusion Criteria:

①diagnosis of hematological or immunological disease

②treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Primary outcomes:
measure: mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00556348: Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Official title: Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Keywords: bevacizumab
AMD
Complications
Visual acuity
OCt
Age Macular Degeneration
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

Detailed description: We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

Exclusion Criteria:

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

Primary outcomes:
measure: Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP
Secondary outcomes:
measure: Ocular side effects (infection, RD, IOP rise, cataract)
Other outcomes:
Locations:
Study officials:
affiliation: UnB and IOG
name: Joao J Nassaralla, Jr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215748: Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
Official title: Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lung Cancer
Keywords: Elderly
Weekly
Lead sponsor: Geriatric Oncology Consortium
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy.

Detailed description: Dose-limiting edema and effusions associated with cumulative docetaxel administraton have necessitated the recommendation that all patients should be premedicated with oral corticosteroids such as dexamethasone prior to docetaxel administration. Dexamethasone pre-medication may also decrease the incidence and severity of acute hypersensitivity reactions associated with docetaxel administration. However, administration of weekly dexamethasone can cause additional untoward side effects, especially in the older population. If the data from this phase II study is encouraging, a study to evaluate an even lower dose of dexamethasone can be conducted.

Eligibility criteria: Inclusion Criteria:

* age ≥ 65 years;
* breast or lung cancer patients to receive docetaxel therapy as per protocol;
* corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events;
* performance status ECOG 0-2;
* peripheral neuropathy ≤ 1;
* adequate kidney and liver functions
* signed study-specific informed consent

Exclusion Criteria:

* Patients who have received an investigational drug within 4 weeks of registration;
* Prior or concurrent malignancies (other than surgically treated carcinoma in situ;
* Serious medical or psychiatric illness which would prevent informed consent;
* Life expectancy \< 3 months;
* Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled.

Primary outcomes:
measure: To evaluate the feasibility of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel therapy with respect to incidence of: Grade 3/4 fluid retention
measure: Grade 3/4 hypersensitivity
Secondary outcomes:
measure: To evaluate the incidence of toxicity of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel with respect to: fluid retention (all grades)
measure: hypersensitivity (all grades)
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Geriatric Oncology Consortium
name: William Ershler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497848: The Compliance Project Concerning People With Schizophrenia
Official title: Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Ministry of the Interior and Health, Denmark
Sponsor class: OTHER_GOV
First posted: 2007-07-09
Enrollment: 70
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment

Detailed description: 50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills.

The individual intervention is based on "Motivational Interviewing" by Miller and "Concordance Strategies" by R. Gray.It is a cognitive behavioral therapy.

The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.

Eligibility criteria: Inclusion Criteria:

* Diagnoses of schizophrenia or schizoaffective psychosis
* 23 years or more
* Ethnic dane
* Living in the city of Odense.

Exclusion Criteria:

* not subject to legal action

Primary outcomes:
measure: compliance assessed on a compliance-scale
timeFrame: follow-up time 6 months
Secondary outcomes:
measure: assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of psychiatry, Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Bent Nielsen, Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01426048: Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination
Official title: Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-08-30
Enrollment: 138
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 191 female patients with genuine or recurrent stress urinary incontinence or mixed incontinence operated on with the TVT procedure at the mean of 10.5 years ago.

Brief summary: A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.


Eligibility criteria: Inclusion Criteria:

* 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital

Primary outcomes:
measure: Objective outcome of the TVT operation
timeFrame: 13.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku university hospital
Study officials:
References:
Clinical trial NCT00531648: Relationships Between Toddlers With Feeding Disorder and SPD and Their Parents
Official title: The System of Relationships Between Parents and Their Toddlers, With Eating Disorders and Sensory Processing Disorders Within Meal and Play Situations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Feeding and Eating Disorders of Childhood
Developmental Disabilities
Keywords: Toddlers that having feeding disorders and SPD
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2007-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents.


Eligibility criteria: Inclusion Criteria:

* Toddlers aged between one year to two and a half years
* Toddlers diagnosed as SPD by occupational therapist
* Toddlers diagnosed as having feeding disorder by psychiatric physician according to DSM-R-IV
* Toddlers that are normally developed as reported by pediatrician

Exclusion Criteria:

* Compliant families
* Toddlers with poor health

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Mental health unit for preschoolers
Study officials:
affiliation: Mental health unit for preschoolers, Ashdod, Israel
name: Irit Orian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental health unit for preschoolers, Ashdod, Israel
name: Inbal Heimann, B.A.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01917448: Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery
Official title: Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Video-assisted Thoracoscopic Surgery
Keywords: postoperative pain
spinal morphine
video-assisted thoracoscopic surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 36
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: One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.


Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologist) physical status I to III,
* Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
* capable of using a patient-controlled analgesia (PCA) machine
* understanding the numeric rating scale (NRS) score for pain assessment.

Exclusion Criteria:

* history of allergy to the study drugs
* bleeding disorder
* infection of the back
* refusing spinal anesthesia
* history of cerebrovascular disease
* using postoperative ventilator support were excluded

Primary outcomes:
measure: Total post-operative morphine requirement.
timeFrame: 48 hours
Secondary outcomes:
measure: Pain after surgery
timeFrame: 48 hour
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, mahidol University
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00466648: Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites
Official title: Randomized Controlled Trial Comparing Two Different Methods of Laparoscopy Port Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cosmesis
Keywords: laparoscopy, port site, closure, Dermabond
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study wishes to compare patient satisfaction and cosmesis of two different closure methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl transcutaneous stitch, with a Bacitracin and Tegaderm dressing.


Eligibility criteria: Inclusion Criteria:

* gynecologic laparoscopy patients

Exclusion Criteria:

* known sensitivity to tissue adhesive, antibiotic ointment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York Presbyterian Hospital
name: Giuseppe Del Priore
role: PRINCIPAL_INVESTIGATOR
References: