louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02022488: Sevoflurane Induced Emergence Agitation
Official title: Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergence Agitation
Keywords: Child
Sevoflurane
Emergence delirium
General anesthesia
Premedication.
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.


Eligibility criteria: Inclusion Criteria:

* 1- 8 years
* American Society of Anesthesiologist (ASA) I-II,
* Patients undergoing procedures below the umbilicus

Exclusion Criteria:

* cardiac diseases
* pulmonary diseases
* hepatic diseases
* renal diseases
* psychological or emotional disorders

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium (PAED) score
timeFrame: 7 months
Secondary outcomes:
measure: Parental separation score
timeFrame: 7 months
measure: Mask acceptance
timeFrame: 7 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University Hospital
Study officials:
References:
Clinical trial NCT03044288: Evaluation of the Effect of Output on Skin Covered by a New Adhesive
Official title: Evaluation of the Effect of Output on Skin Covered by a New Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) -

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene F Nielsen, M. Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455788: Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?
Official title: Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Valve Endocarditis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with heart valve disease and indicated for valve replacement.

Brief summary: Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.


Eligibility criteria: Inclusion Criteria:

* patients who need cardiac valve replacement for rheumatic or degenerative causes

Exclusion Criteria:

* Patients undergoing open heart surgery for any cause other than valve replacement
* patients who are younger than 20 years old.
* Patients undergoing valve repair.

Primary outcomes:
measure: number of patients diagnosed with Infective endocarditis post valve replacement
timeFrame: 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT03431688: Tailored Therapy for Clarithromycin-Resistant H. Pylori
Official title: Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Kangdong Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 660
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.


Eligibility criteria: Inclusion Criteria:

* peptic ulcer disease
* H. pylori gastritis
* low grade MALT lymphoma

Exclusion Criteria:

* history of gastric cancer surgery
* severe comorbidity (ESRD, LC)
* hypersensitivity to drug
* pregnancy

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
Study officials:
affiliation: Kangdong Sacred Heart Hospital
name: Woon Geon Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03253588: Laparoscopic Tubal Preservation Surgery
Official title: Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy)

Brief summary: Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.

Detailed description: All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.

Eligibility criteria: Inclusion Criteria:

* women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion Criteria:

* women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)

Primary outcomes:
measure: peri- and post-operative parameters
timeFrame: between January 2009 and November 2016
Secondary outcomes:
measure: factors affecting the surgical success rate
timeFrame: between January 2009 and November 2016
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei City
Study officials:
References:
Clinical trial NCT05458388: Different Endoscopic Gastric Cancer Risk Assessments
Official title: Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer Screening
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 3500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40-80 years undergoing gastroscopy
* Patients intend to undergo ESD treatment

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* Patients with previous surgical procedures on the stomach
* patients with contraindications to biopsy
* Patients who refuse to sign the informed consent form.

Primary outcomes:
measure: Early gastric cancer detection rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT03664388: Registry of Acute Coronary Syndrome From University Hospital of Vigo
Official title: Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome; Bleeding; Dual antiplatelet therapy
Lead sponsor: Hospital Álvaro Cunqueiro
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted by acute coronary syndrome in the University Hospital Alvaro Cunqueiro of Vigo between January 2010 to January 2018

Brief summary: CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events.

Detailed description: CardioCHUVI is a retrospective study aim to analyze all consecutively patients admitted by acute coronary syndrome to University Hospital Alvaro Cunqueiro of Vigo, between January 2010 to January 2018

The objective of the project was to study cardiac and bleeding complications, such as reinfarction, heart failure, atrial fibrillation, stroke, and bleeding events, together with all-cause and cardiac mortality

Eligibility criteria: Inclusion Criteria:

* Any patient admitted to University Hospital Alvaro Cunqueiro of Vigo for acute coronary syndrome.

Exclusion Criteria:

* Secondary acute coronary syndromes during a hospital admission for another cause (i.e. acute myocardial infarction in the context of a sepsis)

Primary outcomes:
measure: All cause mortality
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Reinfarction
timeFrame: Through study completion, an average of 3 years
measure: Bleeding
timeFrame: Through study completion, an average of 3 years
measure: Ischemic stroke
timeFrame: Through study completion, an average of 3 years
measure: Cancer
timeFrame: Through study completion, an average of 3 years
measure: Heart Failure
timeFrame: Through study completion, an average of 3 years
measure: Atrial Fibrillation
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Department of Cardiology, Hospital Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: University Hospital Álvaro Cunqueiro, Vigo, Spain
name: Emad Abu-Assi, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Álvaro Cunqueiro, Vigo, Spain
name: Sergio Raposeiras-Roubín, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Álvaro Cunqueiro, Vigo, Spain
name: Andres Iñiguez-Romo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05260788: Mapping 3D Bladder
Official title: Feasibility of Spatially Registered Endoscopy for Mapping Bladder Mucosal Disease Into Radiation Planning Morphologic Imaging
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bladder Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation and intent to treat using external beam radiation therapy.

Brief summary: This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. If feasible, this 3D reconstructed shape would be spatially registered to radiological images (CT, MR) that are then used during radiation treatment planning. This analysis would not be used for making any clinical treatment decisions on the patient.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation.
* Intention to treat using external beam radiation therapy as part of standard of care.
* Ability to provide written informed consent to participate in the study.

Exclusion Criteria:

* Prior complete or partial radiation therapy to bladder.
* Contraindications to radiation therapy as determined by the treating physician.
* Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning.

Primary outcomes:
measure: Video recording of Cystoscopy
timeFrame: At study completion, up to 2 years
measure: Contouring of 3D bladder rendering
timeFrame: At study completion, up to 2 years
measure: Registering bladder shape
timeFrame: At study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT00227188: Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.
Official title: Effectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 408
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All public and private hospitals with a pediatric department belonging to one of the two autonomous communities.

Brief summary: The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)


Eligibility criteria: Inclusion Criteria:

* All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD.
* Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00368888: Clinical Study of New Urine Collection Bag for Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Lead sponsor: Bergaliden Barnavårdscentral
Sponsor class: OTHER
First posted: 2006-08-29
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.


Eligibility criteria: Inclusion Criteria:

* Healthy children.

Exclusion Criteria:

* Current infection of any kind. History of urinary tract infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Bergaliden Barnavårdscentral (Child Care Center)
Study officials:
name: Markus Perlhagen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03839888: Short Term Refractive and Ocular Parameter Changes After Topical Atropine
Official title: Short Term Refractive and Ocular Parameter Changes After Topical Atropine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, Left Eye
Keywords: atropine
cycloplegia
refraction
axial length
anterior chamber depth
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 96
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.


Eligibility criteria: Inclusion Criteria:

* Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion Criteria:

* Patients who had already been undergoing cycloplegic treatment for myopia before.

Primary outcomes:
measure: SER
timeFrame: change from SER at 7 days
Secondary outcomes:
measure: AL
timeFrame: change from AL at 7 days
measure: ACD
timeFrame: change from ACD at 7 days
measure: IOP
timeFrame: change from IOP at 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: Ho MC, Hsieh YT, Shen EP, Hsu WC, Cheng HC. Short-term refractive and ocular parameter changes after topical atropine. Taiwan J Ophthalmol. 2019 Feb 20;10(2):111-115. doi: 10.4103/tjo.tjo_110_18. eCollection 2020 Apr-Jun.