louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01991522: A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy
Official title: A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.


Eligibility criteria: Inclusion Criteria:

* Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto

Exclusion Criteria:

* Greater than 20 colonoscopies performed

Primary outcomes:
measure: Transfer of Skills to Clinical Colonoscopy
timeFrame: less than 2 weeks
Secondary outcomes:
measure: Retention of Clinical Skills
timeFrame: 4-6 weeks after intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Samir C Grover, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grover SC, Garg A, Scaffidi MA, Yu JJ, Plener IS, Yong E, Cino M, Grantcharov TP, Walsh CM. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial. Gastrointest Endosc. 2015 Dec;82(6):1072-9. doi: 10.1016/j.gie.2015.04.008. Epub 2015 May 23.
Clinical trial NCT06775522: Bioequivalence (BE) Study Between YHP2205 and YHR2401 in Healthy Volunteers
Official title: An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment two-way crossover
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

Detailed description: 60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by crossover design on day 1, 8 Subjects in group 2 will be administered "comparator" and "YHP2205" by crossover design on day 1, 8.

Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
* Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-36 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-36 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-36 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-36 hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-36 hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
state: Gangseo-gu
Study officials:
References:
Clinical trial NCT02698722: A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making
Official title: A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making - A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Decision-making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2016-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the United States, it is estimated that there are approximately 630,000 patients who have ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this population

Pre-dialysis education programs inform patients of all of their options allowing them to choose renal replacement therapy that is most consistent with their wishes. Recent evidence has supported using different methods of delivering education including videos to complement standard clinical care practices to promote informed decision making. This proposed study will serve to examine the efficacy of a dialysis modality video decision support tool to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.


Eligibility criteria: Inclusion Criteria:

* English-speaking during clinical encounters
* Stage 4 or 5 CKD (defined by the Chronic Kidney Disease Epidemiology Collaboration for estimation of GFR \< 30 ml/min/1.73m2)

Exclusion Criteria:

* Known history of dementia
* Legally blind
* Listed for kidney transplant

Primary outcomes:
measure: Change in knowledge of end-stage renal disease treatments (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
timeFrame: Change in knowledge immediately pre and post intervention and at 12 weeks
Secondary outcomes:
measure: Change in preference for end-stage renal disease treatment (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
timeFrame: Change in preferences Immediately pre and post intervention and at 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Eneanya ND, Percy SG, Stallings TL, Wang W, Steele DJR, Germain MJ, Schell JO, Paasche-Orlow MK, Volandes AE. Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. Am J Nephrol. 2020;51(9):736-744. doi: 10.1159/000509711. Epub 2020 Aug 13.
Clinical trial NCT06498739: Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
Official title: Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy. A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Modified Radical Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Detailed description: Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.

Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block). Ultrasound guided erector spinae plane block (ESPB) was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 60 years.
* Genders eligible for study: female sex.
* American Society of Anesthesiologists (ASA) I-II.
* Undergoing modified radical mastectomy.
* Body mass index (BMI) from 18.5 to 30 kg.

Exclusion Criteria:

* Patient refusal.
* Known allergy to local anesthetics .
* Bleeding disorders; platelets count \<50,000 ,prothrombin concentration \< 60% or any coagulopathy disorder.
* Use of any anti-coagulants .
* Inability to provide informed consent.
* Neurological disorders.
* Patient with psychiatric disorders.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Time 1st rescue analgesia
timeFrame: 24 hours postoperative
measure: Pain score
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Univesity
Study officials:
References:
Clinical trial NCT05233839: Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury
Official title: The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Outcomes and Exercise Compliance in Patients With Degenerative Meniscal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus; Degeneration
Keywords: Degenerative meniscus injury
Telerehabilitation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the home exercise program performed with video-based telerehabilitation in patients with degenerative meniscal injury, and the home exercise program performed with one-on-one training in the hospital with conventional methods.

Detailed description: Conventional rehabilitation (CR) practices will be applied to the first study group. Telerehabilitation (TR) application will be applied to the second study group. It is aimed to evaluate the patients in terms of pain, functionality, quality of life and exercise compliance.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 - 65 years
* Having been diagnosed with degenerative meniscus injury by an orthopedist by MRI examination
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Having an operation due to degenerative meniscus injury problem
* Orthopedic and neurological problems that would prevent evaluation and/or treatment

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 8 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from Baseline WOMAC at 8 weeks
measure: SF-12
timeFrame: Change from Baseline SF-12 at 8 weeks
measure: Muscle Strength Test with Lafayette Hand Held Dynamometer
timeFrame: Change from Baseline Dynamometer Value at 8 weeks
measure: Proprioception Measurement with Baseline Bubble Inclinometer
timeFrame: Change from Baseline Inclinometer Value at 8 weeks
Secondary outcomes:
measure: EARS
timeFrame: Change from Baseline EARS at 8 weeks
measure: TSUQ
timeFrame: Change from Baseline TSUQ at 8 weeks
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman Training and Research Hospital
state: Menteşe
Study officials:
affiliation: Ege University
name: İsmet Tümtürk, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Cem Yalın Kılınç, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06750939: The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation
Official title: The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Endotracheal Intubation in Critically Ill Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Collapse
Intubation Complication
Anaesthetic Complication Cardiac
Keywords: cardiac arrest
intubation
shock index
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.

Brief summary: This prospective observational study evaluates the impact of propofol and ketamine on the risk of cardiovascular collapse during induction for endotracheal intubation in critically ill patients. Induction agents play a crucial role in managing hemodynamic stability, particularly in this vulnerable population. Propofol, known for its vasodilatory and myocardial depressant effects, has been associated with significant hypotension during induction. Conversely, ketamine, with its sympathomimetic properties, is often considered a safer alternative for hemodynamic stability.

In addition to comparing the incidence of cardiovascular collapse-defined as severe hypotension or cardiac arrest-this study examines the relationship between these induction agents and shock indices, including systolic shock index, diastolic shock index, age-adjusted shock index, and modified shock index. These parameters will provide a more detailed understanding of the hemodynamic effects of each agent and their clinical implications. The findings aim to guide induction agent selection to optimize outcomes in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.

Exclusion Criteria:

* Patients who did not provide consent to participate in the study
* Patients intubated due to cardiac arrest
* Patients intubated outside the intensive care unit

Primary outcomes:
measure: cardiovascular collapse
timeFrame: The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
Study officials:
References:
Clinical trial NCT06691139: A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
Official title: A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myringoplasty
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Sohag university hospital

Brief summary: A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty

Detailed description: The aim of this clinical trials is to asses and compare the surgical outcomes of Temporalis fascia graft and periosteal graft in myringoplasty in terms of graft intake and audiological improvement

Eligibility criteria: Inclusion Criteria:

age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .

Exclusion Criteria:

Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.

Primary outcomes:
measure: hearing improvment
timeFrame: from January 2022 to January 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
affiliation: Sohag University
name: ahmed Nada
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05445739: The Effect of an Online Exercise Course on the Increase of Elders' Regular Exercise Intention
Official title: The Effect of an Online Exercise Course on the Increase of Elders' Regular Exercise Intention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Exercise Training
Keywords: exercise
older adults
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan Normal University
First posted: 2022-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The effect of an online exercise course on the increase of elders' regular exercise intention.

Detailed description: This project expects that after the four-week exercise course intervention, the elderly can increase their knowledge about exercise and experience the benefits of exercise, enhance the intention of the elderly to exercise regularly, and reduce the chance of the elderly falling due to muscle loss and causing related diseases.

Eligibility criteria: Inclusion Criteria:

* The patients from outpatient clinic for elderly health examination.

Exclusion Criteria:

* The elderly who has severe hearing impairments.
* The elderly who has severe visual impairments.
* The elderly who has severe health problems.
* The elderly who need to be quarantined.
* The elderly who is living alone.

Primary outcomes:
measure: Change from baseline on the survey of questionnaire
timeFrame: Baseline, within 2 weeks after the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Kun-Pei Lin
Study officials:
References:
Clinical trial NCT04443439: Assess the Risk of Cerebrovascular Disease
Official title: Head and Neck CTA Combined With Multimodal MRI to Assess the Risk of Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disease
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No carotid stenosis - related neurological symptoms and transient ischemic attacks (50 patients in each group, 25 males and 25 females).

Brief summary: Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA, double modal MRI techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the ACS group and normal person the cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the series of indicators and specific degrees.


Eligibility criteria: Inclusion Criteria:

1. Mild stenosis group: CTA suggested carotid stenosis \< 30%;
2. Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;
3. Severe stenosis group: CTA indicated carotid stenosis ≥70%;

Exclusion Criteria:

1. dementia, MMSE score \< 21;
2. previous carotid stenosis related neurological symptoms or transient ischemic attack;
3. other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia);
4. contraindications for MRI examination;
5. recent use of psychoactive drugs or hormones.

Primary outcomes:
measure: Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment
timeFrame: 2020.01
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Wen Wang
Study officials:
References: