louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02483546: High Fidelity Simulation vs Standard Teaching Training of Cardiac Resuscitation
Official title: High Fidelity Simulation In Medecine Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Medical education
simulation
ACLS
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. The term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. Studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. Students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .

Detailed description: This was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .The investigators included 181 fifth-year medical students rotating in the emergency department of Fattouma Bourguiba University hospital of Monastir (Tunisia) during the period from January 2013 to January 2014.Students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82).

The investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (MI) complicated by ventricular fibrillation.

Eligibility criteria: Inclusion Criteria:

* Medecine students

Exclusion Criteria:

* Non Medecine students

Primary outcomes:
measure: better acquisition of cognitive skills for students
timeFrame: just after randomisation (one day)
Secondary outcomes:
measure: Satisfaction 5 point likert scale
timeFrame: just after randomisation (one day)
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: university of Monastir
Study officials:
affiliation: Emergency Department , university Hospital of Monastir 5000 TUNISIA
name: Hamdi Boubaker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department , university Hospital of Monastir 5000 TUNISIA
name: Mohamed habib GRISSA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190746: Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity
Official title: Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Keesler Air Force Base Medical Center
Sponsor class: FED
First posted: 2017-06-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients at an academic medical center

Brief summary: It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could be related to RA disease severity.

Detailed description: Rheumatoid Arthritis (RA) is a chronic inflammatory arthritis of substantial morbidity. Serum biomarkers such as Rheumatoid Factor and anti-cyclic citrullinated peptide assist with disease diagnosis and prognostic assessment of future disease activity. 14-3-3 eta is a relatively new RA serum biomarker. The 14-3-3 family of proteins were named based on chromatographic elution properites and are ubiquitously expressed intracellular chaperon proteins. The isoform relevant in RA is 14-3-3 eta. 14-3-3 eta provides additional information about RA to the clinician-it assists in making diagnosis, provides prognostic assessment of disease severity, and provides insight regarding response to therapy. Thus, 14-3-3 eta serves as an important mechanistic biomarker informing the clinician about patient's RA.

14-3-3 eta is the product of the YWHAH gene, located on chromosome 22q12.3. It is about 13 kilobase long, consisting of two exons separated by a single intron. This gene has been implicated in linkage studies to bipolar disorder and schizophrenia. Six YWHAH single nucleotide polymorphisms (SNPs) were identified in a prior study: rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226. rs2246704 was associated with bipolar disorder (Odds Ratio (OR) 1.31, p=0.03) and psychotic BP (OR 1.66, p=0.002). All six SNPs are intronic. It was hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) could be related to RA disease severity.

Eligibility criteria: Inclusion Criteria:

* Have RA per 1987 or 2010 American College of Rheumatology Classification Criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: Relationship to RA disease severity
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Director
name: Thomas Shaak, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01512381: Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Official title: Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: heart failure
CRT
atrial fibrillation
AV junction ablation
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 11
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 determine whether cardiac resynchronization therapy (CRT) is superior to interventricular right ventricle (RV) septal pacing in respect of reverse remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)


Eligibility criteria: Inclusion Criteria:

* Age of 18-75 years
* CHF II-III NYHA
* Persistent/permanent AF requiring AV node ablation
* LVEF \< 45%
* Signed informed consent
* Able to complete all testing required by the clinical protocol

Exclusion Criteria:

* Myocardial infarction or stroke less than 3 months prior to randomization
* Patients who require revascularization, radiofrequency ablation of pulmonary veins and substrate of AF
* The congenital and acquired heart diseases, LV aneurysm, which requires a surgical correction
* Active inflammatory and autoimmune diseases of a myocardium
* The thyrotoxicosis
* The diseases that limit life expectancy (cancer, tuberculosis, etc.)
* Contraindications to anticoagulants administration at CHADS2\> 2
* Uncompliant patients

Primary outcomes:
measure: Left Ventricle End-Systolic Volume (LV ESV)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of cardiovascular events (hospitalization for worsening heart failure)
timeFrame: 12 month
measure: Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
timeFrame: 12 months
measure: Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test
timeFrame: 12 months
measure: Echocardiographic indexes of LV remodeling
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Almazov Federal Heart, Blood and Endocrinology Centre
Study officials:
References:
Clinical trial NCT00749281: Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease
Official title: Neutrophil Gelatinase-associated Disease: a Potential Biomarker of the Severity of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: atherosclerosis
ngal
coronary artery disease
Lead sponsor: Cardiovascular Research Society, Greece
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for coronary angiography.

Brief summary: Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory marker which correlates to obesity and its metabolic complications. Since neutrophil activation has been implicated in the pathogenesis of coronary artery disease, the investigators hypothesized that serum NGAL levels would be higher in patients with CAD and that serum concentration would correlate with the extent of CAD as documented by coronary angiography, serving as a potential biomarker of the severity of CAD.

Detailed description: Inflammation is considered to play a major role in coronary artery disease (CAD) which accounts for high morbidity and mortality rates in the western world. Several lines of evidence support a role for neutrophils in the development of atherosclerosis and its progression.

Neutrophil gelatinase-associated lipocalin (NGAL), also known as Lipocalin-2, is a 25-kDa secretory glycoprotein that was originally identified in mouse kidney cells and human neutrophil granules. This protein has been used as a marker of neutrophil activation in several studies, while recently it was found to be an inflammatory marker closely related to obesity and its metabolic complications.

Recently, lactoferrin, a protein which co-localizes with NGAL in the specific granules of human neutrophils has been proposed as a more dynamic marker of neutrophil activation compared to the widely used myeloperoxidase in patients with CAD.

In line with the accumulating evidence, this study is designed to investigate the relationship between serum NGAL concentration and the presence or the severity of coronary artery disease according to coronary angiography.

Eligibility criteria: Inclusion Criteria:

* Consenting patients undergoing coronary angiography due to suspected CAD based on clinical history and results from non-invasive testing

Exclusion Criteria:

* Abnormal renal function
* Any known active inflammatory disease
* Receiving medical therapy with antibiotics, corticosteroids, immunosuppressive agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens Euroclinic
state: Attica
Study officials:
affiliation: Athens Euroclinic and Cardiovascular Research Society
name: Demosthenes Katritsis, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05911581: The Effect of the Use of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation
Official title: Investigation of the Effect of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation for Invasive Blood Pressure Measurement by Doppler Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrarterial Catheterization
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Nowadays, intraarterial catheterization is frequently used as an invasive method for intraoperative blood pressure monitoring and control.The radial artery is frequently used in this procedure and the cannula should be flushed with 2-3 ml of heparinized fluid intermittently to prevent occlusion. During the operation, the ambient temperature is approximately 22-24 C and the patient temperature can be 34-36 C. Since the flushing fluids are also in the environment, they are 22-24 C. The aim of this study is to determine whether the fluids at room temperature cause vasoconstriction in the vessel and cause a change in blood pressure arterial values.

Detailed description: The aim of this study is to determine whether room temperature fluids cause vasoconstriction or vasodilatation in the vessel and cause a change in blood pressure arterial values.

Eligibility criteria: Inclusion Criteria:

* ASA I-III risk class,
* Medically undergoing intra-arterial cannulation
* Being between the ages of 18-70

Exclusion Criteria:

* Diagnosis of DM
* Vascular disease,
* Bleeding diathesis,
* inotropic drug use

Primary outcomes:
measure: Arterial flow velocities PSV
timeFrame: 30th seconds after arterial flush
measure: Arterial flow velocities End-diastolic velocity
timeFrame: 30th seconds after arterial flush
measure: Arterial flow velocities resistive indices
timeFrame: 30th seconds after arterial flush
Secondary outcomes:
measure: invasive and non-invasive blood pressure
timeFrame: 10th,30th,60th,90th ,120th and 150th seconds
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
References:
Clinical trial NCT01647581: Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
Official title: Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-polypectomy Bleeding
Polypectomy
Elective Colonoscopy
Keywords: hemoclip
colonoscopy
post-polypectomy bleed
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-07-23
Enrollment: 11182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for elective colonoscopy

Exclusion Criteria:

* Patients in which polypectomy can not be performed safely

Primary outcomes:
measure: Number of Patients With Delayed Post Polypectomy Bleeding
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
Study officials:
affiliation: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
name: Linda A Feagins
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B, Lunsford T, Vizuete J, Mara M, Mascarenhas R, Meghani R, Kundrotas L, Dunbar KB, Cipher DJ, Harford WV, Spechler SJ. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019 Oct;157(4):967-976.e1. doi: 10.1053/j.gastro.2019.05.003. Epub 2019 May 31.
Clinical trial NCT05151081: Overactive Bladder Syndrome
Official title: The Role of Primary Nocturnal Enuresis in the Etiology of Overactive Bladder Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Enuresis, Nocturnal
Keywords: Overactive bladder
Enuresis nocturna
treatment
etiology
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 87
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: up to 18 year and all sex

Brief summary: Purpose:

A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB.

Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.

Detailed description: A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.

Eligibility criteria: Inclusion Criteria:

* overactive bladder syndrome
* enuresis nocturna

Exclusion Criteria:

* diabetes mellitus,
* neurological diseases
* bladder outlet obstruction,
* active urinary system infection

Primary outcomes:
measure: A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
affiliation: Hisar Intercontinental Hospital
name: Basri Cakiroglu
role: STUDY_CHAIR
References:
Clinical trial NCT03588481: IRIS- DESyne X2 in the IRIS-DES Registry
Official title: Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Stenosis
Coronary Occlusion
Coronary Disease
Keywords: PCI
DES
real world
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-07-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with DeSyne X2 stent

Brief summary: This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Intervention with DeSyne X2 drug-eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock

Primary outcomes:
measure: Composite event rate
timeFrame: 1year
Secondary outcomes:
measure: All death
timeFrame: 5years
measure: Cardiac death
timeFrame: 5years
measure: Myocardial infarction
timeFrame: 5years
measure: Composite event of death or myocardial infarction
timeFrame: 5years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5years
measure: Target Vessel revascularization
timeFrame: 5years
measure: Target Lesion revascularization
timeFrame: 5years
measure: Stent thrombosis
timeFrame: 5years
measure: Stroke
timeFrame: 5years
measure: Procedural success
timeFrame: 3days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Hallym Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
Study officials:
References:
Clinical trial NCT00850681: A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Official title: A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Peplin
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.


Eligibility criteria: Inclusion Criteria:

* are healthy males or females;
* in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
* read, understand and provide signed informed consent.

Exclusion Criteria:

* are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
* are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
* are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
* have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

Primary outcomes:
measure: To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: Jonothan S Dosik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.