louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04322474: Russian National Registry of LAAO
Official title: Russian National Registry of Left Atrial Appendage Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
left atrial appendage
stroke prevention
occluder
Watchman device
Amplatzer Cardiac Plug
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2020-03-26
Enrollment: 200
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: Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events

Brief summary: The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.

Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years nonvalvular atrial fibrillation,
* CHA2DS2VASc ≥2,
* high risk of hemorrhagic events,
* non-compliance with pharmacological anticoagulant therapy

Exclusion Criteria:

* significant mitral valve disease,
* left ventricular ejection fraction \<35%,
* the tendency to systemic thrombosis,
* severe co-morbidities

Primary outcomes:
measure: Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
timeFrame: 12 months
measure: The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death
timeFrame: 12 months
Secondary outcomes:
measure: Procedure success rate
timeFrame: intraprocedural
measure: Peridevice leakage
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: National Research Center for Preventive Medicine
name: Karapet Davtyan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04514874: Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
Official title: Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of professional military aircrew of all aeronautical specialties presenting themselves for a periodic medical exam.

Brief summary: The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Professional military aircrew
* Presenting himself/herself for a periodic medical exam

Exclusion Criteria:

* Under 18 years of age
* Parachutists
* Non-professional aircrew
* Presenting himself/herself for a first medical exam
* Pregnant woman, parturient, breastfeeding

Primary outcomes:
measure: Prevalence of COVID-19 infection among French military professional aircrew
timeFrame: At enrollment
Secondary outcomes:
measure: Predictive factors of COVID-19 infection
timeFrame: At enrollment
measure: Techniques used for COVID-19 screening
timeFrame: At enrollment
measure: Reasons for COVID-19 screening
timeFrame: At enrollment
measure: Experienced symptoms of COVID-19
timeFrame: At enrollment
measure: Medical care of COVID-19
timeFrame: At enrollment
measure: Social consequences of the COVID-19 pandemic
timeFrame: At enrollment
measure: Factors associated with pejorative consequences of the COVID-19 pandemic
timeFrame: At enrollment
Other outcomes:
Locations:
city: Clamart
country: France
facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Percy
city: Toulon
country: France
facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References:
Clinical trial NCT03439774: Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
Official title: Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for Topcon TRK-2P With the Topcon SP-1P (Predicate)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 250 subjects will have both of their eyes measured.

Brief summary: The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification \[510(k)\] Submissions, and to the applicable Supplemental Information Sheet. This clinical device study will also assess the substantial equivalence of TRK-2P to a predicate device in regard to pachymetry.


Eligibility criteria: Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;
2. be willing and able to provide written informed consent prior to any study procedures being performed;
3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;
2. have poor or eccentric fixation in either eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
4. have microphthalmos in either eye;
5. have buphthalmos in either eye;
6. be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of an artificial tear;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in either eye;
10. have keratoconus in either eye;
11. have any other corneal or conjunctival pathology or infection in either eye;
12. have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Primary outcomes:
measure: Agreement of IOP
timeFrame: 1 day
measure: Agreement of Corneal Thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT02849574: Evaluation of Changes in Consumption of Drugs and Substances After Incarceration
Official title: Evaluation of Changes in Consumption of Drugs and Substances After Incarceration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addictions
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 629
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: The eligible study population is incarcerated major subjects. The topics will be selected subjects incarcerated in remand centers participating in the study. All subjects were medical examination, Home Maintenance arriving at their entrance into custody. On this occasion, the medical staff will verify the absence of non inclusion criterion and the subject will be informed orally and via an information sheet that will retain an invitation to respond to an anonymous questionnaire will be sent after him 4 or 5 months of detention (as prisons). He may accept or reject this invitation.

Brief summary: To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.


Eligibility criteria: Inclusion Criteria:

* Major subject
* Subject in the fourth or fifth month of incarceration
* Held about agreeing to participate in the study

Exclusion Criteria:

* Patient refusing to participate
* Patient unable to respond to the questionnaire (major difficulties understanding of the French language)

Primary outcomes:
measure: change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period
timeFrame: Until 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Fontenay Le Comte
country: France
facility: Fontenay Le Comte Hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: Laval
country: France
facility: Laval Hospital
city: Le Mans
country: France
facility: Le Mans Hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Caroline VICTORRI-VIGNEAU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02524574: Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients with heart failure, the drive to the effort has demonstrated its safety and its interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is impaired by decreased activity of endothelial NO synthase. The rehabilitation training significantly improves peripheral endothelial function, and this improvement is correlated to the increase in exercise capacity. The impact on coronary endothelial function remains poorly documented, especially in non-ischemic dilated heart disease.

The main objective of this study is to investigate the effectiveness of cardiac rehabilitation on the restoration of coronary endothelial function in cardiac failure patient evaluated with Tomography Positron Emission 15O-H2O.


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure with nonischemic dilated cardiomyopathy
* Class II-III NYHA (New York Heart Association)
* Having no contra-indication to the effort
* Fraction Ejection ≤ 40%
* patient who will have cardiac rehabilitation
* Age over 18 years
* informed consent signed
* patient with a social security scheme

Exclusion Criteria:

* Hypertension\> 160/90 mmHg
* High cholesterol level \> 6.0 mmol / l
* Diabetes known and treated
* Active smoking
* Valvular heart disease, congenital or ischemic
* Pregnant or breastfeeding women
* Age \<18 years
* Major Adult guardianship

Primary outcomes:
measure: Rate of myocardial blood flow during the cold test
timeFrame: change over baseline and after 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Cardiologie
Study officials:
References:
citation: Legallois D, Belin A, Nesterov SV, Milliez P, Parienti JJ, Knuuti J, Abbas A, Tirel O, Agostini D, Manrique A. Cardiac rehabilitation improves coronary endothelial function in patients with heart failure due to dilated cardiomyopathy: A positron emission tomography study. Eur J Prev Cardiol. 2016 Jan;23(2):129-36. doi: 10.1177/2047487314565739. Epub 2014 Dec 18.
citation: Tuffier S, Legallois D, Belin A, Joubert M, Bailliez A, Redonnet M, Agostini D, Manrique A. Assessment of endothelial function and myocardial flow reserve using (15)O-water PET without attenuation correction. Eur J Nucl Med Mol Imaging. 2016 Feb;43(2):288-295. doi: 10.1007/s00259-015-3163-x. Epub 2015 Aug 18.
Clinical trial NCT04091074: Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
Official title: Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carotid Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients undergoing carotid stenting take dual anti platelet therapy to prevent thrombotic complications usually used drugs are aspirin plus clopidogrel but there are patients not respond so ticagrelor may be an effective and safe alternative


Eligibility criteria: Inclusion Criteria:

1. Ischemis stroke of both sex.
2. More than 18 years.
3. Accepting all study requirements.

Exclusion Criteria:

1. Refuse to comply with all study requirements.
2. bleeding tendency or liver diseases

Primary outcomes:
measure: compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting
timeFrame: 15 days before carotid stenting
measure: Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting
timeFrame: 15 days before carotid stenting
Secondary outcomes:
measure: Pattern of carotid stenosis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05446974: Development of Training Programs for Nursing Competency Reinforcement to Spread Trauma Intervention
Official title: Development of Training Programs for Nursing Competency Reinforcement to Spread Trauma Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurses Who Work at the Community Mental Health Welfare Center
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 41
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to improve the trauma intervention competency of nurses through online-based training of the nursing intervention program for trauma-experienced subjects. The specific goals are as follows.

1. Based on Swanson's Caring Theory, develop an online training program for nurses to spread trauma nursing intervention and improve competency.
2. Evaluate the effects of the developed program's workbook and online training on nurses' trauma-related knowledge and attitude, self-efficacy, and professional quality of life.

Of the 42 subjects who enrolled in the study, 1 dropped out before intervention, resulting in 41 participants who completed all interventions and surveys.


Eligibility criteria: Inclusion Criteria:

* Those who have a nurse's license
* Those who work at the Mental Health Welfare Center
* Those who can access the program through a computer or mobile
* Those who understand the purpose of the research and voluntarily agree to participate in the research

Exclusion Criteria:

- Those who do not agree to participate in the study

Primary outcomes:
measure: Attitudes and knowledge about PTSD
timeFrame: one month after the intervention
measure: Pro QOL
timeFrame: one month after the intervention
measure: Self efficacy
timeFrame: one month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT01297374: Effect of Three Non-drug Intervention in Treatment of Children With Overweight
Official title: EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).


Eligibility criteria: Inclusion Criteria:

* age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI \> +2)

Exclusion Criteria:

* chronic diseases

Primary outcomes:
measure: Changes in percentage body fat and basal metabolism after 1 year of randomization
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT00175474: Comparison of a Minimally Invasive Technique for Total Knee Replacement to a Standard Technique
Official title: Minimally Invasive Total Knee Arthroplasty Versus a Standard Surgical Technique: a Single-blinded Single-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of a minimally invasive technique for total knee replacement to a standard technique


Eligibility criteria: Inclusion Criteria:

* No inflammatory arthritis,
* no other lower limb problem,
* no major comorbidity

Exclusion Criteria:

-

Primary outcomes:
measure: length of stay
Secondary outcomes:
measure: Quality of life at 2 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Bassam Masri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03823274: Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients
Official title: Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 1011
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patient

Brief summary: This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients


Eligibility criteria: Inclusion Criteria:

1. Men and women over 60 years old at the time of written consent
2. Those admitted to the hospital within 72 hours after acute cerebral infarction and treated with Aspirin 100 mg and Clopidogrel 75 mg
3. Written informed consent voluntarily signed

Exclusion Criteria:

1. Those with evidence other brain lesions such as brain tumors
2. Those who need oral anticoagulants other than vitamin K antagonists or anticoagulant therapy of warfarin
3. Contraindicate to Aspirin or Clopidogrel or allergic to the drug
4. Subjects who are at risk of active pathological bleeding such as digestive ulcer and intracranial hemorrhage
5. Cancer disease that can shorten life expectancy
6. Patient's condition that may interfere with participation in study such as mental illness, mental retardation, dementia, drug abuse, and alcoholism
7. Subjects other than the above unsuitable for this clinical study identified by Investigator

Primary outcomes:
measure: evaluate the relationship of stroke recurrence and anti-platelet resitance
timeFrame: 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National Universtity Hospital
name: jei Kim
role: PRINCIPAL_INVESTIGATOR
References: