louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03205098: Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail
Official title: Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultra-trail Participation
Keywords: biological markers
mesenteric ischemia
ultratrail
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 200
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: participants or populations are selected based on predefined criteria

Brief summary: To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

Detailed description: During physical exercise, increased sympathetic nervous system activity redistributes blood flow from splanchnic organs to working muscles. With prolonged duration and / or intensity, the splanchnic blood flow can be reduced by 80% or more. A severely reduced of splanchnic blood flow can frequently cause gastrointestinal ischemia. This ischemia associated with reduced vagal activity probably results in changes in motility and absorption.

High symptoms are reported in 40% of runners with reflux and heartburn in 15-20% of runners. The low symptoms have an incidence of about 70% in the long runs type ultra-trail.

Biological markers such as I-FABP have been shown to be useful in the diagnosis of mesenteric ischemia.

Eligibility criteria: Inclusion Criteria:

* Healthy Voluntary Subject
* Age \> 18 years
* Written consent
* Subject affiliated to Social Security
* Medical certificate (mandatory to take part in the ultra-trail)

Exclusion Criteria:

* Refusal to participate
* Subject with legal protection (guardianship, trusteeship)

Primary outcomes:
measure: Assess biological markers of mesenteric ischemia (IFABP)
timeFrame: at day 1
Secondary outcomes:
measure: Relationship between digestive symptoms and biological markers (IFABP).
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573698: Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia
Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose and Multi-Dose Study of DT-216 in Adult Patients With Friedreich Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Friedreich Ataxia
Lead sponsor: Design Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of multiple doses of intravenous DT-216 in adult patients with Friedrich Ataxia.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions.
* Able and willing to sign informed consent form prior to study enrollment.
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA) at screening.

Exclusion Criteria:

* Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study.
* Has clinically significant abnormal laboratory results.
* Has significant cardiac disease.
* Received an investigational drug within 3 months of screening.

Primary outcomes:
measure: Safety Measure
timeFrame: Up to approximately 60 days
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Up to approximately 60 days
measure: Pharmacokinetic parameters
timeFrame: Up to approximately 60 days
measure: Pharmacokinetic parameters
timeFrame: Up to approximately 60 days
Other outcomes:
measure: Pharmacodynamic parameters
timeFrame: Up to approximately 60 days
Locations:
city: Eatontown
country: United States
facility: Clinilabs
state: New Jersey
Study officials:
References:
Clinical trial NCT03260998: ECG Changes in Children and Adolescents With Type 1 Diabetes
Official title: ECG Changes in Children and Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 60 children and adolescents with type 1 diabetes attending Assiut university hospital and 60 sex and age matched control subjects .

Brief summary: Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of vascular and neuropathic complications that are seen in patients with diabetes mellitus type 1.

Detailed description: Cardiovascular risk factors remain the most controversial chronic complication in diabetes mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the response of the coronary vasculature to sympathetic stimulation, which may manifest clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate variability, which can be assessed qualitatively in the clinic. Limited data suggest silent myocardial ischemia is more common in the presence of cardiac autonomic neuropathy . Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in particular in patients with nephropathy.QT dispersion defined as the difference between maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was defined as the time between the first deflection from the isoelectric PR interval and the visual return of the T wave to the T-P segment ) ,Because these electrocardiogram abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac death , early identification may have prognostic value .

Eligibility criteria: Inclusion Criteria:

* All children and adolescents with type 1 diabetes

Exclusion Criteria:

1. Cornary artery disease .
2. Heart failure , congenital heart disease ,
3. Rheumatic valve disease .
4. Primary cardiomyopathy .
5. Thyroid dysfunction .
6. Bundle branch block and atrioventricular conduction abnormalities .
7. Anti arrhythmic drugs .

Primary outcomes:
measure: corrected QT dispersion
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mariam Atef, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566198: Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Official title: Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 300
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 active military members of the Paris Fire Brigade.

Brief summary: Tobacco use is one of the world's leading preventable causes of disease and premature death, and the physician has a central role in detecting smokers and helping them to quit.

Tobacco use in the military undermines fitness, readiness and performance, and increases health care costs.

A study conducted on a French Army contingent on external operations in Afghanistan have shown an increase in tobacco use in situation of operational constraints (stress, shift work, etc.). However, another study conducted in Ivory Coast on a mobile gendarmerie squadron showed no significant difference.

Among the American firefighters who have been exposed to the 9/11 World Trade Center attacks, smoking have been shown to play an aggravating role in the recovery of lung function.

This study is aimed at assessing smoking prevalence in the Paris Fire Brigade, which is composed of young and healthy sportsmen and women who are exposed to strong operational constraints.


Eligibility criteria: Inclusion Criteria:

* To be 18 years of age or older
* To be French
* To be an active military member
* To work in the Paris Fire Brigade

Exclusion Criteria:

* To be a civilian
* To be a reservist
* To be a foreigner

Primary outcomes:
measure: Proportion of smokers
timeFrame: At enrollment (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Médical de Champerret
city: Paris
country: France
facility: Antenne médicale de Ménilmontant
Study officials:
References:
Clinical trial NCT05334498: Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability
Official title: Comparative Effects of Motor and Cognitive Dual-task Gait Training on Balance and Mobility in Persons With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: Motor and cognitive dual task gait training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out the comparative effects of motor and cognitive dual gait training on improving the balance control and mobility skills among intellectual disable patients.

Detailed description: Previous studies had done a lot of work in improving balance and mobility skills by combining both motor and cognitive dual gait training (CDT and MDT) techniques among Down syndrome, Parkinsonism and so on but not a single study was conducted in order to determine the comparative effects of CDT and MDT especially in intellectual disability individuals to improve balance so the study was conducted in order to find the comparative effect for the better understanding of the treatment effects.

Eligibility criteria: Inclusion Criteria:

* Both genders having IQ range between 50-69
* Walk without assistive devices
* Having a Grade I-IV on the RLACFS

Exclusion Criteria:

* Genetic disorders (Down syndrome).
* Age-related diseases like Parkinsonism and Alzheimer disease.
* Cerebrovascular accident, dementia, Cerebral palsy
* Severe visual impairment.
* Medications (sedatives or narcotics)

Primary outcomes:
measure: Rancho Los Amigos Cognitive functional scales
timeFrame: 4th week
measure: Berg Balance Scale
timeFrame: 4th week
measure: Walking while talking test
timeFrame: 4th week
measure: Stair climb test
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Mirpur
country: Pakistan
facility: District headquarter hospital
state: Azad Jammu Kashmir
Study officials:
affiliation: Riphah International University
name: Sara Aabroo, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966598: Machine Learning Predict Acute Kidney Injury in Patients Following Cardiac Surgery
Official title: Using Machine Learning to Predict Acute Kidney Injury in Patients Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Machine Learning
Acute Kidney Injury
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 2108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age over 18 years who underwent cardiac surgery

Brief summary: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The investigatorshere developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes.

The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.


Eligibility criteria: Inclusion Criteria:

* age over 18 years who underwent cardiac surgery

Exclusion Criteria:

* data miss greater than 10%

Primary outcomes:
measure: acute kidney injury
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04839198: Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation
Official title: Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Nicotine patch
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-04-09
Enrollment: 60
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 purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.


Eligibility criteria: Inclusion Criteria:

* a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
* willingness to quit smoking 14 days after the baseline visit
* no contraindications to using Nicotine replacement therapy (NRT).
* If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.

Exclusion Criteria:

* currently smoking less than 5 cigarettes per day

Primary outcomes:
measure: Number of patients who quit smoking as confirmed by absence of salivary cotinine
timeFrame: 4-weeks after quit day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Emily Hebert, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06486298: Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty
Official title: Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty : Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominoplasty Surgery
Keywords: abdominoplasty surgery
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to:

Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery


Eligibility criteria: Inclusion Criteria:

* • Cooperative male and female patients aged between 20-60 years old.

  * All patients in the study presented with varying degrees of excess abdominal skin and adipose tissue, along with a range of underlying abdominal muscle laxity, following volumetric changes of the abdominal cavity.
  * These patients may undergo after bariatric surgery, dietry weight loss or after multiple pregnancies.

Exclusion Criteria:

* • Uncooperative patients unwilling to give consent.

  * Those unsuitable for abdominoplasty surgery, BMI \>30 and those on antiplatelet medication.
  * Unfit for surgery and patients with allergies to any of the anesthesia components.

Primary outcomes:
measure: the subcutaneous collection with vaccum drain
timeFrame: 10 days
measure: the subcutaneous collection with passive drain
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Hospital University
Study officials:
References:
Clinical trial NCT00831298: Assessment of Sleep Disturbance in Alzheimer Disease
Official title: Assessment of Sleep Disturbance in Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: alzheimer disease
sleep disturbance
apathy
memory loss
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.

This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings


Eligibility criteria: Inclusion Criteria:

* alzheimer disease
* MMSE \> 20
* over 65 years old

Exclusion Criteria:

* new psychotropic drug treatment
* patient unable to do neuropsychologic tests

Primary outcomes:
measure: assessment of apathy
timeFrame: at day 0, just after inclusion
Secondary outcomes:
measure: assessment of sleep disturbance
timeFrame: during a week, between day 0 and day 7
measure: determine a genetic relationship between sleep disturbance and alzheimer disease
timeFrame: after all genetic analyses of the study
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Mémoire de Ressources et de Recherche, CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Philippe ROBERT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05124145: Primary Care in AURA for COVID-19
Official title: Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Care : Suspected and Confirmed Cases of COVID-19
Primary Health Care
COVID-19 Pandemic
Keywords: COVID-19
Primary care
Clinical epidemiology
Practice assessment
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting a health professional in primary care in the AURA region, by physical encounter, visio-consultation or telephone call, during the COVID-19 epidemics period

Brief summary: As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.


Eligibility criteria: Inclusion Criteria:

* Suspect or confirmed COVID-19 case consulting in primary care in the Aura region

Exclusion Criteria:

* Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
* Patient refusing to participate to the study

Primary outcomes:
measure: Estimation of the weekly incidence of COVID-19 confirmed cases
timeFrame: 30 days after the COVID-19 suspected
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: RESHAPE
Study officials:
affiliation: Research on Healthcare Performance Lab U1290
name: Laurent LETRILLART, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06912945: Factors Affecting Outcomes of Using Diode Laser Both 980 nm Wave Length and 450 Wavelength on Benign Laryngeal Lesions in Comparison to Traditional Cold Instrumentations as Regard Parameters of Laser Device, Nature of Lesion and Patient Factors
Official title: Factors Affecting the Outcomes of Using the Diode Laser in Benign Laryngeal Lesions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Benign Laryngeal Lesion
Keywords: diode
benign
laryngeal
laser
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations


Eligibility criteria: Inclusion Criteria:

- All patients with benign laryngeal lesions

Exclusion Criteria:

* patients presenting with or have history of malignant laryngeal lesion

Primary outcomes:
measure: change in voice handicap index Arabic version (VHI-Arabic)
timeFrame: 2 months after treatment
measure: change in voice acoustic analysis
timeFrame: 2 months after treatment
measure: change in modified grade of dysphonia, roughness, breathness and asthenia score ( modified GRBAS)
timeFrame: 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Mohammed Abdu Elsamea, Assistant lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arroyo HH, Neri L, Fussuma CY, Imamura R. Diode Laser for Laryngeal Surgery: a Systematic Review. Int Arch Otorhinolaryngol. 2016 Apr;20(2):172-9. doi: 10.1055/s-0036-1579741. Epub 2016 Mar 4.