louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05236244: Motor Imagery in Healthy Individuals
Official title: Does the Effect of Mental Fatigue Created by Motor Imagery on Upper Extremity Functions Change With Diaphragmatic Breathing Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Keywords: motor imagery
mental fatigue
diaphragmatic breathing exercises
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research will be the first to examine the relationship between mental fatigue induced by motor imagery and upper extremity performance. This study, it is aimed to examine whether the effects of mental fatigue created by motor imagery on upper extremity performance can be reduced by diaphragmatic breathing exercises.


Eligibility criteria: Inclusion Criteria:

* Right-handed dominance (it will be decided according to Edinburgh Hand Questionnaire Result)
* Volunteer to participate in the study.
* To be sedentary
* Not having any problems that prevent breathing exercises
* Be between the ages of 18-30

Exclusion Criteria:

* Have any mental or sensory problems in the past 6 months
* Presence of acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc.
* Having had Covid-19
* Having any respiratory disease (asthma, COPD, etc.)
* Having any upper extremity injury and/or operation (trauma, surgery, fracture, etc.) in the -Last 6 months doing regular exercises (at least 30 minutes a day / 5 times a week for a total of at least 150 minutes)
* Be on regular medication
* Be smoking

Primary outcomes:
measure: 1-Isometric Elbow Flexion Force
timeFrame: 8 weeks
measure: 2-Handgrip strength
timeFrame: 8 weeks
measure: 3-Upper extremity reaction test
timeFrame: 8 weeks
measure: 4-Finger reaction test
timeFrame: 8 weeks
measure: 5-Hand performance test
timeFrame: 8 weeks
measure: 6-Position Sense
timeFrame: 8 weeks
measure: 7-Tactile sense
timeFrame: 8 weeks
measure: 8-Two-point discrimination
timeFrame: 8 weeks
measure: 9-Upper extremity endurance test
timeFrame: 8 weeks
Secondary outcomes:
measure: Mental Fatigue (VAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: BandırmaOnyediEylulU
Study officials:
References:
Clinical trial NCT02348944: Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.
Official title: Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effects of; Serum
Urine Marking
Keywords: Biological markers
Cartilage
Lead sponsor: Artialis
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female above 18 years

Brief summary: The purposes of the study are to assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage.

Detailed description: To assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage. Variation factors assessed are:

* Fasting condition
* Sampling time
* Sampling season
* Physical activity
* Duration and temperature of total blood treatment
* Type of blood collection tube.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged above 18 years.
* Sign an informed consent after being informed
* Able to follow the instructions of the study

Exclusion Criteria:

* Serious associated diseases:

  * Severe liver disease
  * Renal failure
  * HIV
  * hepatitis B or C
* Patient who are the subject of a judicial protection measure or under guardianship

Primary outcomes:
measure: Variation of serum and urine sample between baseline, weeks 2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.
timeFrame: Baseline and weeks 2, 16, 52 and 68
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman
Study officials:
affiliation: Clinical Pharmacology Unit, ATC sa, Belgium
name: Bernard Jandrain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03264144: Address Tobacco Use Among Adolescents in Hong Kong
Official title: Changing Social Norms Around Smoking: A Cluster Randomized Controlled Trial to Address Tobacco Use Among Adolescents in Hong Kong
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use
Keywords: Social norms
Adolescent
Smoking
Randomised controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 12868
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the effectiveness of a social norms campaign in correcting smoking misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in Hong Kong adolescents.

Detailed description: The study involves a behavioural intervention with social norms approaches to correct smoking misperceptions, reduce smoking susceptibility and change smoking-related behaviours in Hong Kong adolescents. A 2-arm stratified clustered randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the intervention. A total of 18 secondary schools will be randomly selected from the 5 regions in Hong Kong and invited to the RCT. The schools will then be randomly allocated to intervention or control group in the ratio of 1:1. Secondary 1 to 5 (US Grade 7 to 11) students will be invited. Students in both intervention and control group will complete a baseline survey, and the intervention group will receive the intervention after the baseline. Intervention materials includes posters and table tents at school, flyers to students, and online banner on school website. The intervention adopts social norms approaches, and will highlight the prevalence of adolescents who do not smoke and have no intention to smoke. It will last for 2 months. Both intervention and control groups will complete follow-up surveys at 3 and 9 months. The control group will receive the intervention materials after the RCT.

Eligibility criteria: Inclusion Criteria:

* Local secondary schools that cover grades 1-6

Exclusion Criteria:

* International secondary schools
* Special schools for adolescents with visual, hearing or other physical impairments or disabilities

Primary outcomes:
measure: Perceived adolescent smoking prevalence
timeFrame: At the time of survey
measure: Smoking susceptibility
timeFrame: At the time of survey
Secondary outcomes:
measure: Smoking intensity
timeFrame: Past 30 days
measure: Intention to quit
timeFrame: At the time of survey
measure: Quit attempts
timeFrame: Past 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local secondary schools
Study officials:
affiliation: The University of Hong Kong
name: Sai Yin Ho, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05406544: Df-Life : Quality of Life in Patients With Fibrous Dysplasia
Official title: Df-Life : Quality of Life in Patients With Fibrous Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrous Dysplasia
Keywords: Fibrous dysplasia
quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics: adults coming for consultation or hospitalization for fibrous dysplasia in Hopital Edouard Herriot rheumatology department in Lyon, France.

Brief summary: Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care.

The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).


Eligibility criteria: Inclusion Criteria:

* Men and women
* 18 years and more
* with Fibrous dysplasia
* Being followed in the rheumatology Department of the E. Herriot Hospital in Lyon.
* Non-opposition to take part in the study
* written consent to the audio recording of the discussions.

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Psychiatric or neurological condition that severely impairs comprehension
* Difficulty understanding spoken French
* Patients with another pathology with a major impact on quality of life

Primary outcomes:
measure: FD Qualitative study: notions on quality of life
timeFrame: during group interview (90 minutes)
measure: FD Quantitative study: scores of quality of life and olfaction impairment
timeFrame: during 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital - rheumatology
Study officials:
affiliation: Hospices Civils de Lyon
name: Roland CHAPURLAT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528592: PharmacoMRI of Parkinson Disease
Official title: A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Based on studies showing better responsiveness of motor versus cognitive symptoms to Parkinson's Disease medication, also known as dopaminergic treatments, the investigators hypothesize that comparison of resting state networks in the on versus off medication state in Parkinson's Disease patients will show greater effects on brain networks associated with motor control.

Detailed description: Subject participation includes two 25-30 minute MRI scans. The subject will arrive in the "off" state (PD medications withheld for approximately 12 hours prior to the scan). Following the initial scan, the subject will receive 125% of his or her usual daily morning dose of PD medications which is calculated as levodopa dose equivalents (LDE) and is given as carbidopa-levodopa. The subject will then wait for an hour allowing for the medication to begin working. During this time the subject will complete cognitive assessments, questionnaires regarding the history and current state of PD, and motor assessments. The subject will then undergo a second MRI scan of approximately 25-30 minutes. The subject after completing the second MRI scan is free to leave. The entire study is approximately 2 and 1/2 hours long.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD)
* Older than 30 years of age at the time of diagnosis
* Hoehn and Yahr stage greater than or equal to 2.5
* PD duration greater than 3 years
* Stable regimen of PD medications for at least 2 weeks prior to imaging
* PD medications include carbidopa-levodopa

Exclusion Criteria:

* Patients with a diagnosis of other neurodegenerative conditions
* Patients unwilling or unable to give informed consent
* Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan

Primary outcomes:
measure: Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Darren R Gitelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06667492: Lower Extremity Dynamometry Assessment in Neurotypical Children
Official title: Reliability and Validity of Lower Extremity Dynamometry Assessment in Neurotypical Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Force Measurement
Children
Lower Limb
Assessment Tool
Keywords: dynamometry
lower limb
assessment
child
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of typically developing children aged 5 to 16 years, selected based on specific inclusion and exclusion criteria to ensure the reliability and validity of traction dynamometry.

Brief summary: The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.


Eligibility criteria: Inclusion Criteria:

* typically developing children,
* between the ages of 5 and 16 years,
* have the capacity for voluntary motor control

Exclusion Criteria :

* undergone any treatment or intervention that could impact neuromuscular performance, such as surgery or medication use,
* experienced a recent injury
* demonstrating low levels of compliance during assessments are not included in the study.

Primary outcomes:
measure: Average Peak Torque
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Department of Physiotherapy - University of Thessaly
state: Phthiotis
Study officials:
References:
citation: Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.
citation: Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.
Clinical trial NCT03715192: A Safety Study of LY3462817 in Healthy Participants
Official title: Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Weight at least 45 kilograms (kg)

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have cancer or a malignant disease in the past 5 years
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Are unwilling to receive study drug administration by injections or through the veins

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline through to final follow-up at approximately Week 12
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817
timeFrame: Baseline through to final follow-up at approximately Week 12
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817
timeFrame: Baseline through to final follow-up at approximately Week 12
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Nus Centre for Clin Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06208592: Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.
Official title: Comparative Study of Sedative Requirement Using Sevoflurane With Anaconda Device Versus Conventional Sedation in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Respiratory Failure
Keywords: sedatives
acute kidney injury
SARS-CoV-2
mechanical ventilation
Lead sponsor: Hospital Español de Mexico
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2024-01-17
Enrollment: 43
Sex: ALL
Minimum age (years): 27
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confired COVID-19 infection assited with mechanical ventilation that required sedation.

Brief summary: At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. For the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the ANACONDA conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.

Detailed description: Analyze the difference in intravenous sedation requirements in patients with COVID-19. Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.

Eligibility criteria: Inclusion Criteria:

* Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.

Exclusion Criteria:

* Tranfers to a different hospital.
* Death within the first 24 hours of hospital stay.

Primary outcomes:
measure: Intravenous sedation requirements
timeFrame: 7 days
Secondary outcomes:
measure: Delirium
timeFrame: Hospital stay (up to 30 days)
measure: Acute kidney injury
timeFrame: Hospital stay (up to 30 days)
measure: VAP
timeFrame: Hospital stay (up to 30 days)
Other outcomes:
Locations:
city: Querétaro City
country: Mexico
facility: Hospital H+ Queretaro
state: Querétaro
Study officials:
affiliation: Hospital H+ Queretaro
name: Manuel Lomeli, MD
role: STUDY_CHAIR
References: