louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06792279: Detection of Muscle Quality in Children - Protocol for a Validation Study
Official title: Use of Ultrasound Echo Intensity for the Detection of Muscle Quality in Children - Protocol for a Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ultrasonography
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty boys and sixty girls aged 10-14 years, evenly distributed as follows: normal-weight children, trained young athletes (≥3 training sessions per week), and obese children according to BMI

Brief summary: The goal of this observational study is to evaluate the validity and reliability of ultrasound echo intensity (EI) as a diagnostic tool for assessing muscle quality in children aged 10-14 years, including normal-weight, obese, and trained young athletes. The main questions it aims to answer are:

Can EI reliably and accurately measure muscle quality in children when validated against gold-standard techniques like DXA and isokinetic dynamometry? What are the age-, sex-, and fitness-specific benchmarks for EI to differentiate between normal and pathological muscle quality?


Eligibility criteria: Inclusion Criteria:

• Generally healthy children

Exclusion Criteria:

* Acute illnesses
* Chronic or acute diseases of the endocrine or musculoskeletal systems
* Post-traumatic conditions

Primary outcomes:
measure: Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Skeletal Muscle Mass
timeFrame: Through study completion, an average of 1 year
measure: Muscle Strength
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty of Physical Education and Sport Charles University
state: Czech Republic
Study officials:
References:
Clinical trial NCT00348179: Vascular Function in Adolescent, Diabetic Children
Official title: Vascular Function in Adolescent, Diabetic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Vascular abnormalities
Type 1 diabetes
Healthy control subjects
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of this investigator initiated study are to:

1. Determine if and when vascular abnormalities occur during early adolescence
2. Determine if poor diabetic control is related to vascular abnormalities.

The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.

Detailed description: Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects.

Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls

Exclusion Criteria:

* Children and adolescents who do not meet inclusion criteria

Primary outcomes:
measure: Vascular abnormalities as measured by the SyphmgnoCor equipment
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Kurt Midyett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04445779: Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
Official title: Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Acute Kidney Failure
Lead sponsor: Clinical Hospital Center, Split
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is major risk factor for acute kidney injury/failure (AKI/F).


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

* patients receiving high dose vitamin B supplementation (defined as more that 200% of recommended daily allowances)
* patients under warfarin therapy
* urgent surgery
* end stage kidney disease
* therapy with multiple nephrotoxic drugs
* chronic kidney disease
* obstructive uropathy
* previous cardiac surgery procedure
* alcohol abuse
* malignancy
* allergy to any ingredient of Myoqinon capsule
* patients receiving Myoqinon and fail to demonstrate a significant increase in blood concentration of Q10
* uncontrolled hypertension

Primary outcomes:
measure: Difference in serum creatinine after cardiac surgery indicating kidney injury.
timeFrame: 7 days
measure: Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.
timeFrame: 3 days
measure: Daily urine output during the 72 hours postoperatively.
timeFrame: 3 days
Secondary outcomes:
measure: Length of stay in intensive care unit
timeFrame: 10 days
measure: Advanced glycation endproducts
timeFrame: 7 days
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Clinical Hospital Center Split
state: Splitsko Dalmatinska Županija
Study officials:
References:
Clinical trial NCT03189979: Club Fit: Physical Activity and Healthy Eating at an After School Program
Official title: Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Physical Activity
Dietary Habits
Keywords: community based participatory research
Childhood obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 61
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program.

Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.


Eligibility criteria: Inclusion Criteria:

- Active Boys \& Girls Club participation, which was defined as expected Club attendance at least twice weekly.

Exclusion Criteria:

- None

Primary outcomes:
measure: Change in self-efficacy
timeFrame: baseline, 6 months
measure: Change in motivation
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in body mass index
timeFrame: baseline, 6 months
measure: Change in physical activity
timeFrame: baseline, 6 months
measure: Change in dietary quality
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Boys & Girls Club of Rochester, MN
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark L Wieland, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050179: Chemoreflex Gain on Exercise
Official title: Chemoreflex Gain on Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Exertional Periodic Breathing
Keywords: chemosensitivity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess chemoreflex gain on exercise.

Detailed description: Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. The change in breathing that results from a change in the blood's CO2 concentration is called the chemoreflex.

In heart failure, a condition where the heart muscle is damaged and can not pump as well, this reflex is exaggerated. The result of this can be breathing conditions characterised by patients hyperventilating at times and at other times taking very shallow breaths or even stopping altogether. In the past the only way of measuring this chemoreflex was to get patients to breathe into a large container and to rebreathe their exhaled air and allow the CO2 to rise over time, whilst keeping the oxygen constant. The proportion by which the ventilation increases with increasing carbon dioxide is the chemoreflex gain. Unfortunately, because this test takes a long time to conduct, requires specialist knowledge and equipment it has not been possible to measure this reflex on exercise.

Eligibility criteria: Inclusion Criteria:

* Volunteers: Males aged 18-80 years who are able to perform both running and cycling and can follow simple visual instructions.
* Heart Failure Subjects: Males aged 18-80 with a clinical diagnosis of heart failure who are able to perform both running and cycling and can follow simple visual instructions.

Exclusion Criteria:

* Chest pain of any cause within 4-6 days,
* Pulmonary oedema,
* Uncontrolled hypertension (systolic blood pressure \> 220 mm Hg, diastolic \>120 mm Hg),
* Severe aortic stenosis,
* Severe hypertrophic obstructive cardiomyopathy,
* Untreated life threatening arrhythmia,
* Dissecting aneurysm,
* Recent surgery (within 4-6 weeks), COPD.

Primary outcomes:
measure: chemoreflex gain on exercise
timeFrame: every minute
Secondary outcomes:
measure: Reproducibility of chemoreflex gain on exercise
timeFrame: every minute
Other outcomes:
Locations:
city: Paddington
country: United Kingdom
facility: St Mary's Hospital
state: London
Study officials:
References:
Clinical trial NCT01151579: Effect of Nebulized Bronchodilators on Heart Rate
Official title: Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Sepsis
Shock
Keywords: Tachycardia
tachyarrhythmias
bronchodilator therapy
Critically ill patients
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
Collaborators: name: Ascension Health
First posted: 2010-06-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

Detailed description: A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Eligibility criteria: Inclusion Criteria:

* Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions

Exclusion Criteria:

* Known allergy or sensitivity to study medications
* Baseline heart rate was greater than 110 beats per minute

Primary outcomes:
measure: Heart Rate in Beats Per Minute
timeFrame: Five days
Secondary outcomes:
measure: Arrhythmias
timeFrame: 15 minutes after each treatment for average of 3 to 5 days
measure: Total Number of Participants With Arrhythmias
timeFrame: Five days
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: Ascension Health
name: Fahim Khorfan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascension Health
name: Kimberly R Barber, PhD
role: STUDY_DIRECTOR
References:
citation: Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29.
Clinical trial NCT04995679: Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty
Official title: Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty: a Case Series of 50 Patients With Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 85
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: : Total knee revision arthroplasty is increasing in daily practice and will become more relevant in the years to come. Bone loss is a significant challenge in total knee arthroplasty (TKA) especially in revision procedures. Metaphyseal sleeves are widely used to bypass bone loss and improve stability. This study aims to report the results of primary and revision TKA (R-TKA) using metaphyseal sleeves.


Eligibility criteria: Inclusion Criteria:

* Patients were included if they were older than 18 years and underwent a primary or revision TKA using cement-less metaphyseal sleeves, performed by the same senior surgeon

Exclusion Criteria:

* Patients were excluded from the final analysis if they did not have 18 months of minimum follow-up and if they were lost to the final control.

Primary outcomes:
measure: Evaluation of implant's survivorship
timeFrame: 7 years
Secondary outcomes:
measure: Evaluation of Numerical Rating Scale (NRS)
timeFrame: 7 years
measure: Evaluation of Western Ontario and Mc Master University (WOMAC)
timeFrame: 7 years
measure: Evaluation of Oxford Knee Score (OKS)
timeFrame: 7 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: 2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
state: Milan
Study officials:
References:
Clinical trial NCT04226079: Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding
Official title: Analysis of Volatile Organic Compound (VOC) in Exhaled Breath for the Detection of Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Hemorrhage
Volatile Organic Compounds
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Adults aged 20-80
* Patients who visited emergency room and suspected to have recent or active gastrointestinal bleeding
* Patients who are scheduled to undergo esophagogastroduodenoscopy.

Exclusion Criteria:

* Diagnosis of malignancy diagnosed within 5 years
* Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
* Surgical history of any kind of gastrectomy
* Surgical history of any kind of lung resection which could impact the patient's lung function.

Brief summary: Cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population.

Detailed description: This study investigates the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population. We aimed to find out the biomarkers for GI bleeding.

Eligibility criteria: Inclusion Criteria:

* Adults aged between 20 and 80
* Low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year.
* NSAID non-user (within 1 months before the date of inclusion)

Exclusion Criteria:

* Diagnosis of malignancy diagnosed within 5 years
* Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
* Surgical history of any kind of gastrectomy
* Surgical history of any kind of lung resection which could impact the patient's lung function.

Primary outcomes:
measure: VOC Patterns
timeFrame: 1 day of 1st emergency room (ER) visit for GI bleeding
Secondary outcomes:
measure: Measurement of VOC
timeFrame: 1 day of 1st emergency room (ER) visit for GI bleeding
measure: Change of VOC patterns
timeFrame: 2nd visit (about 2weeks apart from 1st visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin Ju Choi
state: Gyunggi-do
Study officials:
affiliation: Seoul National University Hospital
name: HYUNSOO CHUNG, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03709979: Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope
Official title: Inönü University Department of Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Intubation
Laryngoscopy
Keywords: video laryngoscopy
Pediatric patient
Position
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 96
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.

Detailed description: The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.

The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.

Eligibility criteria: Inclusion Criteria:

* less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery
* American Society of Anesthesiologists' physical status either 1 or 2 are included

Exclusion Criteria:

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation

Primary outcomes:
measure: Percentage of glottic opening score
timeFrame: immediately before endotracheal intubation
Secondary outcomes:
measure: Time to intubation
timeFrame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
affiliation: Inonu University Medical Faculty
name: Zekine Begec, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.
Clinical trial NCT02044679: Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors


Eligibility criteria: Inclusion Criteria:

* Healthy female and male subjects aged 20- 30 years old (both ages included).
* BMI within the range 20-25 kg/m2 (both inclusive).
* Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects.
* Monophasic contraceptive method (female subjects only)
* Smoking less than 10 cigarettes/day
* Fluid intake habits falling within one of three designated arms

Exclusion Criteria:

* Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman.
* Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
* Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.

Primary outcomes:
measure: Osmolality
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: BIOTRIAL
Study officials:
References:
citation: Lemetais G, Melander O, Vecchio M, Bottin JH, Enhorning S, Perrier ET. Effect of increased water intake on plasma copeptin in healthy adults. Eur J Nutr. 2018 Aug;57(5):1883-1890. doi: 10.1007/s00394-017-1471-6. Epub 2017 Jun 3.