linjc16/ctgov huggingface dataset:
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

Detailed Description
-----------------
Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.

Official Title
-----------------
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

Conditions
-----------------
Sleep Deprivation, Healthy Volunteers, Diaphragm

Intervention / Treatment
-----------------
* Behavioral: Sleepless night
* Behavioral: Normal sleep night


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adult volunteers Aged 25 to 45 years Regularly sleeping more than 6 hours per night Not excessive coffee consumers (< 3 expressos / day) Non smokers Absence of respiratory, cardiac, muscular or neurological disease or diabetes With a neutral Horne & Ostberg score Exclusion Criteria: Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations) History of epilepsy or syncope during sleep deprivation Taking medications that interfere with sleep (antidepressants, benzodiazepines…)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Normal sleep night. | Behavioral: Normal sleep night<br>* Normal sleep at home before trial.<br>|
| Other: Group 2<br>Sleepless night. | Behavioral: Sleepless night<br>* Each subject will undergo 28 hours of sleep deprivation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop. |  | The day after one normal night or one sleepless night. |
24-Wk β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males

Study Overview
=================
Brief Summary
-----------------
Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.

Official Title
-----------------
24-Weeks of β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males

Conditions
-----------------
Sports Nutritional Physiological Phenomena

Intervention / Treatment
-----------------
* Dietary Supplement: Beta-alanine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Exclusion Criteria: Smokers Chronic disease Prior or current use of steroids Use of creatine in the last 6 months Use of beta-alanine in the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-Alanine<br>6.4 g/day of beta-alanine for 24 weeks | Dietary Supplement: Beta-alanine<br>* Beta-alanine in sustained-release tablets to increase muscle carnosine content<br>|
| Placebo Comparator: Placebo<br>6.4 g/day of maltodextrin for 24 weeks | Dietary Supplement: Placebo<br>* Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle taurine content in mmol/kg | Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L | Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase will be analysed from venous blood samples | Up to 24 weeks | 
| Albumin; globulin; creatinine in mg/dL | Albumin; globulin; creatinine will be analysed from venous blood samples | Up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiological Phenomena
BGS Neonatal Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.

Official Title
-----------------
Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study

Conditions
-----------------
Pain From Heel Sticks

Intervention / Treatment
-----------------
* Device: BabyGentleStick
* Device: Standard Lancing Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth Sex: male or female Exclusion Criteria: Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders) Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5) Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS) Critical illness in the mother preventing the ability to obtain informed consent from parents

Ages Eligible for Study
-----------------
Minimum Age: 35 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>BabyGentleStick | Device: BabyGentleStick<br>* Experimental device.<br>|
| Active Comparator: Standard of Care<br>HMC Standard Lancing Device | Device: Standard Lancing Device<br>* HMC standard of care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | No device-attributable adverse events. | Up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Response | Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale | 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure |
The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels

Study Overview
=================
Brief Summary
-----------------
To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart

Official Title
-----------------
The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm

Conditions
-----------------
Ischaemia-reperfusion (IR) Injury

Intervention / Treatment
-----------------
* Drug: C-type natriuretic peptide (CNP)
* Drug: Saline
* Drug: Acetylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy human volunteers on no systemic medication, excepting the oral contraceptive pill Exclusion Criteria: History of medical illness Unwillingness to sign consent form Use of non-OCP medications Hypertension on examination of the blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNP<br>Infusion of CNP prior to IR injury | Drug: C-type natriuretic peptide (CNP)<br>* 360 pmol/min for 15 minutes intra-arterially<br>Drug: Acetylcholine<br>* 2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb<br>|
| Placebo Comparator: Saline<br>Effect of saline infusion prior to IR injury | Drug: Saline<br>* Sodium Chloride 0.9% intra-arterially 0.5ml/min<br>Drug: Acetylcholine<br>* 2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area under curve dose-response to acetylcholine after IR injury |  | 2h |
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

Study Overview
=================
Brief Summary
-----------------
In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.

Official Title
-----------------
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

Conditions
-----------------
Epidermolysis Bullosa

Intervention / Treatment
-----------------
* Combination Product: APR-TD011


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa Target wound that has been present for at least 3 weeks and is at least 10 cm2 Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa Exclusion Criteria: Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics Do not agree to avoid bathing or topical application at the target starting the night before the visit. Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EB participants<br>Visits will include screening, pre-treatment (week 0), weeks 4 and 8, followed by a visit without use of the APR-TD011 for 4 weeks (week 12) for microbiome assessment off of therapy. | Combination Product: APR-TD011<br>* APR-TD011 wound cleansing spray (drug/device combination product with a 510k clearance that is commercially marketed in the US for use by or on the order of a physician. Based on its product profile, APR-TD011 has been granted an FDA Orphan Drug Designation for epidermolysis bullosa.<br>* Other names: Nexodyn AOS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome species | Reduction of Staphylococcus aureus between baseline and Week 8. | 8 weeks |
Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: tourniquet inflated
* Other: tourniquet not inflated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion Diagnosis of osteoarthritis Exclusion Criteria: Revision surgery Bilateral knee surgery Age <18 or >80 BMI >40 Baseline lower extremity strength less than 5/5 Vascular calcifications History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours Functionally limiting spine disease Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease) Patients who cannot perform the baseline functional tests Allergy/contraindication to protocol medications Post-traumatic arthritis Inflammatory arthritis Pregnancy Prisoners Patients receiving care as part of a worker's compensable injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tourniquet<br>These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure | Other: tourniquet inflated<br> <br> |
| Other: No tourniquet<br>These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure | Other: tourniquet not inflated<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timed up and go (TUG) score |  | 4 weeks following surgery | 
| Stair Climb test | time, in seconds, to climb one flight of nine stairs | in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op | 
| Visual Analog Scale: Pain |  | in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | calculated blood loss determine by hemoglobin dilution | intra-operative | 
| surgical field visualization | subjective rating provided by the surgeon | intra-operative | 
| range of motion | measured, in degrees, using a goniometer | in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op |
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.

Study Overview
=================
Brief Summary
-----------------
Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.

Official Title
-----------------
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Chloroprocaine
* Drug: Marcaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults under rachianesthesia Exclusion Criteria: Personal history of gastric ulcus ASA 4 Emergency Combined surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Marcaine<br>Rachianesthesia with marcaine or chloroprocaine | Drug: Marcaine<br>* The Group Marcaine will receive: Marcaine: 12,5 mg in rachianesthesia<br>|
| Active Comparator: Chloroprocaine<br>Rachianesthesia with marcaine or chloroprocaine | Drug: Chloroprocaine<br>* The Group Chloroprocaine will receive: Chloroprocaine: 50 mg in rachianesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute pain |  | 1 day of the surgery when patient leave the recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain |  | at 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All
Neuropsychological Effects of Strengthening Exercise for Older Adults

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the benefits to thinking processes of a low intensity, strengthening exercise program for older adults.

Detailed Description
-----------------
The neuropsychological benefits, especially executive function impacts, of four weeks of a low intensity, strengthening exercise program will be examined for community residing older adults.

Official Title
-----------------
Neuropsychological and Physiological Effects of Low-Impact Exercise for Older Adults

Conditions
-----------------
Cognitive Ability, General

Intervention / Treatment
-----------------
* Behavioral: strengthening exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: independent living older adult interested in strengthening exercise program Exclusion Criteria: must meet Strong Bone's screening criteria or have physician's approval

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: strengthening exercise<br>A low intensity strengthening exercise program based on the Tufts University Strong Bones program. Utilizes small free weights and chair exercises. | Behavioral: strengthening exercise program<br>* A low intensity strengthening exercise program based on the Tufts University Strong Bones program. Utilizes small free weights and chair exercises. Participants attend community based class 2-3x/wk for 4 wks.<br>* Other names: Strong Bones;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Function |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropsychological function, cognitive function, exercise, older adult
Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

Study Overview
=================
Brief Summary
-----------------
As principal objective, the study aims to: Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax; Establish the physiopathological basis of Fowler's syndrome; Identify FLVCR2 partners and the signaling pathways involved; Test new candidate genes: GPR124 and possible partners of FLVCR2. As second objective, the study aims to: perform phenotype / genotype correlation if necessary; and propose a prenatal diagnosis in families with identified mutations.

Official Title
-----------------
Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

Conditions
-----------------
Proliferative Vasculopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angiodysplasia restricted to central nervous system with or without glomerular vasculopathy. Informed consent signed. Exclusion Criteria: Vascular malformations not confined to the nevrax. No signature of consent.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological analysis | Morphological analysis : characterisation of cellular lesions by immunolabelling with endothelial markers such as CD34 and CD31, pericytic markers (smooth muscle actin and proteoglycan NG2) and astrocytic markers (GFAP) | throughout the study: 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of novel disease | Identification of novel disease causing genes in addition to FLVCR2 by whole exome sequencing. Fetus with clinical VPCA and no FLVCR2 mutation found by Sanger sequencing, will be studied by whole exome sequencing in order to find mutation in other genes that could explain the phenotype. | throughout the study: 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fowler syndrome