linjc16/ctgov huggingface dataset:
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.

Detailed Description
-----------------
We hypothesize that increased cognitive fatigue would vary as a function of heart rate variability and skin conductance. A machine learning model will be developed that predicts cognitive fatigue through these physiological responses (Lee et al., 2021). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Official Title
-----------------
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance

Conditions
-----------------
Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Skin Conductance

Intervention / Treatment
-----------------
* Other: Baseline
* Other: Fatigue Manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singapore-based Non-clinical 18-35years Exclusion Criteria: Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing Individuals with a history of ear, developmental, neurological, or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatigue Manipulation<br> | Other: Baseline<br>* 5-min urban park video clip (Presented on a TV)<br>Other: Fatigue Manipulation<br>* 20-min 2-back task (Presented on a computer)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Back Task (Change) | Change in Accuracy over time | during fatigue manipulation | 
| 2-Back Task (Change) | Change in Reaction Time over time | during fatigue manipulation | 
| Fatigue State Questionnaire | Fatigue State Questionnaire Score | up to 5 mins after fatigue manipulation | 
| Electrocardiograph (Change) | Change in Heart Rate Variability over time | during fatigue manipulation | 
| Electrodermal Activity (Change) | Change in Skin Conductance Level over time | during fatigue manipulation | 
| Electrodermal Activity (Change) | Change in Skin Conductance Response over time | during fatigue manipulation |
Digital Photographs to Evaluate Blepharoptosis

Study Overview
=================
Brief Summary
-----------------
To compare measurements made by a computer software (ImageJ) made on photographs to the traditional clinical measures with a ruler in the evaluation of blepharoptosis

Official Title
-----------------
Comparison Between Clinical Measurements and Computer-based Measurements on Digital Photographs to Evaluate Blepharoptosis

Conditions
-----------------
Blepharoptosis

Intervention / Treatment
-----------------
* Other: Method comparison


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old or older Patients presenting for evaluation of blepharoptosis of any kind except the one mentioned in the exclusion criteria Exclusion Criteria: Myasthenia gravis Thyroid eye disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical measurements<br>Measurements are made with a paper ruler | Other: Method comparison<br> <br> |
| Smartphone<br>Measurements are made with ImageJ from pictures taken with an iPhone 6 | Other: Method comparison<br> <br> |
| Digital camera<br>Measurements are made with ImageJ from pictures taken with a Nikon D700 | Other: Method comparison<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of measurements made on photographs to evaluate blepharoptosis | Comparison between measurements made on digital photographs with measurements made with a ruler in clinic | Same day | 
| Reliability of measurements made on photographs taken by smartphone to evaluate blepharoptosis | Comparison between measurements made on digital photographs taken by smartphone with measurements made on digital photographs taken with a digital camera | Same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photo
Pediatric Validation of CONOX Monitor During Surgery

Study Overview
=================
Brief Summary
-----------------
Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery

Official Title
-----------------
Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study

Conditions
-----------------
Anesthesia, Anesthesia Awareness, Nociceptive Pain, Pediatric ALL, Surgery, Pain

Intervention / Treatment
-----------------
* Device: Validation of qCON versus BIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General Anesthesia using propofol, sevoflurane or desflurane ASA I - IV Surgical procedure longer than 60 minutes Exclusion Criteria: Neurological disorders Inability to correctly place BIS and CONOX probes in forehead Pregnancy Active prescription for drugs involving chronic pain and / or central nervous system Hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CONOX<br>Patients are monitored with BIS and CONOX | Device: Validation of qCON versus BIS<br>* Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined<br>* Other names: Validation of qNOX Vs MOAA/S Scale;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of qCOX and BIS values | Both values are correlated by a blind investigator | prospective data acquisition through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of qNOX and MOAA/S values | Both values are correlated by a blind investigator | prospective data acquisition through study completion, an average of 1 year |
Gut Microbiome Associated Study of Shanghai Infants With Jaundice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

Detailed Description
-----------------
This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

Official Title
-----------------
Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

Conditions
-----------------
Gastrointestinal Microbiome

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns with jaundice treated with blue light phototherapy Exclusion Criteria: Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 28 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: blue light phototherapy<br>the patients in this arm will not receive probiotics. | |
| Experimental: probiotics concurrent with phototherapy<br>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks | Dietary Supplement: Probiotics<br>* the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5*10^7CFU for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA | change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from birth on gut microbiome at 7 days by 16S rRNA | change of the gut microbiome will be calculated at 7 days in comparison with baseline | 7 days | 
| change from birth and 7 days on gut microbiome at 14 days by 16S rRNA | change of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infants, Jaundice, Probiotics, Gut Microbiome
Effectiveness and Security Testing of a Mobile App

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit/hyperactivity disorder comparing 40 patients with treatment as usual (TAU) with 40 patients with TAU plus the mobile App

Official Title
-----------------
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Device: Mobile app
* Combination Product: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of attention-deficit/hyperactivity disorder High emotion dysregulation severity Aged 14 to 17 years Outpatient setting (Consorci Sanitari del Maresme Exclusion Criteria: Comorbidity with mental retardation Comorbidity with psychotic disorder Comorbidity with autism spectrum disorder

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment as usual plus mobile app<br>Those who will receive naturalistic treatment in outpatient setting and also the mobile app | Device: Mobile app<br>* Medical device for improving emotion dysregulation<br>Combination Product: Treatment as usual<br>* Bimonthly individual psychotherapy and psychostimulant medications<br>|
| Active Comparator: Treatment as usual<br>Those who will receive naturalistic treatment in outpatient setting but not the mobile app | Combination Product: Treatment as usual<br>* Bimonthly individual psychotherapy and psychostimulant medications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion dysregulation severity | Severity of emotional dysregulation as measured by a single score from the The DERS (Difficulties in Emotion Regulation Scale) (range: 0-88; the higher the score, the more severe the emotion dysregulation severity). | 9 months | 
| Smartphone addiction | Severity of smartphone addiction as measured by the Spanish version of the The Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity). | 9.months |
Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.

Official Title
-----------------
A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician. Exclusion Criteria: Currently treated with NovoMix® 30 Subjects who are unlikely to comply with protocol requirements Previously enrolled in this study Hypersensitivity to biphasic insulin aspart or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion<br>* Other names: BIAsp30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life from baseline (using QoLD questionnaire) |  | From baseline to 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | After 26 weeks | 
| Efficacy |  | After 26 weeks |
Sedation During Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
Patients during spinal anesthesia should be sedated.

Detailed Description
-----------------
Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

Official Title
-----------------
A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial

Conditions
-----------------
Sedation During Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged from 18 to 40 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities. Exclusion Criteria: Age: younger than 18 or older than 40. Psychatric or neurological disorders. Cardiovascular disorders. Coagulation disorders. Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min | Drug: Ketamine<br>* Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min<br>* Other names: Ketalar;|
| Active Comparator: Midazolam<br>Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min | Drug: Midazolam<br>* Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min<br>* Other names: dormicum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score | assessed by modified observer's assessment of alertness/sedation score | 90 min after the tested drug adminisred |
A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.

Official Title
-----------------
A Double-Blind Randomized, Double-dummy, Placebo-controlled, Parallel-Group Study of the Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults

Conditions
-----------------
Caffeine Dependence

Intervention / Treatment
-----------------
* Dietary Supplement: Alpinia Galanga
* Dietary Supplement: Alpinia Galanga
* Dietary Supplement: Microcellulose crystalline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of regular caffeine consumption. Body mass index (BMI) of ≥18.5 and <25.00 kg/m2. Fasting blood glucose < 126 mg/dl Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements. Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit. Exclusion Criteria: Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit. Known cases of type II Diabetes Mellitus. Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication. Participants suffering from primary or secondary insomnia with/ without active treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpinia galanga<br>EnXtra: 2 capsules to be taken twice daily after breakfast and evening. | Dietary Supplement: Alpinia Galanga<br>* 2 capsules<br>|
| Active Comparator: Composite (Alpinia galanga + Caffeine)<br>Composite: 2 capsules to be taken twice daily after breakfast and evening. | Dietary Supplement: Alpinia Galanga<br>* 2 capsules<br>* Other names: Caffeine;|
| Placebo Comparator: Placebo<br>Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening. | Dietary Supplement: Microcellulose crystalline<br>* 2 capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ECG from baseline to end of the treatment. | ECG parameters including PR interval, QRS duration, QT interval and RR interval will be evaluated from baseline and end of the treatment | 84 Days |