linjc16/ctgov huggingface dataset:
Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Our aim is to determine if a patient-directed intervention is more effective than computerized clinician reminders alone for improving aspirin use in adults with diabetes.

Detailed Description
-----------------
Many patients with diabetes do not use aspirin to prevent cardiovascular events. Quality improvement initiatives involving both patients and physicians may be more effective than physician-directed approaches alone. In a large urban primary care internal medicine practice, this study seeks to test if a patient-directed intervention is more effective than computerized clinician reminders alone for improving the appropriate use of aspirin in adults with diabetes. The study design is a cluster-randomized trial by physician. The frequency of self-reported regular aspirin use will be compared between patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

Official Title
-----------------
Improving Appropriate Aspirin Use Among Adults With Diabetes in a Primary Care Setting: Using an Electronic Medical Record to Target a Physician-supervised Nurse Practitioner Intervention

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Electronic prompt plus patient-directed intervention
* Behavioral: Electronic prompt to clinician to prescribe aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Age at least 40 years old At least 2 clinic visits in the 18 months prior to the intervention Exclusion Criteria: Primary care physician declined enrollment

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Electronic prompt plus patient-directed intervention|nan|
|Behavioral: Electronic prompt to clinician to prescribe aspirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported aspirin use daily or every other day. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, cardiovascular diseases, aspirin, quality of healthcare
Validation Study of the CORNELL ASSESSMENT PEDIATRIC DELIRIUM (CAPD) Scale in Italian Language

Study Overview
=================
Brief Summary
-----------------
70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

Detailed Description
-----------------
The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic. In this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement). The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Official Title
-----------------
Validation Study of the CORNELL ASSESSMENT PEDIATRIC DELIRIUM (CAPD) Scale in Italian Language

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Behavioral: CAPD scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PICU admission Comfort Behavioral Score > 11 Exclusion Criteria: use of neuromuscular blocking agents at the moment of CAPD evaluation Comfort Behavioral Score < 11

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children admitted in PICU<br>children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later. | Behavioral: CAPD scale<br>* Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inter-evaluator agreement | CAPD evaluation by two operators | 1 hour during PICU stay | 
| intra-evaluator agreement | CAPD evaluation by two operators | 2 minutes during PICU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delirium, monitoring
Optimal Timing for Repair of Right-to-Left Shunt Lesions

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects. The secondary aim being define the criteria for failing medical therapy.

Detailed Description
-----------------
In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia. Study Design and Methodology: Retrospective chart review - approximately 75 patients Preoperative data: Diagnosis Operative data: Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared Postoperative data: Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Official Title
-----------------
Optimal Timing for Repair of Right-to-Left Shunt Lesions

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect Exclusion Criteria: those who do not meet inclusion criteria

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiac, repair of right to left shunt lesions, Tetralogy of Fallot defects
Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Detailed Description
-----------------
32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes. After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Official Title
-----------------
Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: SENSIMED Triggerfish®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer without previous ocular medical history 18 years or more at inclusion Maximal weight: 100kg BMI lower or equal to 30 kg/m2 Subjects having provided informed consent Exclusion Criteria: Silicone allergy Cardiovascular disease Diabetes Narrow or closed iridocorneal angle

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SENSIMED Triggerfish®|Soft contact lens-based device for the continuous monitoring of IOP fluctuations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT |  | 30-45 min after WDT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Triggerfish, Water drinking test
Home Therapy With Replagal in Fabry Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the clinic or at doctor's practice.

Official Title
-----------------
Non Interventional Study of Replagal® Home Therapy in Patients With Fabry Disease

Conditions
-----------------
Fabry Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Male or female patient with a confirmed diagnosis of Fabry disease Age> 4 years Patient is under Replagal since at least 12 weeks ® therapy The patient is compliant, the previous Replagal ® infusions were performed approximately every 2 weeks in the center close to home or at the hospital / general practitioner at Patient has been well tolerated Replagal ® therapy, and there were in the last 12 weeks before inclusion in this study no significant infusion reactions to The patient has been selected before inclusion in this study for a home infusion therapy and has consented to (or their legal representative) The patient / be lawful. Representative has consented in writing to participate in this study. Exclusion Criteria: Patient/legal representative does not give consent to participation in this study Patient/legal representative declines Replagal® home therapy The patient is participating in a clinical trial with a medicinal product

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fabry's Disease under Replagal<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction estimated on a 10-ary Likert scale |  | comparison of baseline to 12 months value | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (per infusion) and severity of infusion-related side effects |  | baseline compared to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with proven Fabry's Disease
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.

Detailed Description
-----------------
Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.

Official Title
-----------------
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

Conditions
-----------------
Tracheal Intubation

Intervention / Treatment
-----------------
* Drug: triamcinolone acetonide
* Drug: chlorhexidine gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II, aged between 20 and 70 years scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation Exclusion Criteria: recent respiratory tract infection or sore throat who were using analgesics or steroid preoperatively who have risk factors for oral cavity infection the surgical duration < 60 minutes or > 300 minutes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: triamcinolone<br> | Drug: triamcinolone acetonide<br>* paste applied over tracheal tube for lubrication<br>|
| Placebo Comparator: chlorhexidine<br> | Drug: chlorhexidine gluconate<br>* jelly applied over tracheal tube for lubrication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of postoperative sore throat |  | postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of postoperative sore throat |  | postoperative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative sore throat, tracheal intubation, lubrication, triamcinolone
Glycemic Index and Polyphenol Bioavailability of Potatoes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the glycemic index of four varieties of potatoes and to determine the bioavailability of polyphenols contained in these potatoes.

Detailed Description
-----------------
Ten healthy persons will have a fasting blood sample drawn and asked to randomly consume a 50g glucose drink (2 occasions), or 50g carbohydrate equivalent of cooked purple, red, yellow and white potatoes. Further blood samples will be obtained at 15,30, 45, 60, 90, 120, 180, 240 mins. Bloods from the first 2 hours will be analyzed for glucose and insulin to determine the glycemic response. Hourly blood samples will be analyzed for polyphenol to determine the bioavailability of polyphenols from the different potato variety. Urine samples will be collected before ingestion of the food items and again at 4 hours, and will be used to determine polyphenol bioavailability.

Official Title
-----------------
A Trial to Measure the Glycemic Index and Polyphenol Bioavailability of Four Different Varieties of Potato.

Conditions
-----------------
Diabetes, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Glycemic response to different varieties of potatoes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, non-smoker on no medication normal glucose tolerance willing to have a catheter inserted in forearm Exclusion Criteria: abnormal glucose tolerance abnormal BMI on medication for a chronic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose Standard<br> | Other: Glycemic response to different varieties of potatoes<br>* the glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard<br>* Other names: Yellow potaot;|
| Experimental: Potato Variety<br> | Other: Glycemic response to different varieties of potatoes<br>* the glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard<br>* Other names: Yellow potaot;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic response |  | 2 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of polyphenols from potatoes |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemic index, Anthocyanin, Potato, Polyphenol
Effect of Feeding Mode on Infant Growth and Cognitive Function

Study Overview
=================
Brief Summary
-----------------
This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.

Official Title
-----------------
Effect of Feeding Mode on Infant Growth and Cognitive Function

Conditions
-----------------
Infant Nutrition

Intervention / Treatment
-----------------
* Other: Investigational nutrient-rich whey protein formula
* Other: Cow's milk based formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 0-120 days of age at study entry Term infant with birth weight of 2500 to 4500 grams Exclusively feed infant formula or exclusively feeding breast milk Signed informed consent Exclusion Criteria: History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised. Feeding difficulties or formula intolerance Receiving complementary feedings

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 120 Days

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational nutrient-rich whey protein formula<br> | Other: Investigational nutrient-rich whey protein formula<br> <br> |
| Active Comparator: Cow's milk based formula<br> | Other: Cow's milk based formula<br> <br> |
| No Intervention: Breast milk<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 24 months | 
| Auditory Event-related Potential |  | 24 months | 
| Body length |  | 24 months | 
| Head circumference |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake |  | 24 months | 
| Medically confirmed adverse events |  | 24 months | 
| Body Composition: Air Displacement Plethysmography |  | 6 months | 
| Body Composition: Deuterium Dilution |  | 12 and 24 months | 
| Blood sample: Micronutrient status |  | 24 months | 
| Blood sample: Metabolic markers |  | 24 months | 
| Bayley Scales of Infant and Toddler Development |  | 12 months | 
| Sleep measures (Amount of time awake & asleep in a 7-day period) |  | 24 months | 
| Language development: Native3 Phoneme Repertory |  | 12 months | 
| Language development: Word Discovery |  | 10 months | 
| Language development: Rule Inference |  | 10 months | 
| Language development: MacArthur Communicative Development Inventory |  | 24 months |
High Body Mass Index and Severity of Coronavirus

Study Overview
=================
Brief Summary
-----------------
A cohort study included 114 adult patients with confirmed COVID-19 were categorized by BMI levels on admission: overweight (25-29.9 kg/m2), and obesity (four categories: 30-34.9 kg/m2, 35-39.9 kg/m2, 40-44.9 kg/m2, and ≥45 kg/m2).

Official Title
-----------------
High Body Mass Index and Severity of Coronavirus Disease 2019 (Covid-19): a Cohort Study

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Other: prospective cohort in high body mass index patient with covid 19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 18 years confirmed COVUID 19 infection body mass index more than 25kg/m2 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: prospective cohort in high body mass index patient with covid 19|A cohort study included 114 adult patients with confirmed COVID-19 were categorized by BMI levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pneumonia | patients percentages | 30 days | 
| sever pneumonia | patients percentages | 30 days | 
| ICU admission | patients percentages | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | days | 30 days | 
| clinical complication | patients percentages | 30 days |