linjc16/ctgov huggingface dataset:
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

Study Overview
=================
Brief Summary
-----------------
This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.

Official Title
-----------------
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

Conditions
-----------------
Common Infant Feeding Problems

Intervention / Treatment
-----------------
* Other: Marketed milk-based lactose-containing infant formula
* Other: Marketed milk-based lactose-free infant formula
* Other: Marketed soy-based lactose-free infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between 2 and 12 weeks of age Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet Subject has never switched to any lactose free formula The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea Signed Informed Consent Exclusion Criteria: Subject is in daycare for more than 4 hours per day (20 hours per week) Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment Subject has acute infectious diarrhea or any other intercurrent illness

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 12 Weeks

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Marketed milk-based lactose-containing infant formula<br> | Other: Marketed milk-based lactose-containing infant formula<br> <br> |
| Other: Marketed milk-based lactose-free infant formula<br> | Other: Marketed milk-based lactose-free infant formula<br> <br> |
| Other: Marketed soy-based lactose-free infant formula<br> | Other: Marketed soy-based lactose-free infant formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Infant Temperament Questionnaire |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Characteristic Questionnaire |  | 14 days | 
| Maternal Efficacy Questionnaire |  | 14 days | 
| Mental Health Inventory Questionnaire |  | 14 days |
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

Detailed Description
-----------------
Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.

Official Title
-----------------
APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| 1. Protopic Exposure<br>Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of systemic or cutaneous malignancy | Standardised Incidence Ratio (versus population cancer rates) | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis, child, tacrolimus ointment, Protopic Ointment
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

Study Overview
=================
Brief Summary
-----------------
Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.

Conditions
-----------------
Ambulation Difficulty

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I obtaining written informed consent from the parents aged 1-5 years, and weighing <20 kg who were undergoing ambulatory hernioplasty or orchiopexy Exclusion Criteria: mental retardation developmental delays neurological or psychiatric illnesses coagulation disorder spinal anomalies bilateral procedures

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br> | Drug: Dexmedetomidine<br>* dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.<br>|
| Placebo Comparator: placebo group<br>normal saline | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the reduction rate of ET-sevo in achieving BIS scores from 45-50 |  | 2 hour(during whole operation period) |
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

Study Overview
=================
Brief Summary
-----------------
Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

Detailed Description
-----------------
Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.

Official Title
-----------------
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

Conditions
-----------------
Diabetes, Hyperglycemia, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of AMI, either with or without ST segment elevation Presence of high blood glucose at admission with no previously known diabetes mellitus (DM) Exclusion Criteria: Age under 18 years old History of DM Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease) Unstable AMI patients (haemodynamic instability or arrhythmic disorders) Platelet aggregation or coagulation disorders Severe conditions with an estimated short (under 1 year) life expectancy Participation in other trials Patient refusal to participate in the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Serum saline<br> | Drug: Insulin<br>* intravenous continuous insulin infusion for 48 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control |  | first 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High-sensitivity C-reactive protein levels |  | At 48 hours and aat hospital discharge |
Neisseria Meningitidis Burden of Disease Study

Study Overview
=================
Brief Summary
-----------------
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.

Official Title
-----------------
Neisseria Meningitidis Burden of Disease

Conditions
-----------------
Streptococcus Pneumoniae, Neisseria Meningitidis, Haemophilus Influenzae

Intervention / Treatment
-----------------
* Other: Data collection
* Other: CSF samples testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. Written informed consent obtained from the subject/from the parent(s)/LAR of the subject. A male or female subject who visits the hospital with suspected bacterial meningitis. CSF sample taken as part of routine practice. Exclusion Criteria: Child in care.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br>Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam. | Other: Data collection<br>* Collection of demographic data and vaccination history<br>Other: CSF samples testing<br>* CSF samples will be tested for the determination of N. meningitidis and other likely bacterial pathogens that cause bacterial meningitis (S. pneumoniae and H. influenzae)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of N. meningitis in CSF samples |  | At enrollment (Day 0) | 
| Serogroup of N. meningitis positive samples |  | At enrollment (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further characterization of N. meningitidis using Multi Locus Sequence Typing |  | At enrollment (Day 0) | 
| Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis |  | At enrollment (Day 0) | 
| Serotype of Streptococcus pneumoniae positive samples |  | At enrollment (Day 0) | 
| Further classification of Haemophilus influenzae positive samples into Type B and non-B Types |  | At enrollment (Day 0) | 
| Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition) |  | At enrollment (Day 0) |
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Official Title
-----------------
A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: aura6000 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe obstructive sleep apnea (AHI 15 to 60). Cannot or will not tolerate CPAP treatment. Body mass index (BMI) between 25 and 40 Able to read, understand, sign and date the written informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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: THN Therapy<br> | Device: aura6000 System<br>* The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline. |  | 3 and 12 months post-implant | 
| Adverse events and Serious Adverse events peri and post-operatively |  | 3 and 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline. |  | 3 and 12 months post-operative | 
| Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline. |  | 3 and 12 months post-implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, neurostimulation, hypoglossal nerve
Myocardial Damage in COVID-19

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.

Detailed Description
-----------------
The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.

Official Title
-----------------
Retrospective Study of Myocardial Damage in COVID-19

Conditions
-----------------
COVID-19, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: non


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging. Exclusion Criteria: No cTnI test on admission

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Discharged group<br>The individual which is defined as patient discharged from hospital | Other: non<br>* no intervention<br>|
| Dead group<br>The individual which is defined as patient with all-cause death | Other: non<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The myocardial injury incidence | The myocardial injury incidence of COVID-19 patients | 75 days | 
| The risk factors analysis for the death | The risk factors analysis for the death of COVID-19 patients | 75 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical characteristics | The clinical characteristics description of COVID-19 patients | 75 days | 
| Clinical course | The clinical course description of COVID-19 patients | 75 days | 
| Cardiovascular comorbidity | The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients | 75 days | 
| Analysis of causes of death | Analysis of causes of death in COVID-19 patients | 75 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, myocardial injury
Simplified Nutritional Screening for Patient Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if patients are able to reliably screen themselves for nutrition risk.

Official Title
-----------------
Validation of Nutritional Screening for Patient Use

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Adults aged > 18years Able to complete screening and provide written informed consent Willingness to take part Exclusion Criteria: Children (<18years) Pregnant women Inpatients Unable to complete screen due to physical or mental incapacity Unable to comprehend oral and written English language Participation in other nutrition studies

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| 1<br>Paper screening | |
| 2<br>Electronic screening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the use of a screening tool for patient use |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess prevalence of malnutrition in outpatients |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Screening
The Effect of Dramatization Simulation on Nursing Students' Ethical Attitudes

Study Overview
=================
Brief Summary
-----------------
Nursing students face many ethical problems in their clinical practice. It is very likely that they will encounter ethical problems after graduation. For this reason, students should be given an ethical attitude before graduating. It is very difficult to gain an ethical attitude. Ethical issues, on the other hand, are very difficult to gain as they are a limited concept. Therefore, different methods should be used in teaching. Dramatization simulation is one of the teaching methods used recently. It is especially effective in making abstract concepts that are difficult to understand concrete. It is thought that students participating in a dramatized simulation will be effective in gaining ethical attitudes by recognizing ethical problems more easily. This research will be carried out to determine the effect of dramatization simulation on the ethical attitudes of nursing students.

Detailed Description
-----------------
The effect of dramatization simulation on the ethical attitudes of nursing students will be evaluated.

Official Title
-----------------
The Effect of Dramatization Simulation on Nursing Students' Ethical Attitudes: A Mixed Method Research

Conditions
-----------------
ETIC

Intervention / Treatment
-----------------
* Behavioral: Dramatization simulation
* Behavioral: In-class case studies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Students who agreed to participate in the study Exclusion Criteria: Not participating in dramatization simulation applications, Not participating in classroom ethical case studies
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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>In-class case studies will be conducted. | Behavioral: In-class case studies<br>* In-class case studies will be conducted with the control group students.<br>|
| Experimental: Experimental<br>Case studies will be done in the form of dramatization simulation. | Behavioral: Dramatization simulation<br>* Ethical attitudes of nursing students will be evaluated with dramatization simulation application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ethical attitude | Ethical attitudes of nursing students will be determined by using the ethical principles attitude scale. | Four weeks |