linjc16/ctgov huggingface dataset:
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Official Title
-----------------
An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

Conditions
-----------------
Peripheral Neuropathy, HIV Infections

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7 Exclusion Criteria: Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor non-compliant during A0081066 trial clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: pregabalin<br>* 75mg BID, titrated up to 300mg according to individual response and tolerability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Visual Analogue Scale (VAS) Pain Scores | Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit. | Baseline, Week 4, Week 8, Week 12, and Endpoint |
Growth and Safety of a Low Lactose Milk-Based Infant Formula

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Detailed Description
-----------------
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Official Title
-----------------
An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

Conditions
-----------------
Growth, Healthy Term Infants

Intervention / Treatment
-----------------
* Other: Low Lactose Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy term infants birth weight 2500 - 4500 g singleton birth 37 - 42 weeks gestation Exclusion Criteria: clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history receiving medications other than vitamins

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Lactose Infant Formula<br> | Other: Low Lactose Infant Formula<br>* Low Lactose Infant Formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length gain |  | 16 weeks | 
| Occipital Head Circumference |  | 16 weeks | 
| Acceptability and Tolerability | Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy term infants, growth, infant formula
Pneumatic Compression and Post-induction Hypotension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of pneumatic compression on post-induction hypotension in elderly patients undergoing robot assisted laparoscopic prostatectomy.

Detailed Description
-----------------
The purpose of this study is to evaluate the effect of pneumatic compression of lower leg, which is performed during 20 minutes after anesthesia induction period, on post-induction hypotension in elderly patients undergoing robot assisted laparoscopic prostatectomy.

Official Title
-----------------
Effect of the Pneumatic Compression of Lower Leg on Post-induction Hypotension in Elderly Patients Undergoing Robot Assisted Laparoscopic Prostatectomy: a Double Blined Randomized Controlled Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Pneumatic compression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled robot assisted laparoscopic prostatectomy under general anesthesia Elderly patients (between 65 and 79 years old) American Society of Anesthesiologists physical status ≤3 Patients who are voluntarily agreed to this clinical study Exclusion Criteria: Uncontrolled hypertension, heart failure (ejection fraction <40%), arrhythmia requiring treatment, unstable coronary artery disease Patient's denial

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 79 Years

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

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 |
| --- | --- |
| Experimental: Pneumatic compression group<br>When inducing general anesthesia, pneumatic compression is performed. | Procedure: Pneumatic compression<br>* Pneumatic compression with preset pressure and cyclic manner is applied from immediately after anesthesia induction to 20 minutes after anesthesia induction in the both legs.<br>|
| No Intervention: Control group<br>When inducing general anesthesia, pneumatic compression is not performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-induction hypotension | Systolic blood pressure below 90 mmHg | From anesthesia induction to 20 minutes after anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure (systolic, diastolic, and mean) | From anesthesia induction to 20 minutes after anesthesia induction | 
| Heart rate | Heart rate derived from electrocardiography | From anesthesia induction to 20 minutes after anesthesia induction |
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

Study Overview
=================
Brief Summary
-----------------
Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.

Detailed Description
-----------------
The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol. The follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.

Official Title
-----------------
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

Conditions
-----------------
Drowning

Intervention / Treatment
-----------------
* Other: Drowning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lifeguard working on the Girondine Atlantic coast up to 18 years old, no smoker, No chronic pathology. Exclusion Criteria: Chronic cardiac pathology, Chronic respiratory pathology, Acrosyndrome, Smoker.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Lifeguard<br>Lifeguards who work on the Atlantic coast of Gironde France. | Other: Drowning<br>* Measurement of pulse oximetry, after lifeguard immersion during their morning training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of abnormal pulse oximetry measure | Quantify the number of subjects, whose pulse oximetry is measured as abnormal (superior to 94%) after immersion for 15 min in the ocean, in real condition. | 3 months after inclusion day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of pulse oximetry according to individuals factors | Measures of immersion time, BMI before / after immersion. | 3 months after inclusion day | 
| Variation of pulse oximetry according to environnementals factors | Measures of air, water temperatures, felt air temperature, wet thermometer temperature, wind speed before / after immersion. | 3 months after inclusion day |
DPBRN Assessment of Caries Diagnosis & Caries Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine what methods Dental PBRN dentists use for diagnosis, prevention, and treatment of dental decay.

Detailed Description
-----------------
The purpose of this project was to identify methods that Dental Practice-Based Research Network (DPBRN) dentist used to diagnose and treat caries lesions. The aims of the Assessment of caries diagnosis and caries treatment study were to: (1) quantify the percentages of DPBRN dentists who reported using selected methods for caries diagnosis; (2) quantify the percentage of DPBRN dentists who reported using a caries-risk assessment protocol of any variety; (3) quantify the percentages of DPBRN dentists who reported intervening surgically at carious states E1, E2, D1, D2, or D3; and (4) test the hypothesis that reported use of a caries-risk assessment protocol was associated with a higher likelihood of reporting use of a preventive program. The aims were met by enrolling at least 200 DPBRN practitioner-investigators in the study, each of whom completed a 10-page questionnaire about caries diagnosis and treatment assessment. Findings from Assessment of Caries diagnosis and caries treatment study will be related to treatment that is actually delivered as determined in Reasons for placing the first restoration on permanent tooth surfaces study and Reasons for replacement or repair of dental restorations study. This group of three studies will lay a critical foundation for subsequent intervention studies designed to move the latest scientific advances about caries diagnosis and treatment into daily clinical practice.

Official Title
-----------------
Assessment of Caries Diagnosis & Caries Treatment

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Dental Preventive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practitioner investigators must have been enrolled in DPBRN and do at least some restorative dentistry in their practices.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Dental Preventive|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A questionnaire was used to quantify the percentages of DPBRN practitioner-investigators who use selected methods for caries diagnosis and caries treatment. |  | Cross-sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Questionnaire, dental caries, diagnosis,treatment
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes

Study Overview
=================
Brief Summary
-----------------
The study was conducted to investigate how postural changes including sitting, supine, and LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes and the fellow eyes in each body position.

Conditions
-----------------
Silicone Tamponade

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had a 23-gauge pars plana vitrectomy must be done with SO(silicone oil,5,000 centistrokes) endotamponade using the Accurus system (Alcon Laboratories, Inc, Hünenberg,Switzerland) Exclusion Criteria: previous history or presence of glaucoma or uveitis IOP of ≥24 mmHg use of any antiglaucoma agents narrow angles corneal abnormality or diseases that could affect IOP refractive error exceeding a spherical equivalent of 6 diopters.

Ages Eligible for Study
-----------------
Minimum Age: 33 Years
Maximum Age: 70 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 |
| --- | --- |
| silicone oil fiiled eye<br>those with a condition | |
| fellow eye<br>the contralateral eye in the same patient | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP(intraocular pressure) at each time point during the change in body position |  | 100 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP(intraocular pressure)differences between the SO(silicone oil)-filled eye and the fellow eyes at each time point during the change in body position |  | 100 minutes |
Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The new assay of troponins T (highly sensitive troponins) detects concentrations much lower than before. Few data are currently available on their kinetics during acute coronary syndrome, especially in regard to the correlation with CK MB. The aim of the present study is to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value with respect to infarct size .

Detailed Description
-----------------
Patients who meet the inclusion criteria will have a highly sensitive troponins and CKMB assays q 8hr for the first day, and q 12h for the next 2 days. If clinically not indicated, the blood sample can be cancelled at any time, as in the case of a patient with an initial suspicion of acute coronary syndrome in which the final diagnosis is something else. Only patients with a definitive myocardial infarction will be analyzed. Subgroup analyses includes ST-elevation MI, Non ST-elevation MI, revascularization vs no revascularization, procedural myocardial infarction. Another analysis conducted is the correlation between the values of troponin and infarct size by echocardiography (in patients who have an echocardiography 2-7 days post AND 2-6 months post myocardial infarction)

Official Title
-----------------
Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years-old Clinical suspicion of an acute coronary syndrome; (will be analyzed only patients with aposteriori definitive diagnosis of unstable angina or myocardial infarction) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Evaluation of troponins kinetic in acute coronary syndromes. |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Creatine Kinase, MB form, Troponin, Acute coronary syndrome, myocardial infarction, Unstable angina
Vaccine Hesitancy: A Survey of Pediatric Clinicians

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the experiences and perceptions of District VI pediatric clinicians on parental vaccine hesitancy and vaccine refusal.

Detailed Description
-----------------
This is a retrospective, convenience sample, descriptive study. Participants will be asked to complete a web-based survey on parental vaccine hesitancy/ vaccine refusal. Survey responses are primarily categorical. Frequencies and averages will be reported using group statistics.

Official Title
-----------------
Vaccine Hesitancy: A Survey of District VI Pediatric Clinicians

Conditions
-----------------
Vaccine Hesitancy, Vaccine Refusal

Intervention / Treatment
-----------------
* Other: web-based survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of District VI American Academy of Pediatrics Exclusion Criteria: Non-English speaking/reading
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 |
| --- | --- |
| District VI AAP clinicians<br> | Other: web-based survey<br>* Anonymous web-based survey<br>|

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
-----------------
vaccine hesitancy, vaccine refusal
POCARED Diagnostics, LTD, Field Study Protocol

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.

Detailed Description
-----------------
This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the P-1000.

Official Title
-----------------
POCARED Diagnostics, LTD, Field Study Protocol

Conditions
-----------------
Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples arriving in the laboratory for urine culture Exclusion Criteria: Samples <=2mL Specimens stored at room temperature for more than 2 hours (unless a preservative is used) Specimens refrigerated for more than 24 hours Specimens requesting low count urine culture (<100,000 CFU/mL [colony forming units per milliliter]) Bloody specimens
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement | Agreement of the POCARED quantification and identification compared with standard methods. | 6 months | 
| Sensitivity | Sensitivity of the POCARED quantification and identification compared with standard methods. | 6 months | 
| Specificity | Specificity of the POCARED quantification and identification compared with standard methods. | 6 months |
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

Study Overview
=================
Brief Summary
-----------------
This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.

Official Title
-----------------
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

Conditions
-----------------
Byler Disease

Intervention / Treatment
-----------------
* Drug: Glycerol phenylbutyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Byler Disease Cholestasis Tolerance of Buphenyl therapy Exclusion Criteria: Allergy/Hypersensitivity to RAVICTI

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glycerol phenylbutyrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |