linjc16/ctgov huggingface dataset:
Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.

Study Overview
=================
Brief Summary
-----------------
Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic monitoring are under-utilized when translating research into decision support. Current medical informatic capabilities can be leveraged to calculate trends in measured parameters to initiate a paradigm shift in critical care from reaction-based treatment to proactive and plausibly preventative care. Therefore, the purpose of this study is to develop baseline understanding of our practice and how data collection utilizing a newly implemented system called T3. We would like to retrospectively review mechanically ventilated patients in which we have collected continuous data to test a newly developed analytic platform. Additionally we would like to compare these results to our standards of practice established by clinical practice guidelines.

Official Title
-----------------
Retrospective Review of Mechanically Ventilated Patients

Conditions
-----------------
Mechanical Ventilation, Acute Respiratory Distress Syndrome, Hypoxic Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient selection will be determined by available data collected in the T3 system. We estimate 50 patients in which mechanical ventilator data has been collected utilizing the limited intellibridge modules (4 systems currently available to collect ventilator data). Exclusion Criteria: Patient not connected to T3 data collection system.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 35 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 |
| --- | --- |
| Device utlization following extubation<br> | |
| Pulmonary mechanics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Extubation | Successful extubation without the use of noninvasive ventilation or requiring reintubation | Within 24 hours of extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALI, ARDS, mechanical ventilation
Nutrition and Neurological Development of Very Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between: the quantity of mother's milk and duration and breastfeeding the intake of polyunsaturated fatty acids and iron during hospitalizations

Detailed Description
-----------------
The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants. In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years. The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA < 32 weeks. The secondary objective is : - to evaluate the association between these factors and communication, developmental and social-emotional delays with the test  Ages and Stages questionnaire  (ASQ) at 3 years of age.

Official Title
-----------------
Early Nutrition and Neurological Development of Very Preterm Infants

Conditions
-----------------
Premature Infant, Infant Nutrition Disorders, Delayed Mental Development

Intervention / Treatment
-----------------
* Other: Premature infants with a GA < 32 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants previously included in EPINUTRI study Non opposition of the parents for the collection of clinical and nutritional data Exclusion Criteria: Refusal of the parents to collect clinical and nutritional data

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 3 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 |
| --- | --- |
| Premature infants<br>Premature infants with a GA < 32 weeks | Other: Premature infants with a GA < 32 weeks<br>* At 3 years of age: ASQ (filled in by parents)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological development | Age and Stages Questionnaire | At 3 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature infants, Nutritional status, Polyunsaturated fatty acids status
Unusual Clinical Findings of Herpes Esophagitis

Study Overview
=================
Brief Summary
-----------------
Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host. The investigators case highlights the importance of performing a detailed laryngoscopic examination in any patient with prolonged husky voice.

Conditions
-----------------
Herpes Esophagitis, Vocal Fold Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of Herpes esophagitis with vocal palsy presentation Exclusion Criteria: Patient of Herpes esophagitis without vocal palsy presentation

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 55 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herpes esophagitis, dysphagia, vocal fold palsy, immunocompetent, husky voice
Implementation Study With Decision Support Based on Data

Study Overview
=================
Brief Summary
-----------------
This study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. The software was developed to support general practitioners in the choice of antibiotic regimen.

Official Title
-----------------
Implementation Study With Machine Learning Based Decision Support Software for Treatment of Urinary Tract Infections in General Practice.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a urinary tract infection in general practice Age > 12 years. Exclusion Criteria: No.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Software practices<br>Patients with urinary tract infection in practices using the clinical decision support software | |
| Control practices<br>Patients with urinary tract infection in practices not using the clinical decision support software | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-recurrent UTI | A subsequent period of time after treatment, in which no new UTI treatment was needed | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Machine learning, Clinical Decision Support Systems
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

Study Overview
=================
Brief Summary
-----------------
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Official Title
-----------------
Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

Conditions
-----------------
GERD, Acid Reflux Disease, Heartburn, Regurgitation

Intervention / Treatment
-----------------
* Drug: AZD3355
* Drug: Placebo
* Drug: Gelusil®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject able to read and write US english and able to use electronic devices Subjects who have experienced GERD symptoms for at least six months Subjects currently taking a prescription or over-the-counter PPI medications for GERD Body Mass Index (BMI) 18.5-35.0, inclusive Exclusion Criteria: Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer Prior surgery of the upper Gastrointestinal (GI) tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD3355<br> | Drug: AZD3355<br>* Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks<br>* Other names: Lesogaberan;Drug: Gelusil®<br>* Chewable tablets taken as needed<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* capsule. administered as a single dose twice daily for 4 weeks<br>Drug: Gelusil®<br>* Chewable tablets taken as needed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary | Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) | Run-in period of 8-12 days and treatment period of 26-30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Acid Reflux, Heartburn, Regurgitation, non-acid reflux, PRO measures
Brief Delay in Cord Clamping and Neurobehaviour in Preterms

Study Overview
=================
Brief Summary
-----------------
RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age

Detailed Description
-----------------
Delayed cord clamping (DCC) : Well described phenomenon in term infants . The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate. Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹ This low cost intervention can have significant public health importance in resource constrained settings. The effect of this intervention on neurobehaviour of preterm neonates has not been assessed. This aspect has been identified by WHO and Cochrane as a potentially researchable area

Official Title
-----------------
A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Procedure: early cord clamping
* Procedure: Brief Delay in cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan. Infants delivered vaginally or by caesarean section in cephalic presentation Singleton pregnancy Parental consent Exclusion Criteria: Fetus with gross congenital anomaly Fetus with hydrops Rh negative pregnancy
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early cord clamping<br>cord clamping within 20 sec | Procedure: early cord clamping<br>* early ( <20 seconds)<br>|
| Experimental: brief delay in cord clamping<br>cord clamping delayed by 30 to 60 seconds | Procedure: Brief Delay in cord clamping<br>* delay in cord clamping 30 to 60 seconds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short term neurobehavioral outcome | using N.A.P.I (neurobehavioural assessment of preterm infant) | at 37 weeks post conceptional age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring cord hematocrit |  | at birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm Birth
Urinary and Anal Incontinence in Tunisian Women

Study Overview
=================
Brief Summary
-----------------
The publications on prevalence and risk factors of urinary and anal incontinence in women were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian population may not be a good practice which justifies this study and demonstrates its importance.

Detailed Description
-----------------
A cross-sectional study will be conducted among female doctors and nurses randomly selected from 3 large hospitals in the center of Tunisia. The prevalence of urinary incontinence and anal incontinence will be measured using validated questionnaires.

Official Title
-----------------
Prevalence and Risk Factors for Urinary and Anal Incontinence in Tunisian Middle Aged Women

Conditions
-----------------
Woman

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional seniority in the current service over than 6 months Subject has given his consent Exclusion Criteria: Resident Intern An ongoing pregnancy A recent birth (less than 6 months) A psychiatric disease An acute or chronic kidney disease Neurological disease

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Prevalence of urinary incontinence | The participant will be asked to fill out the urinary symptom profile questionnaire (USP). This questionnaire contains 13 items to assess stress urinary incontinence, urge urinary incontinence and dysuria. Each question is scored from 0 to 3 providing a maximal score of 9, 21 and 9 for stress urinary incontinence, urge urinary incontinence and dysuria respectively. Women diagnosed with both stress and urge urinary incontinence by the USP were classified as having mixed urinary incontinence. | 1 month | 
| Prevalence of anal incontinence | The participant will be asked to fill out the anal incontinence Jorge and Wexner which contains five questions scored on a scale from zero (normal continence) to 20 (total incontinence). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for urinary and anal incontinence |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence, urinary incontinence, anal incontinence, risk factors, women
Risk of Falling in Chronic Kidney Disease 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the relative importance of the frailty and cardiovascular function as potential exercise-modifiable risk factors for falling in patients receiving haemodialysis.

Detailed Description
-----------------
Falls and fall-related injuries in elderly people are common worldwide, and ageing populations will further raise the burden and costs. Within the UK, falls have become a major government target, as they have been responsible for increased injuries and hospital admissions in elderly people. The fall rate amongst patients on haemodialysis (HD) is much greater than in the general population. There are many well established risk factors for falling, many of which are commonly present in patients on HD, including severe loss of muscle mass, high levels of inactivity, co-existing medical conditions and a high number of medications. Nonetheless, the main cause of health complications and death in Chronic Kidney Disease (CKD) is due to cardiovascular disease. Cardiovascular disease may result in suboptimal regulation of blood pressure and heart rate during exercise, dialysis therapy, body transfers, and general activities of daily living. Associated symptoms such as dizziness, generalised fatigue, and muscular weakness, are commonly reported and may further predispose patients on HD to balance deficits and falls. Despite the evidence of high falls rates in patients on HD and the growing number of elderly patients, falls and their associated risk factors have received little research attention. The aim of this study therefore is explore the relative importance of selected exercise-modifiable risk factors for falling amongst patients on HD.

Official Title
-----------------
Frailty, Cardiovascular Function and Risk of Falling in Patients Receiving Haemodialysis Treatment

Conditions
-----------------
Stage 5 Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old Able to write/speak fluent English Stable dialysis Exclusion Criteria: Unstable dialysis and medication treatment Lower limb amputees without prothesis Unstable cardiac condition Suspected or known aneurysm Clinically severe left ventricular outflow obstruction Critical mitral stenosis Critical proximal coronary artery stenosis Critical cerebrovascular stenosis Pregnancy Severe cognitive impairment

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 |
| --- | --- | --- |
| Falls incidence |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty components | muscle strength, balance, gait speed, body composition | baseline |
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Study Overview
=================
Brief Summary
-----------------
Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks

Official Title
-----------------
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Conditions
-----------------
Induction of Labor

Intervention / Treatment
-----------------
* Drug: Propess insertion group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who admitted for induction of labor Bishop score <= 6 Exclusion Criteria: Contraindication to induction of labor Active labor Vaginal bleeding, unknown origin Hypersensitive to Prostaglandin E History of asthma, glaucoma Infection (birth canal) Placental abruption Multiparity(>5) Pelvic inflammatory disease Heart, lung, kidney disease Multiple pregnancy Major anomaly Fetal distress before induction of labor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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: Propess insertion<br> | Drug: Propess insertion group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction success rate after propess insertion |  | Day 1 after propess insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of prostaglandinE |  | at delivery |