linjc16/ctgov huggingface dataset:
Effect of COVID-19 Related COntainment in ChildreN

Study Overview
=================
Brief Summary
-----------------
The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

Detailed Description
-----------------
Parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. A clinical researcher of pediatric clinical investigation center will collect the responses. If one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assistant to answer the questionnaire. In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria. The duration of the study / participant call and effective response to the questionnaire by the holder of parental authority and the child will takes a maximum of 20 minutes.

Official Title
-----------------
Effect of COVID-19 Related COntainment in ChildreN

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: cries 13 questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate Exclusion Criteria: children aged under 8 and over 15 children whose parents are opposed children refusing to participate holders of minor parental authority

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children between 8 and 15 years old<br>answer to the CRIES 13 questionnaire | Other: cries 13 questionnaire<br>* Participant will be contacted by telephone by a clinical research assistant to answer the CRIES 13 questionnaire. In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of post traumatic stress disorder | Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020 | 1 month |
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.

Official Title
-----------------
A Single Center, Open Label, Single Arm Trial To Evaluate The Effect Of Twenty Four Weeks Of Treatment With 80 Mg To 320 Mg Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance (Igt)

Conditions
-----------------
Hypertension, Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history or presenting hypertension Elevated fasting blood glucose levels - Exclusion Criteria: Pregnancy potential Diabetes mellitus Other criteria apply -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan|24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline insulin sensitivity after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the function of cells that line blood vessels after 24 weeks |  |  | 
| Change from baseline in markers of vascular inflammation after 24 weeks |  |  | 
| Adverse events and serious adverse events at each study visit for 24 weeks |  |  | 
| Hematology, blood chemistries, and urine measurements for up to 24 weeks |  |  | 
| Vital signs and physical examinations for up to 24 weeks |  |  |
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

Study Overview
=================
Brief Summary
-----------------
Determine the consequences of COVID-19 pandemic on routine targeted surgeries. Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation. The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.

Official Title
-----------------
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

Conditions
-----------------
COVID-19 Pandemic, Surgery, Cataract, Hip Arthroplasty, Knee Arthroplasty, Coronary Stent, Pacemaker

Intervention / Treatment
-----------------
* Procedure: surgical procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalizations with at least one act of cataract surgey hip arthroplasty knee arthroplasty coronary angioplasty definitive cardiac stimulation (pacemaker) between January 1, 2019, and June 30, 2021 Exclusion Criteria: -hospitalizations for personal identifier problems in the database
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| - cataract surgery<br> | Procedure: surgical procedures<br>* number of hospital stays<br>|
| - hip arthoplasty<br> | Procedure: surgical procedures<br>* number of hospital stays<br>|
| - knee arthoplasty<br> | Procedure: surgical procedures<br>* number of hospital stays<br>|
| - coronary angioplasty<br> | Procedure: surgical procedures<br>* number of hospital stays<br>|
| - definitive cardiac stimulation (pacemaker)<br> | Procedure: surgical procedures<br>* number of hospital stays<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observed and expected number |  | 2020 and first half of 2021 |
Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia.

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to measure the level of awareness, preconceptions, and level of fear regarding epidural analgesia among childbearing women in KKUH in Riyadh.

Detailed Description
-----------------
This research was designed as a hospital-based observational cross-sectional study conducted at King Khalid University Hospital, using a self-administered questionnaire based on previous research.22-24-26 approved by the Institutional Review Board at King Saud University, College of Medicine, Riyadh, Saudi Arabia on 08.August.2022 Ref. No. 22/0592/IRB. The sample included pregnant women attending an obstetrical clinic for routine antenatal follow-up, and the data collection was conducted during the month of August 2022. The questionnaire included five parts (sociodemographic, preconception, awareness, fear, and desirability). a total of 26 questions with multiple-choice answers. The sample size was determined using the Comrey and Lee criterion Comrey and Lee (1992) stated that a 200-sample size is acceptable. The questionnaire was completed by 202 participants who met the inclusion criteria that is being a pregnant woman and completing the survey, and the exclusion criteria were non-pregnant women and an incomplete survey. The data collectors made it clear to the participants that taking part in the study was completely optional, and the participants signed anonymous consent forms.

Official Title
-----------------
Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia.

Conditions
-----------------
Assess Women Awareness and Fear About EDA for Labor

Intervention / Treatment
-----------------
* Other: survey- no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman completing the survey Exclusion Criteria: non-pregnant women incomplete survey

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey- no intervention|survey- no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awareness | assess awareness among participants | month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Awareness, preconception, fear, epidural analgesia, labor pain
Pediatric Cardiomyopathy Mutation Analysis

Study Overview
=================
Brief Summary
-----------------
The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

Detailed Description
-----------------
Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.

Official Title
-----------------
Pediatric Cardiomyopathy Mutation Analysis

Conditions
-----------------
Cardiomyopathies, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with cardiomyopathy Family members of subjects with cardiomyopathy Exclusion Criteria: Subjects without cardiomyopathy Family members of subjects without cardiomyopathy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected<br>participants with cardiomyopathy | |
| Family Members of affected<br>Family members of participants with cardiomyopathy (can be affected or unaffected) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elucidate the molecular genetics of cardiomyopathy |  | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiomegaly, Cardiovascular Diseases, Heart Diseases, Systolic dysfunction, Diastolic dysfunction, Ventricular hypertrophy, Heart failure
Fetal Ano-genital Distance in 2D Ultrasound.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date. The study also evaluates the feasibility of the measure and its interobserver variability.

Detailed Description
-----------------
The anogenital distance of female newborns is shorter than that of male newborns. Urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance. Anogenital distance is a good marker of fetal exposure to androgenic substances. Prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis). Is the anogenital distance easy to make measure? Can this procedure be reproduced? What are the threshold values to determine fetal sex at each term of pregnancy?

Official Title
-----------------
Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.

Conditions
-----------------
Urogenital Abnormalities, Prenatal Disorder, Sex Development Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman sonographic fetal follow up in Brest Hospital term>18 weeks of gestation Exclusion Criteria: No datation between 11 weeks of gestation and 13 weeks of gestation and 6 days by crown-rump length measurement Minor no consent ultrasound performed by an operator without ultrasonography graduation

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 |
| --- | --- | --- |
| fetal anogenital distance | The distance will be measured from the center of the anus to the posterior convergence of the fourchette in female fetuses and to the posterior base of the scrotum in male fetuses | During fetal ultrasound exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interobserver variability | reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam | During fetal ultrasound exam | 
| Ano-genital distance in mm | the measure is correctly performed and validated by an expert | During fetal ultrasound exam | 
| Estimated fetal weight | Impact of estimated fetal weight and anogenital distance | During fetal ultrasound exam | 
| neonatal sex determination | concordance of anogenital distance and neonatal sex determination | During fetal ultrasound exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anogenital distance, prenatal, sex determination, androgen
Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).

Official Title
-----------------
The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients

Conditions
-----------------
Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Other: Peptamen intense
* Other: Novasource senior


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock Mechanically ventilated Expected length of stay in ICU ≥ 4 days Written informed consent obtained from authorized surrogates Exclusion Criteria: Pregnancy Requirement for inspired oxygen content (FIO2) > 0.60 High output bronchopleural fistula

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Individualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission) | Other: Peptamen intense<br> <br> |
| Active Comparator: Control group<br>Nutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein. | Other: Novasource senior<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function measured through the tool Physical Component Summary - PCS of Short Form 36 |  | Three months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | Up to 1 year | 
| Length of ICU stay |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loss of Physical Function
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Detailed Description
-----------------
No applicable.

Official Title
-----------------
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers

Conditions
-----------------
Bacterial Infection

Intervention / Treatment
-----------------
* Drug: TR-701 FA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females, between 18 and 55 years of age, inclusive Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control Males must be surgically sterile, abstinent, or practicing an effective method of birth control BMI between 20 and 34.9 kg/m2, inclusive Exclusion Criteria: Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes Physician-diagnosed migraine headaches within 3 years Previous enrollment in a TR-701 or TR-701 FA trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteer<br>healthy volunteers | Drug: TR-701 FA<br>* 200 mg, oral, once daily for 3 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters from plasma. | Pharmacokinetic parameters compared with baseline measurements. | Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotic, healthy subjects, pharmacokinetics
Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

Study Overview
=================
Brief Summary
-----------------
This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)

Official Title
-----------------
Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Ibandronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had post menopausal osteoporosis Patients had no contraindication for bisphosphonates Patients had been naive for ibandronate therapy Patients who have signed informed consent and are willing to share their data for data analysis Exclusion Criteria: Is not Ibandronate naïve Hypersensitivity to any component of the bisphosphonates Ibandronate; Administration of any investigational drug within 30 days preceding the first dose of the study drug.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ibandronic acid|As prescribed by physician|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis |  | end of observation 12 months |