linjc16/ctgov huggingface dataset:
Prevention of the Procedural Pain in the Newborn

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

Detailed Description
-----------------
Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Official Title
-----------------
Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn

Conditions
-----------------
Prevention of the Procedural Pain in the Newborn

Intervention / Treatment
-----------------
* Procedure: saccharose versus breast-feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestationnel age included between 37 and 42 weeks Born in the CHRU of Brest Breast-Fed Score of Apgar upper to 7 No pathology malformative Absence of known chromosomal abnormality Consent of parents Exclusion Criteria: Maternal drug use Morphinic treatment Barbiturate treatment Benzodiazépine treatment

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: saccharose<br>20% saccharose | Procedure: saccharose versus breast-feeding<br>* saccharose versus breast-feeding<br>|
| Placebo Comparator: breast-feeding<br>breast-feeding | Procedure: saccharose versus breast-feeding<br>* saccharose versus breast-feeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of the total concentration of haemoglobin | Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection. | Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of rate salivary cortisol | Salivary cortisol sampling | before and after painful gesture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity

Study Overview
=================
Brief Summary
-----------------
In the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).

Detailed Description
-----------------
ChT activity is increased in patients with PCOS in concordance with insulin resistance. These findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.

Official Title
-----------------
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity: A Pathophysiological Link Between Inflammation and Impaired Insulin Sensitivity?

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absence of significant abnormalities on physical examination except hirsutism no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy normal thyroid function and prolactin level absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease Exclusion Criteria: Pregnant ovarian tumors congenital adrenal hyperplasia or BMI greater than 30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS patients<br> | |
| PCOS patients and healthy controls<br>There are two groups in this study. One group is PCOS patients and other group is healthy controls. | |

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
-----------------
polycystic ovary syndrome, chitotriosidase activity
Inflammatory and Fibrotic Markers and Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Inflammatory and Fibrotic protein markers in patients with atrial fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrial fibrillation Exclusion Criteria: Patients with atrial fibrillation who are reluctant for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Official Title
-----------------
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Paracetamol (acetaminophen) solution experimental
* Drug: paracetamol (acetaminophen) solution commercial
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal. Moderate or severe pain within 4 hours after the completion of surgery. Exclusion Criteria: Another acute or chronic painful physical condition Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers Inability to use and understand Visual Analog Scale and Verbal Rating Score

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Paracetamol (acetaminophen) solution experimental<br>* 1 gm IV<br>* Other names: acetaminophen;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* equivalent volume IV 0.9% sodium chloride (equivalent volume)<br>* Other names: saline;|
| Active Comparator: 3<br> | Drug: paracetamol (acetaminophen) solution commercial<br>* 1 gm IV<br>* Other names: acetaminophen;|

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
-----------------
pain, postoperative, surgery, oral, surgery, dental
SKin Uncertainties Modeling

Study Overview
=================
Brief Summary
-----------------
The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers. These data will be used to develop a mathematical model representative of the mechanical behavior of the skin.

Official Title
-----------------
Construction of a Mechanical Data Base for Mathematically Modeling Uncertainties in Human Skin Tissues

Conditions
-----------------
Unrecognized Condition

Intervention / Treatment
-----------------
* Device: Cutiscan® CS 100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged 18 to 50 years old non-opposition to participating in SKUM study Affiliation to french social security Exclusion Criteria: Refusal to participate Volunteer with any skin disease likely to interfere with the primary outcome Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study and / or weak cooperation Subject without health insurance Pregnant woman Subject being in the period of exclusion from another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measures using Cutiscan® CS 100<br> | Device: Cutiscan® CS 100<br>* Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of displacement (mm) of a skin disc. | The displacement will be obtained from repeated measures, on 30 volunteers, on forearm skin, and using Cutiscan® CS100 device. A database of skin viscoelasticity measure will be built from such data. | Month 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin, non lesional, arm
Duodenal Exclusion for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.

Official Title
-----------------
Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: Duodenal Exclusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 20 and 50 years old; BMI between 27 and 34.9; Oral agents or insulin to control T2DM; Inadequate control of diabetes as defined as HbA1c>8.0% but <10% Understanding of the mechanisms of action of the treatment Exclusion criteria: More than 5 years of T2DM diagnosis; C-peptide <1pg/ml (off insulin) Previous abdominal operations; History of gastritis History of GERD History of peptic ulcer disease Inflammatory bowel disease Coagulopathy; Liver cirrhosis; Unable to comply with study requirements, follow-up schedule or give valid informed consent; Currently pregnant (pregnancy test required for confirmation for those of child bearing years) Patient is not available for programmed follow-up during the study period Patient is unwilling to forgo good samaritan blood donation during the study period

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

| Intervention/Treatment |
| --- |
|Procedure: Duodenal Exclusion|duodenal-jejunal bypass|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success based on patients' glycemic control |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic Measurements, Comorbidity improvement, Improvement in QOL |  | 12 Months |
Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage

Official Title
-----------------
Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation for Long-term Use

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma Exclusion Criteria: -
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 |
| --- | --- | --- |
| Incidence of Adverse Events |  | Range of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of asthma control under long-term use |  | At the end of 24 weeks | 
| The level of asthma control under long-term use |  | At the end of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial asthma, Symbicort, long term use,
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.

Official Title
-----------------
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Fondaparinux Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments Exclusion Criteria: Patients with a history of hypersensitivity to the ingredients of fondaparinux Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed) Patients with acute bacterial endocarditis Patients with severe renal impairment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed fondaparinux<br>Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period | Drug: Fondaparinux Sodium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese patients treated with fondaparinux |  | 4 months at maximum | 
| Presence or absence of venous thromboembolism after treatment of fondaparinux |  | 4 months at maximum |
Hyperglycemia in Patients With Takotsubo Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.

Official Title
-----------------
Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up

Conditions
-----------------
Takotsubo Cardiomyopathy

Intervention / Treatment
-----------------
* Other: To report number of HF events and deaths


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome; cardiac biomarker modifications (creatine kinase-MB and troponin I); systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV. Exclusion Criteria: patients with previous previous myocardial infarction; patients with previous TTC event; patients affected by chronic kidney, liver, and cerebrovascular diseases.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TTC patients with hyperglycemia<br>These patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics. | Other: To report number of HF events and deaths<br>* In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.<br>|
| TTC patients with normoglycemia<br>These patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics. | Other: To report number of HF events and deaths<br>* In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of HF events | To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules. | 12 months |
The Validity and Reliability of Self Measurement of Upper Limb Volume

Study Overview
=================
Brief Summary
-----------------
Lymphedema is a common, chronic, side effect resulting from the treatment of breast cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted conservative treatment is based on the anatomy and physiology of the lymphatic system. The aim of the treatment is to reduce the volume of the upper limb by, initial, intensive treatment and then to keep the arm volume at this reduced level.The measurement of limb volume involves measuring the circumference of the arm at defined points and then with the use of a formula the volume of the arm can be calculated. After intensive therapy is complete the responsibility for measuring limb volume moves to the patient. This study will examine the reliability and validity of self measurement of limb volume. The investigators will compare the results of self measurement using the accepted plastic tapemeasure against a paper tape measure adapted for self measurement.Both methods will be compared to the gold standard volume displacement. In the study there will be two meetings with the subjects where the patient and physiotherapist will use the three methods.

Official Title
-----------------
The Validity and Reliability of Self Measurement of Upper Limb Volume in Treating Lymphedema in Breast Cancer Patients

Conditions
-----------------
Limb Volume Measurement

Intervention / Treatment
-----------------
* Other: Self measurement of limb volume +water displacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with arm edema after breast cancer who are being conservatively treated by a physiotherapist. Exclusion Criteria: Active malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Self measurement of limb volume +water displacement|Comparison will be made between self measurement is two types of tape measure compared with water displacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of self measurement of limb volume to water displacement |  | 2 years | 
| validity of self measurement |  | 2 years |