linjc16/ctgov huggingface dataset:
Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

Study Overview
=================
Brief Summary
-----------------
Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

Detailed Description
-----------------
Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature. The investigators therefore decided to evaluate the reliability of the oesophageal temperature in open chest lung surgery by comparing it to the continuous tympanic temperature.

Official Title
-----------------
Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

Conditions
-----------------
Hypothermia, Thoracic Neoplasm, Anesthesia

Intervention / Treatment
-----------------
* Other: Temperature recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients needing pulmonary surgery under thoracotomy Exclusion Criteria: patient refusal esophageal or otological pathology preventing the installation of thermal probes

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracotomy<br>All patients needing pulmonary surgery under thoracotomy | Other: Temperature recording<br>* Tympanic and oesophageal temperatures will be recorded during the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between tympanic and oesophageal temperature. | Evaluate the correlation existing between the tympanic temperature, reflection of the central temperature without variation with an open thorax, and oesophageal temperature subject to changes. | up to 1 day (during the surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of correlation between tympanic and oesophageal temperature during left and right thoracotomy. | Evaluate the correlation existing between the tympanic temperature, reflection of the central temperature without variation with an open thorax, and oesophageal temperature subject to changes. | up to 1day (during the surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic surgery, Body temperature
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance

Study Overview
=================
Brief Summary
-----------------
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.

Official Title
-----------------
GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: GyneFix Viz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women requesting intrauterine contraception willing to have a GyneFix IUD for pregnancy prevention able to return for a follow-up ultrasound able to read and understand consent form Exclusion Criteria: Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.) Immediately after a pregnancy interruption > 10 weeks gestation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GF<br>Women who have a GyneFix Viz inserted | Device: GyneFix Viz<br>* insertion of GyneFix Viz and measurment of the SA distance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serosal-anchor Measurement | endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Number of participants with complications and removals at the end of the 5-year follow-up period | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, contraception
Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

Study Overview
=================
Brief Summary
-----------------
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

Detailed Description
-----------------
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Official Title
-----------------
MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

Conditions
-----------------
Cancer, Mucositis

Intervention / Treatment
-----------------
* Drug: Low dose ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful mucositis Child from 5 to 18 years. Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic. A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h). Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA. First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA > 30 after stop morphine). Assent signed by the parents and each time possible by the child. Exclusion Criteria: The child was already included in the study. The age of psychomotor development is lower than 5 years Presence of a depression or a major depressive episode according to definition DSM IV. Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0) Bilirubin>3N Gamma WP>3N SGOT or SGPT >5N Creatinin>3N

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Low dose ketamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucositis, Pain, Morphine, Ketamine
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes

Detailed Description
-----------------
Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: evogliptin
* Drug: Linagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with 7.0%≤HbA1c≤10.0% at screening Subjects untreated with oral hypoglycemic agents within 8 weeks prior to screening Subjects with 20kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: Subjects with fasting plasma glucose≥270mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subjects with history of myocardial infarction, cerebral infarction within 24 weeks prior to screening Subjects with ALT and AST 3 times or higher than upper normal range

Ages Eligible for Study
-----------------
Minimum Age: 20 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: evogliptin<br>evogliptin 5mg qd | Drug: evogliptin<br>* evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg<br>|
| Active Comparator: linagliptin<br>linagliptin 5mg qd | Drug: Linagliptin<br>* linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg<br>* Other names: Tragenta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | unit: % | Change from baseline at 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose | unit : mg/dL | Change from baseline at 12 week | 
| HbA1c response rate | unit: % | Change from baseline at 12 weeks |
Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt

Study Overview
=================
Brief Summary
-----------------
Parental involvement, both quantitative and qualitative, is fundamental for a good psycho-emotional development of the child. The lack of parental involvement and especially paternal involvement significantly promotes the occurrence of behavioral disorders in children and later, in adolescence, the onset of depressive symptomatology. On the other hand, parental involvement has a protective role in the occurrence of behavioral disorders and decreases the risk of suicide attempts in adolescence. The authors of these cohort studies agree on the need for research on the identification of factors determining paternal involvement in order to organize specific prevention actions and targeted interventions to promote the involvement of fathers in psychiatric care of their adolescents. The prevention of adolescent suicide attempts appears to be a real public health issue in Reunion Island with a suicide rate among under-35s twice as high as in Reunion than in metropolitan France. This work is a continuation of the guidelines of good practice of the High Authority of Health (HAS) which insist on the importance of supporting the parental function by health and public action.

Official Title
-----------------
Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt

Conditions
-----------------
Depression, Child Mental Disorder, Psychiatric Disorder, Suicide, Attempted

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teenagers aged 13 to 17 managed for a depressive episode (ADRS score> 3) or for a suicide attempt speaking and understanding French and / or Creole language Exclusion Criteria: fathers without legal responsibility for the child absence of consent of the adolescent or those responsible for parental authority

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 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 |
| --- | --- |
| Adolescents with paternal involvement<br> | |
| Adolescents without paternal involvement<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion in the most incident factors influencing paternal involvement in psychiatric care of adolescents | After textual analysis of the interviews (qualitative analysis) | One hour after inclusion |
Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Detailed Description
-----------------
Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Official Title
-----------------
Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Conditions
-----------------
Cerebral Stroke, Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic valve replacement Exclusion Criteria: contraindication to undergo MRI

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>conventional aortic valve replacement | |
| 2<br>transfemoral aortic valve replacement | |
| 3<br>transapical aortic valve replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent cerebral embolism |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent cerebral embolism |  | 48 hours |
Ammonia Levels and Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data.

Official Title
-----------------
Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?

Conditions
-----------------
Dementia, Cognitive Decline, Cognitive Impairment, Developmental Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cognitive decline (suspected or documented) able to get blood drawn Exclusion Criteria: liver disease/cirrhosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-cirrhotic patients with cognitive impairment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood ammonia level |  | Baseline, Pretreatment and 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mini-status examination |  | Prior to treatment and 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Alzheimer's, Alzheimers, Cognitive decline, Cognitive impairment, Memory loss, Memory disorder, Forgetfulness, Confusion, Senile, Demented, Developmental delay, Portal systemic shunting, High ammonia level, Elevated ammonia level
A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies

Official Title
-----------------
A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme signed and dated informed consent(ICF) for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required Exclusion Criteria: Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, bronchial, Symbicort
The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes. Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.

Official Title
-----------------
The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: Pulmonary function test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This retrospective study included all patients diagnosed with interstitial lung disease (ILD) who were followed up by the chest department of a tertiary hospital between September 2016 and January 2017 Exclusion Criteria: patients with occupational history collagen vascular disease predisposing them to lung disorders patients who could not undergo pulmonary function testing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Pulmonary function test|forced vital capacity and diffusing capacity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of FVC/DLCO in predicting PAH in IPF | To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs | 6 months |