linjc16/ctgov huggingface dataset:
Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.

Study Overview
=================
Brief Summary
-----------------
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta

Detailed Description
-----------------
Expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Official Title
-----------------
Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.

Conditions
-----------------
Ascending Aorta Aneurysm, Dilation of the Ascending Aorta

Intervention / Treatment
-----------------
* Other: aortic prosthetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Extension of the ascending aorta less than 55 mm Tricuspid Aortic Valves. Extension of the ascending aorta more than 45 mm Exclusion Criteria: Age less 45 years Age more 75 years Multiple organ failure oncological disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy<br>Healthy patients with normal aortic dimensions | Other: aortic prosthetics<br>* aortic prosthetics<br>|
| ascending aortic dilation 45-55, operated on<br>patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on | Other: aortic prosthetics<br>* aortic prosthetics<br>|
| ascending aortic dilation 45-55, non operated on<br>patients with ascending aortic dilation 45-55, tricuspid aortic valves non operated | Other: aortic prosthetics<br>* aortic prosthetics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | death | 30 day after operation | 
| aorto-associated complications | rupture, dissection | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increasing the diameter of the ascending aorta | increasing the diameter of the ascending aorta more than 55 mm | 1 year |
Behavior Management Techniques Adopted by Pediatric Dentists in Egypt

Study Overview
=================
Brief Summary
-----------------
A cross-sectional study to investigate behavior management techniques used by pediatric dentists in Egypt according to AAPD clinical guidelines.

Detailed Description
-----------------
Observational study to investigate behavior management techniques adopted by pediatric dentists in Egypts for different patients ages, by distributing questionnaires in Egyptian govermental universities consisting of participant's demographic information, behavior management techniques used for each age group and their opinion or comments.

Official Title
-----------------
Behavior Management Techniques Adopted by Pediatric Dentists in Egypt: Cross-sectional Study

Conditions
-----------------
Child Anxiety

Intervention / Treatment
-----------------
* Behavioral: Behavior management techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric dentist and holding at least a master degree Exclusion Criteria: refusal to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior management techniques|Pediatric dentists will be questionnaired regarding their adopted behavior management techniques for pediatric patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior management | Questionnaire will be used for measurement using binary questions (Yes, No) to measure the outcome. Summing up Yes responses will reveal the most common behavior management techniques used by pediatric dentists in Egypt | one month |
T-ICD vs S-ICD Shocks: Myocardial Injuries

Study Overview
=================
Brief Summary
-----------------
Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). The aim of our study was to investigate the association between S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers

Official Title
-----------------
Myocardial Injuries and Hemodynamic Stress Biomarkers: a Comparison Between Transvenous and Subcutaneous ICD Shock

Conditions
-----------------
ICD Shock Myocardial Injuries

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who met the criteria for ICD implantation according to the current guidelines Exclusion Criteria: -

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 |
| --- | --- |
| S-ICD<br> | Device: ICD<br>* Implantable Cardioverter Defibrillator<br>|
| T-ICD<br> | Device: ICD<br>* Implantable Cardioverter Defibrillator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial micro-damage | degree of myocardial micro-damage, assessed by calculating the variation in the serum levels of high-sensitivity cardiac troponin I (hs-CTnI) and creatine kinase-MB mass concentration (CK-MB mass), measured before and after an S-ICD shock delivered during intraoperative DFT | 6 months |
Statin Therapy In Patients With Vasospastic Angina

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina

Conditions
-----------------
Angina Pectoris, Variant, Statins, HMG-CoA

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Vasospastic angina LDL less than 160mg/dl Written consent Exclusion Criteria: Coronary artery stenosis more than 50% or ischemic coronary disease History of percutaneous coronary intervention Cerebrovascular diseases or peripheral Dyslipidemia required statin therapy Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery NYHA III and IV Arrhythmia Primary cardiac electrical diseases Cardiac pacemaker or implantable defibrillator Pregnancy or breast feeding Life expectancy less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>20mg QD | Drug: Atorvastatin<br>* 20mg QD<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo drug will be administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization | The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death |  | 3 years | 
| cardiac death |  | 3 years | 
| cardiac arrest |  | 3 years | 
| myocardial infarction |  | 3 years | 
| angina-related hospitalization |  | 3 years | 
| Composite event of death or myocardial infarction |  | 3 years | 
| Composite event of cardiac death or myocardial infarction |  | 3 years | 
| statin-related complications | event rate of statin-related complications | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statin, vasospastic angina
Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

Detailed Description
-----------------
The purpose of this study is to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

Official Title
-----------------
Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients(CVCCP)

Conditions
-----------------
Thrombosis, Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult cancer patients with central venous catheters (CVCs) or peripherally inserted central catheters (PICCs) placed at BeijingHCH. Exclusion Criteria: without written informed consent

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 |
| --- | --- |
| complications<br>catheter-related venous thrombosis catheter-related infections | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related venous thrombosis and catheter-related infections | Catheter-related venous thrombosis and catheter-related infections | 30 days after PICC and CVC line withdrawn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter tip position | Catheter tip position | participants will be followed before PICC and CVC line withdrawn | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheters, Central Venous, complications, cancer
A Study to Investigate Interleukin-6 (IL-6) and IL-6/Soluble IL-6 Receptor (sIL-6R) Complex Levels in Subjects With Active Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with active moderate to severe ulcerative colitis (*partial Mayo ≥ 5) or Crohn's disease (Harvey & Bradshaw ≥ 8) *partial Mayo: 9-point scale that excludes the endoscopic components of the Mayo score Exclusion Criteria: Presence of another inflammatory disease, except for mild cutaneous psoriasis Concomitant gastrointestinal infection or otherwise serious infection including Crohn's disease infectious complication Treatment with Infliximab, Adalimumab, Certolizumab Pegol or other immune-modulating biologics within 8 weeks prior to the visit Having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit Concomitant diagnosed or suspected malignant disease

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling|Blood sample collected at a single visit|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory: Levels of IL-6/sIL-6R Complex | Blood sample was taken for analysis of levels of IL-6/sIL6-R complex. | At Day 1 | 
| Exploratory: Levels of IL-6 | Blood sample was taken for analysis of levels of IL-6. | At Day 1 | 
| Exploratory: Levels of C-reactive Protein (CRP) | Blood sample was taken for analysis of levels of CRP. | At Day 1 |
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

Official Title
-----------------
Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Blood sampling
* Procedure: BIOPSY
* Procedure: SURGERY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged more than 18 years Histologically proven breast carcinoma Neo-adjuvant chemotherapy with anthracyclines and/or taxanes No prior chemotherapy Written informed consent Exclusion Criteria: Metastatic disease

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEC 100 + TAXOTERE<br>FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE TAXOTERE 100 mg/m²/cycle 1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100 | Procedure: Blood sampling<br>* Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy<br>Procedure: BIOPSY<br>* Biopsy at the moment of inclusion, before neoadjuvant chemotherapy<br>Procedure: SURGERY<br>* Surgery after neoadjuvant chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with node invasion |  | 6 months | 
| Correlation with basal, luminal phenotypes, HER2 status or hormonal status |  | 6 months | 
| Correlation with the response measured by ultrasound after chemotherapy |  | After 3 and 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Neo-adjuvant chemotherapy, Proteomic, Histological response
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine. Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.

Official Title
-----------------
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study

Conditions
-----------------
Postoperative Pain, Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 18 informed consent Postoperative cast with spica Exclusion Criteria: Previous surgery in the same hip Other surgical procedure planned at the same time Bilateral surgery Previous allergic reaction to local analgesia

Ages Eligible for Study
-----------------
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: Saline<br>* During the surgery infiltration with saline. Thereafter bolus 3 times a day<br>|
| Active Comparator: Naropin<br> | Drug: Ropivacaine<br>* During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain measured with r-FLACC between the 2 groups |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative, Local infiltration analgesia, Cerebral palsy, r-FLACC
The Effect of Assisted Reproductive Technology on Male Sexual Function.

Study Overview
=================
Brief Summary
-----------------
Men participating in assisted reproductive technology treatments will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth.

Detailed Description
-----------------
Men participating in fertility will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth. In addition, participants will be questioned regarding marital life, sexual intercourse frequency, medical history and treatments for erectile dysfunction in relevant cases. Thes control group will be comprised of male subjects who did not require fertility treatments to conceive.

Official Title
-----------------
The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: Questionnaire and personal interviews.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in fertility treatments. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertility treatments<br>Men participating in fertility treatments. | Other: Questionnaire and personal interviews.<br>* Questionnaire and personal interviews.<br>|
| Spontaneous pregnancy<br>Men whose wives conceived spontaneously. | Other: Questionnaire and personal interviews.<br>* Questionnaire and personal interviews.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in International index of erectile function score | Changes in International index of erectile function score with a possible score ranging from 0 to 75. The higher the score, the better erectile function is. | From recruitment up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual intercourse rate. | Sexual intercourse rate as measured by the average monthly intercourse rate. | From recruitment up to 3 years. | 
| Use of phospho-di-esterase 5 inhibitors | Use of phospho-di-esterase 5 inhibitors as measured by the number of men using this medication. | From recruitment up to 3 years. |
Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Study Overview
=================
Brief Summary
-----------------
Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube (ETT) position in adults and children but has been less studied in neonates. The aim of this study is to evaluate the performance of lung US in determining correct ETT position in neonates, in comparison with X Ray

Official Title
-----------------
Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

Conditions
-----------------
Diagnostic Imaging, Newborn, Intubation, Ultrasonography

Intervention / Treatment
-----------------
* Other: radiography thorax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns treated with mechanical ventilation and required chest X ray for determining ETT position hospitalised in neonatal intensive Care unit , Limoges, France signed parental inform consent Exclusion Criteria: Congenital heart disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: radiography thorax|The ultrasound of the thorax will be performed while waiting for the X-ray thorax|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of ETT positioning according to lung ultrasonography with chest X ray results | X Ray correct ETT position : ETT's tip will be correctly positioned if located between the upper edge of the first thoracic vertebra and the lower edge of the second thoracic vertebra. Ultrasound correct ETT position : ETT'S tip will be correctly positioned if the distance between ETT's tip and the junction of the brachycephalic artery with aortic arch will be measured between 0.8 and 1.5 centimeter | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of realization lung US | time of realization lung US | Day 0 | 
| time of realization chest X ray | time of realization chest X ray | Day 0 | 
| variability inter observator | Concordance of thoracic ultrasound results between the operator and the reviewer | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnostic imaging, Newborn, Intubation, Ultrasonography methods