linjc16/ctgov huggingface dataset:
Tissue Oxygen Saturation for Esophagectomy

Study Overview
=================
Brief Summary
-----------------
Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.

Detailed Description
-----------------
One cause of anastomotic leakage after radical esophagectomy is blood flow insufficiency at the cervical anastomosis site. . Eighteen patients, who underwent radical esophagectomy with gastric tube reconstruction, were studied. The regional tissue oxygen saturation (rSO2) was measured at the tip (point pre 0) and 2, 4, and 6 cm on the anal side of the tip (point pre 1, pre 2, and pre 3, respectively) before the gastric tube was raised to the cervical site through the retrosternal route. After that, rSO2 was measured at the tip, 2 and 4 cm on the anal side of the tip (points post 0, post 1, and post 2), the actual anastomotic site (point AN), and the chest skin as an indicator of whole-body oxygenation . The relationship between rSO2 scores and the rate of anastomotic leakage was determined.

Official Title
-----------------
Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis for Esophagectomy

Conditions
-----------------
Esophageal Neoplasms, Esophagostomy Complication, Anastomotic Leak, Oxygen Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent esophagectomy with gastric tube reconstruction from November 2020 to March 2021. Exclusion Criteria: Patients who underwent esophagectomy with jejunum or colon reconstruction. patients who underwent two-stage operation.
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 |
| --- | --- | --- |
| The tissue oxygen saturation score of gastric tube during esophagectomy | We measured the tissue oxygen saturation (0% - 99%) of several parts of gastric tube during esophagectomy with a use of tissue saturation monitor ''toccare''. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of anastomotic leakage | We investigated the rate of anastomotic leakage in the cervical site (0% - 100%). | 1month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy, Tissue oxygen saturation, Gastric tube, Anastomotic leakage
Vital Values at Circadian Markers in Postoperative Patients

Study Overview
=================
Brief Summary
-----------------
To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.

Official Title
-----------------
Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications

Conditions
-----------------
Postoperative Complications, Circadian Dysrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted for surgery Expected time of surgery was more than 2 hours. Expected post-operative length of stay was more than 2 days. Exclusion Criteria: Allergy to study materials Patients with a pacemaker Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE < 25)

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 |
| --- | --- |
| Patients without postoperative complications<br> | |
| Patients with postoperative complications<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Any complication meeting the ICH-GCP serious adverse event(SAE) criteria: An SAE (...) is defined as any untoward medical occurrence that(...) Results in death Is life-threatening Requires inpatient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity Requires intervention to prevent permanent impairment or damage (May have caused a congenital anomaly/birth defect - Not relevant) | From start of continuous monitoring until 12 hours after monitoring stopped. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative physiology, Vital signs
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age. In this sense, for asthmatic patients treated by Symbicort Turbohaler, AstraZeneca developed the Turbo+, an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application. The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.

Official Title
-----------------
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: Symbicort Turbohaler plus Turbo+
* Drug: Symbicort Turbohaler without Turbo+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - uncontrolled mild or moderate persistent asthma; Exclusion Criteria: acute upper respiratory infections; immunological or metabolic systemic disease; major malformations of the upper airways; active smokers.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symbicort Turbohaler plus Turbo+<br>10 asthmatic children | Device: Symbicort Turbohaler plus Turbo+<br>* Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.<br>|
| Active Comparator: Symbicort Turbohaler without Turbo+<br>10 asthmatic children | Drug: Symbicort Turbohaler without Turbo+<br>* Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Rating Scale (MARS) | Change in the MARS score from baseline to the end of treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood Asthma Control Test (C-ACT) | Change in the C-ACT score from baseline to the end of treatment | 3 months | 
| Asthma Control Test (ACT) | Change in the ACT score from baseline to the end of treatment | 3 months | 
| Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | Change in the PAQLQ score from baseline to the end of treatment | 3 months |
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

Official Title
-----------------
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C

Conditions
-----------------
Beta Thalassemia Major

Intervention / Treatment
-----------------
* Dietary Supplement: spirulina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multitransfused beta thalassemic children with super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction. Exclusion Criteria: liver decompensation child younger than 3 years patients with hepatitis B infection contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>30 multitransfused beta thalassemic children infected with hepatitis C virus diagnosed by serological detection of HCV-antibodies and HCV RNA by polymerase chain reaction will be given Spirulina in a dose of 250 mg/kg/day orally for 3 months. | Dietary Supplement: spirulina<br>* Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane) |  | 3 months |
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)

Study Overview
=================
Brief Summary
-----------------
The primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with high risk coronary artery disease.

Official Title
-----------------
A Perspective, Cohort Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab is Used in Combination With Statin Therapy In Patients With High Risk Cardiovascular Disease

Conditions
-----------------
Dyslipidemia, High Risk Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Evolocumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years of age Coronary artery disease at high risk (Syntax Score ≥ 33) Patients had to have a fasting LDL cholesterol level of 1.4 mmol per liter while they had been taken an optimized regimen of lipid-lowering therapy for at least 4 weeks, which was defined as preferably a high intensity statin but must have been at least atorvastatin at a dose of 20 mg daily or its equivalent, with or without ezetimibe. Exclusion Criteria: New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30% Uncontrolled hypertension Uncontrolled or recurrent ventricular tachycardia Untreated hyperthyroidism or hypothyroidism Homozygous familial hypercholesterolemia LDL or plasma apheresis

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 |
| --- | --- |
| High risk coronary artery disease<br>Participants with high risk coronary artery disease. | Drug: Evolocumab<br>* Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) | MACCE will include all-cause death, cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in LDL-C | Reduction in LDL-C reduction in LDL-C after 1 month, 3 months, 6 months and 12 months of therapy | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the extracellular leading to disruption of the cardiac tissue architecture. Amyloidosis in transthyretin (TTR) are the most common hereditary amyloidosis but remain poorly studied at heart. This is serious and deadly. The prevalence of TTR amyloidosis is probably underestimated in hypertrophic cardiomyopathy (HCM) often of unknown etiology because of the lack of systematic implementation of myocardial biopsy because of their side effects.

Detailed Description
-----------------
A systematic screening of TTR mutations within the MHC would diagnose cardiac amyloidosis in TTR and improve the care of patients and their families. The detection of this disease is important because this disease is fatal and a new treatment to prevent the accumulation of TTR is now available (Tafamidis). This drug has proved effective in stabilizing neurological damage. Depending on the number of patient with cardiac amyloidosis in TTR detected, the prospect will begin a clinical trial to test the effectiveness of a new treatment to prevent the increase in mass of the left ventricle wall objectified resonance nuclear Magnetic.

Official Title
-----------------
Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy

Conditions
-----------------
Cardiac Amyloidosis, Amyloidosis in Transthyretin (TTR), Hypertrophic Cardiomyopathy (HCM)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiomyopathy defined by an ultrasound thickness of the left ventricle >= 13 mm if familial form or >= 15 mm if sporadic form. Patients with a signed consent authorizing the specific blood test for genetic sequencing to look for abnormal TTR gene Exclusion Criteria: Patients with a diagnosis of cardiomyopathy already determined or related already diagnosed. Significant aortic stenosis (≤ 1 cm ²)

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 |
| --- | --- |
| Hypertrophic Cardiomyopathy<br>In the population of Hypertrophic Cardiomyopathy patients, patients suffering from a cardiac amyloidosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ATTRm mutations | Number of ATTRm mutations detected in a large population of patients with HCM. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype and clinical factors | Identify clinical factors associated with biological and echocardiographic different HCM genotypes. | 1 day |
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.

Official Title
-----------------
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study

Conditions
-----------------
Esophageal Neoplasms, Stomach Neoplasms

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven adenocarcinoma of the stomach or gastroesophageal junction stage IV patient receives chemotherapy signed informed consent Age > 18 years Exclusion Criteria: Patient can not understand meaning and purpose of the study patient already received a chemotherapy treatment for advanced disease.

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

| Intervention/Treatment |
| --- |
|Other: non-interventional|non-interventional|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-to-progression | The period from study entry until disease progression, death, or date of last contact. | up to 24 months | 
| overall survival | OS is the duration from enrollment to death. | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-interventional, advanced gastric cancer, Trastuzumab, HER2
Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Detailed Description
-----------------
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking. Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Official Title
-----------------
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus

Conditions
-----------------
Progressive Keratoconus, Corneal Ectasia

Intervention / Treatment
-----------------
* Procedure: Corneal collagen
* Procedure: Sham comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of keratoconus with documented progression over the previous 12 months. Diagnosis of corneal ectasia Must be able to complete all study visits Exclusion Criteria: Prior corneal surgery in the keratoconus group Corneal scarring

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Treatment<br>Corneal collagen cross-linking | Procedure: Corneal collagen<br>* Corneal collagen cross-linking with riboflavin/UVA light<br>|
| Sham Comparator: Control<br>Sham Treatment | Procedure: Sham comparator<br>* Sham treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in keratometry |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle-corrected visual acuity |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
Early Systolic Notching in Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary embolism (PE), is the third most common acute cardiovascular syndrome after myocardial infarction and stroke. In a study conducted by critical care and emergency physicians, lung ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT, and focused cardiac US in terms of right ventricular strain were demonstrated with different diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic value for PE alone in the literature. In a recent study, it is stated that a new cardiac finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in massive and submassive emboli. However, the limited patient population and the exclusion of many patient groups limits the applicability of the study and its use in other patient groups. With this study, it was aimed to determine the diagnostic value of ESN finding within the emergency department conditions by keeping the patient population wider.

Official Title
-----------------
Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism Exclusion Criteria: Pregnant women, Patients under 18 years of age, Those who received thrombolytic therapy, Poor ultrasound imaging.

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 |
| --- | --- | --- |
| To determine the diagnostic accuracy of the ESN finding | What is the diagnostic value of ESN finding in patients with PE diagnosed with pulmonary CT angio? | 6 months |