linjc16/ctgov huggingface dataset:
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.

Official Title
-----------------
A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures Patient has a documented clinical diagnosis of schizophrenia Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit Exclusion Criteria: Patients (female) must not be pregnant or lactating Patients with a known intolerance or lack of response to previous treatment with quetiapine Patients who have previously participated in this study

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate tablets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis

Study Overview
=================
Brief Summary
-----------------
This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

Official Title
-----------------
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy Exclusion Criteria: Under 18 years

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 |
| --- | --- |
| Participants who are suspected with TB<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of new diagnostic technique | sensitivity and specificity of new test | An average of 2 year |
Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.

Conditions
-----------------
Coronary Artery Occlusion

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine, saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with Euroscore ≥ 5 Exclusion Criteria: Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: N-acetylcysteine , saline<br> | Drug: N-acetylcysteine, saline<br>* Inject 100 mg/kg of N-acetylcysteine or the equivalent amount of saline for 15 minutes before the skin incision, then continuously inject 40 mg/kg/day of N-acetylcysteine or the equivalent amount of saline during the next 24 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Tourniquet Application on Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.

Official Title
-----------------
The Effect of Tourniquet Application on Optic Nerve Sheath Diameter and Cerebral Oxygenation During Lower Extremity Surgery

Conditions
-----------------
Intracranial Pressure Increase

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II risk group over the age of 18 Operation planned under general anesthesia Lower extremity surgery with a tourniquet Agreeing to volunteer for research with an informed consent form Exclusion Criteria: Emergency surgical procedures neurological disease, carotid disease Previous intracranial or ocular surgery Neurological symptoms cerebral edema, high IntraCranial Pressure Presence of glaucoma Body mass index (BMI)> 35 Uncontrolled hypertension Diabetic retinopathy anemia coronary artery disease peripheral artery disease

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optic nerve diameter | measuring the change in optic nerve diameter | during the surgery | 
| regional cerebral oxgenation | measurement rSo2 by Near Infrared spectroscopy | during the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourniquet, Optic Nerve Sheath Diameter, Cerebral Oxygenation
An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

Official Title
-----------------
Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >= 65 years of age Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy Having received oral and written information about the study, and having signed a written consent form Exclusion Criteria: Participation in a cancer clinical trial with an investigational medicinal product other than this study Patient previously treated with Avastin Patient under supervision or guardianship

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment |  | Approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients with advanced non-squamous non-small cell lung cancer |  | Approximately 4 years | 
| Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer |  | Approximately 4 years | 
| Progression-free survival |  | Approximately 4 years | 
| Overall survival |  | Approximately 4 years | 
| Quality of Life |  | Approximately 4 years | 
| Safety: Incidence of adverse events |  | Approximately 4 years | 
| Reasons of non-use of Avastin as first-line therapy |  | Approximately 4 years |
Liver Safety Under Upfront Arimidex vs Tamoxifen

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

Official Title
-----------------
A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Anastrozole
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven HR+ invasive breast cancer Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy Postmenopausal woman Exclusion Criteria: clinical evidence of metastatic disease previous adjuvant hormonal therapy for breast cancer liver diseases
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Anastrozole (ARIMIDEX) | Drug: Anastrozole<br>* 1 mg once daily oral dose<br>* Other names: ZD1033;|
| Active Comparator: 2<br>Tamoxifen | Drug: Tamoxifen<br>* 20 mg once daily oral dose<br>* Other names: NOLVADEX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Fatty Liver Disease | The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. | At 48 weeks, 96 weeks, 144 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Abnormal Liver Function | The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure. | At 48 weeks, 96 weeks, 144 weeks | 
| Time to Treatment Failure |  | Within 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen
Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT

Study Overview
=================
Brief Summary
-----------------
This study was designed as a prospective multicenter trial to determine the accuracy of combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic perfusion imaging in patients with suspicious coronary artery disease compared conventional coronary angiography and quantitative dynamic perfusion MRI as standard reference.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Adenosine stress dynamic CT perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women patients, with age ranging 40-80. Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications Patients who are willing to sign the informed consent form Exclusion Criteria: Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min Unstable or uncooperative patients Limited life expectancy due to cancer or end-stage renal or liver disease Evidence of severe symptomatic heart failure (NYHA Class III or IV) Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT perfusion group<br> | Other: Adenosine stress dynamic CT perfusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of stress induced CT perfusion | Diagnostic accuracy of combined stress and rest dynamic CT perfusion and coronary angiography with dual x-ray sources in detection of hemodynamically significant stenosis of coronary artery compared with conventional coronary angiography and perfusion MRI in patients with suspicious coronary artery disease. | 10-30 days |
Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Although most patients seem to tolerate the combination of STP and PP, this method carries risks of ICP (intracranial pressure) and brain perfusion. The head-down position increases arterial pressure as well as CVP, thereby disrupting cerebral venous drainage and increasing hydrostatic pressures in the cerebral vascular system. This increases cerebrovascular resistance and decreases cerebral blood flow by increasing ICP and cerebral edema. Systemic CO2 absorption from pneumoperitoneum causes hypercarbia. Hypercarbia can increase cerebral blood flow through cerebral vasodilation. Seventy-four percent to 95% of cerebral venous drainage in the supine position is provided by IJVs. Studies have shown that IJVs, which are responsible for most cerebral venous drainage, exhibit changes in diameter and blood flow due to TP. These studies were generally conducted on moderate TP and on healthy volunteers. In this study, we aim to evaluate the effects of a steep Trendelenburg position (25°) and pneumoperitoneum on IJV blood flow in patients undergoing operation under general anesthesia

Official Title
-----------------
Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery

Conditions
-----------------
Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II physical status age between 18 and 65 years planned gynecological laparoscopic surgery. - Exclusion Criteria: history of head and neck surgery history of cerebrovascular disease ASA III-IV physical status -

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

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

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 |
| --- | --- | --- |
| Change in internal jugular vein blood flow in laparoscopic gynecological cases | to evaluate the effects of the pneumoperitoneum (PP) and steep Trendelenburg position (STP) on cerebral venous return with internal jugular vein (IJV) blood flow in gynecological laparoscopic surgery | 90 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, cerebral venous drainage, internal jugular vein
Emergency Department CT Scanning for Appendicitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.

Official Title
-----------------
Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Other: Omnipaque


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis Exclusion Criteria: pregnant patients patients with known IV dye or oral contrast allergy patients in whom acute appendicitis is not the primary diagnosis patients with renal insufficiency that may have significant adverse effect from IV dye

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>IV contrast | Other: Omnipaque<br>* oral contrast for CT scan<br>|
| Active Comparator: 2<br>IV contrast and oral contrast | Other: Omnipaque<br>* oral contrast for CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. |  | immediate reading + blinded reading within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient |  | immediate reading and blinded reading within 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, IV Contrast, Oral Contrast, CT scan