linjc16/ctgov huggingface dataset:
Caduet in an Untreated Subject Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.

Official Title
-----------------
An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population)

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Caduet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit. SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL Exclusion Criteria: Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment. Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose > 126 mg/dL at the Screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Caduet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8. |  |  | 
| Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score. |  |  | 
| Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG. |  |  | 
| The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C. |  |  | 
| Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score. |  |  | 
| Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG. |  |  | 
| The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8. |  |  |
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.

Official Title
-----------------
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1

Conditions
-----------------
GERD, Barrett's Esophagus

Intervention / Treatment
-----------------
* Drug: Fluorescein
* Drug: Proflavine hemisulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient 18 years or older colonoscopy for screening or surveillance of polyps or disease of colon anoscopy because of suspected or known anal dysplasia or neoplasia Exclusion Criteria: patient unable to provide informed consent patient found unfit for standard colonoscopy or anoscopy with biopsies

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescein<br>Confocal imaging using contrast agent fluorescein | Drug: Proflavine hemisulfate<br>* 3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)<br>* Other names: Proflavine;|
| Experimental: Proflavine hemisulfate<br>confocal imaging using contrast agent proflavine | Drug: Fluorescein<br>* fluorescent contrast agent, Fluorescein 5ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether tissue is neoplastic or non-neoplastic |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus, confocal microendoscopy
Multi-Centre, Observational Study on Safety of Bevacizumab Biosimilars in Clinical Practice Among Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Monoclonal antibody drugs are expensive, and the listing of biosimilar drugs can help increase the availability and lower prices of biologic drugs, and can better meet the public's demand for biotherapeutic products. The first bevacizumab biosimilar in China was launched in December 2019. Although monoclonal antibody biosimilar drugs are similar to the original drug in terms of quality, safety and effectiveness, their production process may be different from the original drug, and their clinical application cannot be completely equivalent to the original drug. Especially after the market is applied to a wider patient population, the safety and effectiveness are more worthy of attention. This study started from the perspective of pharmacy. Three hospitals in China participated in the real-world safety assessment of bevacizumab biosimilars. An observational cohort study design was adopted to include all cases of lung cancer and colorectal cancer using bevacizumab biosimilars and original drugs during the study period, and the propensity score matching was used to reduce the influence of confounding factors and conduct safety assessment.

Official Title
-----------------
The Safety Study of Bevacizumab Biosimilars in the Real World

Conditions
-----------------
Biosimilar

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ①Inpatients diagnosed with non-small cell lung cancer or colorectal cancer; ②Bevacizumab biosimilars or original drugs were used for treatment during the study period. Exclusion Criteria: ①Age<18 years old; ②Person who has used bevacizumab within six months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Biosimilar group<br> | Drug: Bevacizumab<br>* Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab<br>|
| Originator group<br> | Drug: Bevacizumab<br>* Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | Severity of adverse drug reactions | 12 months |
Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy

Study Overview
=================
Brief Summary
-----------------
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned , which is conducive to accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice. In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided Pelvic and Groin Areas biopsy.

Official Title
-----------------
A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy

Conditions
-----------------
Pelvic and Groin Areas Biopsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 to 90 Single or multiple Pelvic and Groin Areas mass (solid, partially solid) Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week) - Page 3 of 4 [DRAFT] - KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture Planned biopsy with applicable puncture path With informed consent. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Depth | Depth (millimeter) difference between actual puncture and planned puncture pathway | during the operation | 
| Accuracy of Angle | Angle (degree) difference between actual puncture and planned puncture pathway | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of needle puncture | Success rate of needle puncture | during the operation | 
| Complication rate | such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc. | perioperative the operation | 
| operating duration | operating duration from the starting to the ending | during the operation | 
| Number of CT scans | Number of CT scans | during the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic, Groin, Biopsy, Coplanar template.
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient

Study Overview
=================
Brief Summary
-----------------
This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients

Official Title
-----------------
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient

Conditions
-----------------
Cataract, Vitreous Detachment

Intervention / Treatment
-----------------
* Procedure: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult emmetropic patient Without complete posterior vitreus detachment in both eyes before having surgery. Exclusion Criteria: Diabetic retinopathy Ophthalmological treatment in progress History of ophthalmological surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cataract surgery<br>Patient acts as his own control | Procedure: Cataract surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of vitreous detachment in the operated eye |  | 3 months after the cataract surgery |
Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.

Official Title
-----------------
Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section

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

Intervention / Treatment
-----------------
* Drug: Bupivacaine 0.25% Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18-50 years Cesarean Section Exclusion Criteria: Cesarean Section under general anesthesia emergency cases those with a body mass index greater than 35 kg/m2 coagulopathy local infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESP<br>Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side | Drug: Bupivacaine 0.25% Injectable Solution<br>* Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side<br>|
| Active Comparator: Group TFP<br>Ultrasound-guided Transversalis Fascia Plane Block block with 20 ml %0.25 bupivacaine, per side | Drug: Bupivacaine 0.25% Injectable Solution<br>* Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Opioid consumption postroperative period | Postoperative first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Postoperative first 24 hours |
Creation of a Biotheque of Patients of Seine-Maritime With Meningococcal Infection

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined

Official Title
-----------------
CONSTITUTION D'UNE BIOTHEQUE DE PATIENTS DE SEINE-MARITIME AUX ANTECEDENTS D'INFECTION INVASIVE A MENINGOCOQUES

Conditions
-----------------
Meningococcal Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of Seine-Maritime with a meningococcal disease from the year of 2000 parental authority assent if necessary Exclusion Criteria: no parental authority assent child under supervision
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
-----------------
meningococcal infections, biotheque, genetic markers
Observational Study of Blood Pressure Measurements and Continuous Dialysis

Study Overview
=================
Brief Summary
-----------------
Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis. We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.

Official Title
-----------------
Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy

Conditions
-----------------
Kidney Failure, Respiratory Failure, Critical Illness, Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 17 years old CVVHD renal replacement therapy indwelling arterial line Exclusion Criteria: age < 18 years old pregnancy temperature < 34°C severe mechanical ventilator dyssynchrony cardiac arrhythmias precluding automated PPV measurement by ICU monitors non-pulsatile cardiac flow open thoracic cavity

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 |
| --- | --- |
| Mechanically ventilated patients<br> | |
| Non-mechanically ventilated patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD |  | Iterative 24 hr periods for the duration of CRRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased doses of vasoactive agents on CRRT |  | Iterative 24 hr periods for the duration of CRRT | 
| Inability to meet goal ultrafiltration rate |  | Iterative 24 hr periods for the duration of CRRT | 
| Hypotensive events on CRRT |  | Iterative 24 hr periods for the duration of CRRT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulse pressure variation, Continuous venovenous hemodialysis, Volume status, Critical care
Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The study is to observe whether dexmedetomidine could reduce agitation during emergence from general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.

Detailed Description
-----------------
Agitation during emergence is frequent after retroperitoneal urologic surgery. Dexmedetomidine is alpha-2 receptor agonist which shows sedative and algesic effect. In this study we will compare the effect of dexmedetomidine given by different protocols on emergence agitation.

Official Title
-----------------
Effect of Dexmedetomidine on Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: dexmedetomidine
* Other: loading dose
* Other: sustaining dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for retroperitoneal laparoscopic surgery Patients with written informed consent Exclusion Criteria: Patients with difficulty of communication Patients with risk of obstructive sleeping apnea syndrome

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine loading dose<br>dexmedetomidine is given at load dose | Drug: dexmedetomidine<br>* an alpha-2 receptor agonist<br>* Other names: dex;Other: loading dose<br>* 0.8ug/kg of dexmedetomidine is given in 10 minutes<br>* Other names: LD;|
| Experimental: dexmedetomidine sustaining dose<br>dexmedetomidine is given at sustaining dose | Drug: dexmedetomidine<br>* an alpha-2 receptor agonist<br>* Other names: dex;Other: sustaining dose<br>* 0.4ug/kg/min of dexmedetomidine is given<br>* Other names: SD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Score |  | From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough score |  | From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour | 
| Time to awake | time to open eyes to verbal command | From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour |