linjc16/ctgov huggingface dataset:
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age >/=18 years Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC) First line progression-free survival (PFS) >6 months Eligible for second-line chemotherapy regimen Period between first progression and start of second line treatment with Avastin and chemotherapy </=6 weeks Exclusion Criteria: Contraindications, warnings and precautions for use specified in the Avastin SmPC

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Second-line time to progression, in months |  | Time between treatment initiation and tumor progression or death from cancer related cause, with censoring of patients who are lost to follow-up; up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (composite outcome measure): Incidence of all adverse events, adverse events of special interest (AESI) for bevacizumab and pregnancies reported in second line mCRC treatment with Avastin plus chemotherapy |  | Up to 2 years | 
| Safety (composite outcome measure): Incidence, nature and severity of all serious adverse events reported in second line mCRC treatment with Avastin plus chemotherapy and information on outcome and action taken with the drug |  | Up to 2 years |
Patient Retrospective Outcomes (PRO)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Detailed Description
-----------------
This study is a retrospective, multi-center, de-identified patient data review. The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Official Title
-----------------
Patient Retrospective Outcomes (PRO)

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Non Boston Scientific Systems
* Device: Boston Scientific Systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Previously treated with or eligible for use with Boston Scientific Systems 18 years of age or older at the start of Baseline

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 eligible for SCS, RF or other treatment approaches<br>Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc. | Device: Non Boston Scientific Systems<br>* Spinal cord stimulation, RF, IDS etc.<br>Device: Boston Scientific Systems<br>* Spinal cord stimulation, RF, IDS etc<br>|
| Patients Eligible for treatment options with prior treatment<br>Patients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc. | Device: Non Boston Scientific Systems<br>* Spinal cord stimulation, RF, IDS etc.<br>Device: Boston Scientific Systems<br>* Spinal cord stimulation, RF, IDS etc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate | Responder rate for pain relief through study completion. | Through study completion, approximately two years |
Induction Hypotension in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.

Conditions
-----------------
Pediatric Surgical Patients

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between ages of 1 year to 8 years will be included in the study. Patients with ASA physical classification 1 and 2 will be studied. Exclusion Criteria: Patients with any cardiovascular or kidney diseases will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 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 |
| --- | --- |
| Surgical patients<br>Pediatric patients having surgery at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013. | Procedure: Surgery<br>* All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013. --------------------------------------------------------------------------------<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Measure the degree of change from pre-induction levels. | Baseline, 5, 10, & 15 mins. post induction |
Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet. II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.

Detailed Description
-----------------
PROTOCOL OUTLINE: Following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. The diet is free of cholesterol and cholestanol. For the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid. The feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.

Official Title
-----------------
Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)

Conditions
-----------------
Cerebrotendinous Xanthomatosis

Intervention / Treatment
-----------------
* Drug: chenodeoxycholic acid
* Drug: lovastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chenodeoxycholic acid|nan|
|Drug: lovastatin|nan|

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
-----------------
cerebrotendinous xanthomatosis, inborn errors of metabolism, rare disease
Develop and Implement Asthma Controlling Strategies (1)

Study Overview
=================
Brief Summary
-----------------
To develop and implement asthma controlling strategies for inner city and high risk populations.

Detailed Description
-----------------
BACKGROUND: Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations, released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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 |
| --- | --- | --- |
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.

Study Overview
=================
Brief Summary
-----------------
Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.

Detailed Description
-----------------
The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.

Official Title
-----------------
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.

Conditions
-----------------
Low Back Pain, Neck Pain, Shoulder Pain

Intervention / Treatment
-----------------
* Other: Demographic data and range of motion.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 20-40 year of age with symptoms of shoulder Neck and lower back discomfort Exclusion Criteria Red flag sign of the neck

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Group 1: Patients with shoulder, neck and lower back discomfort<br>Patients with shoulder, neck and lower back discomfort. | Other: Demographic data and range of motion.<br>* The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion (ROM) of the neck | Patients' range of motion of the neck in all directions are measured using hand-held devices. | at least 2-week monitoring by wearable devices | 
| Oswestry Disability Index (ODI) | Oswestry Disability Index of the neck is collected for the evaluation of neck functions. | at least 2-week monitoring by wearable devices | 
| Visual Analogue Scale (VAS) | Visual Analogue Scale is collected for pain assessment. | at least 2-week monitoring by wearable devices | 
| Roland-Morris Disability Questionnaire (RDQ) | Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions. | at least 2-week monitoring by wearable devices |
A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained

Official Title
-----------------
A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation

Conditions
-----------------
General Anesthesia and Bronchoscopy Sedation

Intervention / Treatment
-----------------
* Drug: Remimazolam Tosilate for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using rebinim ® during general anesthesia and fiberoptic sedation Patients need to sign informed consent Exclusion Criteria: Patients who are participating in or planning to participate in any interventional clinical trial The investigator considers that there are any other reasons for the patient's ineligibility for the study
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 |
| --- | --- |
| General anesthesia cohort<br> | Drug: Remimazolam Tosilate for Injection<br>* Remimazolam Tosilate for Injection<br>|
| Bronchoscopy sedation cohort<br> | Drug: Remimazolam Tosilate for Injection<br>* Remimazolam Tosilate for Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE | Within 3 days of receiving General anesthesia and bronchoscopy sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events | Refer to SAE definition standards | Within 3 days of receiving General anesthesia and bronchoscopy sedation | 
| Adverse drug reactions | By evaluating the association of adverse events with drugs | Within 3 days of receiving General anesthesia and bronchoscopy sedation | 
| Injection pain | Refer to the NCI-CTCAE <5.0> grading criteria for drug injection site reactions | Within 3 days of receiving General anesthesia and bronchoscopy sedation |
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean

Study Overview
=================
Brief Summary
-----------------
The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.

Detailed Description
-----------------
Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is >5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.

Official Title
-----------------
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean

Conditions
-----------------
Ipsilateral Shoulder Pain

Intervention / Treatment
-----------------
* Procedure: Transnasal SPG block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean Presence of post-operative ISP, VAS >5/10 American Society of Anesthesiologists Class 1 - 3. No allergy to lidocaine Exclusion Criteria: American Society of Anesthesiologists Class 4 or 5. Allergy to lidocaine Nasal pathology (e.g., deviated septum) Patients who receive sedatives during cesarean Bleeding diathesis Any patient who the PI feels will be unable to comply with all protocol related procedures Shoulder pain prior to cesarean

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transnasal SPG block<br> | Procedure: Transnasal SPG block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS) |  | 90 Minutes |
A Register on the Quality of ERCP and Training of Endoscopists in Italy

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational longitudinal study Aim of the study is to collect information: on the organization models of the Endoscopic Units performing ERCP in Italy on the previous and/or ongoing training of the endoscopists performing ERCP on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome

Detailed Description
-----------------
Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series. Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure The study consists of 3 phases: Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information Definition of the the outcome of ERCP assessed after 30 days from the procedure

Official Title
-----------------
A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy

Conditions
-----------------
Biliary Tract Diseases, Pancreatic Diseases

Intervention / Treatment
-----------------
* Procedure: ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to participate in the study Exclusion Criteria: Informed consent not subscribed

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ERCP|Endoscopic procedure used to manage biliary and pancreatic diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | Occurrence of post -ERCP complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of repeated procedure | The rate of ERCPs that have to be repeated within 1 month | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, biliary diseases, Pancreatic diseases, outcome, Quality, Training
Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.

Official Title
-----------------
Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery

Conditions
-----------------
Postoperative Constipation

Intervention / Treatment
-----------------
* Procedure: Degree of constipation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted for planned lung surgery Patients are capable Able to talk and understand Danish Exclusion Criteria: Patients with colostomy and / or ileostomy Neurological or abdominal diseases Feed through a tube

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: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Degree of constipation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation incidence the first month after surgery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defecation pattern measured after The Bristol Stool scale. |  |  | 
| ADL (after Sallings functional scale) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, cancer, surgery, intervention, nursing, postoperative