linjc16/ctgov huggingface dataset:
Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi

Study Overview
=================
Brief Summary
-----------------
In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.

Official Title
-----------------
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study

Conditions
-----------------
Stricture; Trachea, Malignant Neoplasm

Intervention / Treatment
-----------------
* Procedure: Airway stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT. Exclusion Criteria: Severe infection Coagulation disorders
Sexes Eligible for Study
-----------------
All

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

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: Airway Stent for Malignant Stricture<br>Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing. | Procedure: Airway stent implantation<br>* The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Dyspnea using Hugh-Jones classication as criteria | Hugh-Jones classication: dyspnea scale that includes 5 categories. | 3 days | 
| Stent patency time | Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive. | 2 months | 
| Overall survival | OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events that are related to stent implantation | Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D printed, airway stent, carina, distal bronchi
Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations

Study Overview
=================
Brief Summary
-----------------
Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.

Official Title
-----------------
Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations - a Prospective CT-osteoabsorptiometry-based Study

Conditions
-----------------
Obesity, Weight Loss, Knee Osteoarthritis

Intervention / Treatment
-----------------
* Radiation: CT-osteoarbsorptiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 need for bariatric operation knee pain (VAS > 2) Exclusion Criteria: malignancy poor compliance previous bariatric operation pregnancy lack of knee pain (VAC < 2) previous knee operation

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: CT-osteoarbsorptiometry|Conventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mineralization changes after excess weight loss? |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Weight Loss, Knee Osteoarthritis, Subchondral Mineralization
Usability of a Website for People With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will determine the usability of a website for people with schizophrenia versus other websites designed for the same purpose.

Detailed Description
-----------------
The objective of this study is to test and compare the usability of a website developed as part of a NIMH-funded project (see IRB #0208128), versus four other online websites in a effort to continue to improve website design elements and maximize usability by those identified with schizophrenia, a disease that produces cognitive impairments. Prior usability testing done to evaluate a website developed as part of a NIMH-funded project (see IRB #0208128) was used to develop a website designed specifically to meet the needs of those with cognitive deficits. Generally, the website was well received. However, an implicit component of this project was to make quantitative statements comparing the website developed in this project to other existing websites for individuals with schizophrenia, in order to maintain and improve the usability of the website. As such, it is important to test the usability of this website versus other websites to continue to improve design elements and ease of use for those with serious mental illness.

Official Title
-----------------
Schizophrenia Website Usability

Conditions
-----------------
Cognitive Deficits Related to Internet Use

Intervention / Treatment
-----------------
* Behavioral: website comparison


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Schizophrenia Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: website comparison|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject task performance data will be analyzed to determine what website properties influenced subject's performance of various assigned website search-related tasks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Website properties, such as reading level, font size, and amount of content on the homepage, etc will be used to determine what factors influence subject's performance, and thus the usability of the various websites. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
website, comparison
PANORAMA 2 Observational Study

Study Overview
=================
Brief Summary
-----------------
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability. The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.

Official Title
-----------------
Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry

Conditions
-----------------
Heart Rhythm Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable) Patient or Legally Authorized Representative provides signed and dated authorization and/or consent per institution and local requirements Patient will be treated with a commercially available implantable Medtronic CRDM device/ Vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment Exclusion criterion: • Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)

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 |
| --- | --- | --- |
| Describe region-specific clinical practice of CRDM device use | To describe the region-specific current clinical practices associated with the device treatment of patients receiving implantable Medtronic CRDM devices by collecting information on the patient characteristics (demographics, medical history and cardiovascular status), the type of Medtronic CRDM devices used, the indication for the use of the Medtronic CRDM devices and the clinical outcomes of the treatment with the Medtronic CRDM devices (all deaths, cardiovascular hospitalizations, Serious Adverse Device Effects and NYHA class). | 2012-2019 |
Light Needle Positioning Robot Under MRI Guidance

Study Overview
=================
Brief Summary
-----------------
This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it. Additionally, this study will evaluate: the robot precision, the robot detection robustness, the software and device ergonomics, the device security.

Official Title
-----------------
LPRobacus: Light Needle Positioning Robot Under MRI Guidance

Conditions
-----------------
Magnetic Resonance Imaging, Robotic Surgical Procedures

Intervention / Treatment
-----------------
* Device: Robot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person over 18 years old, person with height is under 1m90, person with abdomen height is under 28 cm, person with abdomen width is between 26 cm to 50 cm, person able to hold his breath during 30 seconds, person affiliated to social security or similarly regime, signed consent for participation in the study. Exclusion Criteria: person with a contraindication for abdomen MRI, claustrophobic person, protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot<br>A robot will be used and it's position will be evaluated | Device: Robot<br>* Use of the robot to locate the fictional needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of needle positioning needed to reach the real path wanted, with a 5mm precision (cylinder diameter including the path defined by the two skin marker and the need axe). | evaluate the real needle positioning precision: the robot effectiveness | 1hour20minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of time in percentage of failed robot use. | evaluate the robot detection robustness | 1hour20minutes | 
| Number of time in percentage of failed fixation of the robot over the patient. | match of the robot fixation system | 1hour20minutes | 
| Score from a qualitative evaluation scale of the healthy voluntary discomfort during robot use and the score from a scale of the physician satisfaction (girth, ease, speed). | device and software ergonomics | 1hour20minutes | 
| Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use | Device security | 1hour20minutes |
Effect of Anaesthesia on ER Stress in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane.

Detailed Description
-----------------
We hypothesize propofol and sevoflurane based anesthesia would show different pattern of endoplasmic reticulum stress after cancer surgery in patients with cancer

Official Title
-----------------
Evaluation the Effects of Anaesthetic Agents on Endoplasmic Reticulum Stress During Cancer Surgery

Conditions
-----------------
Endoplasmic Reticulum Stress

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients with cancer Exclusion Criteria: age under 19 years old allergy history to propofol or sevoflurane history of previous cancer

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>patients who anesthesized by propofol | Drug: Propofol<br>* propofol based anesthesia<br>|
| Active Comparator: sevoflurane group<br>patients who anesthesized by sevoflurane | Drug: Sevoflurane<br>* sevoflurane based anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endoplasmic reticulum stress | Change in endoplasmic reticulum stress | baseline, postoperative 1 hours and 24 hours |
Lipase Levels and Coronavirus Disease 2019

Study Overview
=================
Brief Summary
-----------------
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common. In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.

Official Title
-----------------
Association Between Pancreatic Lipase Levels and Coronavirus Disease 2019

Conditions
-----------------
Pancreatitis, Lipase Increased

Intervention / Treatment
-----------------
* Other: Age, gender, hospitalization and mortality rates will be compared


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lipase levels measured during COVID-19 Exclusion Criteria: Patients with age <18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with higher lipase level<br>patients with higher lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection | Other: Age, gender, hospitalization and mortality rates will be compared<br>* Age, gender, hospitalization and mortality rates will be compared<br>|
| Control<br>patients with normal lipase levels in the course of SARS-CoV-2 infection | Other: Age, gender, hospitalization and mortality rates will be compared<br>* Age, gender, hospitalization and mortality rates will be compared<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of lipase enzyme elevation will be compared |  | From 31th March 2020 until 9th July 2021 | 
| The mortaliy rate will be compared |  | From 31th March 2020 until 9th July 2021 |
A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.

Official Title
-----------------
Phase I Study of ASP0456 - A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Non-elderly Healthy Male Subjects

Conditions
-----------------
Healthy, Pharmacokinetics of ASP0456

Intervention / Treatment
-----------------
* Drug: ASP0456
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained Body weight (at screening); ≥50.0 kg,<80.0 kg BMI(at screening): ≥17.6,<26.4 Exclusion Criteria: Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study Received medication within 10 days before dose is administered or is scheduled to receive medication History of drug allergies Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study Concurrent or previous hepatic disease Concurrent or previous heart disease Concurrent or previous renal disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br>ASP0456 receiving group | Drug: ASP0456<br>* oral<br>* Other names: linaclotide;|
| Placebo Comparator: Placebo group<br>Placebo treatment | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP0456 assessed by its plasma concentration change |  | For 48 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests |  | For 48 hours after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP0456, Pharmacokinetics, safety, tolerability
Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.

Official Title
-----------------
Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer

Conditions
-----------------
Gastric Tumor, Early Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion Exclusion Criteria: patients had previously received neoadjuvant chemotherapy or chemoradiotherapy patients with obviously advanced gastric cancer by endoscopy the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging |  | up to 2.5 years (end of study, December 2014) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopy, endosonography, stomach cancer, tumor staging