linjc16/ctgov huggingface dataset:
High Resolution Imaging for Early and Better Detection of Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.

Official Title
-----------------
High Resolution Imaging for Early and Better Detection of Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care. Must be willing and able to participate and provide written informed consent Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation Exclusion Criteria: Patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures. Women with the possibility of having the pregnancy. Patients having acute infection. Person with Lidocaine sensitivity.

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 |
| --- | --- |
| Bladder Cancer Patients<br>High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation. | Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope<br> <br> * Other names: HRME and/or LSC-HRME;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of Bladder Cancer Detection Imaging |  | baseline (at the time of imaging) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suspicious bladder lesion, normal bladder tissue
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

Official Title
-----------------
An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))

Conditions
-----------------
Periodic Fevers Syndrome

Intervention / Treatment
-----------------
* Biological: Canakinumab (AIN457)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age Exclusion Criteria: Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
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: Canakinumab (ACZ885)<br>Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks. | Biological: Canakinumab (AIN457)<br>* Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | Participants were monitored for safety throughout the study. | Participants were followed for the duration until approval, an expected average of 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRAPS, Canakinumab,, interleukin-1, Periodic Fevers Syndrome, HIDS, crFMF, auto-inflammatory diseases, extension study
GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma. The main purposes of this study include: ① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore. ② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.

Official Title
-----------------
An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Anti-GPC3-IRDye800CW


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed with hepatocellular carcinoma. Planned to receive hepatectomy. Liver function Child-Pugh A/B. GPC-3 was validated highly expressed preoperatively. Aged 18 to 75, and the expected lifetime is longer than 6 months. Approved to sign the informed consent. Exclusion Criteria: Allergic to IRDye800. Enrolled in other trials in the past 3 months. Another malignant tumor was found. Undesirable function of heart, lung, kidney, or any other organs. Unable to tolerate a hepatectomy. The researchers considered inappropriate to be included.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: Anti-GPC3-IRDye800CW Intraoperative Fluorescence<br>The patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection. | Drug: Anti-GPC3-IRDye800CW<br>* Drug Injection: Anti-GPC3-IRDye800CW<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC lesions | Numbers of intraoperatively detected hepatocellular carcinoma lesions. | During hepatocellular resection surgery. |
Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.

Official Title
-----------------
Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study

Conditions
-----------------
Survival Status at Day 30 After the Last Intake

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients included in the previous study WYETH 3074A1-4448 then Pfizer B1811030 for which mortality status was not known at the closure of this previous study Exclusion Criteria: Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.

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 |
| --- | --- |
| 1<br>Patients previously included in the initial protocol WYETH 3074A1-4448 / B1811030. (To collect only status survival data 30 days after the last dose of treatment) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline | Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported. | 30 days after last dose of Tigecycline (Day 108) |
Strabismus Recovery With Proparacaine and Oculocardiac Reflex

Study Overview
=================
Brief Summary
-----------------
Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.

Detailed Description
-----------------
In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.

Official Title
-----------------
Does Proparacaine Enhance Strabismus Recovery

Conditions
-----------------
Strabismus, Bradycardia, Nausea, Pain

Intervention / Treatment
-----------------
* Drug: Topical Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Strabismus surgery Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 90 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 |
| --- | --- |
| proparacaine<br>Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery | Drug: Topical Solution<br>* proparacaine 0.5% eye drop<br>* Other names: proparacaine;|
| No proparacaine<br>Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (post op pain Likert scale) | pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain) | hours (1-4) in recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea | observed or described nausea (presence or absence of nausea / vomiting) | hours (1-4) in recovery room | 
| heart rate | recovery room heart rate | hours (1-4) while in recovery room | 
| time to recovery | time in recovery room | minutes (30-240) from entry recovery room to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conjunctiva, post operative recovery, oculocardiac reflex, extra ocular muscle, numbing drop, heart rate
Validation of an Urticaria Control Test

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.

Official Title
-----------------
Development (and Validation) of an Instrument to Assess Disease Control in Patients With Urticaria (Urticaria Control Test)

Conditions
-----------------
Chronic Urticaria

Participation Criteria
=================
Eligibility Criteria
-----------------
all patients suffering from chronic forms of urticaria are eligible

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| chronic urticaria patients<br>all patients suffering from chronic forms of urticaria (chronic spontaneous urticaria as well as chronic inducible forms such as cold contact urticaria) | |

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
-----------------
urticaria, disease control, severity, test
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)

Official Title
-----------------
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Self-managing Emotional Crises in People With Borderline Personality Disorder: A Pragmatic Randomized Controlled Trial

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Treatment as usual (schema therapy)
* Device: Mobile app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD) Aged 18-60 yeats old Exclusion Criteria: Comorbidity with mental retardation Comorbidity with psychotic disorder Comorbidity with antisocial personality Comorbidity with autism spectrum disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment as usual plus mobile app<br>Those who will receive naturalistic treatment in outpatient setting and also the mobile app | Behavioral: Treatment as usual (schema therapy)<br>* weekly group psychotherapy and bimonthly individual psychotherapy<br>Device: Mobile app<br>* Medical device for crisis intervention<br>|
| Active Comparator: Treatment as usual<br>Those who will receive naturalistic treatment in outpatient setting but not the mobile app | Behavioral: Treatment as usual (schema therapy)<br>* weekly group psychotherapy and bimonthly individual psychotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of psychiatric.emergencies and hospitalizations | As reported by computerized clinical charts | 9-month | 
| smartphone addiction | Severity of smartphone addiction as measured by the Spanish version of the Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity). | 9-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Borderline personality disorder, Mobile app, Crisis intervention, Effectiveness, Security
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Official Title
-----------------
A Phase II, Randomized, Active-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With and Without Ribavirin, for 12 Weeks in Patients With Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-Based Therapy

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Celgosivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age, inclusive primary diagnosis of chronic HCV infection non-responders to previous pegylated interferon-based therapy Exclusion Criteria: patients naive to interferon-based therapy for chronic HCV infection

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Celgosivir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis |  |  | 
| HCV viral load |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Celgosivir, HCV, Genotype 1, Non-responders, Early Viral Response, EVR
Sun Protection Factor Assay (317/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay : UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-174)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |