linjc16/ctgov huggingface dataset:
COVID-19 Infection in Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic

Official Title
-----------------
Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort

Conditions
-----------------
Hepatocellular Carcinoma, COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: nasopharyngeal Covid 19 RT-PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CHC and included in the French national prospective cohort CHIEF Hospital and ambulatory patients Infection confirmed by COVID-19 defined by a positive nasopharyngeal PCR or if PCR COVID-19 negative : CT showing COVID-19 compatible pneumonia Suspected COVID-19 infection, not confirmed by COVID-19 PCR or chest CT, with no other known cause of acute pneumonia. Exclusion Criteria: Patient refusal Influenza only, confirmed by a diagnostic test Other proven causes of pneumonia and absence of COVID-19

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: nasopharyngeal Covid 19 RT-PCR|nasopharyngeal Covid 19 RT-PCR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France | Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, COVID-19, Coronavirus disease 2019-Incidence
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin

Study Overview
=================
Brief Summary
-----------------
Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest

Detailed Description
-----------------
Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment

Official Title
-----------------
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest

Conditions
-----------------
Meningioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum 18 years medical follow up in CHRU of Brest treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception meningioma after treatement by progestin or CYPROTERONE ACETATE Exclusion Criteria: history ofbreast cancer history of cerebral radiotherapy history of neurofibromatosis meningioma before treatement by progestin or CYPROTERONE ACETATE minor patient

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of meningiomas caracteristics | meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prescription status of progestogenic treatment | indications, duration of treatment, name and type of treatment | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meningioma,, progestin,, cyproterone acetate
Lactated Ringer's and PlasmaLyte in Critically Ill Adults

Study Overview
=================
Brief Summary
-----------------
In recent years, there has been a large amount of literature reports that normal saline can increase the incidence of renal injury in critically ill patients compared with balanced salt solution.However, no studies have compared the effects of different types of balanced salt solutions on the incidence of renal injury.

Official Title
-----------------
Lactated Ringer's and PlasmaLyte in Critically Ill Adults

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Drug: RL
* Drug: PLA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to ICU Exclusion Criteria: Patients <18 year old when admission Patients who stay less than 24 hours in ICU Patients who do not sufficient data for further analysis Readmission patients during the study period

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 |
| --- | --- |
| Mix group<br>Patients who used two balanced salt solutions during icu stay | Drug: RL<br>* lactated Ringer's<br>Drug: PLA<br>* PlasmaLyte<br>|
| RL group<br>Patients who have only used lactated Ringer's during icu stay | Drug: RL<br>* lactated Ringer's<br>|
| PLA group<br>Patients who have only used PlasmaLyte during icu stay | Drug: PLA<br>* PlasmaLyte<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute kidney injury | The incidence of acute kidney injury | from admission to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidency of CRRT events | the incidency of CRRT events | from admission to 28 days | 
| the ventilation free days | the ventilation free days | from admission to 28 days | 
| the vasopressure free days | the vasopressure free days | from admission to 28 days |
Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy

Detailed Description
-----------------
Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery. With this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy.

Official Title
-----------------
The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications

Conditions
-----------------
Learning Module, Cognitive Non-technical Skills

Intervention / Treatment
-----------------
* Behavioral: Learning Module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgeons and / or surgical residents Complete all the required documents Exclusion Criteria: Refuse to participate in one or more parts of the study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Learning Module|Safe Cholecystectomy Learning Module|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative: Community Survey | Survey data | February - March 2022 | 
| Qualitative: In Depth Interview | Semi-structured interview data obtained from In Depth Interview | March - April 2022 | 
| Qualitative: Delphi Study | Learning Module | May 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safe Laparoscopic Cholecystectomy, Situation Awareness, Decision Making
Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis

Study Overview
=================
Brief Summary
-----------------
We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.

Official Title
-----------------
Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study

Conditions
-----------------
Dermatomyositis, Adult Type, Interstitial Lung Disease

Intervention / Treatment
-----------------
* Drug: triple therapy
* Drug: dual-therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter Anti-MDA5 Antibody-positive Exclusion Criteria: Complicated with other connective tissue diseases Complicated with cardiovascular and respiratory disease caused by other reasons Interstitial lung disease caused by environment and drugs Patients with key research missing data or without informed consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Drug: triple therapy<br>* high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor<br>|
| Experimental: control group<br> | Drug: dual-therapy<br>* high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RPILD | Incidence of RP-ILD in patients after 6 months of treatment | 6 months | 
| Death | Mortality rate in patients after 6 months of treatment | 6 months |
Health Literacy in Adults With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Currently, both oral and written health education make certain assumptions about the health literacy of patients and their parents. The prevalence of health literacy issues is unknown in the adult congenital heart disease (CHD) population. Having a better understanding of a patient's and/or their parents' health literacy will help us develop appropriate education and teaching tools to meet the patient's and their parents' needs.

Detailed Description
-----------------
When providers speak with patients regarding their congenital heart disease, they currently have no assessment of the patient's basic health literacy. If providers are aware of the level of their patients' health literacy, they will be better equipped to provide care on the level the patient best understands.

Official Title
-----------------
Assessment of Health Literacy in Adults With Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18 years of age and older with congenital heart disease. Exclusion Criteria: Developmentally delayed subjects. Any subject not meeting inclusion criteria.

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 |
| --- | --- | --- |
| Assess Literacy | Assess health literacy in human patients ages 18 to 65 with congenital heart disease through data collected from health literacy questionnaire. | The final 3 months will be used for data analysis and the presentation/manuscript preparation. |
Investigation of Plasma Mitochondrial DNA Level in Septic Patients

Study Overview
=================
Brief Summary
-----------------
To determine the plasma levels of mtDNA in ICU department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. Plasma from control, septic and severe septic patients will be collected. The level of mtDNA and systemic cytokine will be measured.

Detailed Description
-----------------
Clinical protocol: Patients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response. Methods: Plasma levels of mtDNAs were measured using real-time quantitative polymerase chain reaction. Levels of mtDNAs were compared among each group, and linear regression was used to assess the association between mtDNAs, IL-6, TNF a and IL-1b in patients with sepsis. The correlation between plasma mtDNA and severity, systemic inflammation and outcomes will be analyzed.

Official Title
-----------------
Plasma Levels of Mitochondrial DNA in Patients Presenting to ICU With Sepsis

Conditions
-----------------
Sepsis, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sepsis and severe sepsis was according to the following guild-line. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012 Exclusion Criteria: Patients lost following-up. Patients who refuse to sign the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| sepsis<br>sepsis defined as suspected infection and systemic inflammatory response | |
| severe sepsis<br>sepsis with organ dysfunction or septic shock defined as sepsis plus hypotension | |
| control group<br>control defined as non-infected patients without systemic inflammatory response. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in plasma mtDNA in septic patients at 7 days | The change from baseline in plasma mtDNA in septic patients at 7 days will be measured by real-time PCR. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days | The change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days will be measured by ELISA. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome, sepsis, mitochondrial DNA, systemic inflammation
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373, High dose
* Drug: KPS-0373, Low dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373) Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction Discontinuations in another clinical trials caused by side effects

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPS-0373<br> | Drug: KPS-0373, High dose<br> <br> Drug: KPS-0373, Low dose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARA (Scale for the Assessment and Rating of Ataxia) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8 (QOL) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
Binah.ai Visual Vitals Application - Validation Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).

Official Title
-----------------
Binah.ai Visual Vitals Application - Validation Study

Conditions
-----------------
Respiratory and Pulse Rate Accuracy Validation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have the ability to understand and provide written informed consent Subject must be ≥18 years of age Subject must be willing and able to comply with study procedures and duration Exclusion Criteria: Subjects who refuse or are unable to provide to sign an informed written consent for study Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region Of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.) Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported) Other known health condition, should be considered upon disclosure in health assessment form

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate accuracy validation | Respiratory Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). | From admission to discharge, up to 2 hours | 
| Pulse Rate accuracy validation | Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG. | From admission to discharge, up to 2 hours |