linjc16/ctgov huggingface dataset:
Combination Diagnostic Strategies in NAFLD

Study Overview
=================
Brief Summary
-----------------
Serial combination of biological and elastography tests is accurate to diagnosing advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) patients. In this study, the investigators compared the diagnostic performances of a 2-step strategy using either vibration-controlled transient elastography (VCTE) or bidimensional shear wave elastography with Supersonic imagine (2D-SWE-SSI), and analysed the added-value of a 3-step strategy.

Detailed Description
-----------------
The investigators retrospectively selected all consecutive adult patients with suspicion of NAFLD who had undergone liver biopsy from November 2011 to July 2019 in 2 French academic centers, Angers and Bordeaux university hospitals. A total of 577 patients were included. Among them, 291 had been previously included in a prospective study comparing diagnostic performances of several non-invasive tests in NAFLD patients. Inclusion criteria were: Age≥18yo, 2D-SWE-SSI and VCTE performed within the two weeks prior to liver biopsy. Exclusion criteria were high alcohol consumption (i.e., >21 drinks, on average, per week in men and >14 drinks, on average, per week in women), associated causes of liver disease (alcoholic, viral, or other causes of liver injury), other aetiologies than NAFLD on pathological examination, and a liver biopsy length of less than 10 mm and/or fewer than 6 portal spaces and/or more than 2 fragments, except for in cases of cirrhosis.

Official Title
-----------------
Transient Versus Bidimensional Shear Wave Elastography in Serial Combination Strategy to Diagnose Advanced Fibrosis in NAFLD Patients

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease, Chronic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - PAtients who underwent a liver biopsy for a suspicion of NAFLD, and liver stiffness evaluation with either Fiborscan and Bidimensional shear wave elastography Exclusion criteria: Other aetiologies of chronic liver disease biopsy length under 10mm

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 |
| --- | --- | --- |
| Diagnostic accuracyclassification | Diagnostic accuracyclassification | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver elastography, Liver fibrosis, Non-invasive diagnosis, NAFLD
Fronto-limbic Functional Connectivity Via Real-time fMRI Neurofeedback

Study Overview
=================
Brief Summary
-----------------
Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions.

Detailed Description
-----------------
In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI neurofeedback training can enable individuals to gain volitional control over their fronto-limbic circuitry. Given that this circuitry has been abundantly implicated in emotional perception and regulation this could facilitate emotional control. Suitable participants underwent fronto-limbic connectivity feedback training and sham training in a cross over design. During both trainings participants are instructed to regulate the neural indices during feedback. We expect that receiving fronto-limbic feedback enhances emotion regulation during the training.

Official Title
-----------------
Voluntary Regulation of Fronto-limbic Functional Connectivity: A Proof-of-concept Real-time fMRI Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: pregnant, taking oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback Training<br>Neurofeedback training - neurofeedback of fronto-limbic functional connectivity. | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2<br> <br> |
| Sham Comparator: Sham Control<br>Sham training - feedback that is not related with fronts-limbic connectivity (motor connectivity) | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural indices of training success |  | three days | 
| Training-induced changes in emotion related processing | The scores of visual analogue scale assessing individuals' anxiety level will be compared between before and after training within each group as well as between twe groups after training | three days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofeedback, Emotion processing, Real-time, fMRI
Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.

Detailed Description
-----------------
In a previous cross sectional study in a group of women without breast cancer and with varying degrees of parenchymal density patterns, a strong association was demonstrated between Transillumination Breast Spectroscopy (TIBS) and x-ray derived mammographic density. From this, we expect that TIBS should also provide a comparable odds ratio (4-6) as mammographic density for breast cancer risk shown in other independent epidemiological studies. It is possible that TIBS may provide complementary information and a higher odds ratio if compared to the incidence of breast cancer. In contrast to mammography derived parenchymal density pattern, no historical TIBS data is available for a retrospective analysis and hence a cross sectional study within a group of screened women is proposed. We hypothesize that TIBS provides physical information about the breast tissue which can be used to construct a breast cancer risk predictor with an odd ratio > 6.

Official Title
-----------------
Transillumination for Breast Cancer Risk Assessment

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are in good health and capable of providing consent Are willing to come in to the Princess Margaret Hospital for a single visit to meet with a female research assistant Exclusion Criteria: Have had breast augmentation or reduction Have a personal history of breast cancer Have had a previous bilateral fine needle aspiration or core biopsy Have a breast tattoo

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with confirmed unilateral breast carcinoma or ductal carcinoma in situ (DCIS) | |
| 2<br>Women without radiological suspicious lesions, matched to cases by age (± 2.5 years), date of screening mammogram, and screening center. | |

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
-----------------
Breast Cancer Risk, Optical Transillumination Spectroscopy, Transillumination Breast Spectroscopy
Long-Term Efficacy and Safety of CT-P10 in Patients With RA

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Official Title
-----------------
An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Rituximab, MTX, folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1. Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period. Exclusion Criteria: Patient has been withdrawn from Study CT-P10 1.1 for any reason. Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.

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

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: Rituximab, MTX, folic acid<br> | Drug: Rituximab, MTX, folic acid<br>* Rituximab IV 1000mg MTX 10 25mg/week Folic acid at least 5mg/week<br>* Other names: Rituximab=CT-P10;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring | Efficacy will be assessed by evaluation of ACR criteria (ACR 20% , ACR 50% , ACR 70%, and hybrid ACR response), Safety will be assessed by evaluation of hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and body temperature),etc,. | 8 week interval |
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.

Official Title
-----------------
Clinical Testing Report for Wrist-used Electronic Blood Pressure Monitor

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wrist circumference: 14 cm-25 cm Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 81 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 |
| --- | --- |
| blood pressure monitor<br>wrist circumference: 14cm-25cm | |
| stethoscopy<br>wrist circumference: 14cm-25cm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of blood pressure |  | 10 s | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BP
A Comparison of Three Nutritional Assessment Methods Predicting Prognosis in COPD With Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during January 2014 to March 2016 by review of medical records. The following variables will be retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2, nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic outcomes, and so on. The purpose of this study is to compare the predictive power of three widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic outcomes in a cohort of COPD patients with respiratory failure.

Official Title
-----------------
Prediction of Prognosis in Patients With Chronic Obstructive Pulmonary Disease With Respiratory Failure: A Comparison of Three Nutritional Assessment Methods

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosis of COPD at West China Hospital during January 2014 to March 2016 Partial pressure of O2 (PaO2) < 60 mmHg and/or partial pressure of CO2 (PaCO2) >50 mmHg Age ≥ 18 years Respiratory rates > 23 bpm Exclusion Criteria: Pregnancy or during lactation Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems Incomplete medical profiles

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 |
| --- | --- | --- |
| Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of in-hospital death |  | up to 27 months | 
| Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 1-year death after discharge |  | up to 27 months | 
| Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 30-day readmission after discharge |  | up to 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of Demographics (age, sex, marriage) |  | up to 27 months | 
| Number of participants with in-hospital death |  | up to 27 months | 
| Number of participants with 1-year death after discharge |  | up to 27 months | 
| Number of participants with 30-day readmission after discharge |  | up to 27 months |
Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis

Study Overview
=================
Brief Summary
-----------------
To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).

Conditions
-----------------
Systemic Inflammatory Response Syndrome, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female aged 18 years old and over; Clinically suspected infection; Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands; Exclusion Criteria: less than 18 years old; immunosuppression; agranulocytosis (granulocyte counts <0.5× 109/L); chronic myeloid leukemia (CML); malignancy; less than 24 hours of the length of ICU stay; reluctant to participate in the study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIRS, SEPSIS<br> | |
| sepsis, severe sepsis, septic shock<br> | |
| health, SIRS, Sepsis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Outcome | The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, alpha-1-acid glycoprotein (AGP), diagnosis, prognosis, SIRS
The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).

Official Title
-----------------
An Open Label, Multicenter Phase II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

Conditions
-----------------
Metastatic Colorectal Cancer, mCRC

Intervention / Treatment
-----------------
* Drug: HLX208


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18Y; Good Organ Function; Expected survival time ≥ 3 months; Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment; At least one measurable lesion as per RECIST v1.1; ECOG score 0-1. Exclusion Criteria: Previous treatment with BRAF inhibitors or MEK inhibitors Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). Active clinical severe infection; A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208<br>Participants receive HLX208 450mg bid po | Drug: HLX208<br>* HLX208 450mg bid po<br>* Other names: BRAF V600E inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 ) | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | 
| OS | Overall survival | from the date of first dose until the date of death from any cause，assessed up to 2 years |