linjc16/ctgov huggingface dataset:
Serological Study of the Exposure of Personnel to Sars-cov-2

Study Overview
=================
Brief Summary
-----------------
A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. The seroconversion test will be with a questionnaire to determine: whether the subject has shown signs of infection in the last 3 recent months if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or scanner) outside of the activity or within the professional activity (patient or colleague) Working conditions during the period The level of knowledge and respect of the barrier measures practices. Respect for distance during meals professional. Overall seroprevalence and stratified seroprevalence by care and administrative areas will be determined.

Official Title
-----------------
Serological Study of the Exposure of Personnel to Sars-cov-2 in an Urban Hospital Two Months After Managing an Influx of COVID Patients 19

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: Sars-Cov-2 serology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave (male or female). Free and informed consent Social security affiliation Exclusion Criteria: Subject refusal Subject on leave during the entire period

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CoVID exposure<br> | Diagnostic Test: Sars-Cov-2 serology<br>* Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff<br>* Other names: serology;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff | Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff | 1 month |
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Study Overview
=================
Brief Summary
-----------------
A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis.

Official Title
-----------------
Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Groups, Multi-Centre Trial.

Conditions
-----------------
Seborrheic Dermatitis

Intervention / Treatment
-----------------
* Drug: ASF1057
* Drug: ASF1057


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of moderate to severe seborrhoeic dermatitis Exclusion Criteria: Other active skin diseases Use of certain systemic and topical treatments Extensive sun exposure

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: ASF1057<br> | Drug: ASF1057<br>* Twice daily, topical<br>Drug: ASF1057<br>* Twice daily, Topical<br>|
| Placebo Comparator: ASF1057 placebo<br> | Drug: ASF1057<br>* Twice daily, topical<br>Drug: ASF1057<br>* Twice daily, Topical<br>|
| Placebo Comparator: ASF1057 Vehicle<br> | Drug: ASF1057<br>* Twice daily, topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders, defined as patients with OSS ≤ 1 score units. |  | Baseline, day 7, day 14, and day 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seborrhoeic dermatitis
Non Invasive Cancer Test (NICT): a Proof of Principle Study.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to collect tumor DNA out of blood of cancer patients. If this is successful this could lead to the development of a cancer test in blood in the future, which is less invasive than current diagnostic methods.

Official Title
-----------------
Non Invasive Cancer Test (NICT): a Proof of Principle Study.

Conditions
-----------------
Neoplasmata

Intervention / Treatment
-----------------
* Genetic: Isolation of tumor DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy. Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent Exclusion Criteria: Patients with a history of malignant disease other than the disease under study, with an exception for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma of the skin and in situ cervix carcinoma. Pregnancy

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 |
| --- | --- |
| Lung cancer<br>Isolate Tumor DNA from the patients blood. | Genetic: Isolation of tumor DNA<br> <br> |
| Breast cancer<br>Isolate Tumor DNA from the patients blood. | Genetic: Isolation of tumor DNA<br> <br> |
| Colorectal cancer<br>Isolate Tumor DNA from the patients blood. | Genetic: Isolation of tumor DNA<br> <br> |
| Glioma<br>Isolate Tumor DNA from the patients blood. | Genetic: Isolation of tumor DNA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA | Demonstrate the presence or absence of ctDNA in patients plasma. Examine if there us a sufficient concentration of ctDNA in the plasma to reliably diagnose cancer and determine the CNV | One year |
68Ga-FAPI PET/MR for Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Detailed Description
-----------------
A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Official Title
-----------------
68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: 68Ga-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intracranial or carotid atherosclerosis patients signed informed consent Exclusion Criteria: pregnancy, breastfeeding contradictions of MRI unstable vital signs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 68Ga-FAPI PET/MR
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI, PET/MR<br>inject 68Ga-FAPI，and then perform PET/MR | Drug: 68Ga-FAPI<br>* intravenously injected with 68Ga-FAPI<br>* Other names: 68Ga-fibroblast activating protein inhibitors;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance | Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients | through study completion, an average of 2 years | 
| FAPI expression | The correlation of SUVmax and pathological FAPI expression | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, 68Ga-FAPI, PET/MR
The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery

Study Overview
=================
Brief Summary
-----------------
The study is to investigate the effect of succinylated gelatin on the blood viscosity and oxygen delivery in patients during surgeries, so as to have a better understanding of the safety in the use of succinylated gelatin for surgical patients.

Conditions
-----------------
Blood Viscosity

Intervention / Treatment
-----------------
* Drug: Ringer's lactate solution
* Drug: Succinylated gelatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 18 years and 60 years ASA physical status I and II surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring Exclusion Criteria: Patients younger than 16 y or older than 60 y Body Mass Index (BMI) <18 or >30 Allergy to any of the drugs used Severe cardiovascular dysfunction Patient refusal

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ringer's lactate solution<br>Infusion of Ringer's lactate solution (10ml/kg) in the control group | Drug: Ringer's lactate solution<br> <br> |
| Active Comparator: Succinylated gelatin<br>Infusion of Succinylated gelatin (10ml/kg) in the test group | Drug: Succinylated gelatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient's arterial blood viscosity (mpa.s) as tested by viscometer |  | up to 5 months (after the infusion of succinylated gelatin ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient's oxygen delivery index (DO2I) as calculated by Vigileo |  | up to 5 months (after the infusion of succinylated gelatin ) |
Continuous Glucose Monitoring System in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
To assess the accuracy, safety, and influence of sampling site of Real-time continuous glucose monitoring system (Medtronic Guardian).

Official Title
-----------------
Continuous Glucose Monitoring System in Intensive Care Unit - Preliminary Study Evaluating Accuracy

Conditions
-----------------
Diabetic Blood Glucose Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old Staying in intensive care units longer than 72 hours Exclusion Criteria: Skin disease DIC Immune suppressed patients

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 |
| --- | --- |
| RT-CGM<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between finger stick blood glucose and real-time continuous glucose monitoring |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement error of real-time continuous glucose monitoring |  | 72 hours |
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer

Official Title
-----------------
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary advanced inoperable disease who were refractory to chemotherapy Patients with recurrent disease following post-operative adjuvant chemotherapy Patients who were not amenable to post-recurrence chemotherapy Exclusion Criteria: Patients with serious, uncontrolled medical illness Patients with previous therapy with taxanes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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: Paclitaxel<br> | Drug: Paclitaxel<br>* Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent<br>* Other names: BMS-181339;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria |  | Each 49 day course of treatment until withdrawal or unacceptable toxicity | 
| Safety: incidence and severity of adverse events, laboratory test abnormalities |  | Each 49 day course of treatment until withdrawal or unacceptable toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer |  | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
Mobile Phone Text for Optimizing Asthma Treatment

Study Overview
=================
Brief Summary
-----------------
The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management. Objective: The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.

Official Title
-----------------
Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: SMS support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthmatics Exclusion Criteria: below 18 and above 45 COPD patients no mobile phone not using the prescribed asthma inhalation medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS intervention<br> | Behavioral: SMS support<br>* The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows. Remember to take your preventive asthma medication (sent at 8.00 am). Were you awakened during the night due to your asthma? Answer YES or NO. How many times have you taken your asthma attack medication during the last 24 hours? Answer a number. What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control test |  |  | 
| EQ-5D |  | 0, 45, 90 days | 
| Use of health services |  | 0, 45, 90 days | 
| Use of preventive medicine |  | 0, 45, 90 days |
Study to Evaluate the Efficacy and Safety of CKD-352

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease

Detailed Description
-----------------
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease

Official Title
-----------------
Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: CKD-352
* Drug: Diquafosol Sodium 3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than the age of 19 years old Subjects with dry eye symptoms for at least 3 month Subjects who sign on an informed consent form willingly Exclusion Criteria: Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora Subjects who have clinically significant medical history of ocular disability Subjects who have malignant tumor within 5 years Subjects with known hypersensitivity to investigational product Women who are nursing, pregnant or planning pregnancy during the study Subjects who have received any other investigational product Impossible subjects who participate in clinical trial by investigator's decision

Ages Eligible for Study
-----------------
Minimum Age: 19 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: CKD-352<br> | Drug: CKD-352<br>* Eye Drop<br>|
| Active Comparator: Diquafosol Sodium 3%<br> | Drug: Diquafosol Sodium 3%<br>* Eye Drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Staining from Baseline and at Week 4 |  | Baseline, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Staining from Baseline and at Week 2 |  | Baseline, Week 2 | 
| Changes in Conjunctival Staining from Baseline and at Week 2,4 |  | Baseline, Week 2,4 | 
| Changes in Tear Break-up Time from Baseline and at Week 2, 4 |  | Baseline, Week 2,4 | 
| Changes in Schirmer I Test from Baseline and at Week 2, 4 |  | Baseline, Week 2,4 | 
| Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 |  | Baseline, Week 2,4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye Disease, CKD-352