linjc16/ctgov huggingface dataset:
Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.

Official Title
-----------------
An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Genexl PM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Patients consented to participate Pathologically diagnosed ovarian cancer FIGO stage IC-IVB ECOG 0-2 Patients with an expected survival of 3 months or more Exclusion Criteria: History of paclitaxel or carboplatin hypersensitivity Inadequate bone marrow function (Neutrophil<1500/mm3, Platelet <100,000/mm3) Pregnancy or breast-feeding state Metachronous or synchronous malignancy Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems Other patients who were judged difficult to be included in this investigation by the investigator in charge

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Genexol PM<br>Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer. | Drug: Genexl PM<br>* Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants showing adverse events | Number of any adverse event assessed based on CTCAE 4.0 | From the time of treatment start date through 30 days following cessation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurotoxicity | Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0 | From the time of treatment start date through 30 days following cessation of treatment | 
| other toxicity | Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0 | From the time of treatment start date through 30 days following cessation of treatment |
Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode. The main objective is evaluating prevalency of full stomach in differents stages of pregnancy in fasted pregnant women.

Detailed Description
-----------------
Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.

Official Title
-----------------
Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study

Conditions
-----------------
Gastric Ultrasound, Fasting ( 6H for Solid ; 2H for Clear Fluid ), Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria An subject must fulfill all of the following criteria in order to be eligible for study enrollment: Aged at least 18 years old Pregnant women Fasted ( at least 6h for solid , 2h for clear fluid ) Exclusion criteria Previous Bariatric surgery / upper gastro-intestinal surgery Adult under protection

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

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

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 |
| --- | --- | --- |
| Qualitative assessment of gastric content | Qualitative assessment of gastric content using Perlas Grade | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative assessment of gastric content | Quantitative assessment of gastric content by measuring antral area | 1 day | 
| Feasibility evaluation of gastric ultrasound | Feasibility evaluation of gastric ultrasound during pregnancy | pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaesthesia, Obstetric, Diagnostic imaging, Stomach, Ultrasonography
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Study Overview
=================
Brief Summary
-----------------
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed Description
-----------------
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Official Title
-----------------
Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China

Conditions
-----------------
Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively ECOG performance status 0-2 with expected more than 6 months of survival time Willingness to comply with required protocols and give permission to use the data for clinical research and products development Exclusion Criteria: Patients have other primary cancers Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders Patients failed in either plasma or tissue sample QC

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of gene mutation pattern between liquid biopsy and tissue biopsy. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liquid biopsy, Next Generation Sequencing (NGS), Tyrosine Kinase Inhibitor (TKI), EGFR Gene mutation
CV Risk Factors at Age 25-64 & Long-Term Medicare Costs

Study Overview
=================
Brief Summary
-----------------
To assess in four large Chicago population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last one to two years of life.

Detailed Description
-----------------
BACKGROUND: Studies will be conducted on the cumulative lifetime Medicare costs of individuals from four Chicago population cohorts from which prior risk factor data are available. One cohort is from the Western Electric Company Study, with 2107 men who were 40-56 when the follow up began in 1957. For this group a physical exam, ECG and cholesterol measures are available along with data from a quantitative diet history conducted at that time assessing 28 days of intake. It is not clear whether the men themselves or their wives provided this information. Repeat measures are available, but attention is paid to their use in the analyses. Also, information on the availability of the quantitative information at the food level is not provided. Two cohorts are from the Peoples Gas Company Study, one with 1594 men aged 40-59 in 1958 and the second with 1609 men aged 25-39 in 1959 . From both cohorts a total of 1802 men are, based on their ages, currently Medicare eligible.The fourth cohort is the Chicago Heart Disease Detection Association Project (CHA) based on an initial survey of 39,573 men and women conducted in 1967-1973 on whom dietary data are not available. DESIGN NARRATIVE: The study assesses the relationships of CVD risk factors measured in young and middle-aged adult men and women to Medicare utilization and charges, from Medicare enrollment to death or attainment of age 70, 75, 80, >80, including in the last one to two years of life. The study determines long-term relationship between earlier low-risk status vs. not-low-risk to subsequent Medicare health care charges. Baseline low risk is all six CVD risk factors favorable: systolic/diastolic pressure 120 mmHg/80 mmHg and no antihypertensive treatment, serum cholesterol <200 mg/dl, not currently smoking, no ECG abnormalities, no history of diabetes or heart attack. The study also determines the relationships between baseline habitual eating patterns and subsequent Medicare utilization and charges. Further statistical methods are developed for optimal analyses of health care expenditures. The database will be extended by obtaining additional years of morbidity-mortality experience and of Medicare charge data to the year 2002.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome. II. Determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a combined open label and double blind randomized study. Patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month. Then, patients are randomized to one of two possible double blind treatments. In the short term pimozide group, patients receive pimozide over 2 weeks. Then, pimozide is gradually replaced by an inactive placebo within the following 10 weeks. Patients in the long term pimozide group receive pimozide. Patients continue treatment for 12 months or until a worsening of tics or behavioral symptoms are present for which an increased dosage is required. Patients who do not experience an exacerbation of tics requiring an increase in dosage are followed for 1 year from the date of entry.

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Drug: pimozide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- DSM-III-R criteria for Tourette syndrome Chronic motor tic disorder with tics sufficiently severe to require neuroleptic therapy --Prior/Concurrent Therapy-- No clonidine for at least 2 weeks or any neuroleptic (e.g., haloperidol, pimozide) within 3 months prior to study Stable dosage of other medications (e.g., antiobsessional, stimulant) for at least 3 months prior to and during study required

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

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

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
-----------------
Tourette syndrome, neurologic and psychiatric disorders, rare disease
Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

Study Overview
=================
Brief Summary
-----------------
In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent. At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems: Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.

Official Title
-----------------
Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

Conditions
-----------------
Infectious Disease Screening

Intervention / Treatment
-----------------
* Diagnostic Test: infectious disease screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hosipital patients Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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 |
| --- | --- |
| patients<br>Preoperative patients needing transfusions | Diagnostic Test: infectious disease screening<br>* Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 | 
| Hepatitis C Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 | 
| HIV Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nucleic acid, pre-transfusion, pre-operative, pathogen detection
Efficacy and Safety of Corticosteroids in COVID-19

Study Overview
=================
Brief Summary
-----------------
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.

Official Title
-----------------
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

Conditions
-----------------
COVID-19, Novel Coronavirus Pneumonia

Intervention / Treatment
-----------------
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years old accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19). admitted in the general wards be able to sign informed consent Exclusion Criteria: severe immunosuppression (HIV infection, long-term use of immunosuppressive agents pregnant or lactation period women glucocorticoids are needed for other diseases unwilling or unable to participate or complete the study participate in other study

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP group<br> | Drug: Methylprednisolone<br>* Methylprednisolone 1mg/kg/day ivgtt for 7 days.<br>|
| No Intervention: Con group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of treatment failure in 14 days | The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical cure incidence in 14 days | The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed. | 14 days | 
| the duration of virus change to negative | the duration from admission to virus negative | 30 days | 
| mortality at day 30 | the patient die in 30 days | 30 days | 
| ICU admission rate in 30 days | the patients transform to ICU because of clinical deteriorate in 30 days | 30 days |
Capillary Refill Time Measurement Utilizing Mobile Application in Children

Study Overview
=================
Brief Summary
-----------------
To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods which will serve as the comparison.

Official Title
-----------------
Capillary Refill Time Measurement Utilizing Mobile Application in Children

Conditions
-----------------
Healthy Children (1 Month to 17 Years Old)

Intervention / Treatment
-----------------
* Device: Mobile Health application (CapApp)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged 1 month to 17 years Exclusion Criteria: Fever or hypothermia Chronic illness including cardiovascular or renal disease Severe injury or blood loss Dehydration Raynaud's phenomenon

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mobile Health application (CapApp)|Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy and precision of a mobile health application (Cap App) | Capillary refill time (CRT) of Cap App compared to two manual methods | Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capillary Refill, Mobile Health Application, Pediatrics
Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Detailed Description
-----------------
Clinical data (prostate-specific antigen [PSA] response after radiotherapy) are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Official Title
-----------------
Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer treated with radiotherapy +/- hormones Exclusion Criteria: Prostatectomy
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, prostate specific antigen, radiotherapy, mathematical modeling