linjc16/ctgov huggingface dataset:
Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas

Study Overview
=================
Brief Summary
-----------------
Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas. Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas. Materials and methods: The study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS.

Official Title
-----------------
Impact of Short-term Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas: A Time Series Regression With 6,000,000 Person-years of Follow-up (ACS - Air Pollution Study)

Conditions
-----------------
Acute Coronary Syndrome, Air Pollution

Intervention / Treatment
-----------------
* Other: Acute coronary syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
The study covered all residents from industrial (Katowice) and non-industrial (Białystok) areas.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Industrial area<br> | Other: Acute coronary syndrome<br>* The effect of air pollution on acute coronary syndrome<br>|
| Non-industrial area<br> | Other: Acute coronary syndrome<br>* The effect of air pollution on acute coronary syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-ST segment elevation myocardial infarction |  | 7 days | 
| ST-segment elevation myocardial infarction |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, Air pollution
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets

Study Overview
=================
Brief Summary
-----------------
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are screened (office-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.

Official Title
-----------------
Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets

Conditions
-----------------
Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis, Peripheral Vascular Diseases, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy Exclusion Criteria: Patients who do not receive cholesterol-lowering therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Lipid profile |  | At screening and 8-5 weeks after screening | 
| HbA1c profile |  | At screening and 8-5 weeks after screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Need-to-treat, NIS, Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor

Study Overview
=================
Brief Summary
-----------------
This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.

Official Title
-----------------
Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC

Conditions
-----------------
NSCLC Stage IV, NSCLC Stage IIIB

Intervention / Treatment
-----------------
* Diagnostic Test: cohort study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects need to sign the informed consent form All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV) Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing Exclusion Criteria: Patients with previous history of lung cancer Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: cohort study|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gene expression and the cell population | Methods for the single cell RNA sequencing and whole exome sequencing of the tumor cells With the tissue biopsied specimens, scRNAseq (by 10X Genomics platform) and whole exome seq will be carried out. | 3 year |
Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Study Overview
=================
Brief Summary
-----------------
Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab. In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.

Official Title
-----------------
Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Conditions
-----------------
Syphilis

Intervention / Treatment
-----------------
* Other: No active intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained Exclusion Criteria: Age <18 years Unable to provide consent Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained

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 |
| --- |
|Other: No active intervention.|No active intervention is undertaken. Collection of samples for bio-informatic analysis only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Genome Sequencing | Whole Genome Sequencing of T.pallidum | From samples collected at baseline | 
| Host Transcriptomic Response | RNA Sequencing from lesion and blood samples | From samples collected at baseline |
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To compare the mean length of hospital stay in laparoscopic trans abdominal preperitoneal repair versus open mesh repair in patients undergoing inguinal hernia repair with mesh.

Detailed Description
-----------------
A total of 334 patients of male gender with Inguinal hernias of any side and ASA score I and II were included in the study. History of Immunosuppression, associated with other abdominal hernias and recurrent hernia were excluded. 167 patients were in Group A or laparoscopic trans abdominal preperitoneal repair group while 167 patients were in Group B or open mesh repair. Data regarding length of hospital stay from both groups was recorded by researcher himself on especially designed proforma.

Official Title
-----------------
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: hospital stay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age 18-60 years Inguinal hernias of any side as per operational definition ASA score I and II Exclusion Criteria: • H/o Immunosuppression Associated with other abdominal hernias H/o recurrent hernia

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-probability consecutive sampling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic trans abdominal preperitoneal repair<br>length of hospital stay | Procedure: hospital stay<br>* hospital stay in in inguinal hernia repair<br>|
| Active Comparator: open mesh repair of inguinal hernia<br>length of hospital stay | Procedure: hospital stay<br>* hospital stay in in inguinal hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitals stay | hospital stay in hours after surgery | 1-2 days |
Physiological Patterns of Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

Detailed Description
-----------------
A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.

Official Title
-----------------
Physiological Patterns of Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Fractional Flow Reserve Motorized Pullback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable coronary artery disease Exclusion Criteria: acute coronary syndromes previous coronary artery bypass grafting significant valvular disease severe obstructive pulmonary disease or asthma bronchial severe tortuosity or severe calcification

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Fractional Flow Reserve Motorized Pullback|A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined) | Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse). | Immediate post-procedure. No follow-up is schedule for this trial. |
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Detailed Description
-----------------
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Official Title
-----------------
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Conditions
-----------------
B-cell Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Biological: CD19 CAR-T cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia ALT/ AST 《 3x normal Creatinine 《 3x normal Age:10-60. Signed informed consent Exclusion Criteria: Active hepatitis B , hepatitis C or HIV infection Uncontrolled active infection Pregnancy or breast-feeding women Survival less than four weeks

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia. | Biological: CD19 CAR-T cells<br>* CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complete remission (CR) rate | The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined | Participants will be followed for the duration of the treatment, an expected average of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CNS B cell acute lymphocytic leukemia
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

Official Title
-----------------
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Currently treated with Oral Antidiabetic Drugs BMI lesser than or equal to 40 kg/m2 HbA1c greater than or equal 7.5 and lesser than or equal to 11% Exclusion Criteria: Proliferative retinopathy or maculopathy Recurrent major hypoglycaemia uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | after 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| body weight |  |  | 
| Hypoglycemia |  |  | 
| Blood glucose |  |  |
Cardiovascular Complications of Carfilzomib

Study Overview
=================
Brief Summary
-----------------
Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.

Official Title
-----------------
Insuffisance Cardiaque Sous Carfilzomib: étude Prospective

Conditions
-----------------
Myeloma, Heart Failure, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intention to treat by Carfilzomib Exclusion Criteria: History of carfilzomib treatment

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 |
| --- | --- | --- |
| Incidence of cardio-vasculo-toxicity of carfilzomib | Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic hypertension | Number of patients with as systemic hypertension | 6 months | 
| Heart Failure Reduced Ejection Fraction | Number of patients with Heart Failure and Reduced Ejection Fraction | 6 months | 
| Heart Failure Preserved Ejection Fraction | Number of patients with Heart Failure and Preserved Ejection Fraction | 6 months | 
| Predictors of Cardiotoxicity | Correlation between cardio-vascular toxicity and patients' chacateristics. | 6 months | 
| Impact on outcomes | Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty. | 1 year | 
| Safety | Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse drug event