linjc16/ctgov huggingface dataset:
Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Study Overview
=================
Brief Summary
-----------------
Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades.It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, and in recent years, a supplemental ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed to define an optimal screening strategy that suits Chinese women and the socioeconomics of China.

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

Intervention / Treatment
-----------------
* Other: mammography
* Other: ultrasound
* Other: mammography and ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent； residence from community or working units Exclusion Criteria: pregnancy； lactation； known metastatic cancer； signs or symptoms of breast disease； presence of breast implants, breast surgery within prior 12 months； had mammography or ultrasound exam within prior 12 months males.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>screening with mammography alone | Other: mammography<br>* participants were screened by mammography alone every year<br>|
| Experimental: group 2<br>screening with ultrasonography alone | Other: ultrasound<br>* participants were screened by ultrasound alone every year<br>|
| Experimental: group 3<br>screening with both mammography and ultrasound | Other: mammography and ultrasound<br>* Participants were screened by both mammography and ultrasound every year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening yield | Sensitivities, specificities, positive predictive values, and negative predictive values | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | cost of each screening modility to detect one cancer | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, screening, mammography, ultrasound
Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy

Study Overview
=================
Brief Summary
-----------------
Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ hypoperfusion. Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde perfusion. However,whether the arterial oxygenation status from different parts of the body are the same in the condition of retrograde perfusion have not been studied. The present study is aimed to determine if there is difference in the arterial oxygenation between peripheral arterial and aortic root during the period of retrograde perfusion.In addition, the impact of artificial ventilation on the difference of arterial oxygenation will also be investigated.

Detailed Description
-----------------
All patients included will be assigned into two different groups according to the surgical approach,one group is named NP with normal perfusion,and the other is named RP with retrograde perfusion. For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root for blood gas analysis at some specific time points. We will focus on the differences of arterial oxygenation between peripheral arterial and aortic root at each group.At the same time,we will analyse the impact of artificial ventilation on it.

Official Title
-----------------
The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy

Conditions
-----------------
Bypass Complications, Disorder of Blood Gas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass Exclusion Criteria: without informed consent 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between peripheral arterial oxygenation and aortic root blood oxygenation | The three time points for blood sample collection are:1.right before clamping the aorta; 2.Three minutes after **** without ventilation;3.5 min after re-initiate mechanical ventilation. | patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION |
Surveillance of Summer Febrile Syndromes of Viral Origin in South of France

Study Overview
=================
Brief Summary
-----------------
The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.

Conditions
-----------------
Summer Febrile Syndromes of Viral Origin

Intervention / Treatment
-----------------
* Other: BLOOD DRAW


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Old: equal to or higher than 5 years Living in the south of France, without voyage abroad in the 2 weeks preceding inclusion Presenting a fever or a syndrome pseudogripal since less than 7 days without diagnostic orientation nor infectious pathology of body, Affiliated with a mode of social security After obtaining free and informed of the written assent Exclusion Criteria: Subject whose adhesion with the protocol is improbable according to the investigator Expectant mother Subject taking part in another clinical trial or in period of exclusion of a preceding clinical trial infectious Pathology of body requiring a specific treatment Discovered after inclusion d' a pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: BLOOD DRAW|specific interview, sequential blood collection to allow virus isolation, molecular and serological diagnostics in patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and characterization of emergent viruses responsible for estival fever in the south of France |  | 3years |
Rapid Learning for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Detailed Description
-----------------
By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Official Title
-----------------
Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients notes as suffering from lung cancer in at least one clinical data source.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective collection<br>Retrospective collection of data from included lung cancer patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Retrospective data will be collected from each included patient from start of radiotherapy until end of study or death (an expected average of 10 years). | From radiotherapy until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | Data will be collected from inclusion in the study until end of study of death (an expected average time frame of 10 years) concerning the local control of this tumour. | From start of treatment until death, | 
| Distant metastases | Data concerning the possible occurence of distant metastases will be collected from each patient from inclusion until end of study or date of death (an expected average time frame of 10 years). | From treatment until end of study | 
| Dyspnea | From each included patient, dyspnea scores will be collected from start of treatment until end of study or date of death (an expected average time frame of 10 years). | From inclusion until end of study | 
| Dysphagia | Dysphagia scores will be collected from each participating patient from treatment until end of study or date of death (an average time frame of 10 years) | From treatment until end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retrospective, Lung cancer
Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-centered US Study

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, case control study of inflammatory bowel disease. This study will analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian population and will help describe clinical characteristics and serologic profiles in Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to historical Caucasian controls. The data from this study will help identify the phenotype characteristics of different ethnic groups and study the epidemiological patterns of the disease.

Detailed Description
-----------------
This study is a retrospective, case control study of inflammatory bowel disease characteristics in patients with origins from the Indian sub-continent. Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States. Using both electronic and paper databases, demographic information regarding age, gender, body mass index, smoking history, dietary habits; medical history such as type of IBD, IBD symptoms, location and behavior, medication use (past and current), history of other autoimmune disorders; surgical history (IBD and non-IBD related); laboratory indices such as IBD serology, Thiopurinemethyltransferase (TPMT), and infliximab levels will be collected. Demographics will be compared between groups using descriptive statistics. Using univariate analysis, variables that are significantly different will be identified. Conditional logistic regression will then be performed to identify those clinical variables that are statistically significant. The study duration will be one year from IRB approval.

Official Title
-----------------
Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-centered US Study

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with origins from the Indian sub-continent Patients will be selected from the IBD registry maintained at respective institutions.
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 |
| --- | --- | --- |
| Phenotypic characteristics of inflammatory bowel disease in southeast asian population | Retrospective chart review | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD
Registry of Patients Treated With Plerixafor (Mozobil®) for Haematopoietic Stem Cell Mobilization Before Autologous Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.

Official Title
-----------------
Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study

Conditions
-----------------
Bone Marrow / Autologous Transplants

Intervention / Treatment
-----------------
* Drug: Plerixafor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012 Patients who have been informed and who have given their written consent for the access to their medical file Exclusion Criteria: Patients already included in a Plerixafor ongoing clinical trial.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Plerixafor|Plerixafor will be prescribed independently by the physician, according to usual practice.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The characteristics of the patients who received treatment |  | 13 months | 
| Dosage of treatment |  | 13 months | 
| Number of CD34+ cells collected following treatment |  | 13 months | 
| Number of patients with the existence of one or more predictive factors of poor mobilisation |  | 13 months | 
| Duration of treatment |  | 13 months | 
| Associated treatments |  | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous stem cell transplantation, lymphoma, multiple myeloma
MIND (Management of Traumatic Brain Injury Diagnosis)

Study Overview
=================
Brief Summary
-----------------
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.

Official Title
-----------------
Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions

Conditions
-----------------
Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent Form Signed 18 years of age or older For women of child-bearing age: Not known to be pregnant AND Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR Bone fracture or poly-traumas, both with no head trauma Exclusion Criteria: Known pre-existing neurological condition that causes observed symptoms Recent history of head injury or seizures (within 1 year of current ED presentation) Prisoner

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 |
| --- | --- |
| Brain Injury<br>Brain Injury | |
| Control<br>Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of specific biomarker(s) for brain injury | Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Injury
Finnish Genetic Study for Arrhythmic Events

Study Overview
=================
Brief Summary
-----------------
Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study assessing the characteristics and genetic background of consecutive series of autopsy verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a specific geographical area in northern Finland.

Official Title
-----------------
Finnish Genetic Study for Arrhythmic Events

Conditions
-----------------
Sudden Cardiac Death, Acute Coronary Event

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sudden cardiac death verified by medicolegal autopsy (cases) Acute coronary event (increased troponin levels/ECG markers of ischemia/angina pectoris; two out of three criteria) (controls). Exclusion Criteria: Sudden death due to other causes (cases). Acute coronary event patients who died during hospitalization (controls).
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 |
| --- | --- | --- |
| sudden cardiac death |  | 20 years |
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

Study Overview
=================
Brief Summary
-----------------
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.

Official Title
-----------------
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: TELFA™ A.M.D. Island dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign an informed consent form that has been approved by the Institutional Review Board. Adults at least 18 years of age. Be undergoing cardiopulmonary bypass surgery with a median sternotomy. Be able to return to the study site, if needed, to have the sternal surgical incision site inspected. Exclusion Criteria: Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study. Be in need of a left ventricular assist device. Have an active pre-operative infectious process. Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TELFA™ A.M.D. Island dressing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group |  |  |