linjc16/ctgov huggingface dataset:
Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data

Study Overview
=================
Brief Summary
-----------------
The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health data which is obtained through blood samples, continuous monitoring devices, medical imaging, a questionnaire, and a blood pressure monitor. Feasibility of collecting individual health data within the OBSERVE PILOT is described as the ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects to participate in the study, (2) the logistics corresponding with the variety, and (3) the regulatory aspects of gathering a broad variety of data.

Official Title
-----------------
Observe Pilot, a Prospective Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is able and willing to provide written informed consent prior to research specific data collection. The subject must be older than 18 years old. Exclusion Criteria: The subject should not suffer from glaucoma. The subject should not be allergic to eye drops.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects willing to join the study | The number of subjects invited compared to the number of patients willing to join | Through study completion, an average of 6 months | 
| The number of health data types that were measured | The number of health data types that were measured compared to the number of health data types anticipated | Through study completion, an average of 6 months |
A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Study Overview
=================
Brief Summary
-----------------
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

Detailed Description
-----------------
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

Official Title
-----------------
Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Conditions
-----------------
Moderate to Severe Dry Eye

Intervention / Treatment
-----------------
* Other: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older, of both sexes, and any race. Willing and able to make all required visits and follow study instructions. A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart Exclusion Criteria: A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. Lasik patients can be included if Lasik surgery was > 6 months prior to the initiation of the study. A history of intolerance or hypersensitivity to any component of the study medications.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Systane Lubricant Eye Drops | Other: Systane<br>* Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining |  | Visit 2 (Week 2) - change from baseline | 
| Best-corrected visual acuity |  | Visit 2 (Week 2) - change from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systane, Dry Eye
Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.

Official Title
-----------------
Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Other: Periodontal screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women older than 18 Pre-term birth between 24 and 37 gestational weeks Exclusion Criteria: Patient's opposition Delivery before 24 gestational weeks or after 37 gestational weeks

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

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

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: Periodontal screening|Periodontal screening in all patients giving birth between 24 and 37 gestational weeks. Bacteriological sampling in the periodontal pocketing. Search for specific cytokines in the periodontal pocketing. Professional prophylaxis and oral hygiene instruction.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sulcular bleeding index as active disease |  | one week after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index |  | one week after delivery | 
| Depth of periodontal pocketing |  | one week after delivery | 
| Clinical attachment level |  | one week after delivery | 
| Bacterial sampling of gingival crevicular fluid |  | One week after delivery | 
| Search for cytokines in the gingival crevicular fluid |  | one week after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal disease, Per-term delivery, Sulcular bleeding index, Bacteriological gingival presence, Cytokines, Active periodontal disease with sulcular bleeding index, Bacteriological sampling in periodontal pocketing, Cytokines in the periodontal pocketing
Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.

Official Title
-----------------
A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: TNB-383B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adequate bone marrow function eGFR ≥ 30 mL/min Total bilirubin ≤ 1.5 × upper limit of normal (ULN) Serum calcium (corrected for albumin) at or below the ULN range Exclusion Criteria: Candidate for treatment regimens known to provide clinical benefit in MM Active infection requiring parenteral anti-infective treatment Any medical or psychiatric condition which in the opinion of the investigator or Teneobio Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety

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 |
| --- |
|Drug: TNB-383B|TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events

Study Overview
=================
Brief Summary
-----------------
To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.

Detailed Description
-----------------
In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.

Official Title
-----------------
Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care Age ≥ 18 years. ECOG performance status 0-2 Adequate organ and marrow function as defined below: INR ≤ 1.5 platelets ≥ 70,000/mcl Ability to understand and the willingness to sign a written informed consent Target liver mass not subcapsular in nature as determined by the participating biopsy team Child Pugh Turcotte score A or B Exclusion Criteria: Previous treatment for HCC Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Liver Cancer<br>Patients that have liver masses suspicious for primary liver cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy of Liver Masses | To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies. | 5 years |
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.

Official Title
-----------------
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial and Sub-study of the BOBS Study (Better Outcomes Following Bariatric Surgery)

Conditions
-----------------
Obesity, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: Daily text message of support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment Exclusion Criteria: Patients who do not have the ability to receive text messages Patients who do not understand written English

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Patients are discharged from the bariatric service at 18 months after surgery. | |
| Experimental: Standard care with text message support<br>Patients are discharged from the bariatric service at 18 months after surgery but receive a daily text message for one year. | Other: Daily text message of support<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of excess weight lost |  | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bariatric Analysis and Reporting Outcome System (BAROS) |  | Twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Sleeve gastrectomy, Text messaging, Weight loss, BAROS, Follow-up care
The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

Detailed Description
-----------------
It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure. The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure.

Official Title
-----------------
The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

Conditions
-----------------
Intubation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient receiving general anesthesia for elective surgery Exclusion Criteria: who doesn't agree to enroll who has any clinical disease or history of surgery in esophagus who has aspiration tendency

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 |
| --- | --- | --- |
| Change of cuff pressure | Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal steothoscope, tracheal intubation
B-cell Chronic Lymphoid Malignancies Markers

Study Overview
=================
Brief Summary
-----------------
Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment. In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained. The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies. The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.

Official Title
-----------------
Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies

Conditions
-----------------
Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia, Mantle Cell Lymphoma, Hairy Cell Leukemia, Follicular Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1) patients that gave their informed consent for the retrospective use of their clinical and biological data Exclusion Criteria: patients under guardianship or curatorship patients who did not gave their consent for the use of their cells and/or data

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 |
| --- | --- | --- |
| Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Chronic B-cell malignancies, Flow cytometry, Statistical algorithms
D-Lung: An Analytics Platform for Lung Cancer Based on Deep Learning Technology

Study Overview
=================
Brief Summary
-----------------
Lung cancer is one of main cause of cancer death in worldwide, characterized of low 5-year survival rate of less than 20%. Pulmonary nodule is considered as the typical imaging manifestation in early stage of lung cancer. The National Lung Screen Trial has demonstrated that the mortality rates could decline greatly, by the utility of low-dose helical computed tomography for screen of pulmonary nodules. Thus, automatic detection, diagnosis and management of pulmonary nodules, play the vital roles in computer-aided lung cancer screening and early intervention.

Official Title
-----------------
D-Lung: An Analytics Platform for Primary Lung Cancer Screening, Diagnosis and Management Based on Deep Learning Technology

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

Intervention / Treatment
-----------------
* Radiation: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with suspicious lung nodules. Thin-layer thoracic CT and pathology examination have been performed for suspicious lung nodules. Exclusion Criteria: Subjects with accompanied lesions on CT images that may interfere to lung nodules analysis
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: computed tomography|thoracic CT examinations for diagnosis, and/or follow-up.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy | proportion of true results(both true positives and true negatives) among whole instances | 2 years | 
| sensitivity | true positive rate in percentage(%) derived by ROC analysis | 2 years | 
| specificity | true negative rate in percentage (%) derived by ROC analysis | 2 years | 
| area under curve (AUC) | area under ROC curve in percentage (%) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average number of false positives per scan (FPs/scan) | FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis | 2 years | 
| competition performance metric (CPM) | Competitive performance metric (CPM) is a criterion used for CAD system evaluation. Based on FROC paradigm, CPM score is computed as an average sensitivity at seven predefined average false positive rates. CPM score ranges from 0 to 1, with higher CPM score indicating better CAD performance. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung nodules, Deep learning