linjc16/ctgov huggingface dataset:
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Study Overview
=================
Brief Summary
-----------------
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Official Title
-----------------
A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone
* Drug: glyburide
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newly diagnosed patients (< 3years) with type 2 diabetes. Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening. No previous treatment with oral or parenteral glucose-lowering therapy. Exclusion criteria: History of lactic acidosis. Anemia (<11g for males, <10 g for females). Unstable or severe NY Heart Association-class 3 or 4. Any NY Heart Association congestive heart failure. Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosiglitazone|nan|
|Drug: glyburide|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to the primary action point (monotherapy failure). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes monotherapy treatment naive
Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy

Official Title
-----------------
Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial

Conditions
-----------------
Myomectomy

Intervention / Treatment
-----------------
* Drug: intravenous tranexamic acid
* Drug: vaginal dinoprostone
* Drug: vaginal placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic fibroids candidate for abdominal myomectomy Exclusion Criteria: patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous tranexamic acid<br>patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision. | Drug: intravenous tranexamic acid<br>* patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.<br>|
| Active Comparator: vaginal dinoprostone<br>patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug: vaginal dinoprostone<br>* patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision<br>|
| Placebo Comparator: placebo<br>patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug: vaginal placebo<br>* patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | estimation of intraoperative blood loss in ml | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood transfusion | need for intraoperative or postoperative blood transfusion | 24 hours |
Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.

Official Title
-----------------
Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must provide informed consent Men or women aged 18 years or more Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study Exclusion Criteria: - Contraindication to the use of Low Molecular Weight Heparin

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Molecular Weight Heparin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription conditions and use of Low Molecular Weight Heparin in the French usual practice for the treatment of symptomatic Venous Thromboembolism in patients with cancer at up to 6 months |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the consistency of the Low Molecular Weight Heparin use with French national recommendations on the treatment of Venous Thromboembolism in patients with cancer. |  | up to 6 months | 
| To evaluate Venous Thromboembolism recurrences, bleeding, thrombocytopenia and deaths during Low Molecular Weight Heparin treatment |  | up to 6 months | 
| To describe clinical factors associated with treatment duration with Low Molecular Weight Heparin and those associated with the occurrence of Venous Thromboembolism in patients with cancer |  | up to 6 months | 
| To evaluate the anticoagulant treatment perception and satisfaction by patients with cancer disease with a validated questionnaire |  | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Thromboembolism, Cancer, Low Molecular Weight Heparin
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma

Official Title
-----------------
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Conditions
-----------------
Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: Association of gemcitabine, oxaliplatin and radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease WHO performance status of 0 or 1 Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed Maximum delay after surgery: 8 weeks No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ Adequate bon marrow reserve No previous chemotherapy or radiotherapy Expected survival > 6 months Exclusion Criteria: Active infection Metastatic disease Inadequate liver function after derivative surgery Inadequate renal function Pregnancy, breast feeding Use of any other investigational agent in the month before enrollment Patients with grade 2 or more neuropathy

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Association of gemcitabine, oxaliplatin and radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Tolerance |  |  |
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To identify photoacoustic features of breast malignancy. OUTLINE: Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.

Official Title
-----------------
Photoacoustic Imaging of Human Breast

Conditions
-----------------
Breast Carcinoma, Healthy Subject

Intervention / Treatment
-----------------
* Procedure: Photoacoustic Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI). Exclusion Criteria: Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening). Women who have had breast implants in the previous 6 months. Women who have had lumpectomy Adults unable to consent. Individuals who are not yet adults (infants, children, teenagers). Pregnant women. Prisoners. There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (photoacoustic imaging of the breast)<br>Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day. | Procedure: Photoacoustic Imaging<br>* Undergo photoacoustic imaging of the breast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify photoacoustic features of breast malignancies | Photoacoustic excitation and detection will be performed | Up to 3 years |
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)

Study Overview
=================
Brief Summary
-----------------
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).

Official Title
-----------------
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Drug: Inotuzumab Ozogamicin (CMC-544)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies. Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma. Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1. Exclusion Criteria: Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article. Patients must not have received bilateral pelvic irradiation. Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: 1<br> | Drug: Inotuzumab Ozogamicin (CMC-544)<br>* Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-cell Non-Hodgkin's Lymphoma, NHL
Perceptions and Representations of Vaccination Against COVID-19

Study Overview
=================
Brief Summary
-----------------
SARS COV2, the virus that causes COVID-19, was first described in Wuhan, China. For this pathology, which causes severe respiratory infections, preventing the transmission of the virus has become fundamental, that is why vaccines have been developed. In France, this vaccination campaign took place in a context where the lack of confidence in vaccination is high: According to a November 2020 IFOP poll, only 41% of French respondents were willing to be vaccinated against COVID-19. To our knowledge, there are still few qualitative studies on vaccination on the current issue of vaccination against COVID-19.

Official Title
-----------------
Perceptions and Representations of Vaccination Against COVID-19

Conditions
-----------------
COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Behavioral: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Patient with a scheduled appointment in consultation or at the vaccination centre Not opposed to participation in the protocol Exclusion Criteria: Patient under guardianship or curatorship Patient unable to give free and informed consent Patient under court protection Patient without the cognitive capacity to ensure an interview

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 |
| --- |
|Behavioral: Interview|Face to face semi-directed interviews about perceptions, representations and experiences of Covid-19 vaccination, including six opened-questions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions, representations and experiences of Covid-19 vaccination | Interview based on 6 opened questions | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key elements to improve the medical discourse on vaccination | Interview based on 6 opened questions | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccination perception
Factors Influencing Cesarean Section Rate: Does the Audit Still Work?

Study Overview
=================
Brief Summary
-----------------
To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate. From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.

Official Title
-----------------
Factors Influencing Cesarean Section Rate: Does the Audit Still Work?

Conditions
-----------------
Cesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women who delivered in a medical center will be included retrospectively in this study Exclusion Criteria: All pregnant women who delivered in a medical center will be included retrospectively in this study , no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 47 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cesarean section rate after audit<br>cesarean section rate after audit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the cesarean section rate audit |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section rate, the cesarean section rate audit