linjc16/ctgov huggingface dataset:
Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

Study Overview
=================
Brief Summary
-----------------
Aim of our study is to find frequency and risk factors for venous thromboembolism development in patients who underwent surgery for incisional ventral hernia. There were 240 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2018 to December 2019. Compression duplex ultrasound of lower legs veins was performed in 2-4 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.

Official Title
-----------------
Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair

Conditions
-----------------
Incisional Hernia, Venous Thromboembolism

Intervention / Treatment
-----------------
* Procedure: hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operated for incisional hernia in Saveljev University Surgery Clinic No Exclusion Criteria.

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 |
| --- |
|Procedure: hernia repair|Open or laparoscopic hernia repair with mesh placement.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous thromboembolism | Screening ultrasound in the postoperative period was aimed at looking for signs of deep vein thrombosis. The imaged vessels included the common femoral, great saphenous, superficial femoral, deep femoral, popliteal, posterior tibial, and peroneal veins of both lower extremities. The presence of a thrombotic process in the vein was evidenced by the rigidity of its walls during compression by the sensor, the presence of hyperechoic inclusions, and the impossibility of visualizing blood flow during color mapping. | was performed with median 3 days (min 1 day, max 7 days, interquartile range 2-4 days) after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hernia repair, thromboprophylaxis
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.

Official Title
-----------------
Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

Conditions
-----------------
Lymphocytic Leukemia, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse Previous treatment with MabThera/Rituxan MabThera/Rituxan treatment planned for current relapse Exclusion Criteria: Richter syndrome Life expectancy <6 months

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 2 years | 
| Complete response rate |  | 2 years | 
| Progression-free survival |  | 2 years | 
| Time to next treatment |  | 2 years | 
| Overall survival |  | 2 years | 
| Safety (incidence of adverse events) |  | 2 years | 
| Safety (incidence of hematologic adverse events) |  | 2 years | 
| Safety (incidence of infections) |  | 2 years | 
| Safety (incidence of secondary malignancies) |  | 2 years |
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.

Official Title
-----------------
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 No clinically overt heart failure Group 2 Known coronary artery disease Group 3 Known heart failure with preserved ejection fraction Group 4 Known heart failure with reduced ejection fraction Group 5 Healthy age-matched controls Exclusion Criteria: Age <18 years Known malignancy with expected survival <1 year Pregnant or recent pregnancy <6 months Recent event (<2 weeks since Acute Coronary Syndrome, Heart failure or other admission Severe mitral or aortic stenosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Percent of patients meeting new diagnostic criteria for HFpEF |  | Up to 5 years |
Self-confidence Study in Patients With Argus II Artificial Retina

Study Overview
=================
Brief Summary
-----------------
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa

Official Title
-----------------
Self-confidence Study in Patients With Argus II Artificial Retina

Conditions
-----------------
Pigmentary Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient (≥18 years old) Patient already operated in France with artificial retina and having 1 year of follow-up Patient who has agreed to use his medical data for research purposes Exclusion Criteria: - Refusal to participate in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-confidence | Evaluation of Self-confidence via a questionnaire | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pigmentary retinopathy, Argus II retinal prosthesis, Self-confidence
Congenital Cataract With Persistent Fetal Vasculature

Study Overview
=================
Brief Summary
-----------------
To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.

Detailed Description
-----------------
methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.

Official Title
-----------------
Surgical Treatment and Prognosis of Congenital Cataract With Persistent Fetal Vasculature

Conditions
-----------------
Congenital Cataract, Persistent Fetal Vasculature

Intervention / Treatment
-----------------
* Procedure: cataract surgery cataract extraction and intraocular implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital cataract with Persistent Fetal Vasculature Exclusion Criteria: congenital cataract with no Persistent Fetal Vasculature
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cataract surgery cataract extraction and intraocular implanta<br> | Procedure: cataract surgery cataract extraction and intraocular implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | level1：visual acuity≥0.3；level 2：0.1≤visual acuity<0.3；level 3：0.02 ≤visual acuity<0.1；level 4：≤0.02 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent fetal vasculature, congenital cataract
Infective Endocarditis in the Elderly

Study Overview
=================
Brief Summary
-----------------
ELDERL-IE is a multicenter national prospective observational study. The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE). The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

Detailed Description
-----------------
Population monitoring: Clinical, therapeutic, biological, microbiological, echocardiographic and geriatric data are collected. (M-2/3 before inclusion; D-15 before inclusion; D0; M3; vital status at 1 year)

Official Title
-----------------
Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : all patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care. the patient should be treated in one of the clinical sites participating at the study. the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients. Exclusion criteria : patients not fulfilling the criteria of definite or possible endocarditis according to Duke modified by Li diagnostic classification that will be applied after collection of all the data at the discharge of the patient.

Ages Eligible for Study
-----------------
Minimum Age: 75 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 from baseline geriatric characteristics at 3 months | OMS score | 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three months mortality | Mortality rate at 3 months | 3 months after inclusion | 
| One year mortality | Mortality rate at 1 year | 1 year after inclusion | 
| Change from baseline geriatric characteristics at 3 months | Karnofsky'score | 3 months after inclusion | 
| Change from baseline geriatric characteristics at 3 months | Score MNA | 3 months after inclusion |
Extended Treatment in Metastatic Breast Cancer With Eribulin

Study Overview
=================
Brief Summary
-----------------
Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

Detailed Description
-----------------
This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.

Official Title
-----------------
Long-term Eribulin Treatment in Metastatic Breast Cancer: A Multicenter, Case-study Analysis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months Exclusion criteria: Lack of accessible clinical records

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated with eribulin for at least 7 months<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 7 months | 
| Progression free survival (PFS) |  | up to 7 months | 
| Objective response rate |  | up to 7 months | 
| Time to response |  | up to 7 months | 
| Post progression survival |  | up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety |  | up to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced or Metastatic Breast Cancer, Eribulin
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.

Official Title
-----------------
Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously untreated AML (excluding acute promyelocytic leukemia) age greater than 60 years old ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2 adequate hepatic/ renal/ cardiac function Exclusion Criteria: acute promyelocytic leukemia significant cardiac disease combined non-hematologic malignancy aleukemic leukemia (only granulocytic sarcoma) CNS (Central Nervous system) involvement significant comorbidity/ uncontrollable bleeding tendency

Ages Eligible for Study
-----------------
Minimum 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

| Intervention/Treatment |
| --- |
|Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)|fludarabine, cytarabine, idarubicin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate | Rate of complete remssion (CR) after two cycles of m-FLAI induction |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious adverse events (SAE) | Number of patients dying from SAE related to m-FLAI induction |  | 
| Event Free Survival | Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission |  | 
| overall survival | Overall survival defined as a period from study enrollment to death from any cause |  | 
| Predictive factors for Complete remission | Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fludarabine, AML, Efficacy, tolerability
Tumor Metabolism of Lung Cancer in Patients Who Underwent Percutaneous Radiation Measured With F-18-FDG-PET

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe the regional and global FDG-kinetics in non-small-cell lung cancer (NSCLC) during percutaneous radiation therapy.

Official Title
-----------------
Tumor Metabolism of Lung Cancer Underwent Percutaneous Radiation Measured With F-18-FDG-PET

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed NSCLC not curable by surgery Karnofsky > 80% Tumor volume and localization allow curative radiotherapy Written consent Exclusion Criteria: Metastases Diabetes Pregnancy Psychiatric impairment

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation therapy, F-18-FDG, NSCLC
Olive Oil With Omega 3 to Treat Stasis Dermatitis

Study Overview
=================
Brief Summary
-----------------
Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin by improving cell membrane homeostasis.

Detailed Description
-----------------
Patients with chronic stasis dermatitis due to venous insufficiency will be treated with the study cream and as control we will use Venoroutone . Patients will be followed weekly at the clinic of the vascular surgery at Assaf Harofeh MC.

Official Title
-----------------
Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Drug: olive oil and omega 3 in a combined cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patints with stasis dermatitis for 6 months at least Exclusion Criteria: skin ulceration or infection

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olive oil and omega 3 in a combined cream|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement, |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
olive oil, stasis dermatitis, Patients with stasis dermatitis for at least six months.