linjc16/ctgov huggingface dataset:
Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

Study Overview
=================
Brief Summary
-----------------
Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study. Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.

Official Title
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Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study

Conditions
-----------------
Epileptic Seizures Related to Drugs, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction

Intervention / Treatment
-----------------
* Biological: inactive SARS-Cov-2 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female participants Have a diagnosis of epilepsy by the end of the study Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group) Exclusion Criteria: Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine Epilepsy patients administrated with non-inactive vaccine Unvaccinated epilepsy patients

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: inactive SARS-Cov-2 vaccine|We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients | Overall relative incidence of epileptic seizures in risk periods compared to control period. | from 90 days before until 21 days after the first dose of vaccine | 
| Risk of epileptic seizures in epilepsy patients of different subgroups | The associations of sex, age or medication status with the relative incidence in risk periods | from 90 days before until 21 days after the first dose of vaccine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy patient, risk of seizure, SARS-Cov-2 vaccine
Key to Improve DiagNosis in Aspiration Pneumonia

Study Overview
=================
Brief Summary
-----------------
To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

Detailed Description
-----------------
Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

Official Title
-----------------
Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.

Conditions
-----------------
Infectious Pneumonia, Coma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest). Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C). Age ≥18 years Patient affiliated to the social security system. No opposition obtained Exclusion Criteria: Immunocompromised patient. Cardiorespiratory arrest requiring therapeutic hypothermia. Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission). Infectious Pneumonia in the previous 30 days. Previous hospitalization in the previous 30 days. Patient under antibiotic at baseline. Bacteremia. Mechanical ventilation begun before unconsciousness. Report Pa02 / FI02 <80. Patient under curatorship and / or guardianship.

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 |
| --- | --- | --- |
| Sensitivity and specificityof amylase test. | Amylase culture in bronchoalveolar fluid is compared to gold standard culture | 5 days after inclusion day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoalveolar lavage, amylase assay, aspiration pneumonia
Natural History of Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.

Detailed Description
-----------------
BACKGROUND: Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases. DESIGN NARRATIVE: Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography. Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Variance of Oral Methadone Dosage: Description of Implicated Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

Detailed Description
-----------------
Patients at the steady state of methadone maintenance treatment may receive oral dosage ranging from 5 to 130 mg per day in our clinical practice. This study is aimed at providing a comprehensive cross-sectional description of factors involved in this variance: comorbidity with addictive and psychiatric disorders severity of pre-existing heroin dependence function of CYP 3A4 enzyme assessed with oral midazolam challenge genetic polymorphisms of enzymes implicated in methadone pharmacokinetic and pharmacodynamic (CYPs, MDR1, OPRM1, COMT) The expected result is a predictive equation of oral methadone dosage at steady state.

Official Title
-----------------
Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

Conditions
-----------------
Heroin Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heroin dependence under maintenance treatment with methadone at steady state: stable oral methadone dosage since 3 months at least Exclusion Criteria: current heroin dependence or abuse current cocaine and/or alcohol and/or sedatives dependence 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 |
| --- | --- | --- |
| Functional activity CYP3A4 | Functional activity CYP3A4 as measured by the ratio of metabolite / parent drug provided by the functional test the oral midazolam. | Day15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methadone, CYP, OPRM1, MDR1, COMT, Midazolam challenge
11C-Methionine PET as Prognostic Marker of Gliomas

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.

Detailed Description
-----------------
This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center. We will review 11C-Methionine PET data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to IDH1 mutation status, MGMT promoter methylation and 1p/19q co-deletion. These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Official Title
-----------------
Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.

Conditions
-----------------
Glioma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of glioma 11C-Methionine within 30 days before surgery Exclusion Criteria: Absence of tumor specimen No clinical data 11C-Methionine can not be evaluated

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 intervention|This is a retrospective study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion, |  | Baseline SUVmax up to 1 month before surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma; 11C-Methionine PET
Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls

Study Overview
=================
Brief Summary
-----------------
The effects of high serum glucose on bone could be direct or could be indirect through its effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have found significant differences in skin blood flow between diabetics and control. The investigators are proposing that blood flow measurements of the skin may be correlated with bone remodeling rates in iliac bone biopsies.

Official Title
-----------------
Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls

Conditions
-----------------
Type 1 Diabetes,, Bone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have completed a previous study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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 |
| --- | --- |
| Case<br>Patients with Type 1 Diabetes Mellitus | |
| Control<br>Age and sex matched healthy controls. | |

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
-----------------
Type 1 Diabetes, Bone
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?

Study Overview
=================
Brief Summary
-----------------
This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.

Detailed Description
-----------------
From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.

Official Title
-----------------
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial

Conditions
-----------------
Rectal Prolapse

Intervention / Treatment
-----------------
* Procedure: starr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal prolapse Rectocele ODS score > 15 Continence score < 3 Resting pressure > 40 mm/Hg Exclusion Criteria: Previous anorectal surgery Ods score < 15 Continence score > 3 Resting pressure < 40 Concomitant pelvic floor diseases Psychiatric diseases Absolute contraindications to surgery

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rectal resection<br> | Procedure: starr<br>* stapled transanal rectal resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of recurrences |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcomes on symptoms and defecography |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ODS, stapled transanal rectal resection
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the impact of a decision aid leaflet on the participation of women invited to participate in the French national breast cancer screening program.

Official Title
-----------------
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis

Conditions
-----------------
Healthy, Breast Cancer

Intervention / Treatment
-----------------
* Device: decision aid group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, aged between 50 and 74 years old living in 11 French departments Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid group<br>Women allocated to the decision aid group received an invitation to participate in the national breast cancer screening program and the specially-designed decision aid (a leaflet), by mail. | Device: decision aid group<br>* The paper-based leaflet DECIDEO is a 12-page pocket leaflet providing scientific information about the advantages and disadvantages of participating in the national breast screening program, understandable by all, constructed to conform with the International Patient Decision Aid Standards<br>|
| No Intervention: Control group<br>Women in the control group received an invitation and the usual standard information by mail. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| women's attendance rate for the breast cancer screening program during the 12 months following the invitation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the delay between the invitation and the date of attendance for breast cancer screening |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer screening, patient decision aids, informed decision, empowerment, randomized control trial, From 50 to 74 years old, invited to national breast cancer screening
Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

Detailed Description
-----------------
18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Official Title
-----------------
Ultra Structure of Peritoneum at Electronic Microscopy in Control Subjects and Patients With Gastric Cancer

Conditions
-----------------
Stomach Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with operable local gastric adenocarcinoma Exclusion Criteria: previous abdominal surgery previous open or blunt abdominal trauma history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity. All other gastric malignancies such as lymphomas, GIST, carcinoids

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 |
| --- | --- |
| Gastric cancer<br>patients with operable local gastric adenocarcinoma were studied | |
| Control group<br>patients operated on for benign diseases served as controls, randomly selected among patients with chronic gastro-esophageal reflux disease who were considered good candidates for antireflux surgery and properly matched in sex and age to study group | |

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
-----------------
Stomach Neoplasms, Peritoneum