linjc16/ctgov huggingface dataset:
Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure. Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria. AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease. It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis. Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies. Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease. Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine. Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.

Official Title
-----------------
Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Conditions
-----------------
Autoimmune Hepatitis

Intervention / Treatment
-----------------
* Diagnostic Test: liver biobsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: under 18 years old. Both sex. children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis Exclusion Criteria: Patient infected with hepatitis B or C. Patient had autoimmune hepatitis after liver transplantation. Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: liver biobsy|all pationt will be subjected yo liver biobsy to confirm diagnosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver biobsy | to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation | 1 year | 
| autoantibody | Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1). | 1 year |
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

Study Overview
=================
Brief Summary
-----------------
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome

Official Title
-----------------
Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women

Conditions
-----------------
Menopause, Climacteric Syndrome, Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopause diagnosis of metabolic syndrome Exclusion Criteria: pharmacologically-induced menopause hormonal therapies sensitizing insulin therapies cancer patient or ex-cancer patient

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 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 |
| --- | --- |
| inositol, phytoestrogens, cocoa polyphenols<br> | Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols<br>* myo-inositol, soy isoflavones and cocoa polyphenols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Change of body weight | [0, 6 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Climacteric | Changes of number of flushes | [0, 6 months] | 
| Climateric | Changes of intensity of flushes measured through questionnaire | [0, 6 months] |
Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess

Study Overview
=================
Brief Summary
-----------------
Conventional techniques for treatment of breast abscess, such as incision and drainage/percutaneous drainage, have disadvantages. Bedside Mini-Incision and Self-Express (MISE) is a novel technique for breast abscess. The outcomes of MISE were compared to the conventional techniques.

Detailed Description
-----------------
outcomes such as recovery time, duration of antibiotics use etc will be compared between the various groups of intervention.

Official Title
-----------------
A Comparison of the Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess With the Conventional Techniques: A Retrospective Comparative Cohort Study

Conditions
-----------------
Breast Infection

Intervention / Treatment
-----------------
* Procedure: Bedside Mini-Incision and Self-Express (MISE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a pathologically confirmed breast abscess and presenting at KK Women's and Children's Hospital, Singapore Exclusion Criteria: Patients with: mastitis granulomatous mastitis breast fillers with infection ruptured abscess prior to intervention other interventions or bilateral breast infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| incision and drainage group<br>patients with breast abscess who undergo incision and drainage | |
| percutaneous drainage group<br>patients with breast abscess who undergo percutaneous drainage | |
| MISE group<br>patients with breast abscess who undergo MISE | Procedure: Bedside Mini-Incision and Self-Express (MISE)<br>* To perform bedside mini incision and encourage patients to self express the pus following the intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time | recovery time for the abscess to resolve | from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years |
Prevalance of Sleep Bruxism Among a Group of Egyptian Children

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are: In a group of Egyptian Children what is the prevalence of sleep bruxism? What is the relation between sleep bruxism and screen time and sugar consumption?

Detailed Description
-----------------
Parents of a group of Egyptian Children aged 6-8 years old will be asked to fill An informed Consent Children Sleep Habit Questionnaire to detect the presence of sleep bruxism or not? Food Frequency Questionnaire of Health Behaviour Sugar Consumption questionnaire Leisure Time, Television Use, Computer Use Sections of the Health Behaviour Sugar Consumption Questionnaire

Official Title
-----------------
Prevalence of Sleep Bruxism in a Group of Egyptian Children and Its Relation to Screen Time and Sugar Consumption

Conditions
-----------------
Sleep Bruxism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive Subject acceptance for participation in the study Healthy children aged 6-8 years old Both genders The presence of mixed dentition with permnant first molar erupted Exclusion Criteria: Children with mental or neurological disorders Children with systemic disorders Children who use medications that could not interfere with the central nervous system Children suffering from sleep disorders. e.g: Obstructive Sleep Apnea

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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 |
| --- | --- | --- |
| Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old | Cross sectional Observational Study | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between sleep bruxism and screen time and sugar consumption | Cross sectional Observational Study | 1 year |
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (TBI) is nearly 1.7 million annually

Detailed Description
-----------------
The authors found that AC use preinjury was associated with ICH progression, immediate neurosurgery intervention, and death after initial scan. AC use has also been associated with worse functional outcomes, and patients are less likely to be discharged home compared to those without AC use prior to injury.6 With increasing prevalence of AC, hospitals are seeing admissions for ICH, making knowledge of optimal AC reversal essential.

Official Title
-----------------
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Conditions
-----------------
Intracranial Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Use of fixed-dosed 4F-PCC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • ≥18 years of age ICH (traumatic and spontaneous) Administration of at least one dose of 4F-PCC Admitted to the MHS between July 1, 2018 and May 30, 2023 Rivaroxaban or apixaban use prior to admission Exclusion Criteria: • Warfarin or dabigatran use prior to admission Prisoners Pregnancy <18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Use of fixed-dosed 4F-PCC|Determine if fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine safety and effectiveness of 4F-PCC | fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing. | 12 hours |
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project

Study Overview
=================
Brief Summary
-----------------
The aim of the MoDiet study is to evaluate the usefulness of the GourMed© prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Detailed Description
-----------------
The objective of the MoDiet study is to evaluate the usefulness of the GourMed© (MedicAir Food srl, Milano, Italy) prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Official Title
-----------------
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Dietary Supplement: GourMed© meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65 years and over Gugging Swallowing Screen ranging 10-20; Exclusion Criteria: known or suspected intolerance to any ingredient taking other prepackaged products for dysphagia creatinine ≥1,5 mg/dl

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dysphagic subjects<br>elderly patients with dysphagia | Dietary Supplement: GourMed© meal<br>* patients receive GourMed© meal as lunch for 7 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of GourMed© meal | The safety of GourMed© meal is monitoring by the registration of the following events: Appearance of coughing and/or changes in the tone of voice immediately after or within 1-2 minutes of swallowing a bite; Spill of food from the nose; Prolonged management of the bolus in the oral cavity Appearance of red or cyanotic color on the face Occurrence of allergic skin reactions Appearance of breathing difficulties Onset of fever Appearance of nausea, vomiting or diarrhea. | during each GourMed© meal (up to day 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the amount of GourMet© meal consumed | The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met | after each GourMed© meal (up to day 7) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysphagia, diet, elderly subjects
Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
This is multicentric, spontaneous, observational, retrospective and prospective study.

Detailed Description
-----------------
In the retrospective part of the study, Tissue Microarrays (TMA) will be prepared from surgical samples of breast tissue from a series of patients with TNBC type breast cancer. In the prospective part of the study will be evaluated the expression of some selenoproteins by ELISA in plasma samples obtained from up to 100 healthy subjects and about 300 ( 100 per year) patients with basally metastatic TNBC breast cancer (150) and metastatic (150) before any treatment.

Official Title
-----------------
Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TNBC breast cancer patients, before any drug treatment healthy women aged 25-60 Exclusion Criteria: donors suffering from diabetes, hypertension, active infectious states, HIV infection, Hepatitis B or C, chronic inflammatory diseases, current or previous neoplasms, heart disease or drug treatment.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of immunohistochemistry investigation (IHC) | In the retrospective part of the study, Tissue Microarrays (TMA) will be prepared from surgical samples of breast tissue from a series of patients with TNBC type breast cancer. The expression of some of the twenty-five selenoproteins will be evaluated by immunohistochemical investigation (IHC) on the TMA (Tumor Microarrays). | 3 years | 
| Prospective evaluation of expression of some selenoproteins by kit ELISA in plasma samples | In the prospective part of the study will be evaluated the expression of some selenoproteins by ELISA in plasma samples obtained from up to 100 healthy subjects and about 300 ( 100 per year) patients with basally metastatic TNBC breast cancer (150) and metastatic (150) before any treatment. | 3 years |
Discovering Patterns in Experiences of Patients in Esophageal Cancer Clinical Research

Study Overview
=================
Brief Summary
-----------------
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This study will investigate the safety and efficacy of esophageal cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future esophageal cancer research.

Official Title
-----------------
Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Diagnosis of esophageal cancer Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Women of childbearing potential without a negative pregnancy test; or women who are lactating. Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. Inability to perform regular electronic reporting

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in a clinical research. |  | 3 months | 
| Number of study participants who remain in clinical research until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer
Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

Study Overview
=================
Brief Summary
-----------------
Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated

Official Title
-----------------
Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

Conditions
-----------------
ACL Tear

Intervention / Treatment
-----------------
* Procedure: ACL Reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL tear Over 18 years Patient information and consent No preexisting knee conditions prior ACL tear; Exclusion Criteria: Under 18 years Preexisting knee conditions Accompanying knee injuries apart from ACL tear

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: ACL Reconstruction<br>Patients undergoing ACL reconstruction | Procedure: ACL Reconstruction<br>* Reconstruction of the anterior cruciate ligament<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported Knee Function (Lysholm Knee Score, Points) | Established patient-reported knee related score | 0 to 12 months after surgery | 
| Objective Knee Function | Standardized physiotherapeutical return to sports test battery, (pass/no pass) | 0 to 12 months after surgery | 
| Psychological Status (ACL-RSI, points) | Established psychological self-awareness score | 0 to 12 months after surgery | 
| Patient Pain (Visual Analoge Scale (points) | Patient reported pain | 0 to 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Maturation | Knee MRI assessing graft maturation | 6 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychology, Gender Medicine
Describing Patient With DME, Their Patient Journey and Disease Progression

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize patients with diabetic macular edema (DME), their progression, the treatment received and associate the functional and physiological outcomes related to the treatment.

Official Title
-----------------
Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)

Conditions
-----------------
Diabetic Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ≥18 years, with a DME diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023) Exclusion Criteria: Patients without the information of laterality will be excluded.

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 |
| --- | --- |
| Patients with Diabetic macular edema cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity |  | From January 2015 to April 2023 | 
| Progression to DME in the fellow eye |  | From January 2015 to April 2023 | 
| Initial treatment of DME |  | From January 2015 to April 2023 | 
| Central retinal thickness (CRT) |  | From January 2015 to April 2023 |