linjc16/ctgov huggingface dataset:
Evaluation of Vitamin A and E Deficiency With Severity of SARS-COV-2 Disease: A Case-Control Study

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease 2019 (COVID-19) is a novel infectious disease that has been spreading worldwide Coronaviridae study group of the International Committee on taxonomy of viruses (2020). The clinical manifestation of COVID-19 can range from asymptomatic infection to critical illness with severe pneumonia, respiratory failure, and death. Vitamin A is of special interest in the field of infectious diseases, especially for pulmonary infections. It is crucial for the development of normal lung tissue and tissue repair after injury due to infection. Therefore, it may play a role in recovery after severe COVID-19 pneumonia. Vitamin A has immune regulatory functions and positively affects both the innate and adaptive immune cell response. The anti-oxidant Vitamin E, and trace element selenium, are major components of anti-oxidant defense. Epidemiological studies demonstrate that deficiencies in, either of these nutrients, alters immune responses and viral pathogenicity. Data concerning vitamin A and E plasma levels in COVID-19 patients are lacking. Therefore, this study aims at characterizing vitamin A and E plasma levels in COVID-19 and analyzing the association of plasma levels with disease severity and outcome.

Detailed Description
-----------------
The aim of the current study is to evaluate the relation of plasma level of Vitamin A and E and their correlation with severity of SARS-COV2 disease.

Official Title
-----------------
Correlation Between Vitamin A and E Deficiency With Severity of SARS-COV2 Disease.

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 positive patients by PCR (polymerase chain reaction) test Patients aging 18 to 75 years Exclusion Criteria: Patients with known immunodeficiency - Patients with known lung diseases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>30 ICU-admitted SARS-CoV-2- infected individuals with ARDS or in need of oxygen supplementation | |
| Group B<br>30 ward-admitted SARS-CoV-2-infected individuals not suffering from ARDS and not in need of oxygen supplementation | |
| Group C<br>30 sex and age-matched normal individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlating between vitamin A and E deficiency and severity of SARS-COV2 | Evaluation of vitamin A and E deficiency with COVID-19 disease severity | From September 2021 to November 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19
Dietary Fiber and Hyperkalemia in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.

Detailed Description
-----------------
A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.

Official Title
-----------------
The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients

Conditions
-----------------
Hyperkalemia, Hemolysis

Intervention / Treatment
-----------------
* Other: dietary fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability Exclusion Criteria: In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 pre-dialysis hyperkalemia<br>To investigate the dietary fiber intake of hemodialysis patients with pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. | Other: dietary fiber<br>* Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia<br>|
| patients without pre-dialysis hyperkalemia<br>To investigate the dietary fiber intake of hemodialysis patients without pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia. | Other: dietary fiber<br>* Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary fiber intake | Dietary fiber intake | 3 day |
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms

Study Overview
=================
Brief Summary
-----------------
Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of en bloc resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia

Official Title
-----------------
Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic Submucosal Dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines. Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery Exclusion Criteria: Final diagnosis of non neoplastic lesion. Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.

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 |
| --- |
|Procedure: Endoscopic Submucosal Dissection|Endoscopic Submucosal Dissection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En bloc resection rate | removal of the lesion into a single piece. | 10 years | 
| R0 resection rate | complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia | 10 years | 
| Curative resection rate | R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk. | 10 years | 
| Complication rate | bleeding, perforation and stenosis. | 10 years | 
| Recurrence rate | dysplastic tissue at the site of resection at follow-up endoscopy. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Submucosal Dissection, Endoscopic Resection
Active Pharmacovigilance of Anti-cancer Medicines

Study Overview
=================
Brief Summary
-----------------
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem, aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment. When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.

Official Title
-----------------
Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.

Conditions
-----------------
Drugs, Oncology, Pharmacovigilance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged <25 years; receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers giving consent to study participation Exclusion Criteria: presence of cognitive problems

Ages Eligible for Study
-----------------
Maximum Age: 25 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the number of grade 3-5 ADRs reported during the active surveillance period | ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3. | Through study completion, an average of 3 years | 
| To compare the number of grade 3-5 ADRs reported during the active surveillance period with the number of grade 3-5 ADRs reported in the previous years | Period of equal length will be compared | Through study completion, an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncology, Drugs, Active pharmacovigilance
Therapeutic Endpoint in Pediatric IBD Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.

Official Title
-----------------
Development of a Therapeutic Endpoint in Pediatric IBD Conditions

Conditions
-----------------
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

Intervention / Treatment
-----------------
* Other: AlgometRx Nociometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 6 years of age at screening. Documentation of an IBD diagnosis as evidenced by history Exclusion Criteria: Documented history of eye disease precluding pupillometry Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 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 |
| --- | --- |
| UC<br> | Other: AlgometRx Nociometer<br>* Physiologic characterization of disease activity<br>|
| CD<br> | Other: AlgometRx Nociometer<br>* Physiologic characterization of disease activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is the measurement of the nociceptive index for clinical output. |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions. |  | 1 Year |
SHARE Project Define

Study Overview
=================
Brief Summary
-----------------
The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH). This is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and HIV (viral suppression) among YPLWH. The study will enroll up to 175 participants between the ages of 18-29 who currently reside in Florida and are living with HIV. In the Model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. The aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among YPLWH to determine potential pathways between cumulative stress and alcohol and HIV outcomes, in the context of individual factors relevant to YPLWH (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators. In the Adapt phase, 42 of N=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.

Official Title
-----------------
Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and 0 months to 29 years and 11 months Currently reside in Florida Report having had at least 1 alcoholic drink in the last 30 days Able to read and understand English Have internet access via smartphone, tablet or computer Be diagnosed as HIV positive and; Willing to provide informed consent. Exclusion Criteria: Adults unable to consent Individuals who are not yet adults Individuals who are not diagnosed as HIV+ Prisoners Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 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 |
| --- | --- | --- |
| Alcohol Use | Hazardous Drinking | 9 months | 
| HIV Viral Load | Viral Suppression | 9 months |
Retrospective Register for Uveal Melanoma

Study Overview
=================
Brief Summary
-----------------
Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs. Aim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021. Patients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.

Official Title
-----------------
Retrospective Register for Uveal Melanoma

Conditions
-----------------
Uveal Melanoma

Intervention / Treatment
-----------------
* Other: any therapy suitable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients 18 - 99 years Diagnosis of uveal melanoma Exclusion Criteria Patients younger than 18 years of age Inadequate or missing information on the clinical course in patient charts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Uveal Melanoma<br> | Other: any therapy suitable<br>* any therapy suitable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conduction of a Register providing the basis for | Retrospective studies analyzing the obtained data and easy identification of patients for prospective studies (e.g. long-term survival analysis) | 1997-2021 |
Treatment Chronic UTI Post Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs.

Detailed Description
-----------------
According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Official Title
-----------------
Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients

Conditions
-----------------
Urinary Tract Infections, Transplant-Related Disorder

Intervention / Treatment
-----------------
* Biological: Phage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable Kidney Transplant Recipients Stable Immunosupression Dose Stable Renal Function Resistant Urinary Infection with Positive UC Exclusion Criteria: Rejection periods Frail Patients
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: UC Positives<br>Stable Transplanted Patients with Positive UC | Biological: Phage<br>* Inserting specific specimen of phages in to the bladder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine culture | Negative Urine Culture | 1 week after administration |
Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)

Study Overview
=================
Brief Summary
-----------------
Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa. The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first time, and a second time 1 week later.

Official Title
-----------------
Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Other: Verneuil questionnaire Validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patient with Verneuil disease Beneficiary of or affiliated to a social security insurance Participation agreement Exclusion Criteria: Patients physically or mentally unable to complete questionnaires. Refusal to participate Patient under legal protection (guardianship, curatorship) or deprived of liberty

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 |
| --- | --- |
| Experimental<br>Patients with Verneuil disease | Other: Verneuil questionnaire Validation<br>* Request patient to Complete the questionnaire for validation of the French version<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the questionnaire |  | During the visit and 1 week later |