linjc16/ctgov huggingface dataset:
Radiotherapy-Associated Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer. Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Detailed Description
-----------------
Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation. Inclusing Criteria: Patients with radiotherapy for thoracic malignancy or breast cancer Between 18-99 years-old Exclusion Criteria: Patients with history of radiotherapy Patients with history of atrial fibrillation Patients with pacemaker implantation

Official Title
-----------------
Radiotherapy-associated Atrial Fibrillation: Onset Time and Frequency

Conditions
-----------------
Atrial Fibrillation New Onset

Intervention / Treatment
-----------------
* Diagnostic Test: ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with radiotherapy for thoracic malignancy or breast cancer Between 18-99 years-old Exclusion Criteria: Patients with history of radiotherapy Patients with history of atrial fibrillation Patients with pacemaker implantation

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 |
| --- | --- |
| Patients with Thoracic Malignancies<br>All patients undergoing RT for Thoracic Malignancies | Diagnostic Test: ECG<br>* 12 lead ecg for each participant<br>|
| Patients with Breast Cancer<br>All patients undergoing RT for Breast Cancer | Diagnostic Test: ECG<br>* 12 lead ecg for each participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of atrial fibrillation | Occurrence of atrial fibrillation | 1 day During radiotherapy | 
| Onset time of atrial fibrillation | Onset time of atrial fibrillation | 1 day During radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, breast cancer, lung cancer, thoracic malignancies, cardiotoxicity
An Evaluation of Operating Room Staff's Awareness of Environmental Sustainability and Medical Waste Management

Study Overview
=================
Brief Summary
-----------------
The main goals of this single-centre cross-sectional study were to measure views on the environmental effects of the operating room and identify the main barriers to recycling in the operating room environment as perceived by the staff. Participants responded a questionnaire to measure their opinions and the views.

Official Title
-----------------
An Evaluation of Operating Room Staff's Awareness of Environmental Sustainability and Medical Waste Management

Conditions
-----------------
Environmental-Pollution-Related Condition

Intervention / Treatment
-----------------
* Other: No interventions were done between groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all personel working in operating room Exclusion Criteria: missing data
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 |
| --- | --- |
| Doctors<br>Anaesthesiologists | Other: No interventions were done between groups<br>* No interventions were done between groups<br>|
| Anaesthesia Nurses<br> | Other: No interventions were done between groups<br>* No interventions were done between groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most reported barriers to recycling |  | 3 Weeks | 
| Views on the environmental effects of the OR |  | 3 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Environment, Inhalational Anaesthetics, Recycling, Global Warming, Carbon Footprint, Operating Room
COVID-19 Post-Vaccination Observation

Study Overview
=================
Brief Summary
-----------------
The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention.

Official Title
-----------------
COVID-19 Post-Vaccination Observation on Immune Exhaustion

Conditions
-----------------
Immune System Diseases, COVID-19 Vaccine Adverse Reaction, Immune System Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
All COVID-19 vaccinated are eligible for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Immune Disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemiluminescent Immunoassay for Human Immunodeficiency Virus |  | 7 months | 
| Carcinoembryonic Antigen |  | 7 months | 
| Alpha Fetoprotein |  | 7 months | 
| Carbohydrate Antigen 19-9 |  | 7 months | 
| Mucin-16 |  | 7 months | 
| Cancer Antigen 15-3 |  | 7 months | 
| Prostate-Specific Antigen |  | 7 months | 
| Leukocytes |  | 7 months | 
| Leukocyte Percentage |  | 7 months | 
| Cholesterol |  | 7 months |
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about in small bowel adenocarcinoma patients. The main question it aims to answer is the association between tumor size and prognosis in patients with small bowel adenocarcinoma. Participants will be compared for the relationship between tumor size and prognosis.

Official Title
-----------------
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study

Conditions
-----------------
Prognosis

Intervention / Treatment
-----------------
* Other: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathology confirmed as SBA; received surgery and complete postoperative follow-up data; histology type code 8140-8380. Exclusion Criteria: Cases with unknown tumor location, size, TNM staging, race, and degree of differentiation were excluded. Finally, 8,163 eligible patients were included in the analysis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tumor size 0-1cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 0-1 cm. | Other: no interventions<br>* no interventions<br>|
| tumor size 1-2 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 1-2 cm. | |
| tumor size 2-3 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 2-3 cm. | |
| tumor size 3-4 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 3-4 cm. | |
| tumor size 4-5 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 4-5 cm. | |
| tumor size 5-6 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 5-6 cm. | |
| tumor size 6-7 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 6-7 cm. | |
| tumor size 7-8 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 7-8 cm. | |
| tumor size 8-9 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 8-9 cm. | |
| tumor size 9-10 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of 9-10 cm. | |
| tumor size >10 cm<br>No intervention. Select small bowel adenocarcinoma patients with tumor size of >10 cm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study | We will study the relationship between tumor size and prognosis in small bowel adenocarcinoma patients in the SEER database | 2024.9.1 |
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD

Study Overview
=================
Brief Summary
-----------------
This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).

Detailed Description
-----------------
This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials. This study consists of: A phone/video interview to provide e-consent and medical history A single home health visit to collect blood sample for antibody testing A phone/video call for communication of AAV8 antibody test results

Official Title
-----------------
Anti-AAV8 Antibody Assessment Study of Boys With Duchenne Muscular Dystrophy Aged 0 to <12 Years

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Diagnostic Test: AAV8 DetectCDx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males at least 0 to <12 years of age Diagnosis of DMD Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements Exclusion Criteria: Prior participation in a gene therapy trial OR recipient of a gene therapy drug Other inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 11 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: AAV8 DetectCDx|An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anti-AAV8 antibodies in patients with DMD | To evaluate the prevalence of AAV8 antibodies in patients with DMD To identify participants who may be eligible for investigational gene therapy clinical trials in males with DMD | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anti-AAV9 antibodies in patients with DMD | • To evaluate the prevalence of AAV9 antibodies in patients with DMD | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMD, Duchenne Muscular Dystrophy, Duchenne
Accuracy of Pulse Oximeters in Profound Hypoxia

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Official Title
-----------------
Accuracy of the Movano Health Ring Pulse Oximeters in Profound Hypoxia

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Pulse oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures. Subject is willing to have their skin color assessed. Exclusion Criteria: Subject is obese with a BMI over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease. Subject has asthma, sleep apnea, or uses a CPAP. Subject has diabetes. Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation. Subject has any other serious system illness. Subject is a current smoker. Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly. Subject has a history of fainting or vasovagal response. Subject has a sensitivity to local anesthesia. Subject has Raynaud's disease. Subject has unacceptable collateral circulation based on an exam by the investigator. Subject is pregnant, lactating, or trying to get pregnant. Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures. Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 |
| --- | --- |
| Healthy Adult Volunteers<br>Minimum of ten (10) subjects meeting the eligibility criteria. | Device: Pulse oximeter<br>* Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMSE compared to arterial blood SaO2 | Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas. | 2 days |
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.

Official Title
-----------------
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis

Conditions
-----------------
Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney, Stone, Urinary, Pediatric Disorder

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone Normal kidney function. Exclusion Criteria: Bleeding diatheses Uncontrolled UTIs Severe skeletal malformations

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin<br>Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session. | Drug: Tamsulosin<br>* Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.<br>|
| Placebo Comparator: Placebo<br>Children in this group will receive Placebo for 3 weeks after ESWL session. | Drug: Placebo<br>* Children in this group will receive placebo once daily for 3 weeks after ESWL session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the Stone-free rate (SFR) between groups | SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Shock Wave Lithotripsy, tamsulosin
Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria

Study Overview
=================
Brief Summary
-----------------
adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .

Official Title
-----------------
Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria

Conditions
-----------------
Chronic Spontaneous Urticaria

Intervention / Treatment
-----------------
* Diagnostic Test: Adenosine deaminase serum level
* Diagnostic Test: IgE antibodies serum level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors). Exclusion Criteria: Pregnancy and lactation. Patients with systemic diseases, especially those with autoimmune diseases and infections. Patients with skin diseases. Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSU group<br>Adult patients complaining of chronic spontaneous urticaria (CSU) | Diagnostic Test: Adenosine deaminase serum level<br>* Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).<br>Diagnostic Test: IgE antibodies serum level<br>* Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).<br>|
| Control group<br>A group of age and sex-matched healthy controls (blood donors). | Diagnostic Test: Adenosine deaminase serum level<br>* Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).<br>Diagnostic Test: IgE antibodies serum level<br>* Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of adenosine deaminase | Difference in serum level of adenosine deaminase between CSU group and control group | 3 months | 
| Serum level of IgE | Difference in serum level of IgE between CSU group and control group | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic spontaneous urticaria, adenosine deaminase, immunoglobulin E
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD

Study Overview
=================
Brief Summary
-----------------
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.

Official Title
-----------------
Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Disease

Conditions
-----------------
COPD, Chronic Obstructive Pulmonary Disease, COPD Exacerbation, CHF, Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 years or older Able to consent Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF) Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months Exclusion Criteria: Significant cardiac valvular disease End-Stage Renal Disease (ESRD) End-Stage CHF End-Stage COPD

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Passive monitoring<br>No intervention | Other: Data collection<br>* Data collection of clinically relevant signals using home-based sensor system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of AI in passive sensor system | Evaluation of AI ability to prospectively detect hospital utilization event | 90 days | 
| Precision of AI in passive sensor system | Evaluation of AI ability to precisely predict hospital utilization event | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of sensor data review by trained nurses | Evaluation of nurse ability to prospectively detect hospital utilization event | 90 days | 
| Precision of sensor data review by trained nurses | Evaluation of nurse ability to precisely predict hospital utilization event | 90 days |