linjc16/ctgov huggingface dataset:
A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.

Official Title
-----------------
A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register

Conditions
-----------------
Rheumatoid Arthritis, Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RA or PsA ≥18 years at index treatment initiation Participants starting treatment with: abatacept non-targeted DMARDs targeted DMARD Exclusion Criteria: - Not applicable

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 |
| --- | --- |
| Abatacept Group<br>Participants with established RA or PsA and receiving abatacept. | |
| Non-targeted Disease Modifying Anti-rheumatic Drug (DMARD) Group<br>Participants with established RA or PsA and not previously treated with any targeted DMARDs and who start treatment with a non-targeted DMARD. | |
| Targeted DMARD Group<br>Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Overall Malignancies |  | 5 years | 
| Incidence Rate of Melanoma |  | 5 years | 
| Incidence Rate of Non-melanoma Skin Cancer |  | 5 years | 
| Incidence Rate of Basal Cell Carcinoma |  | 5 years | 
| Incidence Rate of Squamous Cell Carcinoma |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abatacept, Orencia, Malignancies, Long-term safety follow-up
Charlotte Retention in Care Study

Study Overview
=================
Brief Summary
-----------------
The objective of the Charlotte Retention in Care study is to assess if clinical decision support systems (CDSS) that produce standardized alerts for measures of retention in care across clinics in the city of Charlotte, North Carolina have the ability to increase retention in care measures within clinics and in surveillance reports.

Detailed Description
-----------------
Multiple Charlotte HIV Clinic providers are participating. Primary HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective Electronic Health Record (EHR) system and identified through CHORUS, a Clinical Decision Support System (CDSS) developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study. This study was approved by the Advarra Institutional Review Board.

Official Title
-----------------
Charlotte Retention in Care Study - Clinical Decision Support System Prompts

Conditions
-----------------
HIV I Infection

Intervention / Treatment
-----------------
* Other: Alert to provider


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1+ Any gender 18 years old or older Residing in the Charlotte, North Carolina metropolitan area At least a single entry in the EHR in the last 2 years

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 |
| --- | --- |
| HIV-1<br>HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years. | Other: Alert to provider<br>* Providers receive alerts of sub-optimal patient attendance using 4 rules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement level | Pre and post-baseline engagement level. Engagement level is defined as patients with 0, 1, or 2+ visits to physician (identified as a visit that included the collection of 1 viral load and/or 1 CD4 count lab test). | 12 months, 01-Nov-2018 to 31-Oct-2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kept appointment | Pre and post-baseline kept appointment rate, the proportion of patients who attended their scheduled office visits. | 12 months, 01-Nov-2018 to 31-Oct-2019 |
The Chinese STEMI PPCI Registry (CSPR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.

Detailed Description
-----------------
The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.

Official Title
-----------------
The Chinese ST-Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Registry

Conditions
-----------------
ST-segment Elevation Myocardial Infarction (STEMI)

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction STEMI treated by pPCI Exclusion Criteria: Patient with heart failure in admission STEMI with symptom-onset-to-balloon time>24h pPCI was not successful or only underwent coronary angiography Killip class ≥II in admission

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 |
| --- | --- |
| derivation cohort<br>Data from Renmin Hospital of Wuhan University, The First College of Clinical Medical Science, China Three Gorges University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital，and Wuhan Third Hospital will be used as a derivation cohort. | Other: no intervention<br>* no intervention<br>|
| validation cohort<br>Data from The First Affiliated Hospital of Dalian Medical University and Jiangxi Provincial People's Hopital will be used as a derivation cohort. | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital acute de novo heart failure | Killip class ≥II | in-hospital outcome, until discharge | 
| cardiogenic shock | according to the universal definition | in-hospital outcome, until discharge | 
| death | according to the universal definition | in-hospital outcome, until discharge |
Prospective Data Collection of Patients With Diffuse Parenchymal Lung Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to generate a prospective database of all patients evaluated for diffuse parenchymal lung diseases to provide much needed data on the various disease aetiologies, incidence and prevalence rates, clinical and radiological presentations, pathologic correlations, disease progression and response to treatment, and final outcomes in this group of patients in Singapore.

Official Title
-----------------
Prospective Data Collection of Clinical, Pulmonary Function, Radiological, Bronchoscopic and Fibered Confocal Fluorescence Microscopy Imaging, and Pathological Characteristics in Patients With Diffuse Parenchymal Lung Diseases

Conditions
-----------------
Diffuse Parenchymal Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients 21 years old and older diagnosed with suspected diffuse parenchymal lung disease (multi-lobar pulmonary infiltrates) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Final diagnoses of patients presenting with diffuse parenchymal lung disease after complete evaluation |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diffuse parenchymal lung disease, interstitial lung disease, idiopathic pulmonary fibrosis
The Pilot Study of High-throughput Sequencing in Neonatal Birth Defects

Study Overview
=================
Brief Summary
-----------------
In China, birth defects can reach as high as 5.6%, about 900,000 new cases of birth defects are added each year, making it the second cause of death for infants, with a total death rate of 19.1%. At present, China implements the three-level prevention and control system for birth defects, which is performed before marriage, before birth, and during the neonatal period. Newborn screening is the last line of defense against birth defects. Early screening diagnosis and timely intervention are extremely important, especially for diseases which can be preventive and treatable. This study aims to evaluate the clinical application of high-throughput targeting sequencing in newborns, and investigate whether this new technology can significantly shorten the time of examination, improve the diagnosis rate, guide the intervention treatments and promote prognosis for these disease.

Official Title
-----------------
The Pre-clinical Study of Genomic Sequencing for Birth Defects in Newborns

Conditions
-----------------
Birth Defect, Newborn; Fit, Genetic Diseases, Multiple Malformation, Congenital Malformation

Intervention / Treatment
-----------------
* Diagnostic Test: NGS panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates in one of the study hospitals Abnormal laboratory testing or abnormal response to standard therapy suggestive of a genetic disease Exclusion Criteria: Any infant whose genome has been shown to have large chromosomal aberration (Trisomy 13, 18, 21 or other) Any infant in which clinical considerations preclude drawing 1.0 ml of peripheral blood Parents refuse consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: NGS panel|A next-generation-sequencing panel, which contains a group of genes that specifically cause disease, for mutational analysis in newborns.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence of death | At corrected age of 18 months | 
| Disability Rate | Incidence of disability. Disability defined as a physical or mental handicap, especially one that prevents a person from living a full, normal life or from holding a gainful job. | At corrected age of 18 months | 
| Allele Frequency | Allele frequency, or gene frequency, is the relative frequency of an allele (variant of a gene) at a particular locus in the population the investigators studied, expressed as a percentage. | In 120 days after receipt of all the patients' sequencing data |
A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Official Title
-----------------
A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia

Conditions
-----------------
Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: ezetimibe (+) simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18-79 years of age with high cholesterol and high triglycerides. Exclusion Criteria: Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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

| Intervention/Treatment |
| --- |
|Drug: ezetimibe (+) simvastatin|Duration of Treatment: 6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HDL-C, non-HDL-C, and TG. Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed Hyperlipidemia
Efficacy of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.

Detailed Description
-----------------
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.

Official Title
-----------------
Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study

Conditions
-----------------
Peritoneal Dialysis Access Failure

Intervention / Treatment
-----------------
* Procedure: enema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18; Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease; First-time open surgeon peritoneal dialysis catheterization patient; Only straight double-cuff Tenckhoff dialysis catheters were used. Willing to participate in this study and sign informed consent form. Exclusion Criteria: peritoneal dialysis contraindication; Enema contraindication; Patients refuse enema; Expected survival time < 3 months; Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enema group<br> | Procedure: enema<br>* preoperative enema<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization |  | 3 months | 
| Time of first peritoneal dialysis catheter dysfunction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization |  | 6 months | 
| Catheter survival time |  | 6 months | 
| Incidence of peritoneal dialysis-associated Peritonitis |  | 6 months |
Individualized Electronic Intervention to Promote Work Engagement

Study Overview
=================
Brief Summary
-----------------
To determine if physicians who complete brief tasks intended to promote meaning in work and job satisfaction, foster teamwork and social support at work, nuture personal relationships and work-life balance, recognize and build on personal strengths, encourage effective problem solving, and promote positive emotions have improved resilience, meaning in work, and engagement at work.

Official Title
-----------------
Randomized Controlled Trial Evaluating the Effect of An Individualized Electronic Intervention to Promote Resilience, Meaning, and Engagement for Physicians

Conditions
-----------------
Resilience, Meaning in Work, Engagement at Work

Intervention / Treatment
-----------------
* Behavioral: Electronic intervention suggesting behavioral activity


Participation Criteria
=================
Eligibility Criteria
-----------------
All physicians at Mayo Clinic

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic intervention<br>Completion of 1 self-directed activity from an electronically provided list sent to them weekly for 10 consecutive weeks | Behavioral: Electronic intervention suggesting behavioral activity<br>* 3.6 Those randomized to the intervention will be asked to choose 1 self-directed activity from an electronically provided list sent to them weekly for 10 consecutive weeks. Each activity will take less than 5 minutes to complete. They will also answer 3-5 questions weekly (items taken from the survey items list submitted).<br>|
| No Intervention: control group<br>Completion of baseline and 3 mo survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Job satisfaction | Physician Job Satisfaction Scale and Empowerment at Work Scale | baseline to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | Maslach Burnout Inventory, 2-item Primary Care Evaluation of Mental Disorders [PRIME MD]), Medical Outcomes Study Short Form [SF-8]; Linear Analogue Scales Assessment Well-being Survey [LASA]), 10-item Perceived Stress Scale) | Baseline to 3 months |
Repositioning Method for Left-sided Double Lumen Tubes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.

Official Title
-----------------
Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus

Conditions
-----------------
Airway Morbidity, Intubation Complication

Intervention / Treatment
-----------------
* Procedure: repositioning method for left-sided double lumen tubes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thoracic surgery that requires the placement of left-sided double lumen tubes Exclusion Criteria: intraluminal lesion of left bronchus very distorted anatomy of tracheobronchial tree

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left-sided double lumen tube<br> | Procedure: repositioning method for left-sided double lumen tubes<br>* When a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repositioning success rate |  | up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomic parameters | tracheal diameter, position of carina, angle between trachea and left mainstem bronchus | up to 1 hours |