linjc16/ctgov huggingface dataset:
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
-----------------
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history. Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis. Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections Exclusion Criteria: Subject had previously received anti-TNF therapy. Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy Subject cannot avoid excessive sun exposure Subject is taking or requires oral or injectable corticosteroids Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, adalimumab
Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

Study Overview
=================
Brief Summary
-----------------
Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.

Official Title
-----------------
Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: To be eligible for the study, subjects must meet all of the following criteria: Age ≥ 18 years old Physician diagnosis of asthma confirmed through medical record documentation. Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less. Non-smoker for > 6 months before enrollment into the trial Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking. Willing and able to adhere to the study visit schedule and other protocol-specified procedures. Exclusion criteria: Subjects meeting any of the following criteria may not be enrolled in the study: Existence of lung disease (other than asthma) Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks. Non-English speaking. Participation in another interventional research trial Self-reported pregnancy Inability or unwillingness to provide consent Febrile illness (>38.0˚ C or 100.4˚ F) within 24 hours of visit.

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 |
| --- | --- | --- |
The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt

Study Overview
=================
Brief Summary
-----------------
This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications

Official Title
-----------------
The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Morphological classifications of HCC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pathologically proven Hepatocellular Carcinoma Exclusion Criteria: Other malignant tumors than Hepatocellular Carcinoma Benign tumor

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Morphological classifications of HCC|Morphological classifications of Hepatocellular carcinoma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinicopathological factors of Hepatocellular Carcinoma | Serum alpha-fetoprotein (AFP) level | 10 years | 
| Clinicopathological factors of Hepatocellular Carcinoma | Tumor size and focality | 10 years | 
| Clinicopathological factors of Hepatocellular Carcinoma | Vascular invasion | 10 years | 
| Clinicopathological factors of Hepatocellular Carcinoma | Pathologic stage and grade | 10 years | 
| Clinicopathological factors of Hepatocellular Carcinoma | The reserve of background liver | 10 years |
HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to understand the infectious exposure of SARS-coronavirus 2 (SARS-CoV2) among surgeons and anesthesiologists and to correlate this status with self-reported indices of COVID-19 illness.

Official Title
-----------------
Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV2 serum antibody testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accredited to practice at HSS All anesthesiology and surgery faculty All anesthesia and orthopedic surgery fellows All orthopedic surgery residents Exclusion Criteria: • Refusal to participate in either of the interventions at either of the timepoints of interest

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV2 serum antibody testing|Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serology testing and clinical suspicion of COVID-19 |  | Serology Test #1 (Study Enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SARS-CoV2 exposure |  | Serology Tests #1 and 2 (3 months apart) | 
| Correlation of pre-existing risk factors with results of serology testing |  | Serology Test #1 (Study Enrollment) | 
| Number of asymptomatic participants with positive antibody serology |  | Serology Test #1 (Study Enrollment) | 
| Proportion of antibody- positive participants who subsequently develop COVID-19 |  | Serology Tests #1 (Study Enrollment) and Serology Test #2 (3 months apart) | 
| Proportion of participants who are eligible for in plasma donation |  | Serology Tests #1 and 2 (3 months apart) |
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.

Official Title
-----------------
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma

Conditions
-----------------
To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients

Intervention / Treatment
-----------------
* Drug: Drugs, Investigational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients. Exclusion Criteria: pregnant and lactating women, infection, any eye surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Latanoprost | Drug: Drugs, Investigational<br>* To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle<br>* Other names: Brimonidine;|
| Other: Group B<br>Brimonidine | Drug: Drugs, Investigational<br>* To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle<br>* Other names: Brimonidine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More than 20% IOP reduction | From baseline to month 3 | 0_3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reaction | Record every follow up period baseline to month 3. | O_3 months |
A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is allow the patients suffering from Crohn's disease , who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizumab pegol until the drug is available for the Crohn's disease indication in Greece.

Official Title
-----------------
Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Certolizumab pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease diagnosis Patients having completed the treatment period of study C87055 (previously treated with infliximab) and benefited from the study treatment, as per investigatior's discretion. Exclusion Criteria: Subject withdrawn prematurely from C87055 study. Subject who received treatment other than certolizumab pegol and other than medications permitted in C87055 study. Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Certolizumab pegol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For ethical reasons, provide the opportunity for patients > 18 years suffering from Crohn's disease who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events reported by the patients during the long-term treatment period of the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
certolizunab pegol, long term safety follow-up, Chrohn's disease, infliximab failures patients, Greek population
Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

Study Overview
=================
Brief Summary
-----------------
This retrospective cohort study was intended to analyze the incidence and risk factors of perioperative severe cardiovascular events in patients with diastolic dysfunction.

Detailed Description
-----------------
The investigators retrospected patients underwent noncardiac surgery with pre-operative echocardiography and was diagnosed with diastolic dysfunction in 2015 in Peking University First Hospital. Patients' perioperative data were collected. Major adverse cardiovascular events(MACE), other complication incidence, and post-operative hospital stay were reviewed. propotional harzad ratio cox survival model was established. Risk and protective factors relative to MACE were analysed.

Official Title
-----------------
Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

Conditions
-----------------
Diastolic Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older, with echocardiographic diagnosis of left ventricular diastolic dysfunction (while ejection fraction was > = 50%) conducted by cardiologist within 90 days before surgery. Exclusion Criteria: congenital heart disease, moderate to severe valvular disease (stenosis or insufficiency), atrial fibrillation / atrial flutter, pericarditis, unsatisfied cardiac ultrasound image, ejection fraction < 50%, ASA greater than 4, or Echocardiography is missing or incomplete.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| grade1&2 diastolic dysfunction<br>lower diastolic dysfunction exposure | |
| grade 3 diastolic dysfunction<br>higher diastolic dysfunction exposure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | major cardiac complications | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-cardiac surgery, major adverse cardiac event
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Study Overview
=================
Brief Summary
-----------------
PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.

Official Title
-----------------
PROSPER-FM: Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: Digital ACT
* Other: Digital Symptom Tracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Participant is 22 to 75 years of age, inclusive Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. Participant is capable of reading and understanding English and has provided written informed consent to participate. Key Exclusion Criteria: Lifetime history of bipolar or other psychotic disorder Severe depression at screening (measured by BDI-II) The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale (C-SSRS) Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digital Acceptance and Commitment Therapy (ACT) Arm<br> | Device: Digital ACT<br>* Participants in this arm receive Digital ACT as well as standard of care.<br>|
| Active Comparator: Digital Symptom Tracker<br> | Other: Digital Symptom Tracker<br>* Participants in this arm complete a digital symptom and function tracker and monitor, are provided access to digital fibromyalgia and health education, and receive standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGIC) response rate |  | Week 12 |
Fabry Screening Study

Study Overview
=================
Brief Summary
-----------------
To determine if patients with a deficiency of alpha-galactosidase A are at-risk for cardiac complications that commonly occur in the general population

Detailed Description
-----------------
Fabry disease is an X-linked deficiency of alpha-galactosidase A resulting primarily in an accumulation of globotriaosylceramide (Gb3) in virtually all organs and systems. The main complications of Fabry disease are a 20-fold increased risk of ischemic stroke, cardiac disease including cardiomyopathy, atrio-ventricular conduction defects, a wide variety of arrhythmias, valvular dysfunction (insufficiency or stenosis) and cardiac vascular disease as well as progressive renal failure. Fabry disease cannot be easily diagnosed in patients with routine EKGs, echocardiograms or MRIs. Screening non-selected at-risk populations of patients with ischemic stroke or cardiac disease for urinary Gb3, alpha-galactosidase A activity and GLA gene mutations should enable the identification of patients previously undiagnosed with Fabry disease among the general population of patients with heart disease and stroke

Official Title
-----------------
Expanded Screening for Fabry Trait

Conditions
-----------------
Fabry Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any diagnosis of heart disease. Male or Female Able to donate 12 cc of whole blood and 10 cc of urine Exclusion Criteria: No diagnosis of cardiac disease. Unable to donate 12 cc of whole blood and/or 10 cc of urine

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Identify GLA gene variants | Collect blood and urine sample one time only for analysis | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry, Fabry Disease, Alpha-galactosidase A deficiency, GLA gene, mutations