linjc16/ctgov huggingface dataset:
Real-world Clinical Efficacy of Abatacept in the T3 Data Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n  = 200).

Detailed Description
-----------------
Two secondary hypotheses that will be tested are: Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender. A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.

Official Title
-----------------
Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups

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

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with rheumatoid arthritis Have used Abatacept for 3 or more months Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30. | Drug: Abatacept<br>* As prescribed by a doctor for patient medical care.<br>* Other names: Orencia Intravenous;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores. |  | Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores. |  | Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months. | 
| Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores. |  | Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retrospective, Database, Data warehouse, Data mining, Collaborative effectiveness, Comparative effectiveness, Outcome based medicine, Evidence based medicine
Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.

Official Title
-----------------
Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Procedure: triclosan coated suture for surgical wound closure
* Procedure: regular sutures for surgical wound closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing peripheral vascular surgery procedure Exclusion Criteria: patients refusal

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: triclosan<br>triclosan-coated sutures | Procedure: triclosan coated suture for surgical wound closure<br>* triclosan coated suture for surgical wound closure<br>|
| Placebo Comparator: control<br>sutures without triclosan-coating | Procedure: regular sutures for surgical wound closure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical wound infection |  | one month after surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical wound infection, triclosan-coated suture
Orofacial Difficulties in Rooming-in

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.

Detailed Description
-----------------
Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.

Official Title
-----------------
Orofacial Difficulties During the Maternal Breastfeeding in Rooming-in

Conditions
-----------------
Orofacial Difficulties in Newborns, Maternal Breastfeeding in Newborns, Newborns in Rooming-in

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age. Exclusion Criteria: newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Month

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maternal Breastfeeding, Orofacial Difficulties, Rooming-in, Speech and Language Therapy
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Detailed Description
-----------------
This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Official Title
-----------------
A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Drug: Dexamethasone Phosphate Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 85 years Receive, understand, and sign a copy of the written informed consent form Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Dexamethasone Phosphate Ophthalmic Solution<br>Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System | Drug: Dexamethasone Phosphate Ophthalmic Solution<br>* Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of dexamethasone | Vitreous humor samples will be analyzed for dexamethasone concentrations | Day 1 | 
| Concentration of dexamethasone phosphate | Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations | Day 1 |
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).

Official Title
-----------------
A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD Exclusion Criteria: Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD Known non-responder to stimulant medication Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines Conduct Disorder, hypertension, history of seizure Tic disorder or Tourette's disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: Adderall XR (10 mg)<br> | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)<br> <br> |
| Experimental: Adderall XR (20 mg)<br> | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)<br> <br> |
| Experimental: Adderall XR (30 mg)<br> | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)<br> <br> |
| Experimental: Adderall XR (40 mg)<br> | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)<br> <br> |
| Placebo Comparator: placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg. |  | approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts. |  | Approximately 4 weeks | 
| Adverse events, labs, physical exam, ECG |  | approximately 4 weeks |
Optical Coherence Tomography of the Middle Ear Using Ossiview

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.

Detailed Description
-----------------
Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.

Official Title
-----------------
Optical Coherence Tomography of the Middle Ear Using Ossiview

Conditions
-----------------
Middle Ear Disease

Intervention / Treatment
-----------------
* Device: Ossiview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age ≥18 years Ability to understand the consent process with adequate language and cognitive communication ability Presence of one of the pathologies (either currently or in the past) above or healthy control Exclusion Criteria Narrow or stenotic external meatus (ear canal) Movement disorder causing inability to keep head still during imaging

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ossiview|Imaging of the ear using Optical Coherence Tomography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic correlation with microscopic otoscopy | Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy | 6 months | 
| Diagnostic correlation with CT scans | Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans | 6 months | 
| Diagnostic correlation with Magnetic Resonance Imaging (MRI)s | Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs | 6 months | 
| Diagnostic correlation with audiologic testing results | Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results | 6 months | 
| Diagnostic correlation with surgical reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports | 6 months | 
| Diagnostic correlation with pathology reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports | 6 months |
Assessing Symptomatic Clinical Episodes in Depression

Study Overview
=================
Brief Summary
-----------------
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Detailed Description
-----------------
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Official Title
-----------------
A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: AXS-05
* Drug: Bupropion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently meets DSM-5 criteria for MDD Body mass index (BMI) between 18 and 40 kg/m^2, inclusive Agree to use adequate method of contraception for the duration of the study Additional criteria may apply Exclusion Criteria: Suicide risk History of treatment resistance in current depressive episode History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study Additional criteria may apply

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05<br> | Drug: AXS-05<br>* AXS-05 taken twice daily for 6 weeks.<br>|
| Active Comparator: Bupropion<br> | Drug: Bupropion<br>* Bupropion taken twice daily for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS Score - Overall Change From Baseline | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. | Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AXS-05, Major Depressive Disorder, MDD, Axsome, Depression, Dextromethorphan, Bupropion, Sigma-1, NDMA, ASCEND
The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation myocardial infarction is significantly higher when the glomerular filtration rate below a certain value.

Detailed Description
-----------------
The investigators retrospectively analyzed the clinical data of 1157 patients with ST-segment elevation myocardial infarction. In-hospital adverse cardiovascular events (MACE) was defined as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. All the patients were divided into 3 groups according to the patient's estimated glomerular filtration rate(eGFR) (eGFR≥90ml/min/1.73m2; 90ml/min/1.73m2>eGFR≥60ml/min/1.73m2; eGFR<60ml/min /1.73m2). COX regression analysis and K-M survival curves are used to calculate the correlation between eGFR and in-hospital MACE.

Official Title
-----------------
The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation

Conditions
-----------------
ST Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients with STEMI 2.Patients from whom informed consent has been properly obtained in writing prior to start of the trial Exclusion Criteria: 1.Patients with previous myocardial infarction, congenital heart disease 2.Patients with liver disease, and renal failure 3.Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 93 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 |
| --- | --- | --- |
| major adverse cardiac events | Relationship between reduced eGFR and in-hospital MACE | The median time of 7 days |
Pre- and Post-tests Impact of a Football Tournament on the Mental Well-being of Kuru Community Youths in Jos-South: A Single Arm Mixed Methods Study

Study Overview
=================
Brief Summary
-----------------
Sporting activities such as football tournaments are instrumental in promoting community mental health. A community-based football tournament intervention will benefit the participating individuals' physical and mental health and promote community cohesion. The anticipated benefits of the proposed football tournament are: To bring a greater sense of community cohesion and togetherness. To improve physical and mental health (e.g., increase fitness, reduce anxiety, depression, loneliness, suicidal ideation or self-harm).

Official Title
-----------------
Pre- and Post-tests Impact of a Football Tournament on the Mental Well-being of Kuru Community Youths in Jos-South: A Single Arm Mixed Methods Study

Conditions
-----------------
Football Tournament

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male youths Between 18 and 35 years Able to give informed consent Residents of the Kuru community of Jos-South No history of chronic health concerns (e.g., chronic heart disease, severe depression etc). Exclusion Criteria: Females Below 18 or above 35 years Unable to give informed consent History of chronic health concerns (e.g., chronic heart disease, severe depression etc).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- | --- |
| Change in Football Worry is being assessed | Primary outcome measure would be assessed using the Football Worry Scale | Change is being assessed at pre and post-intervention at 8 weeks | 
| Change in Moral Disengagement in Sport is being assessed | Primary outcome measure would be assessed using the Moral Disengagement in Sport Scale | Change is being assessed at pre and post-intervention at 8 weeks | 
| Change in Positive Mental Health is being assessed | Primary outcome measure would be assessed using the Positive Mental Health Scale | Change is being assessed at pre and post-intervention at 8 weeks | 
| Change in Psychological Well-Being is being assessed | Primary outcome measure would be assessed using the Psychological Well-Being Measure | Change is being assessed at pre and post-intervention at 8 weeks |