linjc16/ctgov huggingface dataset:
COVID-19 Antibody Levels After Vaccines

Study Overview
=================
Brief Summary
-----------------
This study will measure the levels of nasal mucosal Immunoglobulin A (IgA) and blood serum IgA up to one year after COVID vaccination, as well as examining what factors might affect antibody levels in the nose. This will be done through nasal epithelial lining fluid collection and standard venipuncture.

Detailed Description
-----------------
Based on data demonstrating that SARS-CoV-2 infections results in virus-specific nasal IgA levels even in patients with mild infections and no/low serum antibody titers, we hypothesize that COVID vaccinations result in robust nasal IgA levels. Since previous data indicate that SARS-CoV2 specific IgA were transiently present following community-acquired infections, we will follow vaccine-induced nasal IgA levels over time (6-12 months). Our specific aims are as following: Aim 1: Determine COVID vaccine specific immunoglobulin levels and immune mediator profiles in the nasal mucosa pre- and 14 days post second dose of COVID vaccine. Aim 2: Determine COVID specific immunoglobulin levels and immune mediator profiles at 3, 6, and 12 months following complete vaccination.

Official Title
-----------------
Vaccine Ig Levels in Nasal Mucosa as Measured by Nasal Epithelial Lining Fluid

Conditions
-----------------
Vaccine Preventable Disease

Intervention / Treatment
-----------------
* Biological: COVID-19 Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals at least 18 years of age who have or plan to receive a COVID-19 vaccination Able to be seen at UNC Chapel Hill's main campus up to 5 times in the next year Exclusion Criteria: Individuals unwilling to give consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: COVID-19 Vaccination|Receipt of full COVID-19 vaccination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Mucosal COVID-specific IgA | Level of COVID-specific antibodies in the nasal mucosa | Up to 14 months | 
| Serum COVID-specific IgA | Level of COVID-specific antibodies in the blood serum | Up to 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Vaccination
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.

Official Title
-----------------
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Next Generation Diagnostic Instrument (NGDI)
* Device: Zyoptix Diagnostic Workstation (ZDW)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: +10.00D to -20.00D of absolute spherical ametropia Must be part of the Bausch & Lomb research clinic Snellen visual acuity must be correctable to 20/25 Exclusion Criteria: No more than -6.00D of refractive astigmatism

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Next Generation Diagnostic Instrument<br>Next Generation Diagnostic Instrument (NGDI) | Device: Next Generation Diagnostic Instrument (NGDI)<br>* Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes<br>|
| Active Comparator: Zyoptix Diagnostic Workstation<br>Zyoptix Diagnostic Workstation (ZDW) | Device: Zyoptix Diagnostic Workstation (ZDW)<br>* Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of aberrations with the NGDI and the Zywave II. |  | Single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz. |  | Single visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal surface topography, Ocular aberrations
Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy

Study Overview
=================
Brief Summary
-----------------
The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.

Official Title
-----------------
Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Triple therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV patients with compensated cirrhosis (Child-Pugh A) HCV genotype 1 non-responders to a previous course of interferon (IFN)/ribavirin receiving boceprevir or telaprevir Exclusion Criteria: -

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 |
| --- | --- |
| HCV triple therapy<br>Cohort of HCV patients who received first-generation protease inhibitor-based triple therapy | Other: Triple therapy<br>* Cohort of patients who received triple therapy combining pegylated-interferon/ribavirin + first generation protease inhibitor boceprevir or telaprevir as part of routine clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with positive anti-E1E2 antibody level at treatment initiation | Anti-E1E2 antibody levels were determined as previously described (Ndongo et al. Hepatology 2010;52:1531-42) using optical densities obtained after dilution of patients' serum samples at 1/250 and 1/500. Samples with anti-E1E2 levels above 950 (OD value× 1000) were considered positive. | Baseline (initiation of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic of Quantification of hepatitis C viral load (HCV RNA) | Viral load was assessed at baseline (initiation of treatment), and at week 4, 12, 24, 36, and 48 of therapy and 12 weeks after the end of treatment. | baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, anti-E1E2 antibodies, cirrhosis, triple therapy
Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis

Detailed Description
-----------------
CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition of the fixation points to avoid malposition of transpedicular screws and potential visceral, vascular or neurological damage. It is known that multislice CT involves an increased radiation exposure for patients, while dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software. The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis who are candidated for vertebral arthrodesis.

Official Title
-----------------
Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Diagnostic Test: GE CT 750 HD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with progression of scoliosis without vertebral arthrodesis patients able to maintain immobility for the duration of the exam patients from 5 to 20 years old Exclusion Criteria: pregnancy vertebral arthrodesis patients unable to maintain immobility for the duration of the exam non-compliant patients obese patients patients younger than 5 years old or older than 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: GE CT 750 HD|Low-dose dual-energy CT imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | To evaluate the percentage of malpositioning of transpedicular screw. A percentage of malpositioning lower than 10% will be considered as acceptable. | Week 1 (post-surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure | Collection of dosimetric data | Baseline (pre-surgery) and week 1 (post-surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scoliosis, low dose, arthrodesis, dual-energy CT
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

Study Overview
=================
Brief Summary
-----------------
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.

Detailed Description
-----------------
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting. The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Official Title
-----------------
Specific Use-results Study of IMJUDO Intravenous Infusion 25 mg, 300 mg / IMFINZI Intravenous Infusion 120 mg, 500 mg All Patient Investigation in Patients With Unresectable Hepatocellular Carcinoma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC. - Exclusion Criteria: -
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 |
| --- | --- | --- |
| Incidence of ADRs |  | 24 weeks |
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD

Study Overview
=================
Brief Summary
-----------------
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)

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

Intervention / Treatment
-----------------
* Drug: Mixed amphetamine salts (ADDERALL XR)
* Drug: Atomoxetine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation Capable of understanding and following classroom instructions Generally functioning academically at age-appropriate levels Exclusion Criteria: ADHD, predominantly inattentive subtype Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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<br> | Drug: Mixed amphetamine salts (ADDERALL XR)<br> <br> |
| Active Comparator: Atomoxetine hydrochloride<br> | Drug: Atomoxetine hydrochloride<br> <br> * Other names: Strattera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) |  | Approximately 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL |  | Approximately 3 weeks | 
| treatment-emergent adverse events |  | approximately 3 weeks |
Effects of Curcumin on Vascular Reactivity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Detailed Description
-----------------
The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Official Title
-----------------
Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers

Conditions
-----------------
Healthy Volunteers (Middle-aged Smokers)

Intervention / Treatment
-----------------
* Drug: Curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 to 70 year-old volunteers smokers Exclusion Criteria: treated hypertension treated hypercholesterolemia chronic disease vegetarian or other unusual diets chronic alcoholism

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: curcumin<br>The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk | Drug: Curcumin<br>* The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in brachial Flow Mediated Dilatation |  | at Visit 1 (Day 0) and visit 2 (Day3/day5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fingertip arterial tonometry |  | at visit 1 (day 0) and visit 2 (day3/day5) | 
| Modifications of leukocytes transcriptome |  | at visit 1 (day 0) and visit 2 (day3/day 5) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polyphenol, Curcumin, Endothelium, vascular, Endothelium-dependant relaxing factor, Smoking, Transcriptome
Impact of Continuing Medical Education (CME) Insulin Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a continuing medical education (CME) program can change primary care providers' use of insulin therapy - their confidence in selecting doses and engagement of patients in the decision making as to whether to initiate insulin therapy.

Detailed Description
-----------------
We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. Specifically, we will address the following questions: Question 1. Clinical guidelines. Is insulin initiated earlier (at a lower A1C)? Question 2. Decision-making. Does confidence in selecting a starting insulin regimen change? Does confidence in selecting a starting insulin dose change? Does confidence in adjusting insulin change? Does confidence in discussion nutrition guidelines change? Question 3. Application. Do more patients start using insulin? Who usually selects starting dose? How is starting dose selected? How often is insulin adjusted? Question 4. Resources. How available are protocols for insulin use? How available is adequate time to monitor insulin therapy? How available is staff to teach insulin injections? How available is staff to help adjust insulin?

Official Title
-----------------
Impact of CME Program on Self-Reported Confidence and Use of Insulin in Persons With Type 2 Diabetes

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary care provider attending CME training Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| primary care provider<br>attending insulin CME Training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. |  | pre program survey & 2-4 month post program survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-CME training level of patient's A1c when starting insulin therapy compared to post-CME training level of patient's A1c when starting insulin therapy |  | pre program survey and 2-4 month post program survey |
Brief Intervention for OCD Fears

Study Overview
=================
Brief Summary
-----------------
The study will test the efficacy of propranolol or placebo, administered after reactivation of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and avoidance in OCD.

Detailed Description
-----------------
Twenty subjects with OCD will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear reactivation procedure. Primary outcome assessment will be OCD symptoms and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention

Official Title
-----------------
Brief Intervention for OCD Fears

Conditions
-----------------
Obsessive-compulsive Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Principal Diagnosis of Obsessive-Compulsive Disorder Exclusion Criteria: History of other serious psychiatric disorder Current Major Depressive Disorder Women who are pregnant or nursing Current use of psychiatric medication Persons planning to start another treatment during the study period Any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propanolol<br>Propranolol 40 mg capsule, given once after fear reactivation procedure | Drug: Propanolol<br>* Active treatment<br>* Other names: Inderal;|
| Placebo Comparator: Placebo capsule<br>Placebo capsule, given once after fear reactivation procedure | Drug: Placebo<br> <br> * Other names: sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive-Compulsive Scale | Total score on this Clinician-administered measure of OCD symptoms | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Avoidance Task | Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propanolol, obsessive-compulsive disorder