linjc16/ctgov huggingface dataset:
Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.

Official Title
-----------------
Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: AI-enabled ECG-based Screening Tool for AF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Had a 10-second 12-lead ECG done at Mayo Clinic Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3 Exclusion Criteria: Diagnosed atrial fibrillation or atrial flutter Missing date of birth or sex in the electronic health record (EHR) A history of intracranial bleeding A history of end-stage kidney disease Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.

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 |
| --- | --- |
| BEAGLE Participants<br>Adult patients who have not been previously diagnosed with AF, are eligible for anticoagulation and have AI-predicted risks based on a normal sinus rhythm ECG. | Other: AI-enabled ECG-based Screening Tool for AF<br>* A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool to improve atrial fibrillation diagnosis and stroke prevention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Atrial Fibrillation as Detected by Patch Application | The data will be used to examine the performance of the algorithm in detecting unrecognized atrial fibrillation (e.g. positive predictive value, negative predictive value, sensitivity, specificity, and area under the curve [AUC]). | Three Months |
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.

Official Title
-----------------
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Behavioral: Verbal consultation
* Behavioral: Written Action Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will only enroll subjects between the ages of 18-years and 89-years of age. Diagnosis of HS by a board-certified dermatologist Able to read and comprehend study materials No prior exposure to written HS action plans Exclusion Criteria: Those who do not fit the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Verbal Consultation, then Written Action Plan<br>CONTROL GROUP Survey A Routine clinic visit Verbal consultation only Survey B Verbal consultation AND Written Action Plan Survey C | Behavioral: Verbal consultation<br>* Verbal consultation only without written information before receiving written action plan<br>Behavioral: Written Action Plan<br>* Written handout of treatment plan and disease management strategies<br>|
| Experimental: Experimental: Written Action Plan<br>INTERVENTION GROUP Survey A Routine clinic visit Verbal consultation AND Written Action Plan Survey C | Behavioral: Written Action Plan<br>* Written handout of treatment plan and disease management strategies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | Number of visits to ER, urgent care, or hospitalizations because of HS | Through study completion, an average of 1.5 months |
New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics

Official Title
-----------------
Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

Conditions
-----------------
Nosocomial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns > 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of NBI Exclusion Criteria: Early post-operative period ( surgery of less than 48 hours) Multiple malformations Newborn already included in the study for a previous septic events Newborn treated with antibiotics in the last 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 72 Hours
Maximum Age: 90 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A-1<br>Proven nosocomial bacterial infection (NBI) | |
| A-2<br>Possible NBI | |
| B-1<br>Absence of NBI | |
| B-2<br>Probable absence of NBI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. |  | 48 hours and at 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Late onset neonatal sepsis, Nosocomial bacterial infection, Inflammatory markers, multiplex dosage
Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.

Official Title
-----------------
Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected. Screening viral load at least 5000copies/mL. X4-tropic only or non-phenotypeable virus at screening. Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: NRTI, NNRTI, and PI, stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening. Able to receive a ritonavir-boosted protease inhibitor during treatment studies. Women of childbearing potential must use specific forms of contraception. Exclusion criteria: R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study. Pregnant or breastfeeding women. Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness. Current use of certain medications may exclude participation in this study. Additional qualifying criteria and laboratory test requirements to be determined by study physician.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, GW873140, CCR5 antagonist, experienced, treatment experienced
Valproic Acid in Childhood Progressive Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.

Detailed Description
-----------------
Patients with progressive or recurrent pediatric brain tumors are administered valproic acid, an HDAC inhibitor, along with standard of care therapy (radiation and temozolomide) for induction therapy. Thereafter, patients will be able to continue on valproic acid and temozolomide therapy as long as the combination is well tolerated and the tumor is not progressing.

Official Title
-----------------
Valproic Acid for Children With Recurrent and Progressive Brain Tumors

Conditions
-----------------
Pediatric Brain Tumor, Glioma, Anaplastic Astrocytoma, Medulloblastoma, Glioblastoma

Intervention / Treatment
-----------------
* Drug: Valproic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject, parent, or guardian willing and able to give informed consent Recurrent or progressive pediatric brain tumor, with MRI evidence of disease Age at first diagnosis of brain tumor 1-21 years old Lansky or Karnofsky performance score of at least 50 at diagnosis Exclusion Criteria: Pregnancy Prior intolerance to valproic acid History of use of temozolomide Use of enzyme inducing anticonvulsant medications (see appendix B) Known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Treatment arm<br>All participants will be enrolled on to one, open-label arm. Participants will be treated with valproic acid in addition to standard of care therapy. | Drug: Valproic Acid<br>* All participants enrolled on valproic acid arm.<br>* Other names: Valproate, VPA, Depakote, Depakote ER, Depakene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of protocol | Number of participants completing the protocol will be measured. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Participants will be evaluated for progression every 2 months while on the study. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Glioblastoma, Pediatric, Child, Brain tumor, Astrocytoma, Medulloblastoma, PNET
Ophthalmic Manifestations of Patients With Mucopolysaccharidosis

Study Overview
=================
Brief Summary
-----------------
Mucopolysaccharidosis (MPSs) are a group of disorders caused by inherited defects in lysosomal enzymes resulting in widespread intra- and extra-cellular accumulation of glycosaminoglycan(1,2). They have been subdivided according to enzyme defect and systemic manifestations and include MPS IH (Hurler)(3) , MPS IS (Scheie), MPS IH/S (Hurler/Sheie), MPS II(4,5) (Hunter), MPS III (Sanfilippo)(6) , MPS IV (Morquio)(7,8), MPS VI (Maroteaux-Lamy)(9), MPS VII (Sly)(10,11) and MPS IX (Natowicz)(12). Mucopolysaccharidosis have a spectrum of systemic manifestations, including airway and respiratory compromise, skeletal deformities, intellectual and neurological impairment, cardiac abnormalities, gastrointestinal problems and ocular manifestations(13). Ocular manifestation are common in the mucopolysaccharidosis and may result in significant visual impairment(14). Corneal opacification of varying severity is frequently seen, as well as retinopathy, optic nerve swelling and atrophy, ocular hypertension, and glaucoma(14). New treatment modalities for the systemic manifestations of the mucopolysaccharidosis include bone marrow transplant and enzyme replacement therapy have resulted in an improved prognosis in many cases(15).

Official Title
-----------------
Ophthalmic Manifestations of Patients With Mucopolysaccharidosis

Conditions
-----------------
Ophthalmic Manifestations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at any age up to 18 years with any type of MPS confirmed by the enzymatic assay Exclusion Criteria: Any patient other than MPS

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| early detection and management of ophthalmic manifestations in patients with MPS |  | 1 week |
Protein Requirements In Active Populations

Study Overview
=================
Brief Summary
-----------------
Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity. Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data. The purpose of this study is to measure the protein requirement in active, young adult males using the IAAO technique in the presence of a variable intensity exercise stimulus.

Official Title
-----------------
Evaluation of Protein Requirements in Active, Young Adult Males

Conditions
-----------------
Increased Metabolic Requirement, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Amino Acid Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, active, young adult males who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour A minimum score of 10 on the Beep Test (a measure of aerobic fitness) Exclusion Criteria: Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+) Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption) Regular tobacco use Illicit drug use

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active, Young Adult Males<br>Subjects will receive different levels of amino acid intakes varying from 0.2 to 2.6 g/kg/day. | Dietary Supplement: Amino Acid Intake<br>* Amino acid intakes will be varied at 0.2-2.6 g/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13CO2 (carbon dioxide) excretion (μmol/kg/h) |  | 4 hours / study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C-Phenylalanine Oxidation (μmol/kg/h) |  | 4 hours / study day |
Neurofunctional Correlates of Intentional Actions Towards Food Stimuli

Study Overview
=================
Brief Summary
-----------------
In this project, the investigators will explore the cognitive neuroscience of intentional action in relation to food behaviour. To unravel how the brain systems involved in intentional control of actions and how these interact with the reward system in different physiological conditions and in relation to lean-weight or obesity, the investigators will manipulate the degree of intentionality of the behaviours under examination and the level of satiety of the participants.

Official Title
-----------------
Neurofunctional Correlates of Intentional Actions Towards Food Stimuli

Conditions
-----------------
Food Preferences

Intervention / Treatment
-----------------
* Behavioral: Consumption of a standard meal prior to the fMRI data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight (normal BMI) No MRI controindications No neurological or cognitive problems Exclusion Criteria: Underweight or overweight MRI controindications Neurological or cognitive problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fasting-group<br> | |
| Experimental: Fed-group<br> | Behavioral: Consumption of a standard meal prior to the fMRI data collection<br>* Consumption of a standard meal prior to the fMRI data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD (Blood Oxygen Level Dependent) signal | The investigators will measure the changes of the hemodynamic response (BOLD signal) recorded in the whole brain during the execution of the different experimental tasks (e.g. intentionally guided actions towards stimuli of high or low calories food vs externally guided actions towards stimuli of high or low calories food), in the two groups (fasted and satiated subjects). | This outcome will be measured on the recruitment day |
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice

Official Title
-----------------
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Iguratimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Participants with rheumatoid arthritis Participants who take iguratimod Exclusion criteria Participants registered for this survey previously Pregnant women or women suspected of being pregnant Participants with a serious liver disorder Participants with peptic ulcer Participants with known hypersensitivity to iguratimod or any of its excipients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iguratimod<br> | Drug: Iguratimod<br>* The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria) | DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. Good response: Baseline DAS28 less than or equal to 3.2 (low disease activity); DAS28 Improvement >1.2 Moderate response: Baseline DAS28 less than or equal to 3.2; DAS28 Improvement >0.6 and less than or equal to 1.2 or Baseline DAS28 >3.2 and less than or equal to 5.1; DAS28 Improvement >0.6 or Baseline DAS28 >5.1; DAS28 Improvement >1.2 No response: Baseline DAS28 >5.1 (high disease activity); DAS28 Improvement less than or equal to 1.2 or DAS28 Improvement less than or equal to 0.6 | 52 weeks (0-24 weeks and 25-52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Rheumatoid, Iguratimod