linjc16/ctgov huggingface dataset:
Charcot Leyden Crystals in Pathology

Study Overview
=================
Brief Summary
-----------------
Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

Detailed Description
-----------------
In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (> 3%) and the criteria were extended to those with circulating eosinophilia (> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

Official Title
-----------------
Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having Charcot Leyden Crystals in a pathological sample Exclusion Criteria: Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus
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 |
| --- | --- | --- |
| 'Level of asthma control/severity according to GINA stepwise approach |  | Baseline (day 0) | 
| 'Level of asthma control/severity according to GINA stepwise approach |  | Baseline (day 0) to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative annualized dose of inhaled and systemic corticosteroids | The quantity of corticosteroids consumed during the course of a year. | Baseline (day 0) to Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal polyposis, rhinosinusitis, Charcot Leyden Crystals, Eosinophils
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

Study Overview
=================
Brief Summary
-----------------
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Official Title
-----------------
Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)

Conditions
-----------------
Meningitis, Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: None administered in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of Menactra vaccine during the study period. Exclusion Criteria: None
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 |
| --- | --- |
| Menactra Vaccine Recipients<br>Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente. | Biological: None administered in this study<br>* N/A in this study<br>|
| Age-Matched Control<br>Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente | Biological: None administered in this study<br>* N/A in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | Day 0 up to Day 60 post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningitis, Meningococcal disease, Menactra vaccine
Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring

Study Overview
=================
Brief Summary
-----------------
The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.

Detailed Description
-----------------
The SURPRISE study investigates the patients with cryptogenic stroke or transient ischemic attack (TIA), monitoring them with a cardiac loop recorder for up to three years. it aims at estimating the amount of paroxysmal atrial fibrillation within our population of cryptogenic stroke patients. Standard workup for a stroke patient does offer cardiac evaluation, but monitoring is limited to the time admitted, often just a few days.

Official Title
-----------------
Stroke Prior to Diagnosis of Atrial Fibrillation Using Longterm Observation With Implantable Cardiac Monitoring Apparatus Reveal(SURPRISE) -the SURPRISE Study

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA; > 18 years of age, the ability to provide a written consent Exclusion Criteria: prior or known AFIB AF found during work up including 24 hour telemetric monitoring.

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

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
-----------------
cryptogenic stroke, atrial fibrillation, longterm monitoring, loop recorder
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.

Study Overview
=================
Brief Summary
-----------------
To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.

Official Title
-----------------
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: HIV-1 Immunogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 counts >= 550 cells/ml. NOTE: If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806 or wait 6 months before entering the expanded access program. Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies. Patient must not meet inclusion criteria for other Remune trials. Patient must have laboratory tests within specified limits. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction. Current participation in a Remune study. Concurrent Medication: Excluded: Use of any immune-modulating drugs. Induction therapy or initiation of new treatment regimen for an AIDS-defining condition. Current participation in a Remune study. Patients with any of the following prior conditions are excluded: Previous participation in a Remune study. Prior Medication: Excluded: Previous participation in a Remune study. Excluded within 30 days of study entry: Use of any immune-modulating drugs. Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV-1 Immunogen|nan|

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
-----------------
Acquired Immunodeficiency Syndrome, AIDS Vaccines, CD4 Lymphocyte Count, Salk HIV Immunogen
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL

Official Title
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A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: JTT-705 600 mg and simvastatin 40 mg
* Drug: Placebo and simvastatin 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having lipid values as indicated below: HDL-C ≤ 1.0 mmol/L (40 mg/dL) TG ≤4.5 mmol/L (400 mg/dL) Patients with CHD or CHD risk equivalent Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception) Exclusion Criteria: Body Mass Index of ≥ 35 kg/m2 Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception Concomitant use of medications identified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>JTT-705 600 mg and simvastatin 40 mg | Drug: JTT-705 600 mg and simvastatin 40 mg<br>* JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments<br>|
| Placebo Comparator: 2<br>Placebo and simvastatin 40 mg | Drug: Placebo and simvastatin 40 mg<br>* Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in HDL-C; inhibition of CETP activity |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in LDL-C and TC/HDL-C |  | 4-weeks | 
| Plasma concentration of JTT-705 |  | 4-weeks |
Breakfast and Metabolism in Men

Study Overview
=================
Brief Summary
-----------------
This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.

Official Title
-----------------
The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Dietary Supplement: Animal protein
* Dietary Supplement: Plant protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male No medication Athlete (elite or professional) Exclusion Criteria: Diet-related conditions Food allergies Does not regularly consume protein supplements Claustrophobic Underweight

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein isolate<br> | Dietary Supplement: Animal protein<br>* The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.<br>|
| Active Comparator: Pea protein isolate<br> | Dietary Supplement: Plant protein<br>* The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure | Energy expended per minute will be measured using indirect calorimetry. | Time frame is every 30 minutes for four hours following intervention. | 
| Appetite | Appetite will be assessed using a traditional 100-mm visual analog scale (VAS) (3) with opposing anchors (e.g., extremely hungry or not hungry at all) at time points 15, 30, 60, 90, 120, 180 and 240 min. Questions consisted of: how hungry do you feel at this moment, how full do you feel at this moment, how strong is your desire to eat this moment and how much food do you think you can eat at this moment. Participants were asked to place an X on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. Participants were asked to place an X on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. The averages for each time point are taken to represent the feeling of appetitive at a particular time point. | Time frame is every 30 minutes for four hours following intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour food intake | Food intake following the intervention will be recorded using food records. | Food intake will be recorded for one day. |
Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

Study Overview
=================
Brief Summary
-----------------
To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.

Detailed Description
-----------------
The specific aim of this study is to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. Combined videofluoroscopic swallowing studies with pharyngeal manometry are commonly used in the evaluation of dysphagia. However, no published study has compared the results of simultaneous pharyngeal manometry with objective timing and displacement measures on videofluoroscopy. These objective measures, such as the pharyngeal constriction ratio, were developed here at UCD and are not yet routinely used by other practitioners. A secondary aim of this study will be to corroborate recent data in the literature suggesting that the presence of feeding tube through the upper esophageal sphincter does not affect the oropharyngeal phase of deglutition. This topic is currently under hot debate in the speech language pathology realm and has important implications for the evaluation of hospitalized patients with dysphagia.

Official Title
-----------------
Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

Conditions
-----------------
Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07 Exclusion Criteria: those who do not meet the inclusion criteria; pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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
-----------------
pharyngeal manometry, videofluoroscopy
Family Intervention for Suicidal Youth: Emergency Care

Study Overview
=================
Brief Summary
-----------------
This project evaluates a brief intervention in the emergency department (ED) for adolescents presenting with suicide attempts. The intervention aims to capitalize on the opportunity offered by the ED visit to deliver an effective intervention, improve adherence to follow-up care, decrease the risk of repeat suicide attempts, and improve clinical and functioning outcomes.

Official Title
-----------------
Family Intervention for Suicidal Youth: Emergency Care

Conditions
-----------------
Suicide, Attempted

Intervention / Treatment
-----------------
* Behavioral: FISP + Usual Care
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-18 years Suicidal patient presenting to Emergency Department Exclusion Criteria: Acute psychosis/symptoms that impede consent/assessment No parent/guardian to consent (youth <18) Youth not English-speaking Parents/guardians not English or Spanish-speaking.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Usual Care + Family Intervention for Suicide Prevention (FISP) | Behavioral: FISP + Usual Care<br> <br> |
| Other: 2<br>Usual Care | Behavioral: Usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Official Title
-----------------
The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female infants or children 16 years of age or younger Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy Patient with attached vitreous somewhere in posterior pole Patient's parent or guardian must be willing and able to comply with follow-up requirements Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form Exclusion Criteria: Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements Medical problems that make consistent follow-up over the treatment period uncertain. Patient must not have participated in an investigational drug or device study in the prior 30 days Female Patients of childbearing potential must not be pregnant or lactating.

Ages Eligible for Study
-----------------
Maximum Age: 16 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: Ocriplasmin<br> | Drug: Ocriplasmin<br>* 175µg ocriplasmin intravitreal injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope. | Beginning of vitrectomy or after application of suction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety in pediatrics