linjc16/ctgov huggingface dataset:
Study of Circulating Microparticles in Giant Cell Arteritis

Study Overview
=================
Brief Summary
-----------------
To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.

Official Title
-----------------
Study of Circulating Microparticles in Giant Cell Arteritis

Conditions
-----------------
Giant Cell Arteritis, Acute Phase

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
For GCA group: Inclusion Criteria: Men and women ≥ 18 years of age Patient affiliated to social security regimen Informed and having signed the consent form to take part in the study. Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having Either temporal artery biopsy showing characteristic GCA abnormality Or inflammatory arteritis on imaging examination Exclusion Criteria: Persons under protection of the court or guardianship Inability to understand or to follow study procedures Dementia cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery biopsy Any conditions that might interfere with MPs level: diabetes, recent endo-arterial gesture, current treatment with corticosteroids. Participation in another ongoing clinical trial Current anticoagulant therapy Active infectious disease

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GCA group<br> | Other: Blood sample<br> <br> |
| Inflammatory syndrome (without GCA) group<br> | Other: Blood sample<br> <br> |
| Without inflammatory syndrome and without GCA group<br> | Other: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of microparticles in the blood of patients with histologically proven giant cell arteritis. | Level of microparticles (MPs) in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome. | Baseline |
Heart and Lung Function Monitoring System

Study Overview
=================
Brief Summary
-----------------
The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.

Detailed Description
-----------------
The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.

Official Title
-----------------
Heart and Lung Function Monitoring System Evaluation

Conditions
-----------------
Heart Diseases, Lung Diseases

Intervention / Treatment
-----------------
* Device: Integrated CardioRespiratory System
* Device: Transthoracic Echocardiography (TTE)
* Device: Electrocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult's ≥ 18 years old Exclusion Criteria: Wounds, surgical incisions at the site of sensor placement

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart and Lung Function Monitioring<br> | Device: Integrated CardioRespiratory System<br>* Participants will be asked to wear a non-invasive band on their upper abdomen while laying down. This band includes acoustic sensors. A remote monitoring device will continuously monitor and record heart rate and lung volumes and function.<br>Device: Transthoracic Echocardiography (TTE)<br>* Participants will undergo a TTE examination. During the TTE, a technician obtains views of the heart by moving a small instrument called a transducer to different locations on the chest or abdominal wall.<br>Device: Electrocardiography<br>* Participants will also have ECG monitoring as part of the TTE exam, which records the electrical activity of the heart using electrodes placed on the body.<br>* Other names: ECG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acoustic heart sound electronic data | Heart and lung function monitoring | 60 minutes during system trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard echocardiography parameters | Transthoracic Echocardiography (TTE) | 60 minutes during examination simultaneous with system trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac, respiratory, monitoring
Biomodel in Tetralogy of Fallot

Study Overview
=================
Brief Summary
-----------------
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Detailed Description
-----------------
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Official Title
-----------------
Application of Biocardiac Model in Total Correction of Tetralogy of Fallot

Conditions
-----------------
Tetralogy of Fallot

Intervention / Treatment
-----------------
* Procedure: rapid prototyping
* Procedure: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tetralogy of Fallot

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: rapid prototyping|nan|
|Procedure: computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity |  |  | 
| specificity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomodel, rapid prototyping, computed tomograpgy
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Study Overview
=================
Brief Summary
-----------------
Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients. Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).

Official Title
-----------------
Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: liquefaction
* Procedure: Torsional ip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale Exclusion Criteria: Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liquefaction group<br>Subjects that were operated for cataract using liquefaction technology | Procedure: liquefaction<br>* Cataract extraction surgery type<br>|
| Active Comparator: Torsional ip group<br>Subjects that were operated for cataract using torsional ip technology | Procedure: Torsional ip<br>* A type cataract surgery using torsional ip technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell count (ECC) |  | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity (UVA) |  | 1 month postoperatively | 
| Central corneal thickness (CCT) |  | 1 month postoperatively | 
| Central Corneal Sensitivity (CCS) |  | 1 month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, phacoemulsification, liquefaction, torsional ip, endothelial cell count, central corneal edema, central corneal sensitivity
Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.

Conditions
-----------------
Constipated Irritable Bowel Syndrome, Chronic Constipation, Healthy

Intervention / Treatment
-----------------
* Drug: Mosapride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria Exclusion Criteria: Intolerable or hypersensitive to mosapride Known Parkinson's ds Cardio- or cerebrovascular disease within 3 months Malignancy requiring surgery or chemotherapy or radiation within 5 years History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation Refractory diabetes mellitus/hypertension/thyroid diseases Symptomatic heart failure, renal failure, arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 19 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: mosapride<br> | Drug: Mosapride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonic transit time | the change of colonic transit time after mosapride 30mg/day administration : whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mosapride
Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Study Overview
=================
Brief Summary
-----------------
Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour. The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies. The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.

Official Title
-----------------
Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration

Conditions
-----------------
Chronic Renal Failure, Hyperkalemia

Intervention / Treatment
-----------------
* Drug: Albuterol (1,200 μg) through metered-dose inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients regularly attending the nephrological clinic or the dialysis unit persistent potassium concentration above 5 mEq/L Exclusion Criteria: Patients suffering from active ischemic heart disease Patient with a recent history of arrhythmia Patients treated regularly with ß blockers Patients treated regularly with salbutamol or other ß2AR agonists Patients suffering from persistent tachycardia (pulse > 100 beats/min) Patients who are hemodynamically unstable Patients suffering from any acute illness

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Albuterol (1,200 μg) through metered-dose inhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of decrease in plasma potassium concentration |  |  | 
| The extent of increase in plasma glucose concentration |  |  | 
| Plasma concentration of albuterol |  |  |
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

Study Overview
=================
Brief Summary
-----------------
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.

Official Title
-----------------
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

Conditions
-----------------
Gastric Cancer, HER-2

Intervention / Treatment
-----------------
* Other: Dual or Multiple Paraffin Blocks
* Other: One Paraffin Blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual or Multiple Paraffin Blocks<br>Assessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks | Other: Dual or Multiple Paraffin Blocks<br>* Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks<br>|
| Active Comparator: One Paraffin Blocks<br>Assessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks | Other: One Paraffin Blocks<br>* Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positive rate of cohort using dual or multiple tumor tissue paraffin blocks |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, Her2/neu, dual paraffin blocks, trastuzumab
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Official Title
-----------------
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Conditions
-----------------
Sleep Disturbance, Total Joint Arthroplasty

Intervention / Treatment
-----------------
* Drug: melatonin 6mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo unilateral primary total joint arthroplasty Patient willing and able to complete postoperative surveys Exclusion Criteria: Patients who undergo revision total joint arthroplasty Patients who undergo bilateral total joint arthroplasty Patients currently taking melatonin supplementation Patient has history of substance abuse (drug or alcohol) Patient is a workman's comp patient or patient has current litigation pending Patient has an allergy to melatonin Patient has a history of delirium/psychiatric/depression/on antidepressants Patient has a history of insomnia/ on sleep aid medication Anyone on warfarin Sleep apnea Patient discharged to SNF or rehab Patients who have inflammatory conditions Shift work or night work

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Placebo Tablet | Drug: Placebo<br>* Patient given 6 weeks of placebo tablet<br>|
| Active Comparator: Group 2<br>Melatonin (6mg) | Drug: melatonin 6mg<br>* 6 weeks of melatonin (6mg) given to patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Sleep Quality | Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires | 6 weeks |
Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid

Study Overview
=================
Brief Summary
-----------------
A prospective monitoring study for those individuals treated with Paxlovid

Detailed Description
-----------------
The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care. The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform. The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.

Official Title
-----------------
Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Covid positive Qualified for Paxlovid prescription (treatment decision already made prior to enrollment) Exclusion Criteria: Non-english speaking Resides outside of the United States

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paxlovid Cohort<br>Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 1 will include 400 participants that opt to take the 5-day course of Paxlovid. Participation will look identical in this study. | |
| Control Cohort<br>Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 2, control, will include 400 participants that opt out of taking the 5-day course of Paxlovid. Participation will look identical in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paxlovid Rebound | Incidence of paxlovid rebound defined as test positivity after a documented negative rapid antigen test post 5 day course of Paxlovid | 16 day period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paxlovid, Rebound, COVID-19