linjc16/ctgov huggingface dataset:
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.

Official Title
-----------------
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

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

Intervention / Treatment
-----------------
* Drug: Methacholine Chloride (SK-1211)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bronchial asthma FEV1/FVC must be 70% or more <10% decrease in FEV1 in response to inhalation of normal saline Exclusion Criteria: Moderate or severe airflow limitation（FEV1<60% predicted） Heart attack or stroke in last 3 months Uncontrolled hypertension, systolic BP>200, or diastolic BP>100 known aortic aneurysm

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methacholine Chloride<br>children with bronchial asthma | Drug: Methacholine Chloride (SK-1211)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL | The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20. | Visit 1 (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation |  | Visit 1 (Day 1) | 
| The Summary Statistics of PC20 | PC20 : the concentration of methacholine causing 20% fall in FEV1. | Visit 1 (Day 1) |
Management of Atrial Fibrillation With Flecainide : the AFFLEC Study

Study Overview
=================
Brief Summary
-----------------
This is a multicentre non interventional observational study with the objective to follow up patients with atrial fibrillation who based on current indications are treated with per os flecainide , for cardiac pulse maintenance.

Detailed Description
-----------------
the study objectives are record safety and efficiency of flecainide as antiarrythmic treatment in atrial fibrillation study of flecainide in ST interval

Official Title
-----------------
Multicentre Non Interventional Study in the Management of Atrial Fibrillation With Flecainide

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with history of atrial fibrillation patients able to give informed consent Exclusion Criteria: patients with coronary disease or other cardiopathy with left heart champer affected

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST interval and repolarization measures of myocardia in patients under treatment of flecainide |  | 6months |
Botulinum Toxin Injection to Prevent VT Storm

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT Storm.

Official Title
-----------------
Endomyocardial Botulinum Toxin Injection Can Decrease the Number of Episodes of VT Storm: Pilot Study

Conditions
-----------------
VT Storm

Intervention / Treatment
-----------------
* Drug: BT injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 or more episodes of ventricular tachycardia within 24 hours Exclusion Criteria: Failure to provide informed consent. Non-cardiac illness with a life expectancy of less than 3 year Non-cardiac illness imposing substantial operative mortality Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT injection<br> | Drug: BT injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of episodes of VT Storm |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious adverse events |  | 1 year |
The Expecting Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.

Official Title
-----------------
Prenatal Physical Activity Intervention

Conditions
-----------------
Obese, Pregnancy

Intervention / Treatment
-----------------
* Other: Exercise Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 >18 years of age Singleton pregnancy Less than 12 weeks gestation Sedentary Conceived without assisted fertility treatments Cleared by physician to exercise Exclusion Criteria: Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest Women who are using recreational drugs, tobacco, or alcohol during pregnancy Women with contraindications to exercise during pregnancy

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

Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| No Intervention: Control<br>Standard of care | |
| Experimental: Intervention<br>Exercise intervention from 12 week gestation until delivery | Other: Exercise Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of obesity in infants and children | Birth weight, body fat, and metabolism will be evaluated during the first 2 years of life. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal insulin sensitivity | Fasted blood samples will be analyzed to assess glucose and insulin. | 9 months | 
| Maternal inflammation | Markers of inflammation will be investigated in fasted serum samples. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, obese
A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

Study Overview
=================
Brief Summary
-----------------
Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.

Official Title
-----------------
A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: MK0966; rofecoxib
* Drug: Comparator: diclofenac, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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

| Intervention/Treatment |
| --- |
|Drug: MK0966; rofecoxib|nan|
|Drug: Comparator: diclofenac, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during daily activities assessed by a Numerical Rating Score (NRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional impairment evaluated using Neer's functional index. |  |  | 
| Global assessment of disease activity by the patient with a NRS. |  |  | 
| Intensity of night pain evaluated by NRS. |  |  | 
| Rescue treatment take during the study duration. |  |  |
A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

Study Overview
=================
Brief Summary
-----------------
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

Official Title
-----------------
A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks

Conditions
-----------------
Hereditary Angioedema (HAE)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All patients must: Have a diagnosis of HAE and be receiving CINRYZE for prevention or treatment of angioedema attacks Provide written informed consent/assent in compliance with applicable country-specific and local regulations Exclusion Criteria All patients must not: Be receiving CINRYZE in an investigational study Be receiving another HAE therapy as part of a clinical trial
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 adverse drug reactions |  | 12 months | 
| Incidence of thrombotic/thromboembolic events |  | 12 months | 
| Occurrence of pregnancy |  | 12 months |
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),

Detailed Description
-----------------
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Official Title
-----------------
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1

Conditions
-----------------
Primary Hyperoxaluria

Intervention / Treatment
-----------------
* Drug: Lumasiran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of Primary Hyperoxaluria Type 1 Exclusion Criteria: Clinically significant health concerns (with the exception of PH1) Received an investigational agent within 30 days before the first dose of lumasiran or are in follow-up of another clinical study Previously or currently participating in lumasiran clinical study History of liver transplant
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lumasiran|Lumasiran administered as a subcutaneous (SC) injection|

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
-----------------
Hyperoxaluria, Primary Hyperoxaluria, Kidney Diseases, Urologic Diseases, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases, RNA Therapeutic, siRNA
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Goal: To define the causes and issues associated with nonadherence in our population Hypothesis: There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients Methods: A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence. A brief review of demographics and pertinent laboratory information at the same encounter

Detailed Description
-----------------
Objectives: To determine the prevalence of nonadherence in our population To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia) Methods: A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence A brief review of demographics and pertinent laboratory information at the same encounter

Official Title
-----------------
Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate

Conditions
-----------------
Kidney Transplantation, Treatment Refusal, Patient Compliance

Intervention / Treatment
-----------------
* Behavioral: Adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All renal transplant recipients with a working transplant who are currently attending the transplant clinic and who have been transplanted 6 months to 4.5 years ago are eligible. Patients are recruited at random from the transplant clinic waiting area Exclusion Criteria: Less than 6 months post-transplant More than 4.5 years post transplant

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

| Intervention/Treatment |
| --- |
|Behavioral: Adherence|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
-----------------
renal transplant recipient, adherence, compliance, immunosuppression
Sacro-Spinous Ligaments Anterior Apical Anchoring

Study Overview
=================
Brief Summary
-----------------
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

Detailed Description
-----------------
Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Official Title
-----------------
Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Anterior Sacro-Spinous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvic Floor Prolapse > Gr 2, Anterior > Posterior defect, Apical Supportive Defect Exclusion Criteria: Active Pelvic Inflammation, Patient Refusal

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior Sacro-Spinous Support<br>Anterior sacro-spinous mesh implants supported patients | Procedure: Anterior Sacro-Spinous<br>* Anterior Sacro-Spinous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change With Distance Between the Vaginal Apex and the Introitus | The change with distance measured by centimeters, between the vaginal apex and the introitus | One year | 
| Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring | Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening. | one year | 
| Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure | Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure. | one year |
Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study

Study Overview
=================
Brief Summary
-----------------
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.

Official Title
-----------------
Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Other: diabetic retinopathy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1 or type 2 diabetes mellitus Ages 18 and above Male and female Exclusion Criteria: Persistent visual impairment in one or both eyes; Subjects with corneal opacities and advanced cataract. History of retinal vascular (vein or artery) occlusion; Subject is contraindicated for fundus photography (for example, has light sensitivity); Subject is currently enrolled in an interventional study of an investigational device or drug; Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.

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

| Intervention/Treatment |
| --- |
|Other: diabetic retinopathy|This is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater) |  | 3 months | 
| Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater) |  | 3 months |