linjc16/ctgov huggingface dataset:
Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.

Official Title
-----------------
An 8 Week Randomized, Placebo Controlled, Double-blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Tiotropium Bromide Inhalation Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of African descent 40 years of age or older Diagnosis of COPD History of smoking at least one pack per day for at least 10 years Currently experiencing shortness of breath at least with exertion Exclusion Criteria: Asthma Recent myocardial infarction or hospitalization for congestive heart failure

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Tiotropium Bromide Inhalation Powder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC0-3 after single dose, 4 weeks of treatment, peak FEV1 on each test day, trough FEV1 at weeks 4 & 8, FVC trough (weeks 4 & 8), peak and AUC(0-3) (on all test days), FEV1 and FVC at all time points, rescue albuterol use, dyspnea SOP questionnaire |  |  |
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs & symptoms of blepharitis and tear cytokine and eyelid bacterial load levels

Official Title
-----------------
A Multi-Center, Open-Label Study Evaluating the Cytokine and Eyelid Margin Bacterial Load Levels of Subjects Diagnosed With Chronic Blepharitis Following Dosing With AzaSite® (Azithromycin Ophthalmic Solution) 1%

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: AzaSite®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe chronic blepharitis If female of childbearing potential, are non-pregnant and non-lactating Exclusion Criteria: Had ocular surface surgery (LASIK, refractive, etc.) within the past year Unwilling to discontinue use of contact lenses during the study Have glaucoma Unable or unwilling to withhold the use of lid scrubs during the study Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance Currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AzaSite®<br>* Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for  26 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical signs and symptoms associated with blepharitis |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard ocular safety assessments |  | 4 weeks | 
| Change in tear cytokine and eyelid bacterial load levels |  | 4 Weeks |
Minor Increase Over Minimal Risk Research in NICU

Study Overview
=================
Brief Summary
-----------------
Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with more than minimal risk without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations. This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.

Official Title
-----------------
Minor Increase Over Minimal Risk Without Direct Patient Benefit Research in the NICU: Parental and Staff Perspectives

Conditions
-----------------
Infant, Premature, Infant, Late, Infant, Preterm, Infant

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of infants in the NICU Parents of infants on well-baby nursery NICU Staff (nurses and physicians) Exclusion Criteria: Non-English Speaking Less than 18 years old

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 |
| --- | --- |
| Staff<br>Staff nurses and physicians in the NICU | Other: Survey<br>* This was a survey<br>|
| Parents<br>Parents of infants in the NICU and a smaller group of parents of infants in the well baby nursery. | Other: Survey<br>* This was a survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of willingness to participate in research | This is a survey to determine attitudes / willingness to participate in a specific category of research. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
research, vulnerable population, 45 CFR 46.406
A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease and heart attacks are the leading cause of death in the UK. Our population is ageing. The number of older patients suffering heart attacks and having angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty, older patients (80 years of age or over) are at 5 times increased risk of death at one year compared to their predicted normal life expectancy. In addition, many patients present with further heart attacks, stroke and undergo repeat heart catheter test and angioplasty procedures. At present it is not clear who will or will not experience further problems in the future. The ability to predict who will and will not suffer future problems at the time of initial presentation can be helpful in providing additional treatment and close monitoring to those that are at risk of further problems. The ICON 1 study is set out to study just that. In this study, older patients will undergo a comprehensive evaluation of the cardiovascular disease burden by undergoing additional investigations. These results from each patient will be used to develop a risk score that will inform physicians of the patient's future risk of developing adverse events and provide a better understanding of how to manage older patients with coronary artery disease and also help plan future studies looking at treatment strategies that might be beneficial in improving outcomes.

Official Title
-----------------
ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Older patients (65+) presenting with ACS for coronary angiography will be recruited into this study. Exclusion criteria: Those presenting with cardiogenic shock, those with co-existing malignancy with life expectancy less than one year and those with evidence of active infection such as urinary tract infection, pneumonia, sepsis and any wound infection will also be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| ACS undergoing CA and PCI<br>Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding |  | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life SF 36, EQ 5D |  | 1 YEAR |
Nevanac 3-Month Safety Study With QID Dosing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Official Title
-----------------
A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery

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

Intervention / Treatment
-----------------
* Drug: Nepafenac ophthalmic solution 0.1%
* Drug: Ketorolac Tromethamine ophthalmic solution 0.4%
* Other: Nepafenac ophthalmic suspension vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 10 Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Nevanac<br> | Drug: Nepafenac ophthalmic solution 0.1%<br>* 1 drop 4 times daily for 90 days<br>|
| Active Comparator: Acular<br> | Drug: Ketorolac Tromethamine ophthalmic solution 0.4%<br>* 1 drop 4 times daily for 90 days<br>|
| Placebo Comparator: Vehicle<br> | Other: Nepafenac ophthalmic suspension vehicle<br> <br> * Other names: 1 drop 4 times daily for 14 days after surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters |  |  |
β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

Detailed Description
-----------------
Atypical antipsychotic drugs (AADs) induce weight gain, truncal adiposity and may engender a metabolic syndrome which may progress to IFG/IGT or DM. AADs effects in lean schizophrenic patients without metabolic syndrome are not documented, especially the relationship between weight gain and changes in insulin sensitivity (S), beta-cell function (β), and circulating adiponectin. We prospectively determined the outcome of 9-month therapy with AADs on anthropometrics, metabolism and adiponectin, including HOMA-modeling of S, β, and βxS (hyperbolic product, assessing individual β adjusted for S)in 36 schizophrenic subjects (M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1) aged 35±9 years (mean±1SD) free of MetS (NCEP-ATPIII).

Official Title
-----------------
Phase 1 Study of Insulin Sensitivity, Adjusted β-Cell Function and Adiponectin Among Lean Drug-naïve Schizophrenic Subjects Treated With Atypical Antipsychotic Drugs

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: quetiapine or olanzapine or risperidone or aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-55 years body mass index <25.0 kg/m² waist circumference <102 (men) and <88 cm (women) absence of a metabolic syndrome according to NCEP ATPIII criteria normoglycaemic (fasting plasma glucose levels <100 mg/dl) Exclusion Criteria: previous use of antipsychotic drugs concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| A<br>36 lean schizophrenic subjects free of metabolic syndrome(M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1)aged 35±9 years | Drug: quetiapine or olanzapine or risperidone or aripiprazole<br> <br> |

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
-----------------
antipsychotic drugs, schizophrenia, β-cell function, insulin resistance
Association of Epicardial Adipose Tissue Volume Axnd Radiodensity With Coronary Artery Calcification in Patients With HFpEF

Study Overview
=================
Brief Summary
-----------------
Recruiting patients who were diagnosed with HFpEF. Using Non-contrast CT to measure the total Agatston coronary artery calcification score, epicardial adipose tissue volume and attenuation. Analysing the correlation between them.

Detailed Description
-----------------
The study enrolled patients who were diagnosed with HFpEF and admitted to the Cardiology Department of the First Affiliated Hospital of Chongqing Medical University. Using Non-contrast CT to measure the total Agatston coronary artery calcification score, epicardial adipose tissue volume and attenuation. Finally, analysing the correlation between them.

Official Title
-----------------
Association of Epicardial Adipose Tissue Volume Axnd Radiodensity With Coronary Artery Calcification in Patients With HFpEF

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typical symptoms and signs of heart failure Left ventricular ejection fraction≥50% HFA-PEFF score≥5 Exclusion Criteria: severe myocarditis, malignant tumors, liver or renal insufficiency, severe valvular heart disease, and received a bypass surgery or other open-heart surgery

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Association of epicardial adipose tissue volume axnd radiodensity with coronary artery calcification in Patients with HFpEF | Using SPSS software to analysis the relationship of epicardial adipose tissue volume axnd radiodensity with coronary artery calcification in Patients with HFpEF | 2022.09 |
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see if a low glycemic index diet will reduce blood sugar levels in pregnant women with high blood sugar levels.

Detailed Description
-----------------
Women with gestational hyperglycemia, including women with gestational diabetes and impaired glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience better blood glucose control thereby decreasing the risk associated complication(s).

Official Title
-----------------
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Behavioral: Control diet
* Behavioral: Low GI diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with gestational hyperglycemia age between 18 and 45 inclusive willing and able to comply with protocol Exclusion Criteria: <18 or >45 years of age other chronic or acute illness which affects carbohydrate metabolism known multiple pregnancy >34 weeks gestation language barrier (no translator available)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Control diet|nan|
|Behavioral: Low GI diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum glucose |  | Baseline and 4 weeks | 
| A1c |  | Baseline and 4 weeks | 
| Self-blood-glucose-monitoring results |  | daily until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal weight gain throughout pregnancy |  | weekly | 
| number of individuals who receive insulin treatment while participating in the study |  | duration of pregnancy | 
| latency to insulin requirement/ gestational age when prescribed insulin |  | duration of pregnancy | 
| dosage and frequency of insulin |  | duration of pregnancy | 
| ultrasound measurements (if available) |  | according to clinical practice | 
| fasting lipids |  | Baseline and 4 weeks | 
| fasting c-reactive protein |  | Baseline and 4 weeks | 
| infant birth weight |  | at birth | 
| infant blood glucose |  | at birth | 
| infant plasma calcium |  | at birth | 
| infant bilirubin at birth obtained via heel prick |  | at birth | 
| birth complications |  | at birth | 
| perceptions of educational materials |  |  | 
| perceptions of diet treatments |  |  |