linjc16/ctgov huggingface dataset:
Comparative Atorvastatin Pleiotropic Effects

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.

Official Title
-----------------
A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis

Conditions
-----------------
Coronary Arteriosclerosis, Hypercholesterolemia

Intervention / Treatment
-----------------
* Procedure: Blood samples
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects of age of majority to < 80 years Subjects with LDL-C > 0.5 g/L (1.29 mmol/L) and < 1.5 g/L (3.87 mmol/L), TG < 4.00 g/L (4.56 mmol/L) and hs-CRP >1.5 mg/L and < 15 mg/L Subjects with a documented coronary artery disease. Exclusion Criteria: Female subjects of childbearing potential without contraception Subjects with secondary hyperlipidemia Diabetic subjects receiving insulin Subjects with a contra-indication to statin therapy.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood samples|nan|
|Drug: Atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at |  |  |
Doxycycline for Lateral Epicondylalgia - RCT

Study Overview
=================
Brief Summary
-----------------
Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs. This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks. Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.

Conditions
-----------------
Lateral Epicondylalgia (Tennis Elbow)

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Pain at the lateral side of the elbow ≥8 weeks Local tenderness on palpation of the lateral epicondyle Pain on resisted extension of the wrist Exclusion Criteria: Rheumatic disorder History of fibromyalgia or generalised pain Elbow surgery (on the painful side) Active infection Glucocorticoid treatment during the duration of symtoms of epicondylalgia NSAID use within 1 w before presentation and during the study Pregnancy Taking drug that might interact with doxycycline

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |
| Experimental: Doxycycline<br>100 mg twice daily | Drug: Doxycycline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tendinopathy, tennis elbow, lateral epicondylitis, lateral epicondylalgia, MMP-inhibitor
The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment

Study Overview
=================
Brief Summary
-----------------
Efficacy of Ivermectin in larger doses in COVID-19 treatment

Detailed Description
-----------------
Clinical Study Evaluating the Efficacy of Ivermectin in higher doses in COVID-19 treatment

Official Title
-----------------
Clinical Study Evaluating the Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with covid 19 Exclusion Criteria: Allergy or side effects to treatment
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>Ivermectin alone in larger doses | Drug: Ivermectin<br>* ivermectin<br>|
| No Intervention: Standard treatment<br>Standard of care treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement or died | The number of patients with improvement or death | 1 month |
Ghnnam Excision Technique for Pilonidal Sinus

Study Overview
=================
Brief Summary
-----------------
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition

Detailed Description
-----------------
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing

Official Title
-----------------
Ghnnam Excision Technique for Pilonidal Sinus

Conditions
-----------------
Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate

Intervention / Treatment
-----------------
* Procedure: cyanoacrylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient with pilonidal sinus Exclusion Criteria: pilonidal abscess or sever acute inflammation
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: cyanoacrylate dressing,excesion<br>we excise the sinus tip then apply cyanoacrylate dressing and watch for healing | Procedure: cyanoacrylate<br>* excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing<br>* Other names: histoacryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of the sinus |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | no recurrence | 1 year | 
| wound infection | occurrence of wound sepsis | 3-6 months | 
| patient satisfaction | patient satisfied with the procedure | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilonidal disease, Excision, cyanoacrylate
Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that ticagrelor may enhance endothelial healing after DES implantation by increasing adenosine concentrations by the inhibition of adenosine uptake into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal thickness) 3 months after DES implantation by optical coherence tomography (OCT)

Conditions
-----------------
Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina (Intermediate Coronary Syndrome)

Intervention / Treatment
-----------------
* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 20 years old Patients who are hospitalized and expected to undergo PCI for acute coronary syndrome, including acute myocardial infarction and unstable angina. Exclusion Criteria: Age > 80 years Cardiogenic shock or unstable patients Increased risk of bleeding, anemia, thrombocytopenia A need for oral anticoagulation therapy Pregnant women or women with potential childbearing Life expectancy < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor Arm<br>Ticagrelor Arm | Drug: Ticagrelor<br>* Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months<br>|
| Active Comparator: Clopidogrel Arm<br>Clopidogrel Arm | Drug: Clopidogrel<br>* Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent re-endothelialization | Percentage of stent coverage measured by OCT | Three months after stent implantation | 
| Neointimal hyperplasia | Neointimal thickness measured by OCT | Three months after stent implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ticagrelor, strut coverage, DES, ACS, OCT
Burning Mouth Syndrome Mouth Guard Prospective Study

Study Overview
=================
Brief Summary
-----------------
This study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.

Detailed Description
-----------------
The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for BMS.

Official Title
-----------------
Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)

Conditions
-----------------
Burning Mouth Syndrome, Burning Mouth

Intervention / Treatment
-----------------
* Device: Mouthguard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • New patients diagnosed with BMS seen in the oral medicine clinic for the study period. Exclusion criteria includes: • Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis Inclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS. | Device: Mouthguard<br>* The mouthguard is a thin clear acrylic protector fabricated from an impression of a patient's upper teeth and palate. The acrylic protector will be trimmed and will fit onto the patient's upper teeth and palate for use during the day, except when eating to minimize trauma to the tongue that exacerbates burning tongue pain.<br>|
| No Intervention: Control Group<br>Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in pain control | patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as no pain and 5 as excruciating pain | Baseline through 6 month |
Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for the first time. A further purpose is to ascertain and estimate the crude incidence rate of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.

Official Title
-----------------
A Pharmacoepidemiological Study to Examine Patient Characteristics, Drug Utilization Pattern and Crude Incidence Rates of Selected Outcomes in New Users of Ticagrelor, Clopidogrel and Prasugrel in National Swedish Registries

Conditions
-----------------
Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout

Intervention / Treatment
-----------------
* Drug: Risk of selected safety events


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time users of ticagrelor, clopidogrel and prasugrel, respectively Exclusion Criteria: Individuals with more than one of above three antiplatelet drugs dispensed the same day
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure Group 1<br>First time users of ticagrelor | Drug: Risk of selected safety events<br>* First time users of ticagrelor, clopidogrel and prasugrel, respectively<br>|
| Exposure Group 2<br>First time users of clopidogrel | Drug: Risk of selected safety events<br>* First time users of ticagrelor, clopidogrel and prasugrel, respectively<br>|
| Exposure Group 3<br>First time users of prasugrel | Drug: Risk of selected safety events<br>* First time users of ticagrelor, clopidogrel and prasugrel, respectively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization: Description of patient characteristics and drug usage |  | Up to one year after entry into study cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up of safety outcomes: First occurrence of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout |  | Up to one year after entry into study cohort. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, thienopyridine, epidemiology
PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.

Official Title
-----------------
A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function

Conditions
-----------------
Hepatic Impairment, Healthy

Intervention / Treatment
-----------------
* Drug: sotagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female subjects ≥18 to ≤70 years of age Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening Subjects with mild, moderate, or severe hepatic impairment Control group of matched healthy subjects Willing and able to provide written informed consent Exclusion Criteria: Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin History of any major surgery within 6 months History of renal disease, or significantly abnormal kidney function test Women who are breastfeeding or are planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>healthy control subjects with normal hepatic function | Drug: sotagliflozin<br>* single 400 mg dose<br>|
| Experimental: Group 2<br>subjects with mild hepatic impairment | Drug: sotagliflozin<br>* single 400 mg dose<br>|
| Experimental: Group 3<br>subjects with moderate hepatic impairment | Drug: sotagliflozin<br>* single 400 mg dose<br>|
| Experimental: Group 4<br>subjects with severe hepatic impairment | Drug: sotagliflozin<br>* single 400 mg dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters |  | Day 1 to Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events |  | Day 1 to Day 8 |
Hyperopia Detection GCK With Glow Fixation

Study Overview
=================
Brief Summary
-----------------
GoCheck Kids has added to its iPhone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. In pediatric eye patients, the GCK with glow box is compared to cycloplegic refraction as well as School Bus Accommodation-relaxing skiascopy, 2WIN photoscreener and Retinomax.

Detailed Description
-----------------
Patients undergoing comprehensive pediatric eye exam were screened with GoCheck Kids iPhone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as Adaptica 2WIN photoscreener and Retinomax auto refraction all without drops before cycloplegia examination. Reason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted. Refractive amblyopia risk factors utilizing AAPOS 2003 and AAPOS 2013 uniform guidelines were used to validate each screening method. Patients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.

Official Title
-----------------
Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

Conditions
-----------------
Amblyopia Bilateral, Hyperopia of Both Eyes, Astigmatism Bilateral, Accommodation Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: objective pediatric vision screen GCK glow fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having comprehensive pediatric eye examination Exclusion Criteria: Patients with only one eye

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GCK Glow fixation<br>Patients screened with GoCheck Kids flash concentrated iPhone 7+ | Diagnostic Test: objective pediatric vision screen GCK glow fixation<br>* 2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device<br>* Other names: objective pediatric vision screening GCK glow fixation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence | presence of refractive risk factors (anisometropia >1.50D, hyperopia > 3.5D, Astigmatism >1.50D, myopia more than 3D | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amblyopia | Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors. | 1 week |