linjc16/ctgov huggingface dataset:
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Flavoxate Hydrochloride Tablets, 100mg
* Drug: Urispas® Tablets, 100mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening Exclusion Criteria: Positive test results for HIV or Hepatitis B or C History of allergy or sensitivity to Flavoxate hydrochloride or related drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavoxate Hydrochloride Tablets, 100mg<br> | Drug: Flavoxate Hydrochloride Tablets, 100mg<br> <br> |
| Active Comparator: Urispas® Tablets, 100mg<br> | Drug: Urispas® Tablets, 100mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  |  |
NHF vs. COT in Hypoxemic Pandemic Viral Illness

Study Overview
=================
Brief Summary
-----------------
The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.

Official Title
-----------------
Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness

Conditions
-----------------
Acute Viral Bronchitis, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Standard oxygen
* Device: Nasal high-flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute hyperemic viral illness acute hyperemic or hypercapnia respiratory failure Exclusion Criteria: intubation criteria indication for NIV therapy influences of primary endpoint (rip fracture, lung embolism) tracheostomy other interventional trials noncompliance

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 |
| --- | --- |
| Active Comparator: Oxygen use<br>Patients will use standard oxygen via face mask of nasal prongs as usual care. | Device: Standard oxygen<br>* COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).<br>* Other names: COT;|
| Experimental: NHF use<br>Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow. | Device: Nasal high-flow<br>* F is combination of room air supplemented with oxygen can be better patients. This gas mixture will be provided to the patient with a specialized nasal prong.<br>* Other names: NHF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rox index | (SpO2/FiO2)/RR = index without a unit, mean Rox-index in the two groups, comparison between the groups (significant differences), physiological parameter, to assess differences between the two groups | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| paCO2 in mmHg | physiological parameter, to assess differences between the two groups | 72 hours | 
| pH | physiological parameter, to assess differences between the two groups | 72 hours | 
| escalation of therapy | use of noninvasive ventilation, intubation, to assess differences between the two groups | 72 hours | 
| paO2 in mmHg | physiological parameter, to assess differences between the two groups | 72 hours |
Lamina Cribrosa Depth Change With Change in Eye Pressure

Study Overview
=================
Brief Summary
-----------------
This is a study of the compliance of the lamina cribrosa with change in eye pressure.

Detailed Description
-----------------
Glaucoma patients and control subjects will have their internal eye structure (lamina cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye pressures. In some participants, the eye pressure will be changed by one of two interventions, wearing goggles or having laser suturelysis

Official Title
-----------------
Lamina Cribrosa Depth Change With Change in Eye Pressure

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Other: wearing swimming goggles or having laser suturelysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons who consent to drink water and be imaged Exclusion Criteria: non-consenting persons those who cannot be imaged

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: persons drinking water<br>all persons in the study will have images of the eye at baseline eye pressure, then the intervention will be to drink 2 bottles of water to increase eye pressure or decrease eye pressure, then will have images taken a second time | Other: wearing swimming goggles or having laser suturelysis<br>* Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anterior lamina cribrosa depth | OCT position of lamina measured at 2 eye pressures. Data will be calculated as change in parameters of interest per mm Hg change in eye pressure | Up to 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker
IOP Measurements Using ORA After ACXL in Keratoconus

Study Overview
=================
Brief Summary
-----------------
The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.

Official Title
-----------------
Intraocular Pressure Measurements Using Ocular Response Analyzer After Accelerated Corneal Collagen Crosslinking With Riboflavin and Ultraviolet A in Keratoconus

Conditions
-----------------
IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)

Intervention / Treatment
-----------------
* Diagnostic Test: IOP Measurment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: KC patient indicated for CXL Exclusion Criteria: Advanced KC Glaucoma patients

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: IOP Measurment|To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine IOP readings before and after accelerated corneal collagen crosslinking |  | April-October 2020 |
Sun Protection Factor Assay (SPF Assay 19009)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-034)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Alternations of Intestinal Microbiota and Health Impact in CKD

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.

Official Title
-----------------
Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CKD stage 3-5 defined as eGFR <60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy. Exclusion Criteria: Patients with active cancer Patients with liver cirrhosis Patients have taken antibiotics within three months before screening for inclusion. Patients with a cardiac pacemaker or metallic implants, Patients are amputees Pregnant women Patients with inherited renal diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal outcome | a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation | 3-year follow-up | 
| cardiovascular outcome | a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke | 3-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | CV death or non-CV death | 3-year follow-up | 
| neurological outcome | the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years | 3-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body composition, chronic kidney disease, dietary pattern, gut microbiot
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)

Study Overview
=================
Brief Summary
-----------------
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.

Official Title
-----------------
A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.

Conditions
-----------------
Foot Infections in Diabetic Patients

Intervention / Treatment
-----------------
* Drug: MK0826, ertapenem sodium / Duration of Treatment - 24 weeks
* Drug: Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 Diabetes Mellitus treated with diet or medication Clinically or microbiologically documented foot infection below the knee Osteomyelitic bone must be removed within 48 hours of study entry Exclusion Criteria: Uncomplicated skin infections Infected burn wounds Necrotizing fascitis Wounds with gangrene that cannot be removed with debridement Infections of prosthetic materials Foreign materials that can not be removed by surgical debridement Patients with another antibiotic 3 days prior to enrollment without evidence of treatment failure and presence of a positive culture Insufficient blood flow to the limb requiring a revascularization procedure

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826, ertapenem sodium / Duration of Treatment - 24 weeks|nan|
|Drug: Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure/Improvement at discontinuation of IV antibiotic therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy. |  |  |
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Study Overview
=================
Brief Summary
-----------------
An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye

Official Title
-----------------
A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens

Conditions
-----------------
Visual Outcomes

Intervention / Treatment
-----------------
* Device: Acrysof ReSTOR multifocal IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int Exclusion Criteria: Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Acrysof ReSTOR multifocal IOL | Device: Acrysof ReSTOR multifocal IOL<br>* Implanted into the study eye following cataract extraction surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near,intermediate,distance visual acuity |  | pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast sensitivity |  | 6 month after 2nd eye surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical, assessment, of visual, function, with the Acrysof ReSTOR, multifocal IOL
Genotype Information and Functional Testing Study

Study Overview
=================
Brief Summary
-----------------
This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

Detailed Description
-----------------
AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

Official Title
-----------------
GIFT: Genotype Information and Functional Testing Study

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination Exclusion Criteria: See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GRAVITAS Study Arm A<br>Tailored clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months | |
| GRAVITAS Study Arm B<br>Standard clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months. | |
| GRAVITAS Study Arm C<br>Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual platelet reactivity | Outcome 1 is residual platelet reactivity the measurement | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thienopyridine, platelets, CYP2C19, clopidogrel, platelet function tests, platelet, genes, cytochrome P450, single nucleotide polymorphisms, Platelet Aggregation Inhibitors
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE). (Arixtra is a trademark of the GlaxoSmithKline group of companies.)

Official Title
-----------------
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Conditions
-----------------
Ataxia

Intervention / Treatment
-----------------
* Drug: Fondaparinux Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute pulmonary thromboembolism or acute deep venous thrombosis Fondaparinux injection must be prescribed for the first time Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed fondaparinux<br> | Drug: Fondaparinux Sodium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reaction |  | 3 months | 
| Number of patients with any serious adverse event |  | 3 months | 
| Number of patients with any hemorrhagic adverse event |  | 3 months | 
| Presence or absence of reoccurrence of VTE |  | 3 months |