linjc16/ctgov huggingface dataset:
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

Detailed Description
-----------------
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.

Official Title
-----------------
An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo

Conditions
-----------------
Skin Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: SB-275833 ointment, 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Must have primary impetigo with total lesion area being 100 square centimeters or less. Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures. Exclusion Criteria: Any signs and symptoms of systemic infection. Any serious underlying disease that could be imminently life threatening.

Ages Eligible for Study
-----------------
Minimum Age: 9 Months

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-275833 ointment, 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. |  | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits. |  | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical antibacterial, topical antibiotic, impetigo
Increased Tea Consumption is Associated With a Decreased Risk of Renal Stone Disease in a Taiwanese Population

Study Overview
=================
Brief Summary
-----------------
The objective of the this study was to examine the amount and duration of tea consumption in relation to the risk of renal stone disease.

Detailed Description
-----------------
Previous studies have investigated the association between tea consumption and renal stone disease, but the results are still unclear. Besides, the impact of the duration of tea consumption has not yet been investigated in the aforementioned studies. The present study was conducted as a retrospective research to investigate the relationship between both tea consumption amount and time and renal stone disease. Information on tea consumption was obtained by four closed-ended questions in questionnaires, and the diagnosis of renal stones was established on the results of abdominal sonography.

Official Title
-----------------
Increased Amount and Time of Tea Consumption is Associated With a Decreased Risk of Renal Stone Disease in a Taiwanese Population

Conditions
-----------------
Renal Stone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Exclusion Criteria: individuals with a history of hyperuricemia or gout at baseline, findings of abdominal ultrasound showing transplant kidney, only one kidney, or gouty nephropathy, or missing data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 stone diseases | The diagnosis of renal stones was established on the results of abdominal sonography | health check-ups from June 2001 to August 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tea, cup-year, renal stone disease
The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)

Study Overview
=================
Brief Summary
-----------------
1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.

Detailed Description
-----------------
Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.

Official Title
-----------------
Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent, The e-CYPHER(SM)S.T.L.L.R., Registry [Study of Deployment Technique on Clinical Results]

Conditions
-----------------
Coronary Stenosis

Intervention / Treatment
-----------------
* Device: CYPHER® Bx Velocity™ stent (sirolimus-eluting)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of de novo stenosis in major coronary artery Can be treated with stents Candidate for bypass Exclusion criteria: Recent, severe MI Prior brachytherapy Impaired left ventricle function Heart transplant recipient Impaired renal function Disease in vein grafts from previous bypass Similar treatment within the last 30 days

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 |
| --- |
|Device: CYPHER® Bx Velocity™ stent (sirolimus-eluting)|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
-----------------
myocardial ischemia, coronary disease, heart disease, Coronary Stenosis [MeSH heading: C14.280.647.250.285]
Speech-based Digital Biomarker for Psychiatric Disease

Study Overview
=================
Brief Summary
-----------------
The general objectives of this study are to build a proof-of-concept, speech-based, digital biomarker for identifying the presence and tracking the severity of psychiatric disease.

Detailed Description
-----------------
The purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high frequency test administration. Participants will complete a variety of speech and language tasks using the Winterlight Assessment (iOS app) everyday for 30 days. The following is the list of assessments that participants will complete; 1) Daily assessment of mood, 2) Winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) Clinical assessments.

Official Title
-----------------
Preclinical Development of a Speech-based Digital Biomarker for Psychiatric Disease

Conditions
-----------------
Speech, Psychiatric Disorder, Language

Intervention / Treatment
-----------------
* Other: Winterlight Apps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female adults aged 18 to 95. English as a first language, or English as a second language with conversational proficiency. Own an iOS device (iPhone or iPad) and willing to install the study app. A reliable (cellular or WiFi) home internet connection and accessible email address Exclusion Criteria: Residence outside of Canada or the United States. Clinically significant vision impairment (corrected vision is acceptable). Clinically significant hearing impairment (use of hearing aids is acceptable)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| General<br>Participants with or without psychiatric disorders | Other: Winterlight Apps<br>* Longitudinal speech recordings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech recordings | 500+ features to be extracted from each recording | Everyday for 30 business days until study completion, about 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scores | Depression and depression like scores to be collected through surveys | Everyday for 30 business days until study completion, about 2 years |
Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.

Study Overview
=================
Brief Summary
-----------------
Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate. Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.

Detailed Description
-----------------
Data collection by return to the patient record: Clinical score Analysis of imagery (X-rays, CT scan, ) The patients included were those who had undergone arthrodesis of the medial Lisfranc joint

Official Title
-----------------
Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.

Conditions
-----------------
Arthritis Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in Age > 18 ans Exclusion Criteria: Follow-up < 6 months Lost to follow-up lack of data in the patient record.

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 |
| --- | --- |
| Study population<br>Population who underwent a surgical arthrodesis procedure for arthritic or inflammatory involvement of the Lisfranc tarsometatarsal joint | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of the AOFAS score of the midfoot | AOFAS Score | 1 year post surgery |
Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient

Study Overview
=================
Brief Summary
-----------------
The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.

Official Title
-----------------
Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient

Conditions
-----------------
Cognitive Decline, Cognitive Change, Cognitive Impairment, Postoperative Delirium, Anesthesia; Reaction, Anesthesia; Adverse Effect

Intervention / Treatment
-----------------
* Combination Product: Neurocognition Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 65 years old (inclusive) Non cardiac general elective surgery General anesthesia is expected for 2+ hours Exclusion Criteria: Alzheimer's Dementia Parkinson's History of neurodegenerative diseases Medication for depression (ie. Benzodiazepines) Alcoholism Discretion of PI

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 |
| --- | --- |
| Neurocognitive Assessment Arm<br> | Combination Product: Neurocognition Interventions<br>* EEG, Neurocognitive Battery Testing, and Immune Profiles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Neurocognitive Disorders | Neurocognitive Assessment Battery | 3 years |
Efficacy of Zoledronic Acid in Osteoporosis

Study Overview
=================
Brief Summary
-----------------
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

Official Title
-----------------
Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid, Reclast®
* Drug: Zoledronic acid, Reclast® and active vitamin D, alfacalcidol®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients who want to take zoledronic acid Exclusion Criteria: Patients who are allergic to zoledronic acid or vitamin D Patients who are pregnant or breast-feeding Patients who have not taken zoledronic acid for the last 2 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ZA alone<br> | Drug: Zoledronic acid, Reclast®<br>* To examine the efficacy of zoledronic acid in osteoporosis<br>|
| Active Comparator: ZA plus VD<br> | Drug: Zoledronic acid, Reclast® and active vitamin D, alfacalcidol®<br>* To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | Change from Baseline Values at 1 year |
Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2

Study Overview
=================
Brief Summary
-----------------
Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.

Detailed Description
-----------------
Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed. The first objective is to compare the seroconversion rate after full vaccination against SARS-COV2 in patients with IBD treated with anti-TNF drugs versus patients treated with Ustekinumab / Vedolizumab and patients without immunosuppressive treatment. The Patients included in the study belong to the health area of the Virgen Macarena University Hospital who meet the following inclusion criteria and none for exclusion.

Official Title
-----------------
Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be of legal age (> 18 years). Diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis). Complete vaccination schedule (one or two doses depending on previous SARS-Cov2 infection) between one and four months prior to the determination of anti-SARS-Cov2 antibodies. Treatment with biological therapy for at least 6 weeks prior to the time of vaccination for the group of patients treated with biological drugs. Exclusion Criteria: Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients diagnosed with inflammatory bowel disease with the complete vaccination regimen. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with peripheral blood antibodies against SARS-COV2. | Seroconversion rate against SARS-COV2 defined as the presence of antibodies in peripheral blood four months after the complete vaccination schedule against SARS-COV2. | Up to 16 weeks. |
Pseudodrynaria Coronana (Wall) Ching

Study Overview
=================
Brief Summary
-----------------
The Study to evaluate the clinical effect of Gusuibu lasts for 3 years. It aims to evaluate its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver, kidney and the hematological influence will be evaluated, too.

Detailed Description
-----------------
Research of the this traditional chinese medicine clinucal, Gusuibu, curative effect is plan three years time. The entire studyaims to evaluated the effect of the traditional chinese medicine on postmenpausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal woman with established osteoporosis.

Official Title
-----------------
Clinical Effect of Traditional Chinese Medicine - Gusuibu

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: GUSUIBU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal osteoporosis Exclusion Criteria: Insulin dependent diabetes

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GUSUIBU|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year |  |  |
Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and intravitreal triamcinolone for neovascular AMD.

Conditions
-----------------
Neovascular Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: verteporfin, bevacizumab, triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of active neovascular AMD with visual acuity of 20/400- 20/40 Exclusion Criteria: History of glaucoma or ocular hypertension Disciform scar

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: verteporfin, bevacizumab, triamcinolone acetonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness |  |  | 
| Leakage in fluorescein angiography |  |  | 
| Intraocular pressure |  |  | 
| Anterior chamber reaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photodynamic therapy,, Bevacizumab,, Triamcinolone,, Age-related macular degeneration,, Choroidal neovascular membrane