linjc16/ctgov huggingface dataset:
Long-term Observational Study to Evalution the Safety and Efficacy of FURESTEM-AD Inj.

Study Overview
=================
Brief Summary
-----------------
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis

Detailed Description
-----------------
This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.

Official Title
-----------------
Observational Study to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Moderate to Severe Atopic Dermatitis Patients Who Participated in Phase 1/2a Clinical Trial of FURESTEM-AD Lnj.

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] Subject who understands and voluntarily sign an informed consent form Exclusion Criteria: In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| Not applicable-observational study<br>Not applicable-observational study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number of adverse events Safety of FURESTEM-AD Inj. | The severity of each adverse enent was classified according to CTCAE v4.0 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline |  | 3 years | 
| Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value |  | 3 years | 
| Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point |  | 3 years | 
| Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value |  | 3 years | 
| Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FURESTEM-AD Inj., Stem cells
COVID-19 Effectiveness Study in the Philippines

Study Overview
=================
Brief Summary
-----------------
This is a multi-site, observational, prospective test negative design case-control study which primarily aims to determine the protective effectiveness of 2 doses of an inactivated COVID-19 vaccine at least 14 days after the second dose, against hospitalized virologically-confirmed SARS-CoV-2 infection.

Official Title
-----------------
A Multicenter Study to Assess the Effectiveness of an Inactivated COVID-19 Vaccine Against Hospitalized COVID-19

Conditions
-----------------
COVID-19, Vaccine Effectiveness Against COVID-19, Hospitalized COVID-19

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. Aged 18 years of age and above Residing in the catchment area of the participating hospital Admitted to the participating hospital with an acute respiratory illness Able and willing to provide a naso- and oro-pharyngeal swab for RT-PCR testing Exclusion Criteria: 6.2.2.1 Refusal to participate

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 |
| --- | --- |
| Case<br>A COVID-19 confirmed case is a patient with an acute respiratory illness and RT-PCR confirmation of SARS-CoV-2 infection (i.e. any positive RT-PCR results obtained prior to admission or after enrolment in the study). In case the patient has any inconsistent RT-PCR results (e.g. a positive followed by a negative or a negative followed by a positive result), he/s he/she will be considered as a COVID-19 confirmed case if he/she has at least one positive result during his/her illness under consideration. | Other: no intervention<br>* no intervention<br>|
| Test-negative control<br>A COVID-19 negative case is a patient with an acute respiratory illness, in whom all RT-PCR tests are negative for SARS-CoV-2 | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalized virologically-confirmed SARS-CoV-2 infection |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Vaccine effectiveness, hospitalized COVID-19, inactivated COVID-19 vaccine
Genetic Basis of Rosacea Study (Control)

Study Overview
=================
Brief Summary
-----------------
Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.

Official Title
-----------------
Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Other: Skin Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Fitzpatrick skin type II or III Age greater than or equal to 18 years Individuals without a history of rosacea Exclusion criteria include: Women who are pregnant or lactating Use of topical prescription medications or procedures to the face within one month of enrollment Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Participants who do not have rosacea (control group) | Other: Skin Biopsy<br>* Skin biopsies will be performed via the Keys punch technique from normal facial skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea. |  | Up to 2 years |
Colchicine in Coronary Artery Bypass Graft (CABG)

Study Overview
=================
Brief Summary
-----------------
There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.

Official Title
-----------------
Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage

Conditions
-----------------
Elective Coronary Artery Bypass Graft Surgery

Intervention / Treatment
-----------------
* Drug: Colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery. Exclusion Criteria: Excluded are patients: with age > 80 years old scheduled for concomitant valve surgery scheduled for coronary surgery without cardiopulmonary bypass with peripheral vascular disease aﬀecting the upper limbs with acute coronary syndrome within the previous 4 weeks on inotropic or mechanical circulatory support before induction of anaesthesia with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks) with active inflammatory diseases, infectious diseases or known malignancy under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents with known hypersensitivity-allergy to colchicine under chronic treatment with colchicine with severe renal failure (eGFR < 35 ml/min/1.73 m2) with hepatic failure (Child - Pugh class B or C)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients taking placebo | |
| Experimental: Colchicine<br>Active treatment group | Drug: Colchicine<br>* colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial damage marker levels |  | Days 1-2 post-CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | At one and at six months after CABG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reperfusion damage
Effect of Lutein in S-26 Gold On Growth And Safety

Study Overview
=================
Brief Summary
-----------------
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.

Official Title
-----------------
Effect of Lutein in S-26 Gold on Growth and Safety

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

Intervention / Treatment
-----------------
* Other: Lutein fortification
* Other: Standard formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants aged 0-14 days Full Term birth and AGA Parent(s) signed informed consent Exclusion Criteria: Unhealthy infant Participation in other clinical trial Use of prohibited medications

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental=Standard formula with lutein added to the formula | Other: Lutein fortification<br> <br> |
| Active Comparator: 2<br>Active Comparator=Standard formula | Other: Standard formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain/day in grams/day |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of adverse experiences |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effect of lutein fortification growth healthy term infants
Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Official Title
-----------------
Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures

Intervention / Treatment
-----------------
* Drug: Rivaroxaban
* Drug: Enoxaparin
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA Exclusion Criteria: recent history of active bleeding or VTE known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline myocardial infarction or cerebrovascular accident within three months of the scheduled surgery major surgery in the prior three months renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned indwelling epidural catheter for > 6 hours after the end of surgery

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral direct Factor Xa inhibitor<br>Rivaroxaban | Drug: Rivaroxaban<br>* Rivaroxaban was taken orally in a dosage of 10mg once daily<br>|
| Active Comparator: Low molecular weight heparin<br>Enoxaparin | Drug: Enoxaparin<br>* Enoxaparin was injected subcutaneously in a dosage of 40mg once daily<br>|
| Placebo Comparator: Normal Saline<br>Normal Saline | Other: Normal saline<br>* subcutaneous injection of 1 cc of normal saline once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major wound complication | hematoma : size, site woozing : frequency, amount, dressing change count infection : culture | 2 weeks |
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

Detailed Description
-----------------
To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.

Official Title
-----------------
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Pomegranate juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 healthy men aged 18-40 normal sperm counts Exclusion Criteria: History of undescended testes or surgery to the scrotal contents, History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study No alpha adrenergic medications within two weeks of entry into the study, No anabolic steroid use, No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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: Pomegranate juice<br>Pomegranate juice | Dietary Supplement: Pomegranate juice<br>* Pomegranate juice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in sperm counts | The primary outcome will be change in sperm counts relative to baseline with and without POM. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sperm count | The secondary outcome will be change in sperm counts relative to baseline with and without POM. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male infertility
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab

Study Overview
=================
Brief Summary
-----------------
Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Intravitreal Injection of Aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab - Exclusion Criteria: None -

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 |
| --- | --- |
| Diabetic Macular Edema Patients Switched to Aflibercept<br> | Drug: Intravitreal Injection of Aflibercept<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Subfield Thickness on Optical Coherence Tomography |  | 1 year |
Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)

Study Overview
=================
Brief Summary
-----------------
In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: sodium bicarbonate
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 20 years scheduled for elective coronary artery bypass grafting. preoperative estimated glomerular filtration rate (eGFR) : 30   89 % LVEF < 35% NYHA class III or IV age > 70 DM reoperation Exclusion Criteria: acute renal impairment patients who receive dialysis patients who receive steroid ( > 10mg/day prednisolon or equivalent) hemo-alkalosis hypernatremia pulmonary edema Hemoglobin < 10 mg/dL

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIVON group<br> | Drug: sodium bicarbonate<br>* BIVON group were received 0.5 mmol/kg of sodium bicarbonate for 1hours after induction of anesthesia and following 0.15 mmol/kg of sodium bicarbonate during the operation.<br>|
| Placebo Comparator: Placebo group<br>normal saline infusion | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the incidence of acute kidney injury | The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation). | Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium bicarbonate, acute kidney injury, OPCAB