linjc16/ctgov huggingface dataset:
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3

Study Overview
=================
Brief Summary
-----------------
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.

Official Title
-----------------
A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: S6G5T-3
* Drug: Retin-A® 0.1% Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 9 years of age or older. Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF). Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations All females of child-bearing potential and premenarchal, excluding women who are surgically sterile Exclusion Criteria: Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment. Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.; Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function). Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 9 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: S6G5T-3<br>topical cream | Drug: S6G5T-3<br>* once daily<br>|
| Active Comparator: Retin-A® 0.1% Cream<br>topical cream | Drug: Retin-A® 0.1% Cream<br>* once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration | The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated | 14 days |
Photoprovocation Testing in Subjects With Cutaneous Lupus

Study Overview
=================
Brief Summary
-----------------
Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.

Official Title
-----------------
Photoprovocation Testing in Subjects With Cutaneous Lupus

Conditions
-----------------
Lupus Erythematosus, Photosensitivity Conditions

Intervention / Treatment
-----------------
* Other: Phototesting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria. Exclusion Criteria: Participants who do not meet criteria for either CLE or SLE. Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption. Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study. Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity. Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phototesting<br> | Other: Phototesting<br>* Single MED dose on Day 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. |  | 24 hours and 48 hours |
Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression

Study Overview
=================
Brief Summary
-----------------
The investigators would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Detailed Description
-----------------
There have been tremendous advances in the treatment of HIV by combining 3 to 4 of the 20 anti-HIV medications available. Despite these advances, there remain several important complications related to the treatment, most importantly adverse events like nausea, diarrhea, liver toxicity and lipodystrophy (fat wasting or accumulation). Some studies have found that drug levels are higher in women and that these higher drug levels are associated with the increased toxicity in women. The reasons for the higher drug levels remain unclear. It is unknown whether these relate to hormonal influences, drug metabolism, adherence, fat distribution, body size or other factors. For this reason, we would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are HIV infected Are 18 years old or older A biologic woman Are taking their first combination Anti-retroviral regimen that includes a Protease Inhibitor or a Non-Nucleoside Reverse Transcriptase Inhibitor for the past three months with no changes in any part of the combination in that period Are taking either a Protease Inhibitor or an Non-Nucleoside Reverse Transcriptase Inhibitor but not both If taking a Protease Inhibitor, must be taking only one Protease Inhibitor excluding low dose ritonavir used as boosting Have a viral load < 50 copies/mL on two occasions at least 1 month apart including a value at least three months before the baseline visit Have signed and dated a full informed consent Exclusion Criteria: Have difficulty participating in a trial due to non-adherence or substance abuse Pregnant or breast-feeding Have malignancy receiving systemic chemotherapy Have end-stage organ disease Have another significant non-HIV underlying disease that might impinge upon disease progression or death

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, HIV infected women
Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells

Study Overview
=================
Brief Summary
-----------------
Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

Detailed Description
-----------------
Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.

Official Title
-----------------
Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : A Randomized Double Blind Placebo-controlled Trial

Conditions
-----------------
Metformin, CA Endometrium

Intervention / Treatment
-----------------
* Drug: Metformin Hydrochloride 850 MG
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study Exclusion Criteria: Women without diabetes type 1 and 2 Women who have allergy Biguanide Women who have hypoglycemic medication Women who have GFR <45 ml/min/1.73 m2 Women who have evidence of stage 3 or 4 of endometrial cancer
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br>The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy | Drug: Metformin Hydrochloride 850 MG<br>* Regular strength metformin (850 mg/tab)<br>* Other names: if any;|
| Placebo Comparator: placebo<br>The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy | Drug: Placebo Oral Tablet<br>* Starch based placebo manufatured to mimic Metformin 850 mg<br>* Other names: if any;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Ki-67 expression in endometrial tumor | metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of grade in endometrial tumor | metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy. | 4 weeks |
Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery

Study Overview
=================
Brief Summary
-----------------
NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.

Official Title
-----------------
Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery

Conditions
-----------------
Fluid Responsiveness, Prone Position, Non Invasive Cardiac Output Monitoring

Intervention / Treatment
-----------------
* Other: Fluid loading to evaluate fluid responsiveness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II patients undergoing spine surgery in prone position Exclusion Criteria: Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade >2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors BMI >30kg/m^2 or <15kg/m^2 Preoperative serum Cr > 1.3mg/dL Patients with coagulopathy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All enrolled patients<br>This study enrolls patients undergoing elective spine surgery in prone position and all enrolled subjects may receive fluid loading with hemodynamic monitoring by Flotrac/Vigileo and NICOM, but the investigator does not assign specific interventions to the subjects of the study because this is a prospective observational study. | Other: Fluid loading to evaluate fluid responsiveness<br>* loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume variation from NICOM® | predictability of stroke volume variation from NICOM® for fluid responsiveness | 5 min after infusion of bolus fluid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse pressure variation and stroke volume variation from Flotrac/Vigileo system | Correlation with pulse pressure variation, stroke volume variation from Flotrac/Vigileo system | 5 min after infusion of bolus fluid | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid responsiveness, NICOM, Prone Position, Stroke Volume Variation
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.

Study Overview
=================
Brief Summary
-----------------
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%

Detailed Description
-----------------
To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups. The control group: application of MMC after excision of the body of the pterygium without the head The study group: application of MMC after excision of the body and the head of the pterygium

Official Title
-----------------
The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Drug: Mitomycin C 0.02%
* Procedure: Pterygium surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males/females >18 Years old Pterygium with indication to operate Subjects that are able to sign an informed consent Exclusion Criteria: Recurrent Pterygium/suspected tumor lesion Patients with endothelial cell diseases Patients after anterior segment surgery Patients with low compliance Patients without judgment ability Pregnancy Patients participated in another survey

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pterygium surgery: Head and body.<br>Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium. | Drug: Mitomycin C 0.02%<br>* Pterygium excision with application of mitomycin C<br>Procedure: Pterygium surgery<br>* Two different procedures- excision of the head and the body and excision of the head only<br>|
| Active Comparator: Pterygium surgery: Body.<br>Application of Mitomycin C 0.02% after excision of the body only of the pterygium. | Drug: Mitomycin C 0.02%<br>* Pterygium excision with application of mitomycin C<br>Procedure: Pterygium surgery<br>* Two different procedures- excision of the head and the body and excision of the head only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell count |  | 3 months after surgery |
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

Official Title
-----------------
Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Drug: Orphenadrine
* Drug: Baclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month Exclusion Criteria: Patients with allergy to study drugs Renal impairment Peripheral vascular disease Peripheral neuropathy Glaucoma Prostatic enlargement Pregnancy and lactation Patients taking calcium channel blockers, and conjugated estrogens Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study Patients with alcoholic cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orphenadrine group<br>orphenadrine | Drug: Orphenadrine<br>* 100 mg twice daily<br>|
| Active Comparator: Baclofen group<br>Baclofen | Drug: Baclofen<br>* initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment | Questionnaire | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment | Visual analogue scale (VAS) | 12 weeks |
The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.

Conditions
-----------------
End-stage Renal Disease

Intervention / Treatment
-----------------
* Other: renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of patient was between 18 yrs and 79 yrs. The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization Exclusion Criteria: The level of serum albumin was below 2.0 or over 5.0 The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month. The level of Body mass index was below 15 or over 30 Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| ESBL(+) Klebsiella pneumonia<br>All the patient who's the culture result showed ESBL(+) Klebsiella pneumonia in any site during hospitalization | Other: renal replacement therapy<br>* renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )<br>|
| ESBL(-) Klebsiella pneumonia<br>All the patient who's the culture result showed ESBL(-) Klebsiella pneumonia in any site during hospitalization | Other: renal replacement therapy<br>* renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy | The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011) | During hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy | The prevalence of ESBL Klebsiella pneumoina in patient with pneumonia and renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011) | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end-stage renal disease, renal replacement therapy