linjc16/ctgov huggingface dataset:
Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The investigators will apply ranitidine and verapamil to the drug interaction study of metformin.

Official Title
-----------------
Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

Conditions
-----------------
Healthy Adult

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers aged 20 to 50 years at screening Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight : Ideal body weight = (height cm - 100) x 0.9 Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial Exclusion Criteria: Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system. Subjects who have participated in other clinical trial within 1 month prior to the first day of drug administration Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranitidine<br> | Drug: Metformin<br>* Diavex 1000mg on Day1 and 750mg on Day2<br>* Other names: Diavex®;|
| Experimental: Verapamil<br> | Drug: Metformin<br>* Diavex 1000mg on Day1 and 750mg on Day2<br>* Other names: Diavex®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Deep Learning Magnetic Resonance Imaging Radiomic Predict Platinum-sensitive in Patients With Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Platinum-sensitive is an important basis for the treatment of recurrent epithelial ovarian cancer (EOC) without effective methods to predict.We aimed to develop and validate the EOC deep learning system to predict the platinum-sensitive of EOC patients through analysis of enhanced magnetic resonance imaging (MRI) images before initial treatment.Ninety-three EOC patients received platinum-based chemotherapy (>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospitalin China from January 2011 to January 2020 were enrolled. This deep-learning EOC signature achieved a high predictive power for platinum-sensitive, and the signature based on MRI whole volume is better than that on primary tumor area only.

Official Title
-----------------
Deep Learning Magnetic Resonance Imaging Radiomic Predict Platinum-sensitive in Patients With Epithelial Ovarian Cancer

Conditions
-----------------
Predictive Cancer Model

Intervention / Treatment
-----------------
* Other: Radiomic Algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1)Patients with epithelial ovarian cancer (2 )Patients received platinum-based chemotherapy (>= 4 cycles) and debulking surgery Exclusion Criteria: Patients with epithelial ovarian cancer received less than 4 cycles platinum-based chemotherapy or no debulking surgery

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| platinum-resistant group<br> | Other: Radiomic Algorithm<br>* Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction<br>|
| platinum-sensitive group<br> | Other: Radiomic Algorithm<br>* Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platinum sensitivity | Platinum sensitivity | 9 years |
Donepezil Double Blind Trial for ECT Memory Disfunction

Study Overview
=================
Brief Summary
-----------------
This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT. Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.

Official Title
-----------------
Donepezil Double Blind Trial for ECT Memory Disfunction

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Intervention / Treatment
-----------------
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID) Exclusion Criteria: History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence. Pregnant women Patients who recieved ECT within 6 month Patients whith contraindication to Donepezil treatment. Patients with Lithium treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: Donepezil<br> | Drug: Donepezil<br>* Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment<br>* Other names: Donepezil - Memorit;|
| Placebo Comparator: placebo<br> | Drug: Donepezil<br>* Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment<br>* Other names: Donepezil - Memorit;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data will be analyzed using SPSS for Windows. |  | after 5 ECT treatments | 
| Results of the memory and neurocognitive measures will be examined |  | after 8 ECT treatments | 
| using repeated MANOVA with before, within and after ECT treatment. |  | 1 month after the last ECT treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donepezil, ECT, Memory Disfunction
Effect of Two Iron Preparations on Protein in the Urine

Study Overview
=================
Brief Summary
-----------------
This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

Official Title
-----------------
A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients

Conditions
-----------------
Kidney Failure, Chronic, Anemia, Iron-Deficiency

Intervention / Treatment
-----------------
* Drug: Sodium Ferric Gluconate and Iron sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Age ≥ 18 or greater and able to give informed consent Exclusion Criteria: Receiving dialysis Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components Clinically unstable Indication of iron sufficiency

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: Sodium Ferric Gluconate and Iron sucrose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine protein |  | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in various urine chemicals |  | 180 minutes |
Thermographic Imaging in Epidural Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients

Detailed Description
-----------------
Patients will recive standard anesthesia care for epidural placement and additionally, thermographic imaging will be obtained at baseline and up to 30 min after the epidural blockade is performed.

Official Title
-----------------
Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia

Conditions
-----------------
Epidural Blockade

Intervention / Treatment
-----------------
* Device: Thermographic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients in active labor requesting epidural anesthesia for normal vaginal delivery Exclusion Criteria: Patients with lower extremity skin disorders like active infections like cellulitis, ,dermatitis, psoriasis or connective tissue disorders like scleroderma or Raynaud's phenomenon Patients with diagnosed peripheral vascular disease ,venous stasis , deep venous thrombosis. Patients with Severe preeclampsia with significant lower extremity edema Patient on vasoactive agents like vasodilators, calcium channels blockers.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Pt receiving standard Epidural block care for vaginal delivery | Device: Thermographic imaging<br>* Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in temperature in the lower extremities | thermographic images of the lower extremities will be obtained and analyzed for thermography patterns. | at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful epidural blockade | adequate sensory level, pain control, motor blockade as evaluated by care provider | up to 30 min after performing the epidural block | 
| Epidural blockade failure | Failure of the epidural block to adequately control pain, unilateral blockade, optimal sensory level, inadequate motor blockade | Up to 30 min after performing the epidural block | 
| Requirement for Epidural catheter manipulation or replacement |  | Up to 30 min after performing the epidural block |
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation

Study Overview
=================
Brief Summary
-----------------
We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.

Official Title
-----------------
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation

Conditions
-----------------
Bladder Cancer, Bladder Disease, Bladder Neoplasm, Micro-RNA

Intervention / Treatment
-----------------
* Diagnostic Test: MicroRNAs-155
* Diagnostic Test: Human telomerase reverse transcriptase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 years or older. Patient with hematuria suspected to be of bladder origin clinically. Willing to be participate in the study. Exclusion Criteria: Patient having another malignancy. Hematuria of other causes as trauma and stones

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hematuria due to suspicious superficial bladder tumor<br>MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT) | Diagnostic Test: MicroRNAs-155<br>* Quantitative analysis of cell-free miR-155 using RT-qPCR.<br>* Other names: (miRNAs-155);Diagnostic Test: Human telomerase reverse transcriptase<br>* Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.<br>* Other names: (hTERT);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer | compared by standard final pathological specimen | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer | measured serum Vit D in ng/mL. | 1 year |
Optimal Suture Choice for Improved Scar Outcomes

Study Overview
=================
Brief Summary
-----------------
Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Procedure: Intradermal Suture
* Procedure: Intradermal Suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring excision of a lesion on chest, back, or shoulders Exclusion Criteria: History of ionizing radiation History of keloid or hypertrophic scarring History of or current internal malignancy History of bleeding disorder History of collagen or elastin disorder Current use of immunosuppressive medications

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tepha<br> | Procedure: Intradermal Suture<br> <br> |
| Active Comparator: Vicryl<br> | Procedure: Intradermal Suture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar spread |  | 3 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance |  | 3 months and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appearance, Spread, Scar
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Official Title
-----------------
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Oral salmon calcitonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history and symptoms of knee osteoarthritis Exclusion Criteria: Any other disease or medication affecting the bone or cartilage. Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Ages Eligible for Study
-----------------
Minimum Age: 52 Years
Maximum Age: 75 Years

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

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: Oral salmon calcitonin|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Urine CTX-I and CTX-II |  |  | 
| Changes in serum osteocalcin and serum CTX-I |  |  | 
| Number of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
Collagen Cross-linking in Infectious Keratitis Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.

Official Title
-----------------
Collagen Cross-linking in Infectious Keratitis Trial

Conditions
-----------------
Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis

Intervention / Treatment
-----------------
* Procedure: Collagen cross-linking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal) Age more than 6 year Patients can understand and can follow the study protocol Exclusion Criteria: Pregnancy by history or urine test Evidence of herpetic keratitis Evidence of corneal perforation Evidence of autoimmune disease Known allergy to study medication

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Experimental: Collagen cross-linking<br>Collagen cross-linking with standard treatment | Procedure: Collagen cross-linking<br>* Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking. Standard treatment arm will receive only standard medication.<br>|
| No Intervention: standard treatment<br>Standard treatment alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrement of infiltration size | decrement of infiltration size between day0 and day 30 | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events | adverse events after corneal collagen cross-linking (report in descriptive study) | 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corneal ulcer, keratitis