linjc16/ctgov huggingface dataset:
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Official Title
-----------------
A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults

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

Intervention / Treatment
-----------------
* Drug: DA-5207
* Drug: Donepezil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health Male Volunteers (Age : 19 55 years) Body Weight : Male≥55kg, Female≥50kg 18.5≤BMI<25.0 Exclusion Criteria: Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption Allergy or Drug hypersensitivity Clinically significant Medical History AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m² Heavy alcohol intake (more than 210g/week) Heavy smoker (more than 10 cigarettes/day) Heavy caffeine intake

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort1<br>drug : DA-5207 80mg/40cm² placebo : 40cm² | Drug: DA-5207<br>* DA-5207 Transdermal Delivery System<br>|
| Experimental: Cohort2<br>drug : DA-5207 120mg/60cm² placebo : 60cm² | Drug: DA-5207<br>* DA-5207 Transdermal Delivery System<br>|
| Experimental: Cohort3<br>drug : DA-5207 160mg/80cm² placebo : 80cm² | Drug: DA-5207<br>* DA-5207 Transdermal Delivery System<br>|
| Active Comparator: Cohort4<br>drug : Aricept | Drug: Donepezil Hydrochloride<br>* donepezil HCl 10mg QD<br>* Other names: Aricept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | area under the concentration-time curve | patch : 21days, oral : 11days | 
| Cmax | maximum serum concentration | patch : 21days, oral : 11days |
Direct Acting Agents in Hepatitis C Patients

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective study conducted at 36 sites. Planned target patient number is 1000.

Detailed Description
-----------------
Approximately 36 centers will be included in Turkey. Centers will be selected from clinics of infection and clinical microbiology. The inclusion of 1000 patients was targeted. All data will be retrospectively collected from the medical records of the patients. Patient visit is not necessary.

Official Title
-----------------
Evaluation of Efficacy and Safety of Direct Acting Agents in Hepatitis C Patients

Conditions
-----------------
Hepatitis C, Hepatitis C Relapse, Hepatitis C Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who used direct acting agents for Hepatitis C Exclusion Criteria: Patients younger then 18 years

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 |
| --- | --- |
| Direct Acting Agents<br>No Intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease management with direct acting agents | To assess disease management of chronic hepatitis C patients using direct acting agents (DAA) at national level, especially change in HCVRNA levels 12 weeks after the 24 weeks treatment (SVR12) | Beginning of treatment - 12 weeks after the treatment ended (36 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Adverse event list according to CTCAE v.4.03 | Up to 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DAA, Hepatitis
The COVID-19 Mobile Health Study (CMHS)

Study Overview
=================
Brief Summary
-----------------
This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.

Official Title
-----------------
The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp

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

Intervention / Treatment
-----------------
* Other: nCapp, a cell phone-based auto-diagnosis system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk of COVID-19 RT-PCR test result of SAR2-CoV-19 Exclusion Criteria: Not available for RT-PCR test result of SAR2-CoV-19

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training<br> | Other: nCapp, a cell phone-based auto-diagnosis system<br>* Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19<br>|
| Validation<br> | Other: nCapp, a cell phone-based auto-diagnosis system<br>* Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of nCapp COVID-19 risk diagnostic model | Sensitivity, specificity and area under the ROC curve of nCapp model | 1 day |
A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.

Official Title
-----------------
An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: aleglitazar
* Drug: rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, aged 18 to 55 years inclusive at the time of screening Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive Females must be surgically sterile or use two acceptable methods of contraception Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study Exclusion Criteria: Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic) Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C An average alcohol intake of more than 14 units per week Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria Diagnosis of Gilberts Syndrome A positive screen for drugs of abuse at screening or on admission to the clinical unit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aleglitazar<br> | Drug: aleglitazar<br>* Single dose of aleglitazar in Periods 1, 2, 3<br>Drug: rifampicin<br>* Single dose in Periods 1 and 2; multiple doses in Period 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the plasma concentration time curve |  | Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | 14 weeks |
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Study Overview
=================
Brief Summary
-----------------
Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis infection, causing mortality and disability in more than half of the patients. Current standard treatment for TBM is based on those developed to treat pulmonary tuberculosis, which does not take into account the differential ability of anti-tuberculosis drugs to penetrate the brain. With both good central nervous system penetrance and anti-tuberculosis efficacy that have been demonstrated in drug-resistant tuberculosis, linezolid may be a promising antimicrobial in TBM treatment. The purpose of this study is to evaluate the effectiveness of linezolid in the treatment of TBM.

Official Title
-----------------
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Conditions
-----------------
Tuberculous Meningitis

Intervention / Treatment
-----------------
* Drug: Linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients diagnosed as TBM from the electronic medical record system. Exclusion Criteria: Does not meet the established diagnostic criteria; Combine other pathogen central infections; Follow-up confirmed that the final diagnosis considers other diseases (such as tumors, autoimmune encephalitis, etc.); Our hospital has less than one week of anti-tuberculosis treatment; Lack of information

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 |
| --- | --- |
| Background group<br>The treatment regimen does not include linezolid throughout the treatment course. | |
| Background-linezolid group<br>Linezolid was added in the middle of the treatment course but not in the initial treatment regimen. | Drug: Linezolid<br>* To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.<br>|
| Linezolid initial group<br>Linezolid was in initial treatment regimen. | Drug: Linezolid<br>* To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Medical Research Council grade deterioration |  | From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
linezolid
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease. The other aim of this study is to determine the incidence of the various ophthalmopathy subtypes and the utility of orbital antibodies in the diagnosis, classification and monitoring of patients with thyroid-associated ophthalmopathy.

Official Title
-----------------
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Conditions
-----------------
Graves' Ophthalmopathy

Intervention / Treatment
-----------------
* Drug: Carbimazole, radio-active iodine (I131)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy Exclusion Criteria: Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision Age < 18 years Inability to consent to participation in the study Pregnancy History of radio-active iodine therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carbimazole, radio-active iodine (I131)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset or progression of ophthalmopathy following radio-active iodine therapy |  |  |
Rotavirus vs. Sucrose for Vaccine Injection Pain

Study Overview
=================
Brief Summary
-----------------
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.

Official Title
-----------------
A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants

Conditions
-----------------
Vaccination Pain Management

Intervention / Treatment
-----------------
* Drug: Sucrose
* Drug: Rotavirus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life Exclusion Criteria: impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 6 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose<br>Sucrose prior to vaccine injections | Drug: Sucrose<br>* Sucrose 24% orally prior to vaccine injections<br>|
| Active Comparator: Rotavirus<br>Rotavirus prior to vaccine injections | Drug: Rotavirus<br>* Rotavirus vaccine orally prior to vaccine injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress | Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall | immediately after vaccinations in 15 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress | Observer rated cry duration after vaccination | immediately after vaccinations in 1 minute intervals for 2 minutes | 
| Distress | Immunizer rated distress after each injection using a Numerical Rating Scale (0-10) | immediately after vaccinations in 1 minute | 
| Distress | Parent rated distress after each injection using a Numerical Rating Scale (0-10) | immediately after vaccinations in 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotavirus, vaccination, pain management, sucrose
Point of Service Diabetes Screening Evaluation

Study Overview
=================
Brief Summary
-----------------
The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.

Detailed Description
-----------------
The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.

Official Title
-----------------
Point of Service Diabetes Screening Evaluation

Conditions
-----------------
Diabetes Mellitus, Non-Insulin Dependent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Exclusion Criteria: Known to be pregnant (self-reported) Receiving dialysis or known renal compromise Known to have photosensitivity Taking medications that fluoresce Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia. |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Adults 18 years and older
Medical Students and Risk of COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
This study aims to estimate the prevalence of infected medical students with COVID-19 in the University of Jordan and to compare number of cases between students in clinical and basic years. In addition, this can provide insight into the awareness of infection control practices among students. Furthermore, to examine if hospital rotations increased risk of infection between clinical year medical students.

Official Title
-----------------
Medical Students and Risk of COVID-19 Infection: a Descriptive Study From the University of Jordan

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: No intervention, questioner only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All medical Students - Exclusion Criteria: none
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 |
| --- | --- |
| Preclinical medical students<br> | Other: No intervention, questioner only<br>* questioner only<br>|
| Clinical medical students<br> | Other: No intervention, questioner only<br>* questioner only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 infection | Incidence of Infected students with Covid 19 | 3 months |
Repeatability and Stability of Healthy Skin Features on OCT

Study Overview
=================
Brief Summary
-----------------
A test-retest study on the stability and repeatability of healthy skin features on OCT

Official Title
-----------------
Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study

Conditions
-----------------
Optical Coherence Tomography, Artificial Intelligence, Radiomics

Intervention / Treatment
-----------------
* Diagnostic Test: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least18 years of age Exclusion Criteria: Unable to sign informed consent

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Optical coherence tomography|Optical coherence tomography is a non-invasive scanner which generates real-time in-vivo images of the skin and its adnexal structures. Images are generated by light-interferometry.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatable hand-crafted radiomics-features | The number of HRFs that are repeatable in a test-retest setting | Interval of 10 minutes | 
| Interclass Correlation Coefficient (ICC) | Intraclass Correlation Coefficient (ICC) will be used to assess the correlation and repeatability of the HRFs resulting from OCT scans. ICC will be calculated after all scans have been obtained. ICC will be used to rank the HRFs. This statistical test is commonly used reliability index in test re-test studies. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical coherence tomography, OCT, Artificial intelligence, AI, Radiomics, Test-retest, Imaging, Dermatology, Skin