linjc16/ctgov huggingface dataset:
Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fasting State

Study Overview
=================
Brief Summary
-----------------
Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy subjects at Fasting State

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/500mg in Healthy Subjects at Fasting State

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

Intervention / Treatment
-----------------
* Drug: DA-5210 10/500mg
* Drug: DA-5210-R 10/500mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5210 10/500mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/500mg<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5210 10/500mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/500mg<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 48 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 48 hours post-dose |
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

Study Overview
=================
Brief Summary
-----------------
This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).

Detailed Description
-----------------
Same as brief summary

Official Title
-----------------
Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity

Conditions
-----------------
Diabetes, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 19 years of age and <70 years of age HGA1c<6.0% fasting blood sugar less than 100mg/dL Exclusion Criteria: Taking antidiabetic medications for other indications

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure erythrocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic Gastric Bypass. | G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, 12 weeks, 6 months, 12 months and 24 months post surgery. | time of surgery up to 24 months post gastric bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure adipocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass. |  | time of surgery up to 12 weeks post gastric bypass | 
| Measure omentum G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass. |  | time of surgery up to 12 weeks post gastric bypass | 
| Measure hepatocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass. |  | time of surgery up to 12 weeks post gastric bypass |
Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to evaluate anthropometric and functional characteristics of COPD patients correlated with oxygen desaturation during Six-minute walking test (6MWT).

Official Title
-----------------
Composite Analysis on Factors That Predict Oxygen Desaturation During Walking in COPD

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients Ability to perform 6MWT Normal oxygen saturation at rest and at the begin of 6MWT Exclusion Criteria: No-COPD patients Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT) Any co-morbidities

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Walking desaturation group<br>COPD patients that at the end of 6MWT have SO2 nadir <88-90% | |
| Walking No-desaturation group<br>COPD patients that at the end of 6MWT have SO2 nadir >88-90% | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation nadir (SO2 nadir) | Measured by change in percentage (%) | Measured at the end of 6MWT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Oxygen desaturation, Walking test
Oxygen Portable Concentrator During Exercises in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

Detailed Description
-----------------
Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

Official Title
-----------------
Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Oxygen concentrators versus constant flow axygen
* Device: oxygen concentrator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice. Exclusion Criteria: Evolutive heart disease. Unability to understand or realize the tests. Acute exacerbation during the last month.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous v intermittent Oxygen therapy<br>intermittent oxygen compared to constant flow oxygen as regards walking distance | Device: Oxygen concentrators versus constant flow axygen<br>* Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.<br>* Other names: portable oxygen concentrator;Device: oxygen concentrator<br>* comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen<br>* Other names: portable concentrator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Distance |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD patients with respiratory failure
The Association Between Parental Anxiety and Child Behavior.

Study Overview
=================
Brief Summary
-----------------
Parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development. Studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries disease in their children, since they are more resistant to accompany their children to the dentist. People with a high level of dental anxiety, both children and adults, can be difficult to treat, take longer, and have behavioral issues, all of which can lead to a stressful and unpleasant experience for both the patient and the dental practitioner

Official Title
-----------------
The Association Between Parental Anxiety and Child Behavior During Simple Restorative Treatment: A Cross-Sectional Study.

Conditions
-----------------
Parental Anxiety,Child Behavior

Intervention / Treatment
-----------------
* Procedure: Simple restorative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children, age ranging from 4 to 6 years old, of both sexes, have simple Occlusal cavities attending the pediatric dental clinic. Parents of both genders Exclusion Criteria: Children who do not have the cognition to respond to the anxiety test or are not authorized by parents and medically compromised children. Parents who could not respond to the research tools.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Simple restorative treatment|Simple Occlusal Cavity class I then followed by final restoration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Parental anxiety | The Modified Dental Anxiety Scale Scores (5-25) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Child Anxiety | The Modified Venham Picture Test Scores (0- 8) | Baseline | 
| Child behavior in dental care | Venham Behavior Rating Scale. | During the procedure |
A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer

Study Overview
=================
Brief Summary
-----------------
This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.

Conditions
-----------------
Vulvar Cancer

Intervention / Treatment
-----------------
* Procedure: Routine Leg edema and groin dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 18-100 years of age. All races and ethnicities. Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin. Willing participation following informed consent process. Exclusion Criteria: Has not had prior groin surgery or radiation to the groins. Any condition the PI or study physician determines that will put the subject at risk during the procedure. Allergy to blue dye used in lymphatic identification. Pregnant or breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Vulvar Cancer<br> | Procedure: Routine Leg edema and groin dissection<br>* The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe. |  | at time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar, cancer requiring lymph node evaluation for the ipsilateral or contralateral, groin
In Vitro Analysis of Human Urine With the CloudCath Device

Study Overview
=================
Brief Summary
-----------------
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.

Detailed Description
-----------------
Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection. To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months. Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.

Official Title
-----------------
In Vitro Analysis of Human Urine With the CloudCath Device

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Diagnostic Test: Spectral characteristics assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: provide a signed informed consent patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral) Exclusion Criteria: any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI) suprapubic bladder catheter implanted

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 |
| --- | --- |
| UTI-high risk patients<br>patients who are at high risk for developing a urinary tract infection (UTI). | Diagnostic Test: Spectral characteristics assessment<br>* Urine sample analysis for evidence of urinary tract infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectral characteristics of urine specimens | A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity). | During the period of time that the patient is catheterized (expected to be up to  1 week) |
The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit

Study Overview
=================
Brief Summary
-----------------
A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.

Detailed Description
-----------------
Trauma ICU admission of 18 years and older were enrolled in the study. The HIV status was further divided into HIV-positive, HIV-negative, and HIV-unknown subgroups. The gender, ages, mechanism of injury, injuries sustained, ISS, physiological data, septic-related complications, and in-hospital mortality were noted and further analyzed. Descriptive statistics were utilised using STATA version 15, and a p-value of <0.05 was considered statistically significant.

Official Title
-----------------
The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit

Conditions
-----------------
Outcome, Fatal

Intervention / Treatment
-----------------
* Diagnostic Test: Elisa HIV testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trauma patients admitted to a Trauma ICU at CMJAH - Exclusion Criteria: Those under the age of 18 or with incomplete data -

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 |
| --- | --- |
| HIV-positive<br>Those that were actually tested and had HIV-positive results | Diagnostic Test: Elisa HIV testing<br>* HIV testing on a voluntary basis<br>|
| HIV-Negative<br>Those tested and had HIV-negative results | Diagnostic Test: Elisa HIV testing<br>* HIV testing on a voluntary basis<br>|
| HIV-Unknown<br>those who had not volunteered for HIV testing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The HIV testing trends | Number tested for HIV in the study group | study period over two years (from 01 January 2017 till 31 December 2018) | 
| Outcomes | Septic related complications (wound infections, chest sepsis, septicaemia and sepsis related organ failure incidents | study period over two years (from 01 January 2017 till 31 December 2018) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-hospital mortality in the cohort | study period over two years (from 01 January 2017 till 31 December 2018) |
Aromatherapy for Reducing Labor Pain

Study Overview
=================
Brief Summary
-----------------
Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy group will receive the aromatherapy during labor along with standard pain control. Non-aromatherapy group will receive standard pain control during labor

Official Title
-----------------
Efficacy of Aromatherapy for Reducing Pain During Labor

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Aromatherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Nulliparous 37 complete weeks of gestation Cephalic presentation No emergency obstetric complication In labor Exclusion Criteria: Medical or obstetric complication preclude vaginal delivery Essential oil allergy Side effect of aromatherapy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy<br>Receive essential oil diffuse by Aroma diffuser during labor. Pain score and dose of analgesics drug are recorded | Other: Aromatherapy<br>* On the day of admission for labor. Pregnant women select type of essential oil. Aroma diffuser is used during labor. Pain score was record during latent, early active and late active phase.<br>|
| No Intervention: Non-aromatherapy<br>This group receive pain control by standard of care without essential oil (aromatherapy) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early active phase pain using Visual Analog Scale | Visual analog scale used to assess pain during cervical dilate 5-7 cm. | The day of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| latent phase pain using Visual Analog Scale | Visual analog scale used to assess pain during cervical dilate 3-4 cm. | The day of labor | 
| late active phase pain using Visual Analog Scale | Visual analog scale used to assess pain during cervical dilate 8-10 cm. | The day of labor | 
| analgesic drug | doses of analgesic drug request by pregnant women | The day of labor |