linjc16/ctgov huggingface dataset:
Sun Protection Factor - Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose(MPPD).

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. formulation number SR15-39-Z12-002.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Korean Heart Failure Registry III

Study Overview
=================
Brief Summary
-----------------
KorHF III is a multi-center, nationwide, prospective registry of the Korean Society of Heart Failure, which enrolls patients with acute heart failure in Korea. The aim of this registry is to analyze the etiology, treatment, treatment, and prognosis to develop strategies for managing acute heart failure.

Official Title
-----------------
Korean Heart Failure Registry Ⅲ of Korean Society of Heart Failure

Conditions
-----------------
Acute Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and 4 Inclusion Criteria: Symptoms of heart failure Signs of heart failure Lung congestion in Chest-x-ray Objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels Exclusion Criteria: Patients younger than 18 years old Patients who do no consent

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 |
| --- | --- |
| acute heart failure<br>Patients with acute heart failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | In-hospital mortality | 5 years | 
| Post-discharge mortality | Post-discharge mortality | 5 years | 
| Post-discharge re-hospitalization | Post-discharge re-hospitalization | 5 years |
Evaluation of Education and Equipment in the Prehospital Setting

Study Overview
=================
Brief Summary
-----------------
In a national online based survey the investigators are targeting paramedics for these survey that are involved in prehospital setting. In this study the investigators want to get more information about the current standard or levels of education in prehospital emergency medicine (e.g. airway management) and the incidence of the independently application in daily practice. Furthermore the investigators want to know the current hygiene concepts especially in the actual SARS-CoV-2 Pandemic.

Detailed Description
-----------------
Every participant can answer the survey just once.

Official Title
-----------------
Evaluation of Education and Equipment of Paramedics in the Prehospital Setting. A Online Based Survey. The EVAIR-Study

Conditions
-----------------
Airway Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female participants/paramedics Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of intubation success | incidence of failed intubation attempts | through study completion, on average 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of hygiene concepts in SARS-CoV-2 Pandemic | face masks, gloves face shields for hygiene concept | through study completion, on average 1 Month |
Storage Symptom After Laser Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.

Official Title
-----------------
Change in Storage Symptoms Following Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of prostatic hyperplasia underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate 12-months follow-up data were available Exclusion Criteria: previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Photoselective vaporization of the prostate<br>Patients who underwent photoselective vaporization of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available | Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)<br> <br> |
| Holmium laser enucleation of the prostate<br>Patients who underwent holmium laser enucleation of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available | Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the subtotal storage symptom score of the International Prostate Symptom Score (IPSS) | a reduction by ≥ 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline | 12 months after surgery |
A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013. The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description
-----------------
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood. Eligibility criteria Patients who will use Reduning injection in selected hospitals.

Official Title
-----------------
a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China

Conditions
-----------------
Upper Respiratory Tract Infection;, Acute Tracheobronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using Reduning injection from January to March 2013 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- |
| Allergic group<br>All patients who used Reduning Injection have anaphylaxis. | |
| Control group<br>All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction |  | to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning |
Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

Study Overview
=================
Brief Summary
-----------------
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore, in this study the investigators intend to compare the effect of ezetimibe monotherapy or ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.

Official Title
-----------------
Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Ezetrol (Ezetimibe)
* Drug: Vytorin (Ezetimibe + Simvastatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hsCRP > 2 mg/L and LDL cholesterol > 130 mm/dL Exclusion Criteria: history of cardiovascular disease diabetes uncontrolled hypertension active infection previous anti-hyperlipidemic agents within 6 months previous steroid or anti-inflammatory agents within 6 months liver disease renal disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Ezetimibe<br> | Drug: Ezetrol (Ezetimibe)<br>* Ezetrol - 10 mg once daily for 3 months<br>|
| Experimental: Ezetimibe/Simvastatin<br> | Drug: Vytorin (Ezetimibe + Simvastatin)<br>* Vytorin - 10/20 mg once daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups |  | 3 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high risk patients in atherosclerosis
Evaluation of the Composition of Human Milk and Health Outcomes in Children

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the composition of human milk and health outcomes in children.

Official Title
-----------------
Evaluation of the Composition of Human Milk and Health Outcomes in Children

Conditions
-----------------
Respiratory Symptoms, Signs and Symptoms, Digestive, Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Human milk samples from mothers from a larger birth co-hort study Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- | --- |
| Incidence of infectious and allergic Gastrointestinal events through 2 years of age | Number of incidences of infectious and allergic Gastrointestinal events for each participant through 2 years of age | 2 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infectious and allergic respiratory events through 2 years of age | Number of incidences of infectious and allergic respiratory events for each participant through 2 years of age | 2 years of age | 
| anthropometric measurements | participants' weight, length and head circumference | 2 years of age | 
| Incidence of anemia in first 2 years of age | Hemoglobulin measurement | 2 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin symptoms
Effect of Weight Loss on Reproductive Function in Overweight Men

Study Overview
=================
Brief Summary
-----------------
Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.

Official Title
-----------------
Effect of Weight Loss on Reproductive Function in Overweight Men.

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 BMI > 27 kg/m2 Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: weight loss|self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids |  | minimum three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genetic variations in genes involved in metabolism and reproduction |  | no time frame | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obesity, male, fertility
RIGHT IV Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.

Official Title
-----------------
Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study

Conditions
-----------------
Peripheral Intravenous Catheters

Intervention / Treatment
-----------------
* Device: ViaValve Safety IV Catheter
* Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Willing and able to independently sign an English Informed Consent Have adequate veins for placement of IV catheters in both right and left upper extremities Exclusion Criteria: Currently taking anti-coagulation medication Have a known bloodborne disease or bleeding tendency Have a known fear or adverse reaction to needles or blood Women who are pregnant or nursing

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ViaValve Safety IV Catheter<br>Catheter insertion using the ViaValve Safety IV Catheter. | Device: ViaValve Safety IV Catheter<br>* Insertion of the peripheral intravenous catheters into both upper extremities of subjects<br>|
| Active Comparator: Insyte Autoguard BC [Blood Control] Shielded IV Catheter<br>Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter | Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance and acceptability | Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire. | IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IV Catheters, Blood control