linjc16/ctgov huggingface dataset:
Non-immune Related Hypothyroidism in Iodine Sufficient Area

Study Overview
=================
Brief Summary
-----------------
Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary hypothyroidism in iodine sufficient area and has relationship with excess iodine induced hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess iodine have been rarely evaluated. Objective: Therefore, the investigators planned to calculate proportion of non-immune related hypothyroidism and relationship with iodine intake using nationwide data from Korea National Health and Nutrition Examination Survey (KNHANES) 2013-2015. Design: Korea National Health and Nutrition Examination Survey VI (2013 to 2015) - The national data - which is the government designated statistics (Approval No. 117002 ) of South Korea based on the Article 17 of the National Health Promotion Act - were used. The survey was approved by the Institutional Review Board of the Korea Centers for Disease Control and Prevention, and provides only non-identified measures for academic research purposes. The participants who were examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were included. The proportion of immune related and non-immune related hypothyroidism was evaluated. Demographic variables and severity of hypothyroidism were compared between the two groups. To analyze iodine effect on hypothyroidism in TPO Ab positive or negative population, prevalence of hypothyroidism were assessed in each TPO Ab negative and positive population according to UIC subgroups. This study protocol was approved by IRB of SMC (2017-05-149).

Official Title
-----------------
Non-immune Related Hypothyroidism in Iodine Sufficient Area

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Other: The investigators did not apply any intervention for the participants.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) Exclusion Criteria: already have a thyroid disease(benign thyroid diseases or thyroid cancer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The investigators did not apply any intervention for the participants.|The investigators did not apply any intervention for the participants.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The weighted proportion of non-immune related hypothyroidism | Hypothyroidism with TPO Ab negative | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iodine, thyroid peroxidase antibody
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.

Official Title
-----------------
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.

Conditions
-----------------
Healthy, Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: PEP005 Gel
* Drug: PEP005 Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be male or female and at least 18 years of age Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception Ability to provide informed consent Exclusion Criteria: Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days Have any signs of skin irritation or damaged skin at or around the dominant index finger Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers Those who are currently participating in any other clinical trial Those known or suspected of not being able to comply with the requirements of the protocol Females who are pregnant or are breastfeeding

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP005 Gel 0.05%/2 days<br>Subjects will be exposed to investigational product for 2 consecutive days. | Drug: PEP005 Gel<br>* PEP005 Gel 0.05% for 2 consecutive days<br>|
| Experimental: PEP005 Gel 0.015%/3 days<br>Subjects will be exposed to investigational product for 3 consecutive days. | Drug: PEP005 Gel<br>* PEP005 Gel 0.015% for 3 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Skin Responses |  | Up to 8 days |
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

Study Overview
=================
Brief Summary
-----------------
Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.

Official Title
-----------------
Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)

Conditions
-----------------
Nasolabial Folds

Intervention / Treatment
-----------------
* Drug: Hyaluronic acid filler/IMD1 basic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: main inclusion criteria: severity rating scale grade 3 or 4 Exclusion Criteria: main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hyaluronic acid filler/IMD1 basic|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity rating scale assessed by independent rater |  |  |
VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

Study Overview
=================
Brief Summary
-----------------
This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.

Official Title
-----------------
Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.

Conditions
-----------------
Myopic Choroidal Neovascularization, VEGF Aqueous Level, PEDF Aqueous Level

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologic myopia, defined as spherical equivalent >6 diopters and axial length >26 mm posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent); fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization clear ocular media; Exclusion Criteria: previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion history of recent myocardial infarction or other thromboembolic events ongoing uncontrolled hypertension or glaucoma refractive media opacities previous eye surgery

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 |
| --- | --- |
| Myopic Choroidal Neovascularization patients<br> | |
| Control patients undergoing cataract surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular endothelial growth factor (VEGF) aqueous levels | VEGF aqueous levels before and after intravitreal ranibizumab | 2 months | 
| pigment epithelium-derived factor (PEDF) aqueous levels | PEDF aqueous levels before and after intravitreal ranibizumab | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best-corrected visual acuity |  | 2 months | 
| central retinal thickness |  | 2 months |
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?

Study Overview
=================
Brief Summary
-----------------
We aimed to investigate whether Neutrophil Lymphocyte Ratio is a Prognostic Factor of Sepsis in Newborns with operated Neural Tube Defects?

Official Title
-----------------
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?

Conditions
-----------------
Neural Tube Defects, Newborn Sepsis

Intervention / Treatment
-----------------
* Diagnostic Test: Neutrophil to lymphocyte ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <28 days diagnosed with with neural Tüpe Defects To be operated Exclusion Criteria: >28 days

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis group<br> | Diagnostic Test: Neutrophil to lymphocyte ratio<br>* Neutrophil to lymphocyte ratio<br>|
| Non Sepsis group<br> | Diagnostic Test: Neutrophil to lymphocyte ratio<br>* Neutrophil to lymphocyte ratio<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil to lymphocyte ratio is prognostic faktör for Sepsis |  | 3 years |
A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: NNC 55-0414


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Diet treatment only for at least two weeks Body mass index (BMI) between 22-34 kg/m2 inclusive HbA1C between 6.5-12.0% inclusive Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD) Exclusion Criteria: Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator Impaired renal function, serum creatinine greater than 150µmol/L Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks Patients who had a significant history of alcoholism or drug/chemical abuse

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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

| Intervention/Treatment |
| --- |
|Drug: NNC 55-0414|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes. |  |  |
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

Detailed Description
-----------------
The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 weeks.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Conditions
-----------------
Diverticulitis

Intervention / Treatment
-----------------
* Drug: Mesalazine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography Presence of at least one diverticulum of the left colon Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months C-reactive protein (CRP) > upper limit of normal (ULN) at the start of the most recent attack Exclusion Criteria: Complicated diverticular disease Right-sided diverticulitis Previous colonic surgery Presence of symptomatic organic disease of the gastrointestinal tract Active colorectal cancer or a history of colorectal cancer Hemorrhagic diathesis Active peptic ulcer disease, local intestinal infection Asthma if careful medical monitoring is not ensured Abnormal hepatic function or liver cirrhosis Abnormal renal function

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Mesalazine<br>* 3 g per day<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* 0 g per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of recurrence-free patients within 48 weeks |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  |  | 
| Occurrence of diverticulitis-associated fever |  | 48 weeks | 
| Number of days with left lower quadrant pain |  | 48 weeks | 
| Stool consistency |  | 48 weeks | 
| Severity of diarrhea |  | 48 weeks | 
| Quality of Life (QoL) |  | 48 weeks | 
| Health assessment |  | 48 weeks | 
| Assessment of efficacy by investigator and patient |  | 48 weeks |
Improving Door-to-Balloon Time in STEMI

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.

Detailed Description
-----------------
Please see Circulation. 2007;116:67-76

Official Title
-----------------
Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Lab Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: ED Activation/Immediate Transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Study Inclusion Criteria: ST-elevation myocardial infarction patients who undergo percutaneous intervention within 24 hours of ED arrival Exclusion Criteria: Patients who are inpatients A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ED Physician Activation/Immediate Transfer<br> | Other: ED Activation/Immediate Transfer<br>* ED Physician Activation and Immediate Transfer Protocol - see Circulation. 2007;116:67-76<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Door-to-Balloon Time |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct Size |  | 48 hours | 
| In-Hospital Mortality |  |   7 days (during index hospitalization) | 
| Hospital Length of Stay |  |  2-7 days (during index hospitalization) | 
| Hospital Costs |  |  2-7 days (during Index Hospitalization) and One Year Followup |
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI

Study Overview
=================
Brief Summary
-----------------
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI

Official Title
-----------------
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI

Conditions
-----------------
Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Other: acupuncture
* Other: Psychotherapy
* Other: blank control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD). Exclusion Criteria: The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Acupuncture treatment<br> | Other: acupuncture<br>* Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.<br>|
| Active Comparator: Psychotherapy<br> | Other: Psychotherapy<br>* Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.<br>|
| Placebo Comparator: blank control<br> | Other: blank control<br>* Blank control subjects would be observed only during this investigation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Heart Rate Variability at 7 days | The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group | at 1day before and 7 days after percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of HAM-A | scores of HAM-A were recorded on 1day before, 7，14 days after the intervene | 1day before, 7，14 days after the intervene | 
| Scores of AIS | scores of AIS were recorded on 1day before, 7，14 days | 1day before, 7，14 days after the intervene | 
| Scores of HRSD | scores of HRSD were recorded on 1day before, 7，14 days | 1day before, 7，14 days after the intervene | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, PCI