linjc16/ctgov huggingface dataset:
An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Pediatric Subjects

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common wart(s) Ages between 3 to 11 Exclusion Criteria: Other types of wart(s), ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Resiquimod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated common wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated common wart(s) |  |  | 
| Wart recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wart(s), Children, Common Wart(s), Pediatric, 3M Pharmaceuticals, Resiquimod
Impact of Work Environment Absent of Natural Light on Vitamin D Levels

Study Overview
=================
Brief Summary
-----------------
Three types of workers exposed to different levels of natural sunlight will be tested for Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase. In addition, each tested worker will be asked to fill a questionnaire for demographic, medical and personal habit information.

Official Title
-----------------
Impact of Work Environment Absent of Natural Light on Vitamin D Levels

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people employed in their current work place at least 6 months, Exclusion Criteria: people who consume food additives containing Vitamin D. people who have a chronic illness which harms the Vitamin D absorption, such as Celiac, chronic Pancreatitis, Cystic Fibrosis and IBS. people who have a chronic illness which harms Vitamin D metabolism, such as chronic hepatitis, kidney insufficiency and Nephrotic Syndrome. pregnant women. people who require prescribed medicine like steroids, anti-convulsion, and HIV treatments.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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 |
| --- | --- |
| No natural sunlight<br>one group works in a basement with no natural sunlight | |
| Low level of Natural Sunlight<br>the second group work in offices with unopenable windows. | |
| High level of Natural Sunlight<br>The third group works outdoors. | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunlight, Vitamin D, Deficiency
Comparison of 18F FDG PET/CT TO PET MRI

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.

Official Title
-----------------
Comparison of 18F FDG PET/CT TO PET MRI

Conditions
-----------------
Any Condition With a Clinical Indication for PET/CT Exam

Intervention / Treatment
-----------------
* Device: PET/MRI system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Subject must have a clinical indication for a PET/CT exam Subject must be at least eighteen (18) years of age Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging Subject must be able to hear and understand instructions without assistive devices Subject must provide written informed consent Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam. Exclusion criteria Subjects who have any axial diameter larger than 55 cm Subjects with a weight greater than 499 lbs Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator Subjects that have implants with MR Unsafe labeling; Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol; Subjects who have a contraindication to MRI per the screening policy of the participating site.

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 |
| --- | --- |
| Other: Single arm PET MRI<br>single group evaluation of PET/MRI system scan for diagnostic quality of image | Device: PET/MRI system<br>* Compared to PET CT<br>* Other names: PET Electronics (mounted to magnet) and Cables;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/MR Images Clinical Usefulness | Clinically relevant images are obtained | 1 day |
Study of How Low Blood Sugar Affects the Way Blood Vessels Work

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans. This study is designed to explore how hypoglycemia affects the function of the blood vessel lining. This will be determined by measuring blood flow to the arm before and after occlusion of flow. Blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be done but without hypoglycemia.

Detailed Description
-----------------
Purpose: The purpose of the research is to learn more about how low blood sugar (low blood glucose or hypoglycemia) affects the way the blood vessels work in healthy people. Subjects who participate in this research project must be in good health and taking no medications. Methods: A screening visit to the Clinical Research Center of the Ohio State University will be used to assess eligibility to participate. The main study consists of two visits to the Clinical Research Center that occur two to four weeks apart. Each of these visits will involve a procedure known as an insulin clamp. This involves giving insulin and sugar water into a vein. The amount of sugar given varies to keep the blood sugar at a predetermined level. For one of the two visits the blood sugar will be low and the other it will be normal. The function of the blood vessels will be measured three times during each study by measuring blood flow before and after stopping blood flow to the arm for 5 min.

Official Title
-----------------
Hypoglycemia and Endothelial Function

Conditions
-----------------
Hypoglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40 years BMI <27 kg/m2 Exclusion Criteria: Pregnancy Systolic blood pressure >140 mmHg Diastolic Blood pressure >90 mg/dl Spot daytime urine microalbumin concentration > 20 μg/mg creatinine Past or present history of chronic disease (e.g. cancer, hypertension, cardiovascular disease, chronic inflammatory disease) other than diabetes in type 1 diabetic subjects. Use of non prescription medications in the past 3 days Use of prescription medications in the past 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoglycemia, Endothelial function
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 Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


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 (Subject History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) 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 sub site 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: BAY987517<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 Code: Z12-030)<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 |
Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters

Study Overview
=================
Brief Summary
-----------------
The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease. The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.

Official Title
-----------------
Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: Medical file data extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer Disease<br>Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria | Other: Medical file data extraction<br>* Medical file data extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age | Between 01-01-2010 and 31-01-2013 | 
| Sex | Sex | Between 01-01-2010 and 31-01-2013 | 
| Ethnic origin | Ethnic origin | Between 01-01-2010 and 31-01-2013 | 
| Symptoms-diagnose time interval | Interval of time between the apparition of the first symptoms, as reported by the family, and the diagnose. | Between 01-01-2010 and 31-01-2013 | 
| Scheltens scale | Evaluation of the hippocampal atrophy by means of magnetic resonance imaging. Scale from 0 (normal) to 4. | Between 01-01-2010 and 31-01-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease, Objective parameters, Scheltens index
Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration

Study Overview
=================
Brief Summary
-----------------
this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.

Official Title
-----------------
Ethnic Differences in Ischemia/Bleeding Risk Tradeoff During Antiplatelet Therapy After Drug-eluting Stent Implantation

Conditions
-----------------
Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy

Intervention / Treatment
-----------------
* Drug: prolonged DAPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prolonged DAPT|Dual antiplatelet therapy will be prescribed for more than 12 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary ischemic endpoint | major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis | 2 years | 
| primary bleeding endpoints | major bleeding events | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death |  | 2 years | 
| cardiac death |  | 2 years | 
| non-cardiac death |  | 2 years | 
| any myocardial infarction |  | 2 years | 
| any stroke |  | 2 years |
Period Tracker Lay User Study

Study Overview
=================
Brief Summary
-----------------
This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.

Official Title
-----------------
Period Tracker Lay User Study

Conditions
-----------------
Menstrual Cycles

Intervention / Treatment
-----------------
* Device: LH Urine Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Aged 18 to 45 years Willing to give informed consent and comply with the investigational procedures Exclusion Criteria: Used Clearblue® me Period Tracker app Persona or FAM within the last six months Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P&G, or affiliates Is a qualified or trainee healthcare professional (HCP) Has professional experience of using dipstick type tests or lateral flow devices Currently breastfeeding, pregnant or seeking to conceive Currently menstruating∆ *Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LH Urine Test|Test for qualitative detection of LH in urine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lay user usage | Ability of the lay user to perform a test and record their result | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of instructions for use | Ability of the lay user to understand the information provided in the instructions for use | 1 hour |
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy

Study Overview
=================
Brief Summary
-----------------
In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies obtained with flexible cryoprobes compared to standard techniques? For patients with peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue to be obtained and therefore, will increase the diagnostic yield over conventional techniques

Official Title
-----------------
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy

Conditions
-----------------
Lung Nodules

Intervention / Treatment
-----------------
* Procedure: cryobiopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age >18 years 2. Lung nodule (s) identified on CT scan 3. Clinical decision to obtain tissue biopsy of lung lesion 4. CT guided biopsy not preferred technique Previous negative CT guided biopsy Technically difficult nodule location Perceived high risk of pneumothorax or other complications Exclusion Criteria: 1. Lack of informed consent 2. Nodule less than 1 cm or greater than 6 cm long axis 3. Significant mediastinal adenopathy. 4. No suspected sites of disease outside the thorax amenable to biopsy 5. Evidence of endobronchial abnormality on chest CT 6. Medical contraindication to bronchoscopy 7. Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation. 8. Uncontrolled or irreversible coagulopathy platelets <100 INR >1.3 Use of clopidogrel in the 7 days prior to bronchoscopy 9. Confirmed or suspected pregnancy 10. Clinically unable to tolerate a pneumothorax or single-lung ventilation 11. Pacemaker or implanted cardiac defibrillator if it is felt that ENB is needed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Experimental: cryobiopsy<br> | Procedure: cryobiopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental diagnostic yield of cryobiopsy over the standard specimens |  | 1 year after completion of recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchoscopy, lung nodule, diagnosis, cryobiopsy