linjc16/ctgov huggingface dataset:
Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.

Official Title
-----------------
Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Drug: gadoxetic acid
* Other: Magnetic resonance imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid, to characterize focal liver lesion or to investigate diffuse liver disease OR, Liver living donor candidates AND subjects who sign the informed consent. Exclusion Criteria: Minors under 18 years old All contraindication to MRI Hypersensitivity to Gd Biliary obstruction

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 |
| --- | --- |
| Observe1<br>Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI) | Drug: gadoxetic acid<br>* standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration<br>* Other names: primovist;Other: Magnetic resonance imaging (MRI)<br>* Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases. precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Transient Dyspnea. | A sudden onset irregular breathing pattern after EOB administration, based on MRI k-space data (not participants' symptom). The k-space data was analyzed after the enrollment completion. | during 3 minutes after contrast media administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Transient Dyspnea in Participants With Transient Dyspnea. | The duration of transient dyspnea was analyzed based on the MRI k-space data, using a dedicated software. The analysis using the MRI k-space data was performed after the completion of enrollment. | during 3 minutes after contrast media administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gadoxetic acid, transient dyspnea
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.

Detailed Description
-----------------
To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients

Official Title
-----------------
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected lung cancer on chest CT or histologically proven NSCLC Participant is being considered for the conventional/neoadjuvant/targeted chemotherapy or surgery At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST Performance status of 0 to 2 on the ECOG scale Age 20 years or older Able to tolerable PET/CT and CT imaging required by protocol Able to undergo percutaneous needle biopsy before and after chemotherapy Able to give study-specific informed consent Exclusion Criteria: Poorly controlled diabetes Contraindication for CT contrast agent

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| patients with NSCLC<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and genomic profiling of lung cancer | Prognostic stratification will be evaluated using following parameters: Quantitative and qualitative parameters from CT, PET, MRI Genomic data of lung cancer samples | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between genomic and multiparametric imaging profiling | We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC. | five years | 
| Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection. | following parameters exracted from whole lung will be evaluated: Quantitative parameters related to pulmonary function from CT, PET, MRI 2. Prediction of longitudinal changes of pulmonary function after the lung resection | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, CT, PET CT, cancer genomics, Radiomics, Radiogenomics
Sun Protection Factor Assay (SPF Assay 202/2016)

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: Prevention
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:Z46-104)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| 2 Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Perceptions of Ophthalmologists Regarding Contemporary Presbyopia Management.

Study Overview
=================
Brief Summary
-----------------
Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire.

Detailed Description
-----------------
Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire (DePrePer31).

Official Title
-----------------
Perceptions of Greek Ophthalmologists Regarding Contemporary Presbyopia Management.

Conditions
-----------------
Presbyopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Valid license to practice ophthalmology in European Union. Adequate literacy of Greek language. Exclusion Criteria: Pediatric ophthalmologist.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Perceptions on presbyopia | Greek ophthalmologists' attitudes on contemporary presbyopia management | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Presbyopia, disease management, ophthalmologist, attitudes
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: CP-526,555 (varenicline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day Exclusion Criteria: Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-526,555 (varenicline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week continuous quit rate (CQR) for Weeks 9-12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence for Weeks 9-52 and Weeks 9-24 |  |  | 
| Long-term quit rate at Week 52 |  |  | 
| 4-week CQR for Weeks 4-7 |  |  | 
| 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52 |  |  | 
| Continuous abstinence from TQD (Week 1) through Week 12 |  |  | 
| Weekly average number of cigarettes smoked per day for Weeks 1-12 |  |  | 
| Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale |  |  | 
| Evaluation of smoking satisfaction by the Smoking Effects Inventory |  |  | 
| Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges |  |  |
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective

Study Overview
=================
Brief Summary
-----------------
In the present study, we propose objective diagnostic criteria for dry nose (DN) and investigate its characteristics. Questionnaires were completed by each participant during recruitment to record demographic data. DN test strips were used to evaluate the severity of DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test. The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis and its Impact on Asthma consensus statement. Data are expressed as median and interquartile range, unless otherwise specified. Statistical significance was set at P < 0.05. The reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were determined for each test strip length at each time point. This study aimed to investigate the characteristics of and propose objective diagnostic criteria for DN.

Official Title
-----------------
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective

Conditions
-----------------
Diagnostic Self Evaluation

Intervention / Treatment
-----------------
* Diagnostic Test: test strips,sponges and cold dry air test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of dry nose patients. Exclusion Criteria: chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 73 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 |
| --- | --- |
| dry nose patients<br> | Diagnostic Test: test strips,sponges and cold dry air test<br>* Test strips were used to evaluated the degree of dry nose, sponges were used to obtain the nasal secretion and cold dry air test was used to making diagnosis of vasomotor rihinitis.<br>|
| normal controls<br> | Diagnostic Test: test strips,sponges and cold dry air test<br>* Test strips were used to evaluated the degree of dry nose, sponges were used to obtain the nasal secretion and cold dry air test was used to making diagnosis of vasomotor rihinitis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of the test strip. | We propose that the diagnostic criterion for DN is a strip length less than 17.0 mm at 5 min. | 5 minutes |
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.

Official Title
-----------------
A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.

Conditions
-----------------
Atrophic Vaginitis

Intervention / Treatment
-----------------
* Drug: Premarin® Vaginal Cream
* Drug: Premarin® oral tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy postmenopausal women. Intact uterus. Clinical diagnosis of moderate to severe atrophic vaginitis.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Premarin® Vaginal Cream|nan|
|Drug: Premarin® oral tablets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the systemic exposure in postmenopausal women taking a typical regimen. |  |  |
COVID-19 Biorepository

Study Overview
=================
Brief Summary
-----------------
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

Detailed Description
-----------------
While SARS-CoV-2 has some similarities to the SARS-CoV pathogen that led to an epidemic in 2002 and 2003, there is much about the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of the novel virus that remains unknown.3 Additional research is needed to explore the nature of the virus, its spectrum of disease, and potential therapies to combat its spread. The aim of this project will be to establish a biorepository of blood samples from patients infected with SARS-CoV-2 that can then be used by investigators to expand our understanding of COVID-19 and its treatment and, in turn, improve patient outcomes. The COVID-19 biorepository will accomplish the following specific aims: Establish a collection of biospecimens from patients with COVID-19. Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap. Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.

Official Title
-----------------
COVID-19 Biorepository

Conditions
-----------------
Covid-19, SARS-CoV 2, Coronavirus, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP). The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR. Patient is 18 years of age or older. Exclusion Criteria: Participant declines to participate (living patients only) Participant or healthcare surrogate is unable to provide informed consent (living patients only)

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

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 |
| --- | --- | --- |
| Biospecimen Collection | Establish a collection of biospecimens from patients with COVID-19. | From Enrollment to 3 Months | 
| Establishing Connections | Establish a link between biospecimens and longitudinal individual patient data | From Enrollment to 3 Months | 
| Continuing COVID Research | Provide biospecimens and unique patient data to researchers investigating COVID-19 | From Enrollment to 3 Months |
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Study Overview
=================
Brief Summary
-----------------
Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Detailed Description
-----------------
Objectives: To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases To determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo. Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects with proteinuric renal disease (>400 mg/24 hours) Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months

Official Title
-----------------
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Conditions
-----------------
Proteinuric Renal Disease

Intervention / Treatment
-----------------
* Drug: paricalcitol (initial dose 1 mcg orally per day)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable chronic kidney disease Urine protein : Creatinine ratio > 0.4 Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min PTH (intact) >20 pg/ml and <250 pg/ml Age 18-85 If on ACEI/ARB, then dose optimized (BP, K) Exclusion Criteria: Failure to provide informed consent Glomerunephritis requiring active treatment with immunosuppresive therapy Serum phosphorus > 5.2 Serum calcium (adjusted for albumin)> 10.0 Active malignancy Likelihood of requiring renal replacement therapy within 1 year Uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol (initial dose 1 mcg orally per day)|nan|

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

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