linjc16/ctgov huggingface dataset:
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

Detailed Description
-----------------
Phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A. Which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.

Official Title
-----------------
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: YYC506-T
* Drug: YYC506-A
* Drug: YYC506-T + YYC506-A
* Drug: YYC506-A + YYC506-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 ages healty men Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2 Men who dont have congenital disease and other cronic disease need to be cared etc. Exclusion Criteria: Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN) Men who have drunken or eatten something including carffeine within 24 hours before etc.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Group<br>Two cohort, single sequence | Drug: YYC506-T<br>* single administration<br>Drug: YYC506-T + YYC506-A<br>* concomotant administration<br>|
| Experimental: B Group<br>Two cohort, single sequence | Drug: YYC506-A<br>* single administration<br>Drug: YYC506-A + YYC506-T<br>* concomotant administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokietic parameters administration: Cmax | YYC506-T, YYC506-A, and concomitant administration Cmax | Until 48 hours | 
| Pharmacokietic parameters administration: AUC | YYC506-T, YYC506-A, and concomitant administration AUC | Until 48 hours |
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration [FDA] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.

Official Title
-----------------
Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options

Conditions
-----------------
Advanced Cancers and FGFR Genetic Alterations

Intervention / Treatment
-----------------
* Drug: Erdafitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has a documented fibroblast growth factor receptor (FGFR) alteration Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment) Life expectancy is greater than (>) 3 months (determined by treating physician's assessment) Participant has exhausted treatment options for their disease (review of prior treatments) Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erdafitinib|Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Study Overview
=================
Brief Summary
-----------------
Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed. The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.

Detailed Description
-----------------
Refer to Brief Summary

Official Title
-----------------
Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Conditions
-----------------
Sickle Cell Disease, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented sickle cell disease Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization. Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS) Parental/patient consent and child assent Exclusion Criteria: Primary diagnosis other than vasoocclusive pain Concurrent Acute Chest Syndrome (ACS) Patient previously enrolled in this study Inability to understand English

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 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 |
| --- | --- |
| Sickle Cell Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPPAQ | This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle Cell Disease, Pain, Assessment
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport

Study Overview
=================
Brief Summary
-----------------
This study is being done to see what impact having a Lifeport device has on quality of life for children with sickle cell who are getting chronic transfusions, from the child's perspective.

Detailed Description
-----------------
There is a paucity of research that focuses specifically on quality of life (QoL) among patients with sickle cell. This study aims to explore the QoL of children who are receiving chronic transfusion therapy (CTT) using a Lifeport device, which allows them to undergo erythrocytapheresis, rather than standard transfusion therapy. Erythrocytapheresis is less time consuming and is associated with less iron overload than conventional transfusion therapy; however, little is known about the implications for the child's QoL. This study will explore QoL from the child's perspective.

Official Title
-----------------
Quality of Life of Children With Sickle Cell Disease Who Are Receiving Chronic Transfusion Therapy With a Lifeport Device

Conditions
-----------------
Anemia, Sickle Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a diagnosis of sickle cell disease between the ages of 8 & 18 years currently receiving chronic transfusion therapy via a Lifeport device Individuals have been utilizing the Lifeport for at least 6 months and no more than 18 months Individuals have received transfusions previously using conventional transfusion therapy (simple or exchange transfusions) Individuals have permission of parents (when applicable) and assent Exclusion Criteria: Individuals who, in the opinion of the study staff, would suffer negative consequence, psychosocial trauma, or undue stress as a result of participation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, chronic transfusion therapy
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029

Study Overview
=================
Brief Summary
-----------------
This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: MYO-029


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 18 to 45 years inclusive on study day 1. Elderly men and women aged 65 to 80 years inclusive on study day 1. Women must be postmenopausal for > or = 1 year (with estradiol < 25 pg/mL and an FSH > 40 mIU/mL). Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram. Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation. Non-smoker.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MYO-029|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Aged
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.

Official Title
-----------------
Insulin Resistance in Polycystic Ovary Syndrome (PCOS)

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal women that meet the Rotterdam criteria for PCOS (BMI < 40) Age and BMI matched control women that do not have any signs or symptoms of PCOS Exclusion Criteria: BMI > 40. mani fest diabetes or other known diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>lean control women without PCOS | |
| 2<br>lean women with PCOS | |
| 3<br>Obese control women without PCOS | |
| 4<br>Obese women with PCOS | |
| 1xx - 04 LC<br>lean control women | |
| 1xx-04 LP<br>lean women with PCOS | |
| 1xx-04 OC<br>obese control women | |
| 1xx-04 OP<br>obese women with PCOS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 2004-2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of cytokines in fatty tissue |  | 2004-2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polycystic ovary syndrome (PCOS)
The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.

Official Title
-----------------
The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery

Conditions
-----------------
Mental Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Elective planned cardiac surgery Consent to participate Exclusion Criteria: Patients diagnosed with clinical depression Patients deemed not competent to provide consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optimism<br>Based on quality of life assessment | |
| Pessimism<br>Based on quality of life assessment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Discharge from hospital (average of 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ITU stay |  | 2 days | 
| Risk-adjusted survival |  | Discharge from hospital (average of 10 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optimism, Pessimism, Recovery, Elective Cardiac surgery
Cornell Translational Behavioral Science Research Consortium: Hypertension Qualitative Study

Study Overview
=================
Brief Summary
-----------------
To explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population.

Detailed Description
-----------------
The first goal is to explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population. Through a series of open-ended questions we will explore and build a better understanding of how hypertensive African American patients view their illness and the difficulties they have in taking their antihypertensive medications as prescribed. The second goal of the qualitative phase is to use the responses obtained to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in hypertensive African American patients.

Official Title
-----------------
Cornell Translational Behavioral Science Research Consortium: Hypertension Qualitative Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Semi-structured, open ended interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be self-identified as African-Americans. All patients must be aged 18 years and older. All patients must be diagnosed as having hypertension: For this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure > 140 mm hg or a diastolic blood pressure > 90 mm hg or if participants are taking any prescribed antihypertensive medication. Patients must be able to provide informed consent in English. Exclusion Criteria: Patients who refuse to participate Patients who are unable to provide informed 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

| Intervention/Treatment |
| --- |
|Behavioral: Semi-structured, open ended interview|nan|

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
-----------------
African American, Hypertension, Medication adherence, Risk reduction
Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Detailed Description
-----------------
Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months.

Official Title
-----------------
Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)

Conditions
-----------------
Coronavirus Disease 2019 (COVID-19)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old symptoms suggestive of COVID-19 positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2 Exclusion Criteria: Bacterial community acquired pneumonia

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| severe COVID-19 | death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula | 17/04/2020 to 01/06/2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus Disease 2019 (COVID-19), Vitamin D Deficiency, Severe Acute Respiratory Syndrome, Angiotensin Converting Enzyme 2