linjc16/ctgov huggingface dataset:
The Food Effect on the Pharmacokinetics of NVP-1402

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.

Detailed Description
-----------------
This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.

Official Title
-----------------
The Food Effect on the Pharmacokinetics of NVP-1402

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

Intervention / Treatment
-----------------
* Drug: NVP-1402


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males No history of clinically significant medical disorder Capable of consent to participate in the study Exclusion Criteria: History of hypersensitive reactions to study drug or other related drugs Any significant abnormality found during screening Any significant medical history History of alcohol abuse, smoking continuously History of drug abuse Clinically significant surgery within 4 weeks prior to administration of the study drug Participation in another clinical trial within 3 months prior to administration of the study drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1402-1<br>NVP-1402 was administered once a day for 24 hours | Drug: NVP-1402<br>* Oral<br>|
| Experimental: NVP-1402-2<br>NVP-1402 was administered once a day for 24 hours | Drug: NVP-1402<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of plasma: Cmax | Maximum measured concentration of the analyte in plasma | up to 24 hours after administration | 
| Pharmacokinetics of plasma: AUClast | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point | up to 24 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of plasma: AUCinf | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 24 hours after administration | 
| Pharmacokinetics of plasma: Tmax | Time from dosing to the maximum measured concentration of the analyte in plasma | up to 24 hours after administration | 
| Pharmacokinetics of plasma: t1/2 | Terminal half-life of the analyte in plasma | up to 24 hours after administration |
Calculation of Platelet-rich Plasma Preparation Yield

Study Overview
=================
Brief Summary
-----------------
This is a study to determine 1) the consistency of platelet-rich plasma produced by several methods, and 2) whether the platelet content of platelet-rich plasma can be accurately estimated from a baseline CBC platelet count.

Detailed Description
-----------------
In the first phase of this study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The platelet count will be measured in each PRP preparation and compared to the CBC platelet count to determine the platelet yield for each method. In the second phase of the study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The CBC platelet count will be used to calculate the estimated platelet content of each sample/method based on the platelet yields determined in the first phase. The platelet count will be measured in each PRP preparation and compared to the estimated platelet content to determine the predictive accuracy for each method.

Official Title
-----------------
Calculation of Platelet-rich Plasma Preparation Yield From Baseline CBC Platelet Count

Conditions
-----------------
Platelet-rich Plasma Production

Intervention / Treatment
-----------------
* Procedure: venipuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Exclusion Criteria: platelet count < 150,000 platelet count > 350,000 History of blood disorder History of altered platelet function History of chemotherapy or radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: venipuncture|blood draw for the purpose of determining the platelet concentration in PRP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet yield | the number of platelets in a PRP sample as a percentage of the number of platelets in the blood from which the PRP was prepared. | within 8 hours of blood draw | 
| Platelet yield estimate accuracy | standard deviation of the difference between the estimated platelet yield and the actual platelet yield. | within one month of final data collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet-rich plasma, platelet
Role of Angiotensin II in Insulin-induced Microvascular Activity

Study Overview
=================
Brief Summary
-----------------
In this study we hypothesize infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects?

Official Title
-----------------
Role of Angiotensin II in Insulin-induced Microvascular Activity

Conditions
-----------------
Insulin Sensitivity, Microcirculation

Intervention / Treatment
-----------------
* Drug: Angiotensin II
* Drug: Phenylephrine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18-60 years 2.Caucasian 3.Blood pressure <140/90 mmHg. Exclusion Criteria: Obesity (BMI>27kg/m2) Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure) Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA Smoking Alcohol use >4U/day Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs) Pregnancy Wearing contact lenses

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: Angiotensin II<br>Angiotensin II | Drug: Angiotensin II<br>* Angiotensin II<br>|
| Active Comparator: Phenylephrine<br>Phenylephrine | Drug: Phenylephrine<br>* Phenylephrine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional recruitment of capillaries in the skin |  | January 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perfused capillary density in the nailfold |  | January 2009 | 
| Endothelium- (in)dependent vasodilatation of finger skin microcirculation |  | January 2006 | 
| Insulin sensitivity |  | January 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angiotensin II
Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.

Official Title
-----------------
A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Device: Surgical mask
* Device: N95 mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses who work in emergency departments and medical units Nurses expected to work full time (defined as > 37 hours per week) Exclusion Criteria: Nurses who were not fit tested Nurses who could not pass a fit test
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Surgical<br>surgical mask | Device: Surgical mask<br>* Surgical mask worn for patients with febrile respiratory illness<br>|
| Active Comparator: 2. N95 Respirator<br>N95 respirator | Device: N95 mask<br>* N95 mask worn for patients with febrile respiratory illness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed Influenza Infection | Laboratory confirmed influenza | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Visits for Respiratory Illness | visit to primary care MD | one year | 
| Influenza-like Illness | Cough and fever | Over entire study period | 
| Absenteeism | Absent from work because of flu-like illness | over study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N95, Respirator, mask, influenza, efficacy
Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?

Study Overview
=================
Brief Summary
-----------------
Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.

Detailed Description
-----------------
Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests

Official Title
-----------------
ROLE OF E COLI IN Colorectal Tumourigenesis

Conditions
-----------------
Enteropathogenic Escherichia Coli ., Colorectal Carcinoma

Intervention / Treatment
-----------------
* Other: colonoscopic biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with colorectal carcinoma after have been diagnosed Exclusion Criteria: Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.
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 |
| --- | --- |
| group 1<br>colonoscopic biopsies from patients with colorectal cancer patients | Other: colonoscopic biopsies<br> <br> |
| (Group 2<br>colonoscopic biopsies from healthy controls | Other: colonoscopic biopsies<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virulence genes: eaeA, bfpA and stx. PCR | E. coli colonies isolated from the mucosa of colorectal cancers and from healthy controls were harvested and subjected to DNA extraction (QIAGEN) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPEC serogrouping: | Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests to detect EPEC using O-specific nonavalent E.coli antiserum (O26, O55, O86, O111, O114, O119, O124, O125, O126, O127, O128, O142), according to the manufacturer's instructions (Bio-Rad). | 1 week | 
| Strains: OF E COLI | The specimens were immediately transferred to the lab, inoculated in nutrient broth and vortexed for a few seconds then incubated overnight. The following day the broth culture was subcultured on enteric isolation media. Identification of E. coli was carried out by using standard biochemical methods. | 1 week |
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

Official Title
-----------------
A Randomized, Open Label, Crossover Study to Explore Drug-drug Interaction Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Co-administration of DWC20155/DWC20156
* Drug: DWC20161


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepts healthy volunteers Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study effect of DWC20161 on DWC20155/DWC20156 PK<br>To study effect of DWC20161 on DWC20155/DWC20156 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20161<br> <br> |
| Experimental: Study effect of DWC20155/DWC20156 on DWC20161 PK<br>To study effect of DWC20155/DWC20156 on DWC20161 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20161<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 0 24 hours | 
| Area under the plasma concentration versus time curve (AUC) |  | 0 24 hours |
18F-AV-1451 High Resolution Autopsy Study

Study Overview
=================
Brief Summary
-----------------
The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Official Title
-----------------
A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: 18F-AV-1451


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Projected life expectancy ≤ 6 months Exclusion Criteria: Primary brain tumor, known metastases to the brain, central nervous system lymphoma Major, focal structural brain lesion Aggressively being treated with life sustaining measures Clinically significant infectious disease History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation Have received or participated in a trial with investigational medications in the past 30 days Females of childbearing potential who are pregnant or not using adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 89 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: Autopsy Cohort<br>End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of 18F-AV-1451. | Drug: 18F-AV-1451<br>* Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.<br>* Other names: [F-18]T807;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of 18F-AV-1451 scan and pathology | Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy. | autopsy within 6 months of scan |
Spirituality and Will to Live in Patients With HIV/AIDS

Study Overview
=================
Brief Summary
-----------------
This study is assessing the extent of spirituality in patients with HIV/AIDS and will determine the relationship between spirituality, health status, and the will to live.

Detailed Description
-----------------
Approximately 1,000,000 Americans have HIV/AIDS. Although advances in treatment have made HIV/AIDS a relatively manageable chronic disease, the disease can cause significant morbidity and mortality. Surprisingly, research has found that some HIV/AIDS patients feel that their life is better than it was before they had HIV/AIDS. Many of these patients show a strong will to live and often express a preference for longevity over quality of life. Patients who prefer longevity often ascribe their feeling to spiritual growth, or finding a meaning to life. This study is examining the spiritual beliefs of HIV/AIDS patients and will determine the relationship between spirituality, health status, and the will to live. The study consists of interviews with HIV/AIDS patients from Cincinnati and Washington, D.C. who have been interviewed twice over 12 to 18 months. During the interviews, participants completed self-report scales to assess their quality of life, life satisfaction, concerns about medication, trust in their health care providers, depressive symptoms, self-esteem, optimism, and various clinical and demographic variables. Participants were also asked about their spiritual well-being; spiritual beliefs; spiritual, religious, and social support; and overall functioning.

Official Title
-----------------
Spirituality and Will to Live in Patients With HIV/AIDS

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HIV or AIDS Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 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
-----------------
HIV, AIDS, Spirituality