linjc16/ctgov huggingface dataset:
Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects

Official Title
-----------------
Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: DA-5206(Fasting)
* Drug: DA-5206(Fed)
* Drug: TALION®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer 19 years to 45 years Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate Exclusion Criteria: Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease Subject with acute disease within 28 days before the first dose of Investigational product Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TALION®<br> | Drug: TALION®<br>* Reference drug : Talion®<br>|
| Experimental: DA-5206(Fasting)<br> | Drug: DA-5206(Fasting)<br>* Test drug l : DA-5206(Fasting)<br>|
| Experimental: DA-5206(Fed)<br> | Drug: DA-5206(Fed)<br>* Test drug ll : DA-5206(Fed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) | PK Parameter | 0 24hr | 
| Peak Plasma Concentration (Cmax) | PK Parameter | 0 24hr |
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated. Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

Detailed Description
-----------------
The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.

Official Title
-----------------
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1

Conditions
-----------------
Diabetes Mellitus Type 1

Intervention / Treatment
-----------------
* Other: Microvascular assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 1 patients Matched control-subjects Exclusion Criteria: Patients or subjects with anti-inflammatory drugs

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes type 1 patients<br>The intervention will be : Microvascular assessment with laser speckle contrast imaging | Other: Microvascular assessment<br>* Microvascular assessment<br>|
| Active Comparator: Matched control-subjects<br>The intervention will be : Microvascular assessment with laser speckle contrast imaging | Other: Microvascular assessment<br>* Microvascular assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurovascular microcirculatory response | Neurovascular response will be assessed by laser speckle contrast imaging using various microvascular tests such as deionized water iontophoresis, local heating test. Results will be explained in Laser Speckle Perfusion Units (LSPU) | one day |
Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue

Study Overview
=================
Brief Summary
-----------------
In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance. Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells. Develop and implement quantitative and sensitive methods for measuring morphological properties. Clinical measurements.

Detailed Description
-----------------
Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.

Official Title
-----------------
Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue

Conditions
-----------------
Cervix, Cancer

Intervention / Treatment
-----------------
* Procedure: Colposcopy, Spectroscopy, and Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with abnormal Pap smears who are referred for colposcopy. Exclusion criteria include: Anyone of the male sex since this study focuses on cervical cell abnormalities Any woman who has had a hysterectomy, LEEP, or chemotherapy.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Colposcopy, Spectroscopy, and Biopsy|During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions. |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIH, Non-Invasive diagnosis of cervical tissue, Los Alamos/NIH
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

Study Overview
=================
Brief Summary
-----------------
Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Per Oral Endoscopic Myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm. Exclusion Criteria: Patients will be excluded from this study with the followings - Pregnancy Informed consent not available Previous history of esophagectomy or mediastinal surgery Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POEM<br>Endoscopic Myotomy | Procedure: Per Oral Endoscopic Myotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in LES pressure |  |  | 
| Eckhart score |  |  | 
| Operative time |  |  | 
| Length of myotomy |  |  | 
| Time to resume diet |  |  | 
| Morbidities |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertensive LES
Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

Study Overview
=================
Brief Summary
-----------------
The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

Official Title
-----------------
Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

Conditions
-----------------
Meningitis/Encephalitis

Intervention / Treatment
-----------------
* Diagnostic Test: FilmArray Meningitis/Encephalitis (ME) Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residual cerebrospinal fluid samples after routine tests; Samples obtained by lumbar puncture; Sample volume is not less than 0.5 mL; Samples that have not been centrifuged; Exclusion Criteria: Samples from repeatedly enrolled patients; Samples that have not been preserved as required

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FilmArray Meningitis/Encephalitis (ME) Panel|The FilmArray ME pouch is a closed system disposable that houses all the chemistry required to isolate, amplify and detect nucleic acid from multiple meningitis and encephalitis pathogens within a single CSF specimen obtained from a lumbar puncture. The rigid plastic component (fitment) of the FilmArray ME pouch contains reagents in freeze-dried form. The flexible plastic portion of the pouch is divided into discrete segments (blisters) where the required chemical processes are carried out. The user of the FilmArray ME Panel loads the sample into the FilmArray ME pouch, places the pouch into the FilmArray instrument/Module, and starts the run. All other operations are automated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sensitivity and specificity of the FilmArray ME Panel | Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay | 6 days upon sample collection |
Fluorine-18-α-Methyltyrosine Positron Emission Tomography for Diagnosis and Staging of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Objective: L-[3-18F]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino acid transporter 1 (LAT1) expression also investigated. Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical study.

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven or suspected non-small cell lung cancer Exclusion Criteria: uncontrolled diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 2 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
-----------------
Fluorine-18-α-methyltyrosine,, Positron emission tomography,, Fluorodeoxyglucose, Lung cancer,, Amino acid transportor 1,, Ki-67, Proven or suspected non-small cell lung cancer were enrolled in the study
Methylprednisolone Addition in IVF Treatment of Infertile Couples

Study Overview
=================
Brief Summary
-----------------
Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment

Detailed Description
-----------------
The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.

Official Title
-----------------
Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles

Conditions
-----------------
In Vitro Fertilization

Intervention / Treatment
-----------------
* Other: In vitro fertilization treatment for infertility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 36, more than 10 antral follicles, FSH<12 Exclusion Criteria: endometriosis stage III&IV,

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 36 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Follicular Medrol<br>In an Antagonist protocol for IVF patients will also receive 4mg tabl. Methylprednisolone twice a day from the day 2 of ovarian stimulation and until the day of the pregnancy test on luteal day-14 post oocyte retrieval | Other: In vitro fertilization treatment for infertility<br>* IVF treatment<br>* Other names: progesterone;|
| Placebo Comparator: No medrol group<br>Patients will receive only Antagonist protocol for IVF as usual | Other: In vitro fertilization treatment for infertility<br>* IVF treatment<br>* Other names: progesterone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progesterone rise above 1.5ng.ml on the day of HCG | Incidence or high progesterone on the day of HCG triggering | up to 14 days of follicular ovarian stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Success rate in IVF cycles | Follow pregnancy until delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methylprednisolone, IVF, progesterone, corticosteroid, late follicular phase, pregnancy rates
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

Study Overview
=================
Brief Summary
-----------------
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

Official Title
-----------------
An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431

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

Intervention / Treatment
-----------------
* Drug: Sitagliptin phosphate anhydrous formulation
* Drug: Comparator: sitagliptin phosphate monohydrate form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Female subjects must have a negative pregnancy test Subject is within 30% of ideal body weight Subject does not smoke Subject agrees to follow the study guidelines Exclusion Criteria: Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject Subject has a history of hypoglycemia Subject has a history of any hepatic disease Subject is taking any oral, parenteral, topical or implantable contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: 1<br>Sitagliptin anhydrous formulation | Drug: Sitagliptin phosphate anhydrous formulation<br>* Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.<br>|
| Active Comparator: 2<br>Sitagliptin monohydrate FMI formulation | Drug: Comparator: sitagliptin phosphate monohydrate form<br>* Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication | 
| Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication |
Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer

Study Overview
=================
Brief Summary
-----------------
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.

Detailed Description
-----------------
Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol within the NIH Pancreatic Cancer Detection Consortium. Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol within the NIH Pancreatic Cancer Detection Consortium.

Official Title
-----------------
Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer

Conditions
-----------------
Pancreatic Cyst, Pancreas Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Bio-Specimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 with pancreas cyst Older than 18 at high risk for Pancreas cancer Exclusion Criteria: Unable to provide consent Not willing to provide bio-specimens

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 |
| --- | --- |
| Pancreatic Cysts<br>Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected | Diagnostic Test: Bio-Specimen Collection<br>* Collection of bio-specimens and observation over time.<br>|
| High Risk Individuals<br>Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected | Diagnostic Test: Bio-Specimen Collection<br>* Collection of bio-specimens and observation over time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreas Cancer | Development of Pancreas Cancer | 5-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early detection, biomarkers, pancreas cancer