linjc16/ctgov huggingface dataset:
A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.

Official Title
-----------------
A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: PF-05175157


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects with normal results in all screening examinations. Body Mass Index of 17.5 to 35.5 kg/m2 Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Known history of intolerance to simvastatin or other statins.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm, fixed sequence dosing<br> | Drug: Simvastatin<br>* Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)<br>Drug: PF-05175157<br>* Days 2-9 inclusive: daily dosing of PF-05175157 200 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration curve of simvastatin and simvastatin acid |  | 10 days | 
| Maximum observed plasma concentration of simvastatin and simvastatin acid |  | 10 days | 
| Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed |  | 10 days | 
| If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time |  | 10 days | 
| If the data permit, terminal elimination half-life of simvastatin and simvastatin acid |  | 10 days |
Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study

Study Overview
=================
Brief Summary
-----------------
The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer than flat and polypoid lesions.

Official Title
-----------------
Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study

Conditions
-----------------
Nonpolypoid Colorectal Neoplasms(NP-CRN)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive adult patients undergo colonoscopy by one endoscopist

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
-----------------
nonpolypoid colorectal neoplasms(NP-CRN), prevalence, histology
Single Dose CHG Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.

Official Title
-----------------
Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)

Conditions
-----------------
Surgical Skin Preparation

Intervention / Treatment
-----------------
* Drug: Chlorhexidine Gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were: non- or ex-smokers body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg negative pregnancy test for female subjects healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal application of 2% CHG<br> | Drug: Chlorhexidine Gluconate<br>* 2% CHG<br>|
| Experimental: Groin application of 2% CHG<br> | Drug: Chlorhexidine Gluconate<br>* 2% CHG<br>|
| No Intervention: Control treatment with no application<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment. | Up to 24 hours after product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With of Treatment Emergent Adverse Events. | Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA). | Up to 24 hours after product application, overall, up to 3 weeks |
Partners in Health: A Couples-based Approach to Obesity Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. The primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.

Official Title
-----------------
Partners in Health: A Couples-based Approach to Obesity Prevention.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Women >18 years old 15-22 weeks gestation BMI >= 25 cohabitating with partner for at least 3 months or recently married willing to consent Non-pregnant Partner BMI >= 25 cohabitating with partner for at least 3 months or recently married willing to consent Exclusion Criteria: Untreated medical or psychological problem Inability to be physically active

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br> | |
| Experimental: Lifestyle Intervention<br> | Behavioral: Lifestyle Intervention<br>* The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used. | 16 weeks gestation, 35 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partner's weight loss | Weight lost by the non-pregnant partner during the study will be assessed by subtracting their weight at the 35 week gestation visit from their study entry weight. | study entry, when pregnant partner reaches 35 weeks gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Gain, Weight Loss, Overweight, Obese, Pregnancy
Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

Study Overview
=================
Brief Summary
-----------------
Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

Official Title
-----------------
Topical and Intravenous Use of Tranexamic Acid in Posterior Lumbar Interbody Fusion - A Prospective, Double-blind, Randomized Study

Conditions
-----------------
Lumbar Disc Degeneration, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observation<br>Clinical data analysis | Other: Observational<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation |  | 1 |
Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study

Study Overview
=================
Brief Summary
-----------------
study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes

Detailed Description
-----------------
The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas. CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.

Official Title
-----------------
Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study

Conditions
-----------------
Cone-Beam Computed Tomography

Intervention / Treatment
-----------------
* Diagnostic Test: Voxel size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Selection of the human dry mandibles will be independent of age, gender and ethnicity. They should be intact, free from any bone defects, fractures, pathology. Dentate state of the mandibles is not an element in selection criteria; either dentulous or edentulous mandibles are acceptable Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: voxel size<br>200 μm and 300 μm Voxel Sizes | Diagnostic Test: Voxel size<br>* 200 μm and 300 μm Voxel Sizes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of linear measurement | Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes | 1 year |
Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section. Healthy pregnant women will serve as a control group.

Detailed Description
-----------------
The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study: fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section. Bloods will be analyzed for insulin, c-peptide, glucose and fat profile Placenta and fat tissue will be analyzed for miRNA and total RNA Clinical and anthropometric measurements will be taken from the mother Placenta status will be taken

Official Title
-----------------
Biological Changes in the Adipose Tissue (RNA Profile) Among Pregnant Women With Diabetes

Conditions
-----------------
Pregnancy, Diabetes

Intervention / Treatment
-----------------
* Other: Diabetes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-45 pregnant signed consent form going through an elective C-section Diabetic reference group: healthy women with no background illness Exclusion Criteria: <18 or >45 chronic illness that may effect the outcome polypharmacy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with diabetes<br>Pregnant women with diabetes type 1, type 2 or gestational diabetes | Other: Diabetes<br>* the trial is observational with no intervention<br>|
| Healthy pregnant women<br>Healthy pregnant women with no underlying illness | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA profiling |  | samles are taken during C-section samples will be analyzed after completion of collection |
Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

Conditions
-----------------
Hypotrichosis

Intervention / Treatment
-----------------
* Drug: bimatoprost ophthalmic 0.03% solution
* Drug: vehicle sterile solution (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American/ethnic black Adults at least 18 years of age Eyelash prominence assessment of minimal or moderate Exclusion Criteria: Subjects with uneven lashes or longer on one side than the other Any eye disease or abnormality Eye surgery Severe hyperpigmentation around the eye Eyelash implants Eyelash extension application Any use of eyelash growth products within 6 months Any use of prescription eyelash growth products Treatments that may affect hair growth Requiring eye drop medications for glaucoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LATISSE®<br>bimatoprost ophthalmic 0.03% solution | Drug: bimatoprost ophthalmic 0.03% solution<br>* Apply one drop of study medication along the upper eyelid margin once daily in the evening<br>* Other names: LATISSE®;|
| Placebo Comparator: Placebo<br>vehicle sterile solution | Drug: vehicle sterile solution (placebo)<br>* Apply one drop of study medication along the upper eyelid margin once daily in the evening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 | Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence). | Month 4 |
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.

Conditions
-----------------
Cholestasis, Cystic Fibrosis, Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Drug: ursodiol


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Chronic cholestatic liver disease Cystic fibrosis-associated liver disease --Prior/Concurrent Therapy-- Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil --Patient Characteristics-- Pulmonary: No serious respiratory deficiency No acute illness No inability to swallow No fertile women

Ages Eligible for Study
-----------------
Minimum Age: 4 Months

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ursodiol|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
-----------------
cholestasis, cardiovascular and respiratory diseases, cystic fibrosis, gastrointestinal disorders, genetic diseases and dysmorphic syndromes, rare disease
Brief Computerized Feedback for Smokers in Recovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to find out more about smokers in recovery from addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior feedback session. The hypothesis is that a brief computerized smoking behavior feedback session will motivate more smokers to quit smoking than a control condition.

Official Title
-----------------
Brief Computerized Feedback for Smokers in Recovery

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Other: Brief computerized feedback
* Other: Resources only (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years of age or older Be in recovery from addiction to alcohol and/or drugs (self-defined) Have smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week Have smoked at least 100 cigarettes (lifetime) Have an expired air carbon monoxide (CO) level of > 6 ppm (verifies current smoking) Be cognitively able to understand the proposed research design (screening followed by random assignment to one of the two conditions, if appropriate) To be eligible to receive NRT (if chosen by the participant), participants must: Not be pregnant, breastfeeding, or plan to become pregnant in the next year Not have experienced a myocardial infarction (heart attack) or have been hospitalized for a heart-related problem in the last 2 weeks

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief computerized feedback<br>Brief computerized feedback | Other: Brief computerized feedback<br>* Brief computerized feedback<br>|
| Active Comparator: Resources only<br> | Other: Resources only (control)<br>* Participants randomized to the control group will discuss the option of quitting smoking, along with an information sheet, highlighting resources available to assist participants with smoking cessation, such as the Virginia Quitline (1-800 QUIT NOW) and nicotine replacement therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % quit smoking |  | 4 weeks |