linjc16/ctgov huggingface dataset:
Efficacy Study of Bowel Preparation Before Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.

Official Title
-----------------
Efficacy Study of Bowel Preparation Before Colonoscopy

Conditions
-----------------
Bowel Cleansing Prior to Colonoscopy

Intervention / Treatment
-----------------
* Drug: FM-601


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age. Are able to communicate with study personnel and comply with study requirements. Are able and willing to follow study-specified testing, diet, and hydration regimen. Have been informed of the nature and risks of the study and have given written informed consent. Exclusion Criteria: Have known or suspected liver disease or any history of abnormal liver function tests. Have clinically active cardiovascular disease within the past 6 months. Have blood pressure greater than 150/90 mm Hg. Have known or suspected renal insufficiency. Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus. Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease. Have diabetes or a history of diabetes. Have clinical evidence of dehydration. Are pregnant or breast-feeding. Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study. Use prohibited medications of the study in the defined timeframes. Have received any investigational agent within 30 days before dosing. Have any known contraindications to the study treatment. Have any known or suspected allergies to the components of the study medication. Have any other condition which would make the subject unsuitable for inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FM-601|Dose-escalation, split dosage, liquid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of bowel cleansing based on a grading scale. |  | During colonoscopy |
Early Exposure to Lead and Adult Antisocial Outcomes

Study Overview
=================
Brief Summary
-----------------
Prior research indicates a link between early lead exposure and risk for delinquent behavior. In this study, we follow a large birth cohort from the Cincinnati Lead Study into early adulthood to determine whether this increased risk persists. Outcome measures include official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality Disorder, self-report of delinquent behavior, and a psychopathy scale. Predictors include pre-natal and post-natal blood lead levels. Multivariate statistical methods will control for potential confounders/covariates.

Conditions
-----------------
Lead Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Part of original CLS birth cohort - Exclusion Criteria: (1) Moved out of geographic area -

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 |
| --- | --- | --- |
| Lead Exposure and Antisocial Behavior |  | Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years) |
An Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.

Detailed Description
-----------------
In this study 60 menopausal women randomly allocated to intervention group(n=30) and control group(n=30). Intervention group participated in an educational program that had designed in four sessions based on teach back method. Control group revived no education.

Official Title
-----------------
The Effect of an Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Other: An Educational Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopausal women(1-5 years after menopause) no history of hysterectomy no history of oophorectomy literacy for reading and writing Exclusion Criteria: no interest for continuing the study no participating in all educational sessions

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 57 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>An Educational Program | Other: An Educational Program<br>* An educational program was designed for self-care during menopause using teach back method.<br>|
| No Intervention: Control group<br>This group(n=30) received no intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-care practice | self-care practice regard menopausal health was measured using a researcher made questionnaire | one month |
Cost Effectiveness and Utility of Computed Tomography Angiography (CTA) and Cardiac Cath

Study Overview
=================
Brief Summary
-----------------
This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.

Detailed Description
-----------------
This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.

Official Title
-----------------
Cost Effectiveness and Utility of Coronary Artery Computed Tomography Angiography (CTA) in Screening for Coronary Artery Disease

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have had both CTA and Coronary angiogram. 18 years old and older. Exclusion Criteria: Under 18 years of age Memory Impairment: Stroke Traumatic brain Injury Dementia

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 |
| --- |
|Other: Survey|To determine patient preference for the two tests CT angiography (CTA) and catheter coronary angiography (CCA).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of CT and catheter angiography | Utility of CT and catheter angiography was compared within patients who had both tests performed. | Within 6 months of testing with CT and catheter angiography |
Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study was to investigate if a six months period of physical exercise could improve motor memory consolidation in elderly people.

Detailed Description
-----------------
38 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Official Title
-----------------
Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Other: Motor memory consolidation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals not engaged in physical activity; persons aged from 65 years. Exclusion Criteria: sensory abnormalities; mental abnormalities; motor abnormalities; other atypical health problems.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 72 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Other: Motor memory consolidation<br>* Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects performed a Finger Tapping Sequence to measure a performance in Motor memory consolidation. | The participants were required to learn a Finger Tapping Sequence (4_1_3_2_4) by using a computer keyboard. The finger sequence corresponded to computer keys as follows: digit 1 - Index finger; digit 2 - Middle finger; digit 3 - Ring finger; digit 4 - Little. The participants were requested to repeat the sequence as quickly and as accurately as possible for 30 seconds. | 6 months |
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This surveillance's objectives are: Unknown adverse reactions Incidences of adverse drug reaction Factors considered to have effect to safety and effectiveness

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: E7040


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with Hepatocellular carcinoma Exclusion criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E7040<br> | Device: E7040<br>* E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .<br>* Other names: DC Beads;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as measured by Adverse Events |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of DC bead as assessed by embolic performance |  | Up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Hepatocellular
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.

Detailed Description
-----------------
To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control. Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).

Official Title
-----------------
Multi Center, Open Label Study to Evaluate the Influence of Pioglitazone Treatment Over 6 Months on Metabolic Control in Type II Diabetic Patients Previously Treated With Insulin

Conditions
-----------------
Type 2 Diabetes Mellitus, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: pioglitazone and glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus insulin therapy > 1 year residual ß-cell function (C-peptide increase in iv glucagon test) written informed consent Exclusion Criteria: type 1 diabetes oral therapy life-threatening disease heart failure (NYHA I-IV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>pioglitazone/glimepiride | Drug: pioglitazone and glimepiride<br>* switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.<br>* Other names: Amaryl - glimepiride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change of HbA1c Insulin resistance according to minimal model and HOMA-S analysis change of insulin resistance according to minimal model and HOMA-S analysis to baseline first phase insulin response |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, insulin treatment, ß-cell function
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)

Study Overview
=================
Brief Summary
-----------------
The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.

Official Title
-----------------
A Double-Blind, Multicenter, Placebo-Controlled Study of MK0777 Gel Extrusion Module (GEM) 1.5 mg b.i.d. in the Treatment of Outpatients With Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: MK0777
* Drug: Placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Current diagnosis of Generalized Anxiety Disorder Age 18 - 70 Exclusion Criteria: Women who are pregnant, or breast-feeding Use of illicit drugs History of drug or alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>Drug | Drug: MK0777<br>* Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo (unspecified)<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the reduction of anxiety |  | after 4 weeks and at end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy |  | throughout study and at end of study |
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration

Study Overview
=================
Brief Summary
-----------------
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.

Official Title
-----------------
The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.

Conditions
-----------------
Postoperative Pain, Analgesic Efficacy

Intervention / Treatment
-----------------
* Drug: 20 mL ropivacaine 5 mg/mL
* Drug: 10 mL ropivacaine 10 mg/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for total knee arthroplasty Able to give informed oral and written consent to participate Exclusion Criteria: Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.) Allergies to any of the drugs administered.
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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low volume local anesthetic<br>bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL) | Drug: 10 mL ropivacaine 10 mg/mL<br> <br> |
| Experimental: high volume local anesthetic<br>bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) | Drug: 20 mL ropivacaine 5 mg/mL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 32 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty, postoperative pain
Human Factors and Home Use Study of the Vigilant Diabetes Management Application

Study Overview
=================
Brief Summary
-----------------
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.

Official Title
-----------------
Human Factors and Home Use Study of the Vigilant Diabetes Management Application

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Vigilant Diabetes Management Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with diabetes mellitus testing blood glucose 3 or more times per day Clinicians who see diabetes patients Exclusion Criteria: Admission for diabetic ketoacidosis in the 6 months prior to enrollment A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Usability testing<br>Patients will participate in summative human factors testing of the Vigilant Diabetes Management Application in a controlled environment and during home use testing. Clinicians will participate in summative human factors testing in a controlled environment. | Device: Vigilant Diabetes Management Application<br>* Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale) | An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined. | 1 month home use | 
| Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed) | Percent successful initial or reattempt task completion across the range of usability tasks. Example: One task is to access the Trends screen to review and interpret weekly and monthly trend data for blood glucose variability and average glucose values. | Controlled in-office testing for up to 2 hours |