linjc16/ctgov huggingface dataset:
Clinical Evaluation of a Bioactive Material

Study Overview
=================
Brief Summary
-----------------
The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite [Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo, Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Official Title
-----------------
Clinical Evaluation of a Bioactive Material

Conditions
-----------------
Tooth Disease

Intervention / Treatment
-----------------
* Device: bioactive composite
* Device: posterior composite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age range will be 18 to 65 patients should have at least 2 approximal caries lesions require restoration healthy periodontal status a good likelihood of recall availability Exclusion Criteria: poor gingival health adverse medical history potential behavioral problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioactive composite<br>Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) | Device: bioactive composite<br>* Cention N<br>|
| Experimental: posterior resin composite<br>G-ænial Posterior (GC, Tokyo, Japan) (GP) | Device: posterior composite<br>* G-ænial Posterior<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different restorative systems according to FDI criteria | Two year results according to FDI criteria | two years |
Progranulin and CTRP3 in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify the clinical meaning of these two adipokines in the subjects with or without metabolic syndrome

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20<age<80 apparently healthy subjects Exclusion Criteria: a history of CVD diabetes stage 2 hypertension malignancy severe renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apparently Helathy Subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of progranulin in the subjects with metabolic syndrome |  | 12week | 
| Serum concentration of CTRP3 in the subjects with metabolic syndrome |  | 12week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of serum progranulin levels with cardiovascular risk factors |  | 12 week | 
| The relationship of serum CTRP3 levels with cardiovascular risk factors |  | 12 week |
Investigation of the Effect of Toilet Training Given to Children

Study Overview
=================
Brief Summary
-----------------
In the study, it was aimed to examine the factors affecting the toilet training of children aged 18-36 months who have no problems in social-emotional development and the effect of professional support on the toilet training process.

Detailed Description
-----------------
Toilet training studies in Turkey and analyzes of bladder, bowel control and training completion times in these studies are limited. In this study, training processes were examined separately, and the factors that were not studied frequently until today were investigated. Also the effects of the professional support provided to children who did not have problems in social-emotional development on the process were examined.

Official Title
-----------------
Investigation of the Effect of Toilet Training Given to Children Who Have no Problems in Their Social-emotional Development on the Process of Acquiring Toilet Habits

Conditions
-----------------
Toilet Training

Intervention / Treatment
-----------------
* Behavioral: Toilet training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not having received toilet training age of the child between 18-36 months normal social-emotional development no known chronic disease Exclusion Criteria: having received toilet training the child's age is outside the range of 18-36 months abnormal social-emotional development presence of chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Children and families included in the study group were directed to the child development unit to receive toilet training. | Behavioral: Toilet training<br>* As the training model, Brazelton's child-oriented toilet training method was taken as the basis in study group. In addition, literature studies on toilet training in Turkey were scanned and the final form of training to be given to mothers was created. In the control group, families manage training process themselves.<br>|
| No Intervention: Control Group<br>The control group consisted of families who wanted to manage toilet training process themselves. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toilet training completion age | It was defined as the age at which bladder and bowel control were fully achieved. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toilet training, Social-emotional development, Child
Preventable Paediatric Trauma - Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre with injuries of all systems, major and minor, in order to determine the exact circumstances of the injury, whether this might have been preventable and design a Haddon Matrix of risk factors for injury to target prevention. Hypothesis: injury prevention interventions can be targetted by finding out local causes of Paediatric Trauma

Detailed Description
-----------------
A Trauma Registry is already kept in the hospital. It is confidential and data is supplied to the government from this registry. The procedure is to be granted access to the database and access data stored on the mechanism and outcome of Paeditric Trauma. This data will be stored on the work computer of the principal investigator and will be password protected. Methods: Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.

Official Title
-----------------
Preventable Paediatric Trauma - Retrospective Analysis

Conditions
-----------------
Pediatric Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients classified as Paediatric according to Israeli law (up to the age of 18 years). This includes pregnant women and patients presenting with multiple complaints as well as Trauma, isolated injuries and polytrauma. Exclusion Criteria: Patients for whom no history is available.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing exact mechanism of injury | This is a retrospective study. We approximate that since the Trauma registry began in 2007, there have been 200 Paediatric injuries every year. By the end of this year's data collection, therefore, we estimate that we would have collected data from 1000 patients. | 5 years (2007-2012) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fall, burn, road traffic crash
Meditation-Based Stress Reduction in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).

Official Title
-----------------
Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: stress reduction program
* Behavioral: meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714; 18 years of age or older; Able to read and write English; Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore; Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week; Stable on rheumatoid medications for at least one month. Exclusion criteria: Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.); Active alcoholism or drug dependency; Scheduled for major surgery during the study period; Enrolled in randomized clinical trial for rheumatoid arthritis during the study period; Planning to move out of the area in the next 12 months; Unwilling to be enrolled in a control group; Use of assistive device other than a cane; Serious health condition(s) that the investigator determines would make it difficult to complete the 6 month study; Diagnosis of fibromyalgia.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: stress reduction program|nan|
|Behavioral: meditation|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
-----------------
rheumatoid arthritis, stress reduction, meditation, mindfulness, MBSR, mindfulness-based stress reduction, mind-body skills
Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device

Study Overview
=================
Brief Summary
-----------------
The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions

Detailed Description
-----------------
The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions. Measurements will be taken at 15 minutes intervals during the day and 30 minutes intervals during the night.

Official Title
-----------------
Comparison of Arterial Tonometry Sensor (BPro) With Standard Oscillometric Blood Pressure Monitoring Device (Oscar 2) for Ambulatory Use

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: BPro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give informed consent Exclusion Criteria: Difference in blood pressure between the arms higher than 10 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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 |
| --- | --- |
| Experimental: BPro vs Oscar 2<br>Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions | Device: BPro<br>* BPro and Oscar 2 comparison for 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices | Mean of the absolute differences in systolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours | 24 hours | 
| Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices | Mean of the absolute differences in diastolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure
Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.

Study Overview
=================
Brief Summary
-----------------
A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.

Detailed Description
-----------------
From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery. Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.

Official Title
-----------------
Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologic T3 tumours of esophagus or GEJ Exclusion Criteria: pT other than pT3 R2 resections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| R0<br>Complete resection | |
| R1<br>Incomplete resection, microscopical tumor residu left behind | |
| CRM<1mm<br>complete resection (R0), however tumor spreads till less than 1 mm from the section pane. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | 5 years overall survival after esophagectomy | 5 years after esophagectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy
Pediatric Epilepsy Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Official Title
-----------------
A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: To enter this study, patients must: Have a diagnosis of partial seizures Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication Be willing to be hospitalized for up to 5 days Weigh a minimum of 6.6 lbs Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease Have normal laboratory results EXCLUSION CRITERIA: To enter this study, a patient must not have or be: Seizures caused by metabolic disturbance, toxic exposure, or active infection A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) A history of status epilepticus within 30 days Seizures not related to epilepsy This study has some AED restrictions Serum sodium levels <135 mEq/L Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy A history of chronic infection (e.g., hepatitis or HIV) Significant electrocardiogram (ECG) abnormalities A nursing mother taking anti-convulsant drugs A history of substance abuse (including alcohol) Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds Used experimental medication within 30 days of entering this study

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 Years

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: oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial seizures
Study Evaluation LXR-623 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.

Official Title
-----------------
A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: LXR-623


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy adults. Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening. Exclusion Criteria: A history or active presence of clinically important medical disease. Any metal implants or devices. Claustrophobia.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LXR-623|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety is the primary outcome. |  |  |
The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients

Study Overview
=================
Brief Summary
-----------------
It has been shown retrospectively that participation and even the willingness improves the survival of patients after myocardial infarction or heart failure. We aimed to prospectively analyse the role of participation in cardiology trials on the survival of patients in a high volumen tertiary center.

Official Title
-----------------
The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients

Conditions
-----------------
Myocardial Infarction, Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Optimal medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalisation due to acute myocardial infarction, and or heart failure Singed informed consent Exclusion Criteria: Previous participation in any clinical study Haemodinamically instable, shock, intubation Pregnancy, breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Willing to participate in clinical study<br> | Drug: Optimal medical therapy<br>* Optimal medical therapy<br>|
| Not-willing to participate in clinical study<br> | Drug: Optimal medical therapy<br>* Optimal medical therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 2-years |