linjc16/ctgov huggingface dataset:
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Primary: To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Secondary: To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Official Title
-----------------
12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)

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

Intervention / Treatment
-----------------
* Drug: Insulin Glulisine
* Drug: Lispro
* Drug: Insulin Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetic patients Measure HbA1c 6.5% to 11.0% at visit 1 More than 3 months of continuous insulin treatment immediately prior to study entry Exclusion Criteria: Pregnant women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Administration of Insulin Glulisine | Drug: Insulin Glulisine<br>* 3 times a day before each meal<br>Drug: Insulin Glargine<br>* once daily<br>|
| Active Comparator: 2<br>Administration of Lispro | Drug: Lispro<br>* 3 times a day before each meal<br>Drug: Insulin Glargine<br>* once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic episodes |  | From the beginning to end of the study | 
| Change in HbA1c |  | From baseline to endpoint | 
| Adverse events |  | From the beginning to the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | From baseline to weeks 12 | 
| blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus. |  | from baseline to week 12 |
Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients

Study Overview
=================
Brief Summary
-----------------
Primary Objective: - To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation.

Detailed Description
-----------------
Researchers are currently conducting a survey on how important it is to women who are having a stem cell transplant to have information about the effects of the treatment on their fertility (their ability to have children) and on the risk of early menopause. Researchers know that some women who had transplants think that the information that they received may have been lacking or was not appropriate for their needs. Therefore, researchers would like to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to report what kind of information they got and would like to have gotten before or during their treatment.

Official Title
-----------------
Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among Young Women Who Underwent Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Stem Cell Transplantation

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center. Age 16 to 50 years at the time of the transplant. Exclusion Criteria: History of ovarian cancer. History of hysterectomy/oophorectomy Non-English speaking patients

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey Participants<br>Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center. | Behavioral: Survey<br>* 3-Part Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Survey Responders |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fertility, Menopause, Hematopoietic Stem Cell Transplantation, Questionnaire, Survey
Your Health in On Click

Study Overview
=================
Brief Summary
-----------------
A health education program was provided to higher education students aged between 18 and 25 years. Students were recruited either by posters and leaflets on campus, or during their mandatory medical survey at the University Medical Department. The objectives are to assess health behavior risk among college student : e.g eating disorders, binge drinking, electronic cigarettes and also stress, burnout

Official Title
-----------------
Your Health in On Click : Risk Behavior Among College Students

Conditions
-----------------
College Student Drinking, Eating Disorder, Stress, Psychological, Burn Out Syndrome, Cigarette Smoking, Hyperactivity, Health Behavior, Impulsive Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-25 years College students Exclusion Criteria: No college students

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of binge drinking, eating disorders, burn out and other risk behaviors among college students |  | 1 day |
Aminoterminal Propeptide of Type III Procollagen and Severity of Coronary Artery Disease in Patients Without Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Background: Myocardial fibrosis is a major component in cardiac remodeling in patients with myocardial infarction or hibernation. However, the association of cardiac fibrosis and coronary artery disease (CAD) in patients without infarction or hibernation is still unclear. In the present study, we analyzed the relationship between serum concentrations of procollagen propeptides and severity of CAD in such patients. Patients and methods: Forty-six patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular contractility were enrolled into this study. Myocardial infarction was excluded by history and electrocardiograms. All patients received stress thallium-201 single photon emission computed tomography (SPECT) and analysis of the serum levels of the aminoterminal propeptide of type I and III procollagen (PINP and PIIINP).

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We prospectively studied 46 consecutive patients aged 50 to 75 years (32 men and 14 women; mean age was 64 years) who were referred for chest pain evaluation. Exclusion Criteria: MI was excluded by history and electrocardiograms. Regional wall motion abnormalities and impaired left ventricular contractility (left ventricular ejection fraction < 50%) were excluded by routine echocardiography.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Synovial Chondrosarcoma: a Single Institution Experience

Study Overview
=================
Brief Summary
-----------------
single institution cases series review of histological, radiological and clinical data

Detailed Description
-----------------
single institution cases series review of histological, radiological and clinical data. Investigators will retrieve from the archives of the Rizzoli institute all the cases with a histological diagnosis of synovial chondrosarcoma.

Official Title
-----------------
Synovial Chondrosarcoma: a Single Institution Experience

Conditions
-----------------
Synovial Chondrosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients treated at Rizzoli Institute from 01 January 1982 to 31 December 2017 Diagnosis of synovial chondrosarcoma Age ≥ 18 years Histological slides / formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: Patients with histological diagnosis different from synovial chondrosarcoma

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| selection and review of cases of Synovial Chondrosarcoma | IDH1 and IDH2 analysis will be performed in order to better understand tumor characteristics and to identify the best therapeutic approach. | baseline (Day0) |
Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the factors influencing the decision about breast reconstruction after breast amputation for breast cancer. The study will be conducted at the University Hospital in Brussels using only a questionnaire. The results might help us to evaluate and improve the satisfaction among patients about the received information and guidance.

Detailed Description
-----------------
The questionnaire will be completed during one interview. This interview will take place preferably right after the patient visited her doctor at the Breast Clinic at the University Hospital in Brussels. Before starting the interview all the necessary information to decide whether or not to participate in the study will be given as well as the time to read the informed consent carefully.

Official Title
-----------------
Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren

Conditions
-----------------
Breast Cancer Female, Mastectomy, Breast Reconstruction

Intervention / Treatment
-----------------
* Other: semi-structured interview using a questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female Dutch speaking must have undergone a mastectomy for breast cancer in the following period: 2010 - 2015 must be a patient of the Breast Clinic at the University Hospital in Brussels Exclusion Criteria: bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast reconstruction<br>The patients choosing for breast reconstruction after mastectomy for breast cancer. | Other: semi-structured interview using a questionnaire<br>* semi-structured interview using a questionnaire<br>|
| No breast reconstruction<br>The patients not choosing breast reconstruction after mastectomy for breast cancer. | Other: semi-structured interview using a questionnaire<br>* semi-structured interview using a questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions) |  | december 2016 - may 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer Female, Mastectomy, Breast Reconstruction, questionnaire
Application of Ultrasonic Elastography in Lung Lesions

Study Overview
=================
Brief Summary
-----------------
Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a mainstream tool for ultrasound-based diagnosis. This compressibility property of materials, mathematically expressed as the change in tissue displacement as a function of its distance from the compressing device, is known as strain and is the parameter that is imaged in an elastogram. Elastography has currently shown promising result in differentiating viscoelastic nature of various organs, which is a consequence of certain underlying diseases. At present, there are limited literatures revealing the application and feasibility of ultrasonic elastography in lung lesions. This is essentially important as it may serve as an adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and feasibility of ultrasonic elastography on lung lesions.

Detailed Description
-----------------
Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound elastography. The strain ration was measured and was compared between necrosis, atelectasis, consolidation and tumor.

Official Title
-----------------
Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases

Conditions
-----------------
Elastography

Participation Criteria
=================
Eligibility Criteria
-----------------
A. Inclusion Criteria: Patients with radiographic findings of: consolidation obstructive pneumonitis tumors B. Exclusion Criteria: Patients with poor acoustic window Unable to hold breathing Not cooperative Presence of pleural effusion

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of strain ratio between necrosis, atelectasis, consolidation and tumor | The strain ratio was measured under ultrasonic elastography. At least three measurements were performed each time and we average all the measurements as the final strain ratio. Independent t test was used for comparison. | Up to 15 months |
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

Study Overview
=================
Brief Summary
-----------------
The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.

Official Title
-----------------
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

Conditions
-----------------
Pneumothorax, Spontaneous

Intervention / Treatment
-----------------
* Procedure: simple exsufflation
* Procedure: Fuhrman catheter and ambulatory care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Episode of primary spontaneous pneumothorax wide according to the criteria Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simple exsufflation<br> | Procedure: simple exsufflation<br>* simple exsufflation<br>|
| Experimental: Fuhrman catheter and ambulatory care<br> | Procedure: Fuhrman catheter and ambulatory care<br>* Fuhrman catheter and ambulatory care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful patient rates of ambulatory care |  | Day 6 |
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

Study Overview
=================
Brief Summary
-----------------
Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese children. Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A prospective transversal study.

Detailed Description
-----------------
The population of study will be make for children of both sex, between 3 and 14 years old and with body mass index (BMI) ≥ 95 percentile and with informed consent. METHODS: In all children included in the study, the investigators will carry out: previous history, history of snoring and Chervin´s screening questionnaire of SAHS, general physical and otorhinolaryngologic examination with nasopharyngoscopy, blood test with determination of glucose, lipids, insulin, leptin, adiponectin, and ghrelin, polysomnography (PSG) with transcutaneous CO2. The diagnosis of SAHS will be made if on PSG the Respiratory disturbance Index (RDI) is ≥ 3 and/or obstructive hypoventilation is present.

Official Title
-----------------
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors

Conditions
-----------------
Sleep Apnea, Children, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of both sex, between 3 and 14 years old Body mass index (BMI) ≥ 95 percentile With informed consent. Exclusion Criteria: Without informed consent

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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 |
| --- | --- | --- |
SENSIMED Triggerfish Sensor Sizes

Study Overview
=================
Brief Summary
-----------------
This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.

Official Title
-----------------
A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: SENSIMED Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject without previous ocular disease Aged ≥ 18 years, of either sex Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye Not more than 6 diopters spherical equivalent in the study eye Having given written informed consent, prior to any investigational procedures Exclusion Criteria: Corneal or conjunctival abnormality precluding contact lens adaptation Severe dry eye syndrome Subjects with allergy to corneal anesthetic Subjects with contraindications for silicone contact lens wear Subjects not able to understand the character and individual consequences of the investigation Participation in other clinical research within the last 4 weeks Any other contra-indication listed in the TF user manual

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SENSIMED Triggerfish<br>There is only 1 arm in the study. SENSIMED Trigerfish lens sensors with different base curves are placed on subjects in random and double-blinded manner in sequential sessions. | Device: SENSIMED Triggerfish<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit |  | 24 hours |