linjc16/ctgov huggingface dataset:
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the the current status of diabetes management, control, and complications in diabetic subjects with type 2 diabetes in Bangladesh.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh

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

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Exclusion Criteria: Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with diabetes (type 2)<br> | Other: No treatment given<br>* Patients will fill out a questionnaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% |  | Evaluated at the first visit (only one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fasting Plasma Glucose (FPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean Postprandial Plasma Glucose (PPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean HbA1c of patients |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having dyslipidemia and hypertension |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having cardiovascular complications |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having peripheral vascular disease |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic nephropathy |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic eye complications |  | Evaluated at the first visit (only one study visit) |
Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Study Overview
=================
Brief Summary
-----------------
Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.

Official Title
-----------------
Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Conditions
-----------------
Pharmacokinetics, Extracorporeal Membrane Oxygenation, Tigecycline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline. Exclusion Criteria: People who had taken tigecycline in the past week People who were pregnant People who had coagulation dysfunction

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 |
| --- | --- | --- |
| Serum drug concentration of tigecycline | Serum drug concentration at different time points in each adult ICU patient treated with ECMO | predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose |
Cyberknife Precision Radiation Delivery System for Tumors of the Spine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions.

Official Title
-----------------
Cyberknife Precision Radiation Delivery System for Tumors of the Spine

Conditions
-----------------
Spinal Cord Cancer, Brain (Nervous System) Cancers

Intervention / Treatment
-----------------
* Procedure: Stereotactic radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Intra-axial, extra-axial, or vertebral spinal lesion Age > 5 Histologic confirmation of malignant primary lesion or radiographic diagnosis of benign or vascular spinal lesion No rapidly deteriorating symptoms of spinal cord compression No instability of the spine Life expectancy > 6 months Exclusion Criteria:- Patients without tumors of the spine Patients younger than 5 years old

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Stereotactic radiosurgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions |  | completed |
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Official Title
-----------------
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)

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

Intervention / Treatment
-----------------
* Drug: Pneumostem
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVH grade 3-4 age : within postnatal day 28 gestational age: 23-<34 weeks Exclusion Criteria: Patient with severe congenital abnormalities Patient with antenatal brain hemorrhage Patient with asphyxia or Hypoxic ischemic encepalophathy Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc) Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc) Patient withCRP > 30 mg/dL; Severe sepsis or shock Patient with a history of participating in other clinical studies Patient who is considered inappropriate to participate in the study by the investigator

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control group receives placebo medication (normal saline) | Drug: Normal saline<br>* direct intracerebroventricular injection of normal saline via ventricular tap<br>|
| Experimental: MSC group<br>MSC group receives mesenchymal stem cells transplantation (Pneumostem) | Drug: Pneumostem<br>* direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap<br>* Other names: Umbilical cord blood derived mesenchymal stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or shunt operation | Death or shunt operation | until 40 weeks of corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventricular dilatation | volume ratio of ventricle to whole brain in the brain MRI | until 40 weeks of corrected age | 
| Death | Death | until 40 weeks of corrected age |
Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge

Study Overview
=================
Brief Summary
-----------------
In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.

Detailed Description
-----------------
The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients. Patients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.

Official Title
-----------------
Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study

Conditions
-----------------
Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit

Intervention / Treatment
-----------------
* Other: video
* Other: standard education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-critical emergency room patients being prescribed Lortab age 18 year or older Exclusion Criteria: emergency room patients not receiving Lortab as their first prescribed medication age less than 18 years

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: video<br>If randomized to this arm patient watches a 3 minute video | Other: video<br>* watch a 3 minute video<br>|
| Active Comparator: standard education<br>If randomized to this arm patient receives standard verbal education from healthcare provider. | Other: standard education<br>* Receives standard verbal education from healthcare provider<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction and knowledge | comparison of patient completed survey following education via standard format or 3 minute video | survey is completed immediately after education, estimated time to complete survey is 5 minutes |
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

Study Overview
=================
Brief Summary
-----------------
The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.

Official Title
-----------------
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

Conditions
-----------------
Inherited Arrhythmias and Valvulopathies

Intervention / Treatment
-----------------
* Other: Skin biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with a family history of inherited arrhythmia or valvulopathy Age : 22-60 yo. patient no confine to bed Male or female Written consent Patient affiliated to the French social security Exclusion criteria: Pregnant woman Patient under 22 yo or adults under guardianship Indication against local anesthesia Anticoagulant treatment Absence or positivity of HIV, HBV, HCV serology

Ages Eligible for Study
-----------------
Minimum Age: 22 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

Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: inherited arrhythmias<br>6 patient with inherited arrhythmias | Other: Skin biopsies<br> <br> |
| Other: valvulopathies<br>6 patient with valvulopathies | Other: Skin biopsies<br> <br> |
| Other: controle<br>8 healthy people for these pathologies | Other: Skin biopsies<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iPS, fibroblast, arrhythmias, valvulopathies, electrophysiology, genetics
Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making.

Detailed Description
-----------------
Two shortened systematic review formats were developed to enhance their use in clinical decision making. An online randomized controlled trial is planned to make comparisons of the shortened formats to a full-length systematic review. To prepare for the full-scale trial, a pilot study will be conducted to test methods and procedures in order to refine the processes.

Official Title
-----------------
Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial

Conditions
-----------------
Evidence-Based Medicine

Intervention / Treatment
-----------------
* Other: Shortened Format
* Other: Full Length


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians who were in practice full- or part-time at study enrollment were recruited for participation Participants had to have access to the Internet as the study was conducted online. Exclusion Criteria: The systematic reviews in all formats were only available in English, thus any participants who were not able to read and understand English were not eligible to participate. Anyone who had taken part in any phase of the development of the shortened versions of the systematic reviews (cased-based or evidence-expertise formats) were not eligible for recruitment.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shortened Format<br>Shortened format of a systematic review | Other: Shortened Format<br>* Shortened format of a systematic review<br>|
| Active Comparator: Control<br>Full length systematic review | Other: Full Length<br>* Full length systematic review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of participant's answers measured using a kappa statistic | Feasibility of assessing participants' answers | 6 months | 
| Rate of recruitment | Feasibility of recruiting participants in a timely manner | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Review Literature as Topic
The HPV Self-test as a Test of Cure in Madagascar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

Detailed Description
-----------------
The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+). A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening. The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

Official Title
-----------------
The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar

Conditions
-----------------
Human Papilloma Virus Infection, Cervical Intraepithelial Neoplasia Grade 2/3

Intervention / Treatment
-----------------
* Device: HPV test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women previously positive at HPV testing Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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: HPV self-test<br>Women will perform the HPV self-test. | Device: HPV test<br>* Women will perform the HPV self-test and will also undergo a physician-performed HPV test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical intra-epithelial neoplasia grade 2 or worse |  | 4 months |
To Study Gene Expression of Postburn Hypertrophic Scar

Study Overview
=================
Brief Summary
-----------------
Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.

Detailed Description
-----------------
Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied clinical therapeutic methods have been used, none of them has been widely accepted as a standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for scar treatment. To investigate the correlation between the clinical presentation of the hypertrophic scar and its gene expression, we propose an analysis of gene expression in the hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may form the base of clinical treatment. Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients with postburn hypertrophic scar require surgical treatment. Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected and transported to tissue bank with a vacuum low temperature container. The specimen will be kept in a -80℃ refrigerator. RNA extraction from skin tissue: The RNA extraction will be performed using kit available in the market. Spectrophotometer and gel electrophoresis will be used to measure the purity and concentration of RNA. Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to analyze RNA expression of hypertrophic scar and normal skin. Statistics: Student's t-test will be used to compare statistically gene expression between hypertrophic scar and normal skin. P < 0.05 will be considered as statistical significance.

Official Title
-----------------
To Study Gene Expression of Postburn Hypertrophic Scar

Conditions
-----------------
Cicatrix, Hypertrophic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age20 80, hypertrophic scar patient Exclusion Criteria: no specific limitation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| hypertrophic scar<br>1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery. | |
| normal skin<br>When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |