linjc16/ctgov huggingface dataset:
A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by CCTA and to identify risk factors attributable to the development of coronary atherosclerosis in a Korean DM population.

Detailed Description
-----------------
Patients with diabetes mellitus, who underwent initial CCTA (coronary computed tomographic angiography) at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be evaluated for inclusion in the study. All DREAM-CCTA study patients will undergo follow-up CCTA based on order from their primary physician. CCTA and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial CCTA and at the time of follow-up CCTA.

Official Title
-----------------
Diabetes Follow-up Study for REduction of cardiovAscular outcoMes: a Coronary Computed Tomographic Angiography Cohort Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 years or older Asymptomatic patients with type 2 DM who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012 Willing and able to provide informed written consent Exclusion Criteria: Blood test results that the Creatinine level exceeds 1.5 mg/dL A person with a history of anaphylaxis or allergic shock associated with a contrast medium Pregnant women Unable to undergo follow-up CCTA Uninterpretable CCTA

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| The change in coronary atherosclerosis detected by initial and follow-up CCTA | the natural history of coronary atherosclerotic plaque development and progression over time by CCTA | about 10 years after first CCTA |
Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are: Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets. Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices. Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.

Official Title
-----------------
Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients

Conditions
-----------------
Esophageal Varices

Intervention / Treatment
-----------------
* Device: wired magnetic assisted capsule endoscopy
* Device: esophagogastroduodenoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biliary atresia patients > 6 years old Vital signs are stable Without acute gastrointestinal bleeding Exclusion Criteria: Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices Throat or esophageal obstruction leading to dysphagia patients Consciousness disturbance patients unable to swallow Patients with acute upper gastrointestinal bleeding Patients with platelet lower than 40K or PT INR > 1.5

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wired magnetic assisted capsule endoscopy<br> | Device: wired magnetic assisted capsule endoscopy<br>* once<br>|
| Other: esophagogastroduodenoscopy<br> | Device: esophagogastroduodenoscopy<br>* once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerosol-generating amount |  | 1-2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper endoscopy, biliary atresia
Prognostic Models for HCC Based on Tumor Micronecrosis

Study Overview
=================
Brief Summary
-----------------
The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.

Official Title
-----------------
Development and Validation of Novel Models Including Tumor Micronecrosis for Predicting the Postoperative Survival of Patients With Hepatocellular Carcinoma

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

Intervention / Treatment
-----------------
* Other: observing whether HCC patients having tumor micronecrosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically diagnosed as HCC; curative hepatectomy with R0 resection; conserved liver function with Child Pugh class A or B Exclusion Criteria: with macrovascular invasion or extrahepatic metastasis; receiving other anti-tumor treatments such as TACE or systemic drugs; with other primary cancers; incomplete follow-up data; without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| training cohort<br>HCC patients receiving curative hepatic resection | Other: observing whether HCC patients having tumor micronecrosis<br>* whether HCC patients having tumor micronecrosis or not<br>|
| validation cohort<br>HCC patients receiving curative hepatic resection | Other: observing whether HCC patients having tumor micronecrosis<br>* whether HCC patients having tumor micronecrosis or not<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Harrell concordance index (C-index) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time-dependent area under the receiver operating characteristic curve(tdAUROC) |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Tumor micronecrosis, Nomogram
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to compare frequency of intraoperative hypothermia between fragilitly groups of eldery patients who underwent orthopedic surgical procedures. It aims to answer those questions: İs there any difference between fragility groups in terms of hypothermia frequency during orthopedic surgical procedures? Are there any other factors that influence the frequency of hypothermia such as age, body mass index, room temperature etc. ? Participants body temperature before anestesia application,and before surgery had started was measured and measurament was done during whole procedure. Measuraments had been done by tympanic thermometer.

Official Title
-----------------
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study

Conditions
-----------------
Hypothermia; Anesthesia, Fragility

Intervention / Treatment
-----------------
* Diagnostic Test: body temperature measurament


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Orthopedic Surgery Candidates 65 years old or older Exclusion Criteria: Emergency surgery Patiens who required multiple (2 or more) blood component transfusions Neurologic disorders tyroid dysfunction Patiens who are already hypothermic before surgery

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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 |
| --- | --- |
| pre-frail patients<br>That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail. | Diagnostic Test: body temperature measurament<br>* body temperature of every patient was measured with tympanic thermometer during surgical procedure<br>|
| frail patients<br>That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail. | Diagnostic Test: body temperature measurament<br>* body temperature of every patient was measured with tympanic thermometer during surgical procedure<br>|
| very frail patients<br>That patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail. | Diagnostic Test: body temperature measurament<br>* body temperature of every patient was measured with tympanic thermometer during surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of hypothermia | difference between frailty groups in terms of frequency of hypothermia | during the orthopedic surgical procedure |
Exercise Intervention After Lung Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
A combination of supervised and un-supervised exercise in patients after lung cancer surgery is evaluated with regards to aerobic capacity, strength, physical activity and health-related quality of life.

Official Title
-----------------
Combination of Supervised and Non-supervised Exercise After Lung Cancer Surgery

Conditions
-----------------
Rehabilitation After Lung Cancer Surgery

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective lung cancer surgery Ability to perform tests Able to communicate in Swedish Willing to participate in supervised exercise Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Supervised exercise one session per week, un-supervised exercise two sessions per week, for tree months, followed by three months without organized exercise. | Other: Exercise<br>* Aerobic and strength exercise.<br>|
| Other: Control group<br>Three months without organized exercise, followed by the same exercise as the Treatment group for three months. | Other: Exercise<br>* Aerobic and strength exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test | Measuring the distance walked in 6 minutes. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30/LC13 | Scale 0-100, for function scales higher is better, for symptom scales higher means more symptoms. | 10 minutes | 
| 30 s chair stands test | Measuring the number of stands from a chair during 30 seconds. | 5 minutes | 
| OMPAQ | Categorical question on physical activity performed during the last month. | 2 minutes | 
| Actigraph GT3X | Accelerometer providing information about steps and time in different intensities of physical activity | 7 days |
Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.

Official Title
-----------------
Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

Conditions
-----------------
Oropharyngeal Carcinoma, Human Papilloma Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with oropharyngeal carcinoma or patients with cancer of the unknown primary that is HPV associated, or possibly deemed to be originating from the oropharynx. Exclusion Criteria: Not willing to sign consent

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 |
| --- | --- | --- |
| Sample collection | 30-50cc of blood | prior to start of treatment | 
| Sample collection | 30-50cc of blood | up to 36 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor sample | tumor sample (FFPE) or fresh tissue post-excision or surgery, this will only be collected, if and when feasible, after the tumor has been removed post procedure. | Day 1 |
Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.

Official Title
-----------------
Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects

Conditions
-----------------
Neural Tube Defects, Folic Acid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years Under 45 years of age Having at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth defect with aneuploidy, history of GDM or known DM) for Case Group. Singleton pregnant women Exclusion Criteria: under 18 years old Above 45 years old Multiple pregnancies

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Singleton pregnant women over the age of 18 and under the age of 45 who have at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth history with aneuploidy, history of GDM or known DM). | |
| Control<br>Singleton pregnant women over 18 years of age and under 45 years of age who do not have any risk factors for neural tube defects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High awareness level for high-risk pregnant women | Pregnant women with at least one risk factor for neural tube defects have statistically higher folic acid use and awareness than control group pregnant women. | up to 12 weeks | 
| Low awareness level for society, regardless of the risk situation | Low folic acid knowledge and awareness in the sample groups, regardless of risk status | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neural tube defects, folic acid, awareness, perinatology, pregnancy
Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

Study Overview
=================
Brief Summary
-----------------
clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and degenerative conditions of the knees

Detailed Description
-----------------
to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

Official Title
-----------------
Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: stromal vascular fraction injection in the osteoarthritic knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis any grade knee chondromalacia grade 2 and above Exclusion Criteria: active HIV pregnant women Mental disease severe cardio vascular disease severe coagulation disorders infected tissues patients on other experimental studies within 3 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: knee osteoarhritis<br>patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis | Procedure: stromal vascular fraction injection in the osteoarthritic knee<br>* stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain level | visual analog scale 0-10 ( 10 being worst) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage cartilage thickness change | as measured by MRI | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis, knee chondromalacia
The Experience of the Child With Cancer When Port à Cath Needle : Child's Speech

Study Overview
=================
Brief Summary
-----------------
This qualitative research refers to the descriptive phenomenological method of Hurssel which allows an analysis of the experience and an understanding of the phenomenon. Semi-structured interviews are carried out with 10 children followed for cancer in 3 pediatric hemato-oncology departments. The children interviewed are aged 6 to 12 and can be with their parents. A thematic analysis approach is used to analyze the data of this research.

Official Title
-----------------
The Experience of the Child With Cancer When Port à Cath Needle : Child's Speech

Conditions
-----------------
Pediatric Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child followed in pediatric oncology for cancer or hematological disease Child wearing a Port-a-cath needle placement and minimum use once a week Exclusion Criteria: Child no speaking the French language

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Experience of self management of port-a-cath needle placement | Evaluation from the patients' point of view on how they self-manage a port a cath needle placement, semi-structured qualitative interviews with patients. | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics; Cancer; Care; Experience; Port-a-cath