linjc16/ctgov huggingface dataset:
Development of a Prenatal Test for Fetal Aneuploidy Detection

Study Overview
=================
Brief Summary
-----------------
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

Official Title
-----------------
Prenatal Test for Fetal Aneuploidy Detection

Conditions
-----------------
Fetal Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has singleton pregnancy Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality Subject is able to provide informed consent Subject is ≥ 18 years of age Exclusion Criteria: Subject is pregnant with more than one fetus Subject (mother) has a known aneuploidy

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

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

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 |
| --- | --- | --- |
| Identification of aneuploidy |  | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal, aneuploidy, non-invasive, prenatal, cell free DNA
Effects of Bariatric Surgery in Swedish Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of bariatric surgery on overall mortality and obesity-related co-morbidities.

Detailed Description
-----------------
The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled intervention study designed to examine the long-term effects of bariatric surgery compared to usual care in obese subjects.

Official Title
-----------------
Effects of Bariatric Surgery in Swedish Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women. Exclusion Criteria: Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery Gastric ulcer during the past 6 months; ongoing malignancy Active malignancy during the past 5 years Myocardial infarction during the past 6 months Bulimic eating pattern; drug or alcohol (>0·75 L 40% liquor per week or corresponding amount of ethanol) abuse Psychiatric or cooperative problems contraindicating bariatric surgery Other contraindicating conditions (such as continuous glucocorticoid or anti-inflammatory treatment).

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bariatric surgery<br>Bariatric surgery | Procedure: Bariatric surgery<br>* Gastric banding, vertical banded gastroplasty, gastric bypass<br>|
| Other: Controls<br>Usual care | Other: Usual care<br>* Non-surgical obesity treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | The SOS study was started in 1987 and effect of bariatric surgery on overall mortality (primary endpoint) was reported in 2007. Cut off date for the analysis was November 1, 2005. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, bariatric surgery, weight loss
Water Flosser vs String Floss vs Manual Toothbrush Safety

Study Overview
=================
Brief Summary
-----------------
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Detailed Description
-----------------
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.

Official Title
-----------------
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Conditions
-----------------
Soft Tissue Injuries

Intervention / Treatment
-----------------
* Device: Water Flosser
* Device: String Floss
* Device: Manual Toothbrush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent prior to participation Good general health and non smoker Have scorable Ramfjord's teeth Exclusion Criteria: Probing depth >4mm on Ramfjord's teeth Moderate to severe gingivitis Advanced periodontitis Medications that impact soft tissue.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water Flosser<br>Power interdental Cleaning Device | Device: Water Flosser<br>* Power interdental cleaner<br>|
| Active Comparator: String floss<br>Manual interdental cleaning device | Device: String Floss<br>* Mechanical interdental cleaner<br>|
| Active Comparator: Manual Toothbrush<br>ADA standard manual toothbrush | Device: Manual Toothbrush<br>* ADA standard soft bristle toothbrush<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Levels | Measurement from the junction Epithelium to the cemento enamel junction | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | Measurement from the junction Epithelium to the free gingival margin | 6 weeks |
Hypermethylation of VTRNA2-1 Promoter in HCC Outcome

Study Overview
=================
Brief Summary
-----------------
The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval.

Detailed Description
-----------------
This study was approved by the Institute Review Board (IRB) of Chang Gung Memorial Hospital, Linkou Branch (IRB 201801969B0). The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. HCC tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the Central Biobank of Chang Gung Memorial Hospital. The personal information was protected with decoding and registered with number.

Official Title
-----------------
Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies Exclusion Criteria: history of different malignant disease. subjects cannot be treated with curative surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypermethylation<br>The hypermethylation group was defined as differential methylation status of tumor- normal ≥ 5%. | |
| hypomethylation/no change<br>The hypomethylation were defined as differential methylation status of tumor- normal <5% | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival (DFS) | The length of time from curative hepatectomies treatment and recurrence or mortality | a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The length of time from hepatectomies treatment for HCC and still alive. | a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTRNA2-1 promoter, recurrence, methylation
Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30

Study Overview
=================
Brief Summary
-----------------
The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.

Official Title
-----------------
Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study. Exclusion Criteria: Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to regional anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Success rate of costoclavicular brachial plexus block | Determine the success rate of the block in patients with body mass index greater than 30. Assess the effectiveness of the block by performing required assessments | Within 45 minutes of completion of block placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of costoclavicular space | Describe how the costoclavicular space and its contents are easily identifiable in patients with a body mass index greater than 30. Identify the costoclavicular space by using ultrasound | during placement of the block |
Use Cord Blood Single Nucleotide Polymorphism to Predict the Later Development of Atopy and Allergy

Study Overview
=================
Brief Summary
-----------------
The aim of our study was firstly to detect in cord bloods the polymorphism of genes related to atopy and allergic diseases and to examine their mutual interaction and their associations with cord blood IgE and cytokines. After that, in the prospective follow-up visits, we liked to investigate if the measurement of cord blood SNPs of genes related to atopy and allergic diseases was helpful in predicting the development of atopy and allergic diseases later in life.

Official Title
-----------------
Observational Study of Cord Blood Single Nucleotide Polymorphisms of Genes Related to Atopy and Allergic Diseases

Conditions
-----------------
Atopy, Allergic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apgar score of 5 minutes not less than 7 gestational age not less than 36 weeks Exclusion Criteria: Apgar score of 5 minutes < 7 gestational age < 36 weeks

Ages Eligible for Study
-----------------
Maximum Age: 1 Minute

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
single nucleotide polymorphism
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate effectiveness and safety of drug-eluting stent implantation in the real world daily practice.

Official Title
-----------------
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary disease amenable to percutaneous coronary intervention (PCI) no clinical and lesion limitations Exclusion Criteria: patients with a mixture of several drug eluting stents terminal illness with life expectancy less than 1 year patients with cardiogenic shock

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 |
| --- | --- |
| Drug eluting stent<br>Patients who receiving drug eluting stents | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Event | Death from any causes, myocardial infarction or any repeat revascularization | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause Death |  | 1year | 
| Myocardial Infarction |  | 1year | 
| The composite of Death or myocardial infarction |  | 1year | 
| Any repeat revascularization |  | 1year | 
| Target vessel revascularization |  | 1year | 
| Target lesion revascularization |  | 1year | 
| New lesion revascularization |  | 1year | 
| Stent thrombosis by Academic Research Consortium criteria |  | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug eluting stent, coronary artery disease
Near-Infrared Spectroscopy for Blood Glucose Measurements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of a near-infrared transmission measurement in blood samples collected from healthy volunteers. We propose that NIR spectroscopic blood glucose measurements in healthy patients are as accurate as handheld glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood samples spiked with pharmacological interferents to test if the spectroscopic glucose measurement is affected by common medications.

Detailed Description
-----------------
Luminous Medical is developing an automated glucose measurement system that addresses the rapidly growing clinical demand for tight glycemic control in the intensive care unit (ICU), operating room (OR), and intermediate care units. The system automatically measures glucose and other analytes by spectroscopically analyzing blood as it passes through a disposable Sensor Set. Our unique optical measurement does not chemically interact with blood, is insensitive to sensor fouling, and, unlike a biosensor, does not require frequent recalibration.

Official Title
-----------------
Near-Infrared Spectroscopy for Blood Glucose Measurements

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between the ages of 18 and 65 Healthy Not currently pregnant Hematocrit >38% Exclusion Criteria: Pregnancy (Self Reported) Females that have given birth 6 weeks prior (self reported) Anemia (hematocrit <38%) Hematocrit is checked via a capillary fingerstick and a blood hematocrit reader. Under the age of 18 or over the age of 65. Diagnosed with Type I or II Diabetes (Self-Reported). Donated blood (>25 mls) in the last 8 weeks Heart rate >100 beats per minute Weigh less than 110 lbs. Currently taking anticoagulants (ex: coumadin) Abnormal blood pressure (diastolic >90)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition

Study Overview
=================
Brief Summary
-----------------
Background: Previous studies on Internet-based treatment with eating disorders have shown promising results. Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. The second aim was to examine the role of knowledge acquisition. Method: 138 participants were recruited. Screening consisted of online questionnaires followed by a telephone interview. A total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). Treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. The control group consisted of a waitlist who later received treatment.

Detailed Description
-----------------
As above

Official Title
-----------------
Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition

Conditions
-----------------
Bulimia, Eating Disorders

Intervention / Treatment
-----------------
* Behavioral: Internet-delivered CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have reoccurring eating disorder uns or bulimia BMI above 17,5 Exclusion Criteria: Suicide prone Ongoing psychological treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Internet-delivered CBT | Behavioral: Internet-delivered CBT<br>* Guided internet treatment<br>|
| No Intervention: Control group<br>Waitlist control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorders Examination Questionnaire |  | post (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Inventory (QOLI) |  | Pre and post (8 weeks) | 
| Body Shape Questionnaire (BSQ) |  | post (8 weeks) | 
| Patient Health Questionnaire (PHQ-9) |  | post (8 weeks) | 
| Generalised Axiety Disorder Assessment (GAD-7) |  | post (8 weeks) | 
| Satisfaction With Life Scales (SWLS) |  | post (8 weeks) | 
| Expectancy/Credibility Questionnaire (CEQ) |  | post (8 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emotional eating, restrictive eating, body dissatisfaction
The Role of Regulatory T Cell in Patients With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find the pathogenesis of this autoimmune disease.

Detailed Description
-----------------
Type 1 diabetes mellitus (T1D) is an autoimmune disease characterized with T cell mediated destruction of pancreatic βcell. Dysregulated B and T cells were reported in the animal model. The loss of maintenance of immune homeostasis is thought to be major mechanism and result in persistence of autoreactive T cell in the periphery. Therapies which modulate the immune dysfunction may be helpful for the patients of T1D. Immune homeostasis means a balance between the responses that control infection and tumor growth and reciprocal responses that prevent inflammation and autoimmune disease. CD4+ CD25+ regulatory T cells (Tregs) are critical to maintain such functions. Their actions can be through cell-to-cell contact or bystander effect. The specific markers of Tregs include CD25 molecule (IL-2 receptorαchain), Foxp3 (forkhead-winged helix transcription factor). The Foxp3 is a transcription factor that controls some genes encoding Tregs associated molecules, such as CD25, CTLA-4 and GITR. The previous studies of modulation of Tregs in T1D show positive results in animal model. But the relative sizes of CD4+CD25+ population in human are still controversial. Our hypothesis is that the imbalance of Tregs and autoreactive T cells is the pathogenesis of T1D. Therefore, we used flow cytometry to determine the number of CD4+CD25+ Tregs population and quantitative real-time PCR to assay the expression of Foxp3, CLTA-4, GITR in patients with different stages and normal control. Besides, autoantibodies to GAD65 is associated with T1D in 60-80% patients. It is a marker of autoimmune diabetes. We anticipated that the realization of Tregs functions in patients of T1D will help our further guide of immunotherapy of patients with T1D and other autoimmune disease.

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: blood drawing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric type 1 DM Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood drawing|nan|

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

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