linjc16/ctgov huggingface dataset:
Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.

Official Title
-----------------
Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes

Conditions
-----------------
Elevated Liver Enzymes

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects More than 18 years of age Patients with elevated liver enzymes Written informed consent Exclusion Criteria: Patients refusing to participate to the study and to provide written informed consent clotting disorder ongoing treatment with anti-coagulant or anti-aggregant advanced or decompensated cirrhosis (Child-Pugh class C) hepatocellular carcinoma other cancer history of surgery for brain aneurysm pace maker or defibrillator ocular metal foreign body

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 |
| --- | --- |
| patients with abnormal liver enzymnes<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver stiffness |  | one year |
Chiropractic and Acupressure for Headaches

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.

Official Title
-----------------
A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device

Conditions
-----------------
Cervicogenic Headache, Tension-type Headache, Migraine Headache

Intervention / Treatment
-----------------
* Other: chiropractic treatment
* Device: Dr. Zaxx pillow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females ages 21-60 recurrent headaches sub-occipital tenderness a minimum of 4 headaches per month Exclusion Criteria: migraine with aura sinus headache any other organic pathology any contraindications to cervical manipulation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chiropractic<br>spinal manipulation, mobilization, massage, advice, exercises | Other: chiropractic treatment<br>* 12 sessions over 4 weeks<br>|
| Experimental: Chiropractic PLUS pillow<br>spinal manipulation, mobilization, massage, advice, exercises, pillow | Device: Dr. Zaxx pillow<br>* Daily use of an acupressure pillow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency from a Headache Diary | Daily Headache Diary | change from baseline in headache frequency at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache disability | Headache Disability Index | baseline / end of treatment (5 weeks) | 
| Treatment satisfaction | Small scale for rating satisfaction with treatment | end of treatment (5 weeks) | 
| Adverse events | pain, stiffness, dizziness | up to five weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headache, chiropractic, manipulation, acupressure, self-care
Tolerance of Myocardium to Ischemia Injury

Study Overview
=================
Brief Summary
-----------------
This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.

Official Title
-----------------
Morning / Afternoon Variation in Myocardial Ischemia Tolerance

Conditions
-----------------
Reperfusion Injury, Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: cardiac surgery scheduled in the morning
* Procedure: cardiac surgery scheduled in the afternoon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation Patient in sinus rhythm at the time of surgery Patient older than 18 Patient able to understand the information and consent forms Exclusion Criteria: Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug left ventricle ejection fraction < 40% Pregnancy Patient in emergency condition

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: morning group<br>cardiac surgery scheduled in the morning | Procedure: cardiac surgery scheduled in the morning<br>* cardiac surgery scheduled in the morning<br>|
| Other: afternoon group<br>cardiac surgery scheduled in the afternoon | Procedure: cardiac surgery scheduled in the afternoon<br>* cardiac surgery scheduled in the afternoon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemia reperfusion injury in ex vivo conditions | measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion | the day of the myocardial biopsy |
Influence of Neuromuscular Block on Mask Ventilation

Study Overview
=================
Brief Summary
-----------------
Difficult mask ventilation might lead to a life-threatening situation, if endotracheal intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous ventilation. However, controversies exist if NMBA improve or impede face mask ventilation. Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors for difficult face mask ventilation.

Official Title
-----------------
Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia

Conditions
-----------------
Effect of a Neuromuscular Block on Ventilation

Intervention / Treatment
-----------------
* Drug: rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with risk factors for difficult face mask ventilation Patients scheduled for general anaesthesia with endotracheal intubation Exclusion Criteria: Increased Risk for pulmonary aspiration scheduled for awake fiberoptic intubation 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: neuromuscular block<br> | Drug: rocuronium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minute volume |  | 15 min (from Induction of anaesthesia until onset of NMBA ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of difficult mask ventilation - tidal volume < 150 ml |  | 15 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilation, face mask, NMBA
A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)

Study Overview
=================
Brief Summary
-----------------
This integrated research project is cooperated by an fully-experienced team of Taipei Medical University and National Institutes of Health. We hope that we can find out the disease of balance, anxiety and sick headaches through the translation of basic research to clinical diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).

Official Title
-----------------
A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to accept this research age above 17 years old brain injury patients who are in Glasgow Coma Scale(GCS) between 13 to 15 Exclusion Criteria: age under 16 years old serious brain injury patients pregnant women people who have accepted ears surgery once uremia Liver Cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

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
-----------------
Minor Traumatic Brain Injury, Translation
Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation

Study Overview
=================
Brief Summary
-----------------
This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.

Official Title
-----------------
Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation

Conditions
-----------------
Irritable Bowel Syndrome, Constipation

Intervention / Treatment
-----------------
* Drug: YKP10811 5mg
* Drug: YKP10811 20mg
* Drug: YKP10811 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years old patients met with ROME III criteria for C-type IBS Exclusion Criteria: pregnancy or lactation a history of surgery for gastrointestinal tract a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit inflammatory bowel disease or malignant tumor within 5 years of screening visit taking drugs that could have impact on efficacy assessment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks. | Drug: YKP10811 placebo<br> <br> |
| Experimental: YKP10811 10mg<br>Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks. | Drug: YKP10811 5mg<br> <br> |
| Experimental: YKP10811 20mg<br>One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks. | Drug: YKP10811 20mg<br> <br> Drug: YKP10811 placebo<br> <br> |
| Experimental: YKP10811 40mg<br>Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks. | Drug: YKP10811 20mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain intensity & stool frequency responder | an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject global assessment | the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable Bowel Syndrome, Constipation, C-IBS
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.

Detailed Description
-----------------
Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.

Official Title
-----------------
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus: A Brazilian Case Study

Conditions
-----------------
Educational Problems

Intervention / Treatment
-----------------
* Behavioral: orientation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes Exclusion Criteria: non diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>control | |
| 2<br>treated | Behavioral: orientation<br>* patients will be oriented<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in glycemic control | Evaluation of the glycemic indices | 1 year |
Study of Patient Satisfaction With the Cancer Clinical Trial Experience

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the quality of the clinical trial experience of cancer patients participating in cancer research studies through Summa Health System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons for participating, facility, consent and treatment, personal issues and overall assessment. The secondary objective of this study is to determine areas for improvement to make the patient's clinical trial experience a satisfying and positive journey.

Official Title
-----------------
Study of Patient Satisfaction With the Cancer Clinical Trial Experience

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program. Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey. Exclusion Criteria: Participant has withdrawn consent for clinical trial participation and/or follow up. Participant has a major medical illness that would prevent completion of the survey.

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 |
| --- | --- | --- |
| Evaluation of surveys to determine if there are opportunities for performance and/or quality improvement projects.patient satisfaction regarding reasons for participating, facility, consent and treatment, personal issues and overall assessment. |  | Survey will be sent to subject 3 months after study registration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program., Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey.
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection

Study Overview
=================
Brief Summary
-----------------
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

Detailed Description
-----------------
Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

Official Title
-----------------
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

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

Intervention / Treatment
-----------------
* Drug: Injection Sclerotherapy
* Drug: N-butyl-2-cyanoacrylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhotic patients presented with actively bleeding Exclusion Criteria: other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
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 |
| --- | --- |
| Active Comparator: Injection Sclerotherapy<br>5% ethano lamine oleate | Drug: Injection Sclerotherapy<br>* 5% ethanolamine oleate group<br>* Other names: 5% ethanolamine oleate;|
| Active Comparator: N-butyl-2-cyanoacrylate<br>N-butyl-2-cyanoacrylate injection group | Drug: N-butyl-2-cyanoacrylate<br>* N-butyl-2-cyanoacrylate injection group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with controlled bleeding | The Number of patients with controlled bleeding | 6 months |