linjc16/ctgov huggingface dataset:
Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

Study Overview
=================
Brief Summary
-----------------
Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. In this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied: A. Assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease. B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker. Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E. Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease. Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased in patients with active autoimmune liver diseases. Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease. Probable implications to Medicine: Identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.

Conditions
-----------------
Autoimmune Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Freely given informed consent Autoimmune disease 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| autoimmune disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biotin level Test |  | Baseline |
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Pulse Oximeter

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the efficacy of T2, T3 sympathetic block using thermal radiofrequency versus chemical neurolysis in postmastectomy pain syndrome using perfusion index derived from pulse oximetry.

Detailed Description
-----------------
Postmastectomy pain is a chronic pain condition with neuropathic nature. Several drugs and methods are used for its management. This study was designed to compare the efficacy of both thermal radiofrequency and chemical neurolysis in management of postmastectomy pain through using perfusion index derived from pulse oximetry.

Official Title
-----------------
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Thermal Radiofrequency Versus Chemical Neurolysis Using Perfusion Index Derived Pulse Oximeter

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: Thermal Radiofrequency
* Procedure: Chemical Neurolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with postmastectomy pain syndrome ≥ Age 18 years ASA II-III Exclusion Criteria: patient refusal coagulation defects abnormal kidney or liver functions local infection at site of injection bone metastases severe cardiorespiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Radiofrequency<br>T2, T3 block by thermal radiofrequency lesioning at 80°c for 60-90 seconds | Procedure: Thermal Radiofrequency<br>* Radiofrequency lesioning at level of T2, T3 using 80°c for 60-90 seconds<br>|
| Active Comparator: Chemical Neurolysis<br>T2, T3 block by chemical neurolysis using 2-3 ml of phenol in glycerin 6% | Procedure: Chemical Neurolysis<br>* injection of 2 to 3 ml of the chemical neurolytic agent (phenol in glycerin 6%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion index trend | measuring the change in perfusion index in the ipsilateral limb compared to the control limb | procedure time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score | minimum score 0 and maximum score 10 | 6 weeks | 
| Opioid consumption | total opioid consumption | 6 weeks |
Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.

Official Title
-----------------
An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: MCI-196
* Drug: Placebo of MCI-196 Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL. Patients whose HbA1c is 7.0% or above during the observation period. Exclusion Criteria: Patients with serious cardiac, hepatic or renal complications. Patients with serious diabetic complications. Patients with complete biliary obstruction or ileus. Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: MCI-196<br> | Drug: MCI-196<br>* Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)<br>* Other names: CHOLEBINE;|
| Placebo Comparator: Placebo<br> | Drug: Placebo of MCI-196 Tablet<br>* Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose at Baseline |  | 0 weeks | 
| Change From Baseline in Blood Glucose at Week 12 |  | 12 weeks (baseline to week 12) | 
| Hemoglobin A1c (HbA1c) at Baseline |  | 0 weeks | 
| Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 |  | 12 weeks (baseline to week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 |  | 12 weeks (baseline to week 12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, anion-exchange resin
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: CP-461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory chronic lymphocytic leukemia. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL. Expected remaining life span > or = three months. ECOG performance status 0 - 2. 18 years or of legal age. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal. Negative serum pregnancy test, if fertile female. Willingness and ability to sign an informed consent document. Exclusion Criteria: Evidence of CNS involvement. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. Previous therapy with Campath. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System. Concurrent immunotherapy. Concurrent use of steroids. Use of an investigational medication or device within 1 month of initiating study therapy. Patients who have had allogeneic bone marrow transplantation. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal. AST or ALT > 2.5 times the upper limit of normal. Any condition or any medication which may interfere with the conduct of the study.

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-461|nan|

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
-----------------
Chronic Lymphocytic Leukemia, Leukemia, CLL
The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis. The investigators also intend to prove that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.

Detailed Description
-----------------
In order to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis, the investigators intend to explore that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.

Official Title
-----------------
The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy: a Prospective Cohort Study

Conditions
-----------------
Sepsis, Cardiomyopathies, Echocardiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are diagnosed as sepsis according to sepsis 3.0 criteria Exclusion Criteria: patients with history of organic heart disease; patients with history of heart failure holder of cardiac implanted device; patients with history of atrial fibrillation; refusal to participate in the study

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 |
| --- | --- | --- |
| 28-day mortality | 28-day mortality of sepsis | 28 days |
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

Study Overview
=================
Brief Summary
-----------------
This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone [GHRH-arginine-CRH-LHRH] test) after 4 and 12 months.

Detailed Description
-----------------
Recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury (TBI) and/or subarachnoid hemorrhage (SAH). However, most of these studies referred to retrospective evaluations. There are only few prospective data, and no longitudinal study routinely taking into account the assessment of anterior pituitary function in the acute phase after TBI or SAH so far. We prospectively evaluate pituitary functions in patients in the acute phase after TBI or SAH and a control group of patients with trauma not involving the brain. Endocrine data included basal anterior pituitary lobe hormone, IGF-1 and testosterone serum levels (Immulite 2000) within the first 8 hours after TBI or SAH. Further endocrine evaluation was performed by means of either a combined GHRH-arginine-CRH-LHRH test or an insulin-induced hypoglycemia test after 4 months and 12 months. To rule out an assay related bias with regard to GH and IGF-1, all hormone levels were cross-checked by a supersensitive assay in another laboratory.

Official Title
-----------------
Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH

Conditions
-----------------
Traumatic Brain Injury, Subarachnoid Hemorrhage, Hypopituitarism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TBI or SAH Control group: injury without involvement of the brain/skull Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury, Subarachnoid Hemorrhage, Hypopituitarism
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation

Study Overview
=================
Brief Summary
-----------------
In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Detailed Description
-----------------
This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected. Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Official Title
-----------------
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial

Conditions
-----------------
Colonoscopy, Bowel Preparation

Intervention / Treatment
-----------------
* Drug: itopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who are scheduled for colonoscopy Exclusion Criteria: pregnancy, breast feeding, known or suspected bowel obstruction, and known allergy to PEG or Itopride , presence of severe illness(renal failure, congestive heart failure, liver failure,), and refusal of consent to participate in the study

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Split-dose PEG<br>Bowel preparation using split dose PEG without prokinetics | |
| Active Comparator: Split dose PEG with prokinetics<br>Bowel preparation using split-dose PEG with prokinetics | Drug: itopride<br>* itopride, 10mg, twice per day, for 1 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel cleaning quality according to Ottawa scale scores |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time and polyp detection rate | cecal intubation time, polyp detection rate, degree of patient discomfort | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, bowel preparation, PEG, Prokinetics
The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV

Study Overview
=================
Brief Summary
-----------------
While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. This study aims to see the opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.

Conditions
-----------------
PONV, Propacetamol

Intervention / Treatment
-----------------
* Drug: Propacetamol
* Drug: PCA regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for either 1-2 level spine fusion or laminectomy ASA (American Society of Anesthesiology) physical status 1 or 2 Non-smoking female patients, between the age 20 and 65 Exclusion Criteria: Administration of any anti-emetic agents within 24 hours prior to surgery Administration of any opioid agents within 7 days prior to surgery Regular administration of any steroid agents Drug or alcohol-abuser Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign. Patients administered to Intensive Care Unit after surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propacetamol<br> | Drug: Propacetamol<br>* total 4g of Propacetamol added to patient's PCA regimen<br>|
| Placebo Comparator: PCA regimen<br>routine PCA drug | Drug: PCA regimen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV | Incidence of postoperative nausea, vomiting - Number of events | from immediate postop to 24 hours after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Vomiting