linjc16/ctgov huggingface dataset:
Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.

Conditions
-----------------
Severe Acute Exacerbation of Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on; serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%; serum ALT of 20 times or more the ULN. Exclusion Criteria: superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus; other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis; ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; decompensated liver cirrhosis; severe bacterial or fungal infections; a history of diabetes or cardiac disease or hypertension or nephrosis.

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 |
| --- | --- |
| Experimental: glucocorticoid treatment group<br> | Drug: methylprednisolone<br>* methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid<br>|
| No Intervention: conventional treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | eight weeks | 
| liver function | ALT,albumin,bilirubine, | eight weeks | 
| HBV-DNA |  | eight weeks | 
| prothrombin activity |  | eight weeks | 
| Child-Pugh degree |  | eight weeks | 
| model for end-stage liver disease |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of patient stay |  | eight weeks | 
| hospitalization costs |  | eight weeks |
Characteristics of Infective Endocarditis in East China

Study Overview
=================
Brief Summary
-----------------
This was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (IE) as per the modified Duke criteria between January 2008 and December 2015, which was performed at the Second Affiliated Hospital of Zhejiang University, School of medicine (SAHZU), a tertiary care referral hospital located in East China.

Detailed Description
-----------------
Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.

Official Title
-----------------
Study of the Clinical Presentations, Treatment and Outcomes of Infective Endocarditis Patients in a Tertiary Hospital in East China

Conditions
-----------------
Infective Endocarditis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical diagnosis of infective endocarditis. Exclusion Criteria: Patients did not meet the modified Duke criteria.
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 diagnosed during 2008-2011<br>Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011 | Other: no intervention<br>* no intervention<br>|
| Patients diagnosed during 2012-2015<br>Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2012-2015 | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis | A neurological event was defined as symptomatic or asymptomatic stroke, hemorrhage, or encephalopathy. Systemic embolization was defined as an embolic event outside of the central nervous system. Congestive heart failure was defined as with class III, or IV heart failure and an ejection fraction of 40% or less. | During the hospitalization, average of 1 months | 
| Mortality | Patients dead or moribund before discharge | During the hospitalization, average of 1 months |
Caloric Stimulation on Cerebral Blood Flow

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.

Detailed Description
-----------------
Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.

Official Title
-----------------
The Effect of Vestibular Stimulation on Cerebral Blood Flow

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Device: ThermoNeuroModulation (TNM) Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no history of neurological disease Exclusion Criteria: persons under the age of 18 pregnant or nursing women history of neurological disease history of psychiatric disease congenital heart defect, known cardiac shunt inner ear or pulmonary disease

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ThermoNeuroModulation (TNM) Device|Non-invasive neurostimulator used for up to 20 minutes in a session.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cerebral blood flow | Changes in cerebral blood flow will be quantified through the use of bilateral transcranial Doppler (TCD). The baseline TCD of three vessels will be compared with measurements taken at 30 second intervals for 5 minutes after caloric stimulation. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in EEG readings | EEG readings occurring between baseline, active CVS induction, and post-CVS induction periods will be assessed to identify and characterize alterations in the readings. | 40 minutes | 
| Alterations in regional cerebral brain flow (rCBF) | A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment. | 40 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer
Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma

Official Title
-----------------
Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Procedure: High-dose chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast carcinoma at first clinical evidence of metastatic disease must have measurable disease by physical exam, x-ray, or scan Age < or equal to 55 performance status 0-2 Exclusion Criteria: can't have had more than one prior chemotherapy regimen can't have had concurrent hormonal therapy no brain metastases no previous pelvic radiation no history of another malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: High-dose chemotherapy<br>* Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of maximal response; time to initial disease progression; and overall survival |  | undetermined | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer |  | undetermined |
Registry for Degenerative Spinal Disease (RDSD)

Study Overview
=================
Brief Summary
-----------------
The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

Detailed Description
-----------------
The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research. Included patients Degenerative cervical spinal disease. Degenerative lumbar spinal disease.

Official Title
-----------------
Registry for Degenerative Spinal Disease

Conditions
-----------------
Degeneration Spine, Surgery

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Degenerative lumbar spinal disease. Degenerative Cervical spinal disease Exclusion Criteria: combined progressive cancer disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar<br>Patients undergo lumbar spinal surgery for degenerative lumbar spinal disease. | Procedure: Surgery<br>* Patients who undergo spinal surgery for degenerative spinal disease<br>|
| Cervical<br>Patients undergo cervical spinal surgery for degenerative cervical spinal disease. | Procedure: Surgery<br>* Patients who undergo spinal surgery for degenerative spinal disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability index | Improve of disability index more than 30% from the baseline | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C7-sagittal vertical axis (C7-SVA) | Change of C7-SVA, quantative comparison between preoperation and postoperative year 20 years. | 20 years | 
| European quality of life questionnare _ 5 dimension (EQ-5D) | Improve of EQ-5D more than 30% from the baseline | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spine, Outcomes, Degeneration spine, Surgery
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

Study Overview
=================
Brief Summary
-----------------
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.

Official Title
-----------------
Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell

Conditions
-----------------
Diabetic Foot, Lower Limb Ischemia

Intervention / Treatment
-----------------
* Biological: Mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the age of 30-78 years old, men and women there is no limit. in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria. with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line. treatment on a voluntary basis, and sign the informed consent. Exclusion Criteria: with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant. clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly. the prodrome of acute infectious diseases. participated in clinical subjects within three months before test. adherence is poor, can not complete the course.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 78 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells<br>Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight). | Biological: Mesenchymal stem cells<br>* 10-20 x 10^6 cells/20mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events | Frequency and severity of Adverse Events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Wound Area Regression of 40% or More at 6 Week |  | 6 week |
Post-operative Exparel Study Following Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

Official Title
-----------------
The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial

Conditions
-----------------
Rotator Cuff Tears

Intervention / Treatment
-----------------
* Drug: Liposomal bupivacaine
* Drug: Ropivacaine injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery. Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function. Exclusion Criteria: Revision shoulder surgery History of more than 1 prior surgery performed on the operative shoulder Concomitant severe glenohumeral arthritis Concomitant adhesive capsulitis Worker's compensation claim Pregnancy History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics History of renal or hepatic failure Chronic neuromuscular deficit affecting the surgical limb. Uncontrolled psychiatric or neurologic disorder

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liposomal bupivacaine<br> | Drug: Liposomal bupivacaine<br>* interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine<br>|
| Active Comparator: ropivacaine<br> | Drug: Ropivacaine injection<br>* interscale nerve block administered before surgery using 30mL 0.5% ropivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | postsurgical opioid consumption | surgery through 48 hours post-op |
Natural History Study of Patients With Chronic Myelogenous Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care. PURPOSE: This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (CML). Determine the natural history of patients with CML who achieve response to imatinib mesylate. Determine the health perceptions, symptoms, insurance issues, and work issues of these patients. Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients. Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients. OUTLINE: This is a longitudinal, prospective, cohort study. Patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years. Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be examined in the future in gene array studies and mutation analyses.

Official Title
-----------------
Chronic Myeloid Leukemia (CML) Cohort

Conditions
-----------------
Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Age 18 years and over Diagnosis within one year of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Impact of current procedures for diagnosis, management, and follow-up on disease status |  | 5 years | 
| Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate |  | 5 years | 
| Health perceptions, symptoms, insurance issues, and work issues |  | 5 years | 
| Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness |  | 5 years | 
| Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia