linjc16/ctgov huggingface dataset:
Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

Study Overview
=================
Brief Summary
-----------------
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.

Official Title
-----------------
A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).

Conditions
-----------------
Bunionectomy, Orthopedic Surgery

Intervention / Treatment
-----------------
* Drug: Lornoxicam 8 mg
* Drug: Lornoxicam 16 mg
* Drug: Ketorolac 30 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic. Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications. Subjects are in generally good health with no uncontrolled chronic illnesses or diseases. Exclusion Criteria: Subjects who are pregnant. Subjects who have significant obesity. Subjects with medically significant heart, liver, kidney, lung or endocrine disease. Subjects with active viral disease, i.e. hepatitis, HIV.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lornoxicam 8 mg|nan|
|Drug: Lornoxicam 16 mg|nan|
|Drug: Ketorolac 30 mg|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy) |  |  | 
| To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo. |  |  |
The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear

Study Overview
=================
Brief Summary
-----------------
To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear

Detailed Description
-----------------
Mycophenolate mofetil (MMF), which inhibits T and B lymphocyte proliferation, is widely used to treat a variety of autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN). We are the first to show that mycophenolic acid (MPA), the active metabolite of MMF, in association with lipopolysaccharide (LPS), is able to promote the secretion of interleukin (IL)-1β, which contradicts the traditional conception that immunosuppressants inhibit the secretion of inflammatory factors. In this study, we first determined the effects of MPA in association with LPS on IL-1β production. Then, we explored whether the synergized effect on IL-1β production was mediated through the nuclear factor （NF）-κB pathway that produces more pro-IL-1β, or through the triggering of NLRP3 inflammasome that leads to enhanced activation of caspase-1 and accelerated degradation of pro-IL-1β into mature IL-1β. This study is not only conducive to clarify the mechanisms, signal transduction pathways and potential clinical significances of IL-1β production in LPS and MPA combined treatment, but also to provide experimental data as well as theoretical rationales for more effective and more logical immunosuppressive protocols.

Official Title
-----------------
The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: mycophenolic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers，age 18-60. Exclusion Criteria: Don't agree with informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolic acid|Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes. |  | six months |
An Individualized-health eLibrary App for People With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple sclerosis.

Detailed Description
-----------------
Participants will use our developed app for 21 days and take a before-use survey and a post-use survey.

Official Title
-----------------
An Individualized-health eLibrary App for People With Multiple Sclerosis: Testing Feasibility and Effectiveness of a Brief Education Intervention

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: SavvyHealth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with MS; 18 years or older; one comorbidity evaluated by a validated comorbidity questionnaire for people with MS; willing to take a survey; willing to use the app for 21 days; willing to be assigned to either the intervention or control group. Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SavvyHealth<br>Participants will use the new app, SavvyHealth, for 21 days. | Device: SavvyHealth<br>* Participants will use the new app, SavvyHealth, for 21 days.<br>|
| No Intervention: Waiting list<br>Participants will be on the waiting list. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS Self-management Scale | A self-reported 5-point scale, five factors: healthcare provider relationship and communication, treatment adherence, social support, MS knowledge, and health maintenance behavior. Change is being assessed. | Through study completion, an average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eHealth, mHealth
Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.

Official Title
-----------------
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

Conditions
-----------------
Advanced Malignancies

Intervention / Treatment
-----------------
* Drug: Patupilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age ≥ 18 years of age Life expectancy ≥3 months Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study Exclusion criteria History of/or active bleeding disorders Known hypersensitivity to warfarin or related compounds The use of vitamin K Central lines that require anticoagulant maintenance The use of agents containing warfarin and heparin Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone<br> | Drug: Patupilone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies. |  |  | 
| Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, EPO, Patupilone, Solid tumors, Advanced malignancies
Survey Study About Endoscopy During COVID-19 Pandemic for IBD Doctors

Study Overview
=================
Brief Summary
-----------------
Performance of diagnostic or therapeutic endoscopic procedures in inflammatory bowel disease (IBD) patients can be challenging during a viral pandemic; the main concerns being the safety and protection of patients and health care providers (HCP). The aim of this study is to identify endoscopic practice patterns and outcomes of IBD and coronavirus disease 19 (COVID-19) with a worldwide survey of HCP.

Detailed Description
-----------------
The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn's and Colitis Foundation. The data of the survey was collected and analyzed.

Official Title
-----------------
Patterns of Endoscopy During COVID-19 Pandemic: a Global Survey of Interventional Inflammatory Bowel Disease Practice

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctors who are involved in the endoscopic treatment of IBD patients; The endoscopist reads and signs an informed consent online. - Exclusion Criteria: Doctors who are not involved in the endoscopic treatment of IBD patients Doctors who need the help of an agent, a witness, or someone else who can not complete the questionnaire independently. Other conditions that the researchers considered unsuitable for inclusion or influenced the participants'ability to complete the study.-

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one group that is IBD endoscopist who perform the endoscopy for IBD patients<br>Complete the questionnaire online | Other: observation<br>* IBD doctors who perform the endoscopy perform the questionnaire<br>* Other names: endoscopy with no drug;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist | The incidence of scheduled IBD endoscopies were postponed or cancelled due to the pandemic. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of COVID19 in IBD patients who underwent endoscopy | The percentage of IBD patients who underwent endoscopy since the outbreak was tested positive for COVID 19 | 1 week |
Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.

Official Title
-----------------
ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention

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

Intervention / Treatment
-----------------
* Other: Blood draws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA) Planned percutaneous coronary intervention during admission Exclusion Criteria: Recent history (< 6 months) of an acute coronary syndrome (other than current admission) or stroke Recent history (< 6 months) of major surgery, trauma or thromboembolic event Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months Current evidence of infection

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 |
| --- | --- |
| coronary artery disease<br>Subjects with coronary artery disease undergoing percutaneous coronary intervention | Other: Blood draws<br>* Observational: blood draws only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels | Assess the relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels in subjects with coronary artery disease prior to and after undergoing PCI in this exploratory study | change from baseline to after percutaneous coronary intervention |
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Caregiver's burden in rehabilitation is important for both patients physical and mental health. Therefore researching caregivers burden and treatment of any depression or associated any psychological disorders of caregiver is crucial.

Official Title
-----------------
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation

Conditions
-----------------
Stroke Rehabilitation and Caregivers

Intervention / Treatment
-----------------
* Other: Caregiver's Burden Inventory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke, Exclusion Criteria: More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Conventional Rehabilitation<br> | Other: Caregiver's Burden Inventory<br>* The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.<br>|
| Robotic Therapy<br> | Other: Caregiver's Burden Inventory<br>* The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden Inventory | Caregiver Burden Inventory(CBI) first designed by Novak and Guest in 1989 to measure burden of patient's caregiver. Caregiver can be a relative or a professional. CBI consists of 5 different subscales(Time Dependency Items(5 question),Development Items(5 question),Physical Health Items(4 question),Emotional Health Items(5 question),Social Relationship Items(5 question)), a total of 24 questions. Every question should be answered by the caregiver according to a likert scale (0=Never,1=Rarely,2=Sometimes,3=Quite Frequently,4=Nearly Always) and a total of 96 points. 36 point is a limit to a professional help for caregiver and the higher the points get there is more burden for caregiver. | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregivers, Exoskeleton Device, Stroke Rehabilitation
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus

Study Overview
=================
Brief Summary
-----------------
This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.

Official Title
-----------------
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study

Conditions
-----------------
Non Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: plasma pentraxin-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NAFLD. Patients with NAFLD and chronic hepatitis C viral infection. Exclusion Criteria: Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively. Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids. Patients who take statins as it has lowering effect on plasma PTX3. Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal. Patients with heart failure. Patients with autoimmune rheumatic disease. Patients with chronic kidney diseases. Patients with sepsis.
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 |
| --- | --- |
| 25 patients with non-alcoholic fatty liver disease<br> | Diagnostic Test: plasma pentraxin-3<br>* Plasma pentraxin-3 was measured using ELISA<br>|
| 25 patients with NAFLD and chronic HCV<br> | Diagnostic Test: plasma pentraxin-3<br>* Plasma pentraxin-3 was measured using ELISA<br>|
| 20 healthy controls<br> | Diagnostic Test: plasma pentraxin-3<br>* Plasma pentraxin-3 was measured using ELISA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection | Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls | 1 year |