linjc16/ctgov huggingface dataset:
The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear. In a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with COPD and pneumonia).

Official Title
-----------------
The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

Conditions
-----------------
Adrenal Insufficiency, Inflammatory Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18-80 yo Patients diagnosed with pneumonia or exacerbated COPD Healthy controls 18-80yo Signed informed consent Exclusion Criteria: Pregnant or lactating females Life threatening severe disease Known primary or secondary adrenal insufficiency Systemic steroid therapy in the last 8 weeks Systemic therapy with opioid Systemic therapy with Ketoconazol, Mitotane, Metopyron, Etomidat, Rifampicin In healthy controls: relevant respiratory disease or known adrenal insufficiency or indication of infection Allergic reaction to ACTH Missing informed consent

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?
-----------------
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
-----------------
Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation

Study Overview
=================
Brief Summary
-----------------
About 30% of patients were reported to suffer inadequate bowel preparation.

Detailed Description
-----------------
Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.

Official Title
-----------------
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation

Conditions
-----------------
Bowel Cleansing Quality, Predictors, Colonoscopy, Boston Bowel Preparation Scale

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing colonoscopy. patients older than 18 years. Exclusion Criteria: patients referred for emergency colonoscopy.

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 undergoing colonoscopy<br>patients undergoing colonoscopy were observed in terms of the bowel preparation quality which is measured by Boston Bowel Preparation Scale (BBPS). | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score. | inadequate bowel preparation | 5 months |
Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation

Study Overview
=================
Brief Summary
-----------------
In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.

Detailed Description
-----------------
This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.

Official Title
-----------------
Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute stroke patients Exclusion Criteria: No
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independence (mRS 0-2) at 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 1 year |  | 1 year | 
| Brain hemorrhage at 24-72 hours after hospitalization |  | 72 hours | 
| The incidence of recurrent stroke or other vascular events at 1 year |  | 1 year | 
| Independence (mRS 0-2) at 5 year |  | 5 year | 
| The incidence of recurrent stroke or other vascular events at 5 year |  | 5 year | 
| All-cause mortality at 5 year |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thrombolysis, thrombectomy, hospitalization
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health

Study Overview
=================
Brief Summary
-----------------
prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development

Official Title
-----------------
Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: maternal SARS-CoV-2 infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals Exclusion Criteria: aggravation of symptomatology requiring specific treatment and/or hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID19<br>- Women with SARS-CoV-2 infections | Other: maternal SARS-CoV-2 infection<br>* positive PCR in nasopharinx and/or presence of antibodies in serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 RNA | levels of viral RNA from SARS-CoV-2 in breast milk | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast milk immune | interleukines, cytokines and growth factors, immunoglobulins | 1st year | 
| breast milk microbiota | microbiota composition and diversity | 1st year | 
| breast milk metabolite | metabolite profile | 1st year | 
| infant microbiota | infant microbiota profile | 1st year | 
| infant growth and development | z-scores growth curves | 1st year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast milk, Microbiota, Sars-CoV-2, metabolites, immune compounds, infant growth and development
The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock. Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).

Detailed Description
-----------------
This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters. Informed consent is obtained of the relatives.

Official Title
-----------------
The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU

Conditions
-----------------
Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Drug: nitroglycerin iv
* Drug: placebo = nacl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe sepsis Proven infection Informed consent Exclusion Criteria: Age < 18 years Pregnancy Use of nitroglycerine within 24 hours prior to ICU admittance Necessity to use nitroglycerine iv for instable angina

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: 1<br>nitroglycerine iv | Drug: nitroglycerin iv<br>* loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes<br>* Other names: nitropohl;|
| Placebo Comparator: 2<br>nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes | Drug: placebo = nacl 0.9%<br>* 4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes<br>* Other names: isotonic saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of MFI by nitro-glycerine |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease of length of stay decrease of SOFA decrease of morbidity/mortality |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, sepsis, nitroglycerine, SDF imaging
Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

Study Overview
=================
Brief Summary
-----------------
Primary Objectives: To classify the types of wound healing complications that occur after pre-operative radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas of the extremity. To evaluate the impact of each complication type on patient function and quality of life using the Toronto Extremity Salvage Score (TESS).

Official Title
-----------------
Functional Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma and Pre-Operative Radiotherapy

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of soft tissue sarcoma with histopathologic confirmation. Treatment protocol that includes pre-operative radiation therapy. Treatment protocol that includes limb-sparing surgical resection. Patient has received MD Anderson Cancer Center multidisciplinary care. Patient must be at least three years post-operative. Exclusion Criteria: Previous radiotherapy to the local site. Presence of regional or distant metastases. Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

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 |
| --- | --- |
| 1<br>Patients with a diagnosis of soft tissue sarcoma. | Behavioral: Questionnaire<br>* Toronto Extremity Salvage Score (TESS) questionnaire.<br>* Other names: Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints for this study will be anatomic site, histological subtype, primary wound closure, wound complication type, need for secondary operation and type of secondary operation. |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft Tissue Sarcoma, Limb Sparing Surgery, Toronto Extremity Salvage Score, Radiotherapy, Quality of Life, Questionnaire, Survey, TESS
Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Official Title
-----------------
A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Drug: sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dialysis patients who will be receiving their first kidney transplant Weight over 88 pounds (lbs.) Exclusion Criteria: Very high cholesterol levels Obesity Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR) |  |  | 
| Non-inferiority of the composite of graft loss and death at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks |  |  | 
| quality of life at 24, 52 and 104 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized controlled trial, Clinical Trial Phase III, Drug therapy, Immunosuppression, Treatment outcome, Kidney transplantation, Kidney function tests
Postoperative Acute Myocardial Ischemic Injury

Study Overview
=================
Brief Summary
-----------------
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG System for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery. A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the post-anesthesia care unit. On the first, second and third post operative morning a 10 second CEB dynamic sequence will be recorded. Blood will be sampled for troponin as well. On the first, second and third post operative afternoons a 10 second CEB dynamic sequence will be recorded. The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will continue as long as the patient remains hospitalized.

Official Title
-----------------
Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Device: VectraplexECG System with CEB®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. ≥ 45 years old. Anticipated hospitalization of at least two nights. Exclusion Criteria: Inadequate ECGs, based on an initial 10-second trace, as defined by: wandering baseline excessive noise ventricular ectopy pacer spikes or lead placement error Atrial fibrillation. Average heart rate exceeding 90 beats/minute. Evidence of previous myocardial infarction: Pathologic Q waves (≥0.04 sec) and/or Pathologic findings of a healed or healing MI and/or Evidence from an imaging study of a region of loss of viable myocardium

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Noncardiac surgery<br>VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively | Device: VectraplexECG System with CEB®<br>* The device will be used after noncardiac surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Accuracy of VectraplexECG System with CEB | 1 minute to complete the test |
Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.

Official Title
-----------------
A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Pyrimethamine and Metformin IR After Oral Administration in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Metformin and Pyrimethamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive) 100 kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor Subject judged not eligible for study participation by investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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: Metformin and Pyrimethamine<br>Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8) | Drug: Metformin and Pyrimethamine<br> <br> * Other names: Daraprim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(area under the plasma concentration-time curve) | AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2 | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUG(total area under the serum concentration-time curve for glucose) | AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration) | predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Pyrimethamine, Drug interaction