linjc16/ctgov huggingface dataset:
Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.

Official Title
-----------------
Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.

Conditions
-----------------
Surgery, Malignancy, Acute Kidney Injury, Cronich Kidney Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Serum creatinine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Scheduled for elective surgery Surgery for oncological disease Exclusion Criteria: Patients undergoing postoperative chemotherapy Patients who died within 12 month after surgery

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 |
| --- | --- |
| surgical patients<br>Adult patients undergoing major elective general abdominal surgery for ontological disease | Diagnostic Test: Serum creatinine<br>* Will be described: 1) the number of patients actually screened with postoperative serum creatinine and 2) the number of patients actually screened with the same parameter at the long-term after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption of serum creatinine as marker of acute kidney injury postoperively | Number of actual patients screened postoperatively | 3rd postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury | Number of patients with a postoperative diagnostic increase of serum creatinine, in accordance with KDIGO guidelines | 3rd postoperative day | 
| Adoption of serum creatinine as marker of long term kidney dysfunction | Number of actual patients screened at the long term | 12 month after surgery | 
| Incidence of long term kidney dysfunction | Number of patients with a long term reduction in GFR greater than 10 ml/min with respect to the baseline | 12 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum creatinine, kidney dysfunction
Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to analyze the expression of genes and sequences encoding the human mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome, acute myeloid leukemia and other myeloproliferative diseases.

Detailed Description
-----------------
Leukocytes and myeloid lineage cells from these specimens will be assayed for expression of DRF genes using standard molecular biological approaches to measure mRNA levels. Extracted DNA will be analyzed for mutations that affect expressions or function using direct sequencing techniques. Alternatively, expression of DRF gene products (mDia proteins) will be assessed using specific antibodies and flow cytometry. Molecular findings resulting from these assays will be correlated with clinical information recorded in specimen logbook.

Official Title
-----------------
Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders

Conditions
-----------------
MDS, Myeloproliferative Disorder, AML

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and over Male Female Diagnosed with MDS, MPD and AML Exclusion Criteria: Under the age of 18 Received bone marrow transplant Control Group Criteria: inclusion: healthy men and women ≥ 55 years of age exclusion: history of hematological condition history of cancer

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 |
| --- | --- |
| adults<br>male and female with MDS and MPD and AML | |
| Healthy<br>Healthy control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine if defective DRF1 expression or mDia1 function may contribute to myeloid malignancies and point to mDia1 as an attractive therapeutic target in MDS and MPS |  | within a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene expression, gene sequencing, gene encoding, MPD, MDS, AML, mDia
Somnotouch-NIBP Compared to Standard Ambulatory 24-hours Blood Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Official Title
-----------------
Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement - a Prospective Registry

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Ability to give informed consent Exclusion Criteria: Age < 18 years Medical reasons that forbid blood pressure measurements on upper extremities Not able to give informed consent

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 |
| --- | --- | --- |
| Difference in mean 24 hours systolic blood pressure | Difference in mean 24 hours systolic blood pressure | 24 hours |
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.

Official Title
-----------------
An Open Label Single Arm Study to Investigate the Safety and Efficacy of Multiple Administrations of NI-0801, a Fully Human Anti-CXCL10 Monoclonal Antibody in PBC Patients With an Incomplete Response to Ursodeoxycholic Acid

Conditions
-----------------
Primary Biliary Cirrhosis

Intervention / Treatment
-----------------
* Drug: NI-0801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC) Elevated liver enzyme levels at screening Have given written informed consent Exclusion Criteria: Screening bilirubin > 2.9 mg/dL (50 μmol/L) Screening creatinine clearance < 80 ml/min History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites) Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C Known or previous diagnosis of malignancy Presence of any active infection Previous history of active TB within 12 months of screening

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 |
| --- | --- |
| Experimental: NI-0801<br> | Drug: NI-0801<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Study Overview
=================
Brief Summary
-----------------
Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in rebalanced homeostasis. However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.

Official Title
-----------------
The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Conditions
-----------------
Cirrhosis, Coagulopathy

Intervention / Treatment
-----------------
* Biological: Blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy Exclusion Criteria: Patients on blood thinners (prophylactic anticoagulation is permissible) Hemodynamically unstable patients requiring pressors (ie ICU level patients) Pregnant or lactating individuals Inability to provide consent for any reason

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEG<br>Blood transfusion | Biological: Blood transfusion<br> <br> |
| Active Comparator: Prothrombin Time (PT)/International normalized ratio (INR)<br>Blood transfusion | Biological: Blood transfusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of fresh frozen plasma (FFP) and platelet transfused | Will compare how much FFP and platelet transfusion patients receiving between 2 groups. | 2 week |
Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fasting State

Study Overview
=================
Brief Summary
-----------------
Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fasting State

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/1000mg in Healthy Subjects at Fasting State

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

Intervention / Treatment
-----------------
* Drug: DA-5210 10/1000mg
* Drug: DA-5210-R 10/1000mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5210 10/1000mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/1000mg<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5210 10/1000mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/1000mg<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 48 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 48 hours post-dose |
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy. The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.

Official Title
-----------------
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)

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

Intervention / Treatment
-----------------
* Behavioral: Psychotherapy
* Drug: Medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI. Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain. Only patients in whom complete revascularization is achieved are being enrolled in the study. Exclusion Criteria: Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy<br>Psychotherapy and medical therapy | Behavioral: Psychotherapy<br>* humanistic-existential psychotherapy conducted in individual and group meetings<br>|
| Active Comparator: Control<br>Optimal medical therapy | Drug: Medical therapy<br>* Optimal medical therapy after Acute myocardial infarction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative incidence of new cardiological events and the occurrence of new medical pathologies |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of re-hospitalisations |  | 5 years |
Staphylococcus Aureus Skin and Soft Tissue Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training. This study will be conducted on three different bases among groups of male recruits to IDF training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for skin infection until the end of the training program.

Official Title
-----------------
Evaluating Strategies to Prevent Staphylococcus Aureus Skin and Soft Tissue Infections in Soldiers During Infantry Training

Conditions
-----------------
Staphylococcus Aureus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new recruit for a combat training unit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| company A-Training Base No.1<br> | |
| company A-Training Base No.2<br> | |
| company A-Training Base No.3<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Cane in Osteoarthritis (OA) Patients

Study Overview
=================
Brief Summary
-----------------
Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.

Detailed Description
-----------------
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

Official Title
-----------------
The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Cane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Knee osteoarthritis (ACR criteria) VAS for knee pain between 3 and 7 No changes the NSAID intake or physical activity in the previous 3 months Exclusion Criteria: Symptomatic heart or pulmonary disease Severe systemic disease Other symptomatic disease in the lower limb or in the upper limb that will carry the cane Joint injection in the previous 3 months PT in the previous 3 months Previously cane use Start regular physical activity in the last month

Ages Eligible for Study
-----------------
Minimum Age: 40 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: 1<br>Cane group | Device: Cane<br>* This group use the cane every day since the baseline<br>|
| No Intervention: 2<br>Control Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - visual analogue scale |  | T0, T30 and T60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function - Lequesne index |  | T0, T30 and T60 | 
| Function - WOMAC questionnaire |  | T0,T30 and T60 | 
| Quality of life - SF-36 |  | T0, T30 and T60 | 
| Energy consumption (VO2)- gas analysis with and without cane during the 6MWT |  | T0, T30 and T60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis, Daily cane use, Pain, Function, Quality of life, Energy consumption during the gait
Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.

Detailed Description
-----------------
To examine our hypothesis, we will incubate PBMC samples from obese and nonobese patients with IFN, followed by microarray analysis to compare the IFN response patterns in both groups of patients and to identify genes differentially regulated between these two groups. Identification of such genes will provide important insight to the mechanism of the antiviral effect of HCV. The identified genes will have the potential of serving as targets for pharmaceutical intervention aiming at enhancing the efficacy of IFN therapy for obese patients. This is an open-label study. Ten obese and 10 nonobese patients with chronic hepatitis C will be recruited. For the purpose of this study, obese is defined as body weight >85 kg and BMI >30, and nonobese as body weight <75 kg and BMI<25.

Official Title
-----------------
Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Conditions
-----------------
Obesity, Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese (weight > 85kg and BMI>30) or non-obese patients (<75kg and BMI <25) with chronic Hepatitis C Chronic Hepatitis C infection with documented HCV RNA Body habitat either as obese or non-obese as defined above Currently not under IFN therapy Non-African American Exclusion Criteria: Body habitat neither obese or non-obese as defined for the purpose of this study Unable to give consent On immunomodulatory agents such as prednisone Active infection other than Hepatitis C Co-infection with HBV or HIV Active or excessive alcohol use Other cause of chronic Hepatitis

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 |
| --- | --- |
| Obese<br> | |
| Non-Obese<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
-----------------
Microarray Analysis, Obesity, Chronic Hepatitis C