linjc16/ctgov huggingface dataset:
Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

Study Overview
=================
Brief Summary
-----------------
To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.

Official Title
-----------------
Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)

Conditions
-----------------
Bacterial Infection

Intervention / Treatment
-----------------
* Drug: Extended-Spectrum-Lactamases (ESBLs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted or transferred to the ICU/pulmonary/hematology units. Patients of either sex, 18 years of age or older Exclusion Criteria: Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy). Patients who have the contraindications of using Tazocin (pipercillin/tazobactam) Other exclusions 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-Spectrum-Lactamases (ESBLs)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacterial infection
Clinical Study of Novel Diagnostic Techniques for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.

Official Title
-----------------
Comparison Between Intra-articular Ultrasound Imaging, Non-invasive Ultrasound Imaging, Quantitative MRI Imaging, Contrast-enhanced CT Imaging and Arthroscopy for Diagnostics of Knee Osteoarthritis

Conditions
-----------------
Knee Injuries, Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Intra-articular ultrasound imaging of knee joint during arthroscopy
* Other: Non-invasive ultrasound imaging of knee
* Other: Quantitative MRI imaging of knee
* Other: Contrast-enhanced CT imaging of knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI Age >= 20 years Exclusion Criteria: Tumor or inflammation in the knee Severe general diseases Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Knee pain<br>Group with knee pain problems referred to an arthroscopy. | Other: Intra-articular ultrasound imaging of knee joint during arthroscopy<br> <br> Other: Non-invasive ultrasound imaging of knee<br> <br> Other: Quantitative MRI imaging of knee<br> <br> Other: Contrast-enhanced CT imaging of knee<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopical OA grade |  | 2014 |
Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

Study Overview
=================
Brief Summary
-----------------
transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as hemoglobin drop or hemoglobin drift, has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.

Official Title
-----------------
Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

Conditions
-----------------
Surgical Blood Loss, Surgery, Perioperative/Postoperative Complications

Intervention / Treatment
-----------------
* Diagnostic Test: Hemoglobin concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery. Exclusion Criteria: Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents). Requirement for surgical gauzes during surgery, including conversion to open surgical techniques. Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period. Significant postoperative bleeding (> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss). Postoperative hemodynamic instability (defined as requirement of vasoactive drugs). Other major postoperative complications during the observable period.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Hemoglobin concentration|Perioperative hemogloin concentration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin concentration | Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours) | 2-5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobin, Hemoglobin drop, Surgical Blood loss
Hormonal Levels in Men With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Subjects will be 1000 men meeting the following inclusion criteria: 1) male, age 18-65 years; 2) meeting DSM-IV criteria for major depressive disorder within the past one year, with a HAM-D score >12. Subjects will be excluded if they exhibit 1) a substance abuse or dependence disorder within the past year; 2) current psychotic symptoms; or 3) a history of bipolar disorder. Procedure After informed consent, eligible patients will have blood drawn for serum hormone levels; cortisol, DHEA-S and testosterone or they will provide a salivary sample for measurement of hormone levels. We will also test hormone level form 1000 healthy males (from blood or saliva) at the same age for comparison.

Official Title
-----------------
Hormonal Levels in Men With Major Depressive Disorder

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: Saliva sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Major Depression Disorder 18-65

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Saliva sample|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male, MDD, Testosterone, DHEA-S,Cortisol, Male, 18-65, Major Depression
Invasive Pulmonary Aspergillosis and Severe Influenza

Study Overview
=================
Brief Summary
-----------------
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection. Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.

Official Title
-----------------
Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?

Conditions
-----------------
Aspergillosis, Influenza, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection with influenza A or B Admission to one of the participating sites Exclusion Criteria: age < 18 patients with invasive pulmonary aspergillosis prior to intensive care admission consent withdraw

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 |
| --- | --- | --- |
| Invasive Pulmonary Aspergillosis | incidence of invasive pulmonary aspergillosis | up to 100 days |
Xerotic Dermatitis in Aged People

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population

Conditions
-----------------
Itching Symptoms, Xerotic Dermatitis

Intervention / Treatment
-----------------
* Device: DC086
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 70 years With xerotic dermatitis, clinically assessed , At least on the anterior part of lower and/or upper limbs, Presenting itching xerotic dermatitis evolving from at least 3 weeks Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time With MMSE score ≥ 20 dating less than 6 months Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation) Exclusion Criteria: Criteria related to pathologies Severe form of other dermatitis requiring either systemic treatment -- Itching xerotic dermatitis from iatrogenic origins Dermatological disease other than xerotic dermatitis which could interfere with the assessment, Systemic disease that may generate xerotic dermatitis and /or pruritus Immunosuppression condition, History of serious disease considered by the investigator hazardous for the patient or incompatible with the study. Criteria related to treatment - Use of treatment which could interfere with the evaluation of the disease or the course of the disease Criteria related to the population Ongoing participation to another clinical trial or participation in the previous month before the inclusion Patient under guardianship or trusteeship

Ages Eligible for Study
-----------------
Minimum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC086<br>cream | Device: DC086<br> <br> |
| Placebo Comparator: placebo<br> | Device: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Itching symptoms intensity change |  | From Day 1 to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
associated, aged population
Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine whether a clinically relevant laboratory measurement (of seven specific immunologic biochemicals in the blood) can identify which bone marrow transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to devise a comprehensive and inclusive laboratory test that is effective at determining who is likely to go on to respiratory failure, in order to facilitate early medical intervention.

Official Title
-----------------
Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients at Risk for Respiratory Failure

Conditions
-----------------
Blood Stem Cell Transplant Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Hematopoietic stem cell transplantation (HSCT) for any indication. Patients will range from age 0 to age 21. There is no gender restriction. We expect the male to female ratio to end up being about 50/50 Ability to understand and the willingness to sign a written informed consent document.

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
| Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine. |  | weekly during hospitalization for transplant |
To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Study Overview
=================
Brief Summary
-----------------
Prevention of COVID-19 infection to severe pneumonea or ARDS

Official Title
-----------------
Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: EC-18
* Drug: Placebo EC-18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Male or female age 19 years or older Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia Exclusion Criteria: Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia Pregnant or nursing at the time of signing informed consent Known sensitivity to any study medication Unwilling or unable to complete study diary Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC-18 Arm<br>EC-18 QD | Drug: EC-18<br>* EC-18 QD<br>|
| Placebo Comparator: Placebo Arm<br>Placebo EC-18 QD | Drug: Placebo EC-18<br>* Placebo EC-18 QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of transition to ARDS |  | 14 days after starting IP administration |
Vascular Effects of Sertraline in Heart Failure

Study Overview
=================
Brief Summary
-----------------
To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression

Official Title
-----------------
Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure, Depression

Intervention / Treatment
-----------------
* Drug: sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic heart failure with LVEF<40%, age >21 years Depression requiring medical treatment with sertraline Exclusion Criteria: Known intolerance of sertraline

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| A<br>Chronic heart failure patients with concomitant depression | Drug: sertraline<br>* open label 25-50 mg daily as tolerated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular endothelium, nitric oxide, depression, heart failure, vascular biology
Retrospective Medical Record Review of Mind Body Depression Group Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers.

Detailed Description
-----------------
This is a retrospective review of medical records. The study aims to evaluate the effects of participation in the Relaxation Response Intervention for Depression Clinical groups, on patient measures of: 1) depression, anxiety and perceived stress; 2) work productivity and activity impairment; 3) demand for, and adherence to behavioral medicine; 4) medication use for depression and/or anxiety; and 5) dose-response effects.

Official Title
-----------------
Retrospective Medical Record Review of Mind Body Depression Group Participants

Conditions
-----------------
Depression, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving care through MGH-Health Centers a diagnosis of depression and/or anxiety 21 years of age or older Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Change from baseline in Depression scales (CES-D 10) at 8 weeks |  | Pre- and Post-Intervention (8 weeks) | 
| Change from baseline Anxiety Scales (STAI-20) at 8 weeks |  | Pre- and Post- Intervention (8 weeks) | 
| Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks |  | Pre- and Post-Intervention (8 weeks) |
Use of Hair to Diagnose Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer. The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.

Official Title
-----------------
A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.

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

Intervention / Treatment
-----------------
* Procedure: Cutting scalp hair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women (aged >20) who are undergoing mammography, and Who are willing and able to provide informed consent; and Who have usable scalp hair Exclusion Criteria: Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN: cervical intra-epithelial neoplasia) within 5 years.

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cutting scalp hair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
x-ray diffraction, hair, breast cancer, synchrotron