linjc16/ctgov huggingface dataset:
Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

Study Overview
=================
Brief Summary
-----------------
The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.

Detailed Description
-----------------
A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.

Official Title
-----------------
Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer

Conditions
-----------------
Sepsis, Severe Infection

Intervention / Treatment
-----------------
* Diagnostic Test: CBC-Diff Monocyte volume width distribution (MDW)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18-89 years) presenting to ED All races & ethnicities CBC with Differential performed upon presentation Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted) Exclusion Criteria: Previously enrolled Subjects discharged <12 hours form ED presentation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CBC-Diff Monocyte volume width distribution (MDW)|MDW measurement used to detect sepsis. Results will not be used to manage patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2) | Determination of the diagnostic accuracy, area under the receiver operating characteristic curve | 12 hours after presentation to the ED |
Therapeutic Lactose to Support Vaginal Microbiota

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV). Design: Double-blind, placebo-controlled randomised trial. Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic. Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets. Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.

Official Title
-----------------
Effect of Vaginal Lactose on the Vaginal Microbiota in Women With Bacterial Vaginosis: Double-blind, Placebo-controlled Randomised Trial

Conditions
-----------------
Bacterial Vaginoses

Intervention / Treatment
-----------------
* Dietary Supplement: Lactose
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH>4.5 and Clue cells in a wet smear. Exclusion Criteria: Not able to provide written informed consent.

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

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

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

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: Lactose<br>Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg | Dietary Supplement: Lactose<br>* Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg<br>|
| Placebo Comparator: Placebo<br>Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg | Dietary Supplement: Placebo<br>* Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load after intervention | quantitative measurements with qPCR for G. vaginalis, Prevotella spp., A. vaginae, Megasphaera type 1, L. gasseri, L. crispatus, L. jensenii and L. iners after intervention | 7 days |
Foot/Ankle at 7T MRI

Study Overview
=================
Brief Summary
-----------------
To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to improve detailed depiction of the complex anatomy of this region. To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).

Official Title
-----------------
High-Resolution MRI (7 Tesla) Findings of the Plantar Plate Compared With Current Clinical Standard Sequences (1.5 or 3 Tesla) and Surgical Reference Standard

Conditions
-----------------
Plantar Plate Tear

Intervention / Treatment
-----------------
* Diagnostic Test: 7 Tesla MRI of the foot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent as documented by signature (Appendix Informed Consent Form) at least 18 years old Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears, plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at the normal microanatomy of different structures, mainly the plantar plate) Control group: No evidence of the respective pathology. Exclusion Criteria: previous foot surgery with metal in vivo pregnancy or breast feeding any MRI contra-indications

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: 7 Tesla MRI of the foot|7 Tesla MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity / specificity | The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI | 2 years |
Alster Stem Cells - Intramyocardial Stem Therapy

Study Overview
=================
Brief Summary
-----------------
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

Official Title
-----------------
Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells

Conditions
-----------------
Acute Myocardial Infarction, Early Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Procedure: Percutaneous Coronary Intervention
* Procedure: BMNC therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI conventional therapy according to the ESC guidelines for heart failure BMI > 20 and < 35 Exclusion Criteria: PCI elder then 21 days relevant valvular disease history of stroke/multivessel disease/thromboembolic event etc. DM Type I pregancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PCI plus BNNC Therapy after acute myocardial infarction | Procedure: BMNC therapy<br>* Injection of BMNC after common PCI<br>|
| Active Comparator: 2<br>Percutaneous Coronary Intervention after acute myocardial infarction | Procedure: Percutaneous Coronary Intervention<br>* common Percutaneous Coronary Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF). |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration. |  | 12 months | 
| Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters. |  | 12 months |
Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma

Official Title
-----------------
Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation Using a Nonmyeloablative Preparative Regimen and Post-transplant Cyclophosphamide, in Patients With Poor Prognosis Lymphomas

Conditions
-----------------
Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide Exclusion Criteria: none

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 |
| --- | --- | --- |
| Evaluation of T lymphocytes and NK cells absolute number |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of discrete T-cells populations | Evaluation, by flow cytometry, of discrete T cell populations, including CD4+ and CD8+ TN, TSCM, TCM and TEM, NK and NKT cells, B cells, dendritic cell subsets | 1 year | 
| Evaluation of antigen-specific T cell populations | Evaluation of antigen-specific T cell frequency towards CMV, EBV and influenza virus by MHC tetramers | 1 year | 
| Evaluation of antigen-specific T lymphocyte's functionality | antigen-specific T lymphocyte's functionality towards tumor cell line evaluated using a degranulation assay | 1 year | 
| Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells |  | 1 year |
Specific Respiratory Infections as Triggers of Acute Medical Events

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.

Detailed Description
-----------------
We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity. This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.

Official Title
-----------------
Specific Respiratory Infections as Triggers of Acute Medical Events: Time Series Analysis Using LabBase and Hospital Episode Statistics

Conditions
-----------------
Influenza, Human, Respiratory Syncytial Virus Infections, Parainfluenza, Rhinovirus, Adenovirus, Human Metapneumovirus Pneumonia, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age Exclusion Criteria: Outcome events occurring in people aged <45 years

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Acute myocardial infarction | ICD-10 coded | 01/01/2004 to 31/12/2014 | 
| Stroke | ICD-10 coded | 01/01/2004 to 31/12/2014 |
Lutein and Alzheimer's Disease Study

Study Overview
=================
Brief Summary
-----------------
Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants may suppress this free radical damage associated with AD. Carotenoids are a family of naturally occurring antioxidants that have important functions for human health. Carotenoids are known to reduce oxidative damage, but their effects have not been studied in AD patients. The objective of the study is to examine whether lutein supplementation helps to reduce oxidative damage from free radicals in AD patients.

Official Title
-----------------
Lutein and Oxidative Stress in Alzheimer's Disease - A Pilot Study

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Dietary Supplement: lutein/zeaxanthin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with moderately severe Alzheimer's disease

Ages Eligible for Study
-----------------
Minimum Age: 55 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: 1<br>Daily Lutein/zeaxanthin supplementation with a meal | Dietary Supplement: lutein/zeaxanthin<br>* daily supplementation of lutein and zeaxanthin at dose of 12 mg/day<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: placebo<br>* placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative damage markers |  | 3 months |
Feasibility of Breast Cancer Risk Evaluation in Women From the General Population

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.

Official Title
-----------------
Feasibility of Breast Cancer Risk Evaluation in Women From the General Population

Conditions
-----------------
Breastcancer

Intervention / Treatment
-----------------
* Other: Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman from 40 to 74 years old Understanding the French language Exclusion Criteria: Women will not be eligible for study if they are in any of the following situations: Cancer active or in the course of treatment type surgery, chemotherapy, or radiotherapy, whether breast or other organ Recent diagnosis <1 year of suspicious or cancerous lesions Psychiatric pathology not compatible with the study Poor understanding of the French language

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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 |
| --- | --- |
| General practitioner<br> | Other: Information<br>* information of women about their risk of breast cancer and the screening methods recommended for them<br>|
| gynecologist<br> | Other: Information<br>* information of women about their risk of breast cancer and the screening methods recommended for them<br>|
| radiologist<br> | Other: Information<br>* information of women about their risk of breast cancer and the screening methods recommended for them<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation |  | up to 1 year |
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)

Study Overview
=================
Brief Summary
-----------------
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.

Official Title
-----------------
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI

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

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing revascularization for significant coronary artery disease age range 21-85 years Exclusion Criteria: non-STEMI, STEMI cancer renal failure with creatinine>3.0mg/dl liver cirrhosis lymphoproliferative disorder pregnancy thrombocytopenia<150'000 coagulopathy (INR>1.5) abnormal liver function tests illicit drug use history of statin intolerance history of rhabdomyolysis planned use of Glycoprotein IIb/IIIa inhibitors during PCI current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 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 |
| --- | --- |
| No Intervention: No atorvastatin<br>Patients do not receive Atorvastatin prior to PCI in cath lab | |
| Experimental: atorvastatin<br>Atorvastatin 80mg po given prior to PCI in cath lab | Drug: Atorvastatin<br>* Atorvastatin 80mg po given one time before PCI in cath lab.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural Myonecrosis |  | 16-24 hours post PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Dietary Supplement: DHA-O
* Dietary Supplement: Fish oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-79 fasting TG levels, 150-499 mg/dL baseline DHA intake <200mg/d active and in good health Exclusion Criteria: recent diagnosis of CHD or history of revascularization within 6mos of study use of lipid altering medications (other than stable statins) use of anticoagulants use of omega-3 products within 4 weeks of screening serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening lipid altering foods or supplements women who are pregnant or of childbearing potential not using adequate birth control current use or history of drug or alcohol abuse inability to swallow capsules

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA-O<br> | Dietary Supplement: DHA-O<br> <br> |
| Active Comparator: Fish oil<br> | Dietary Supplement: Fish oil<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in TG levels |  | week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lipid panel measures |  | week 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia