linjc16/ctgov huggingface dataset:
Coffee Consumption and NASH in the French Population.

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

Official Title
-----------------
Coffee Consumption and NASH in the French Population.

Conditions
-----------------
Non Alcoholic Steatohepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any newly diagnosed case of NASH histologically proven graded according to SAF criteria Or Metabolic syndrome defined by the IDF 2005 criteria: waist size> 94cm (men) or> 80cm (women) and the presence of at least two of the following criteria: blood pressure: Systolic ≥ 130mmHg OR diastolic ≥ 85 mmHg OR antihypertensive treatment Triglycerides ≥ 1.5g / L or lipid-lowering therapy HDL cholesterol <0.4 g / L (men) or <0.5 g / L (women) or lipid-lowering therapy fasting blood glucose:> 1 g / L or type 2 diabetes AND Hepatic steatosis diagnosed on liver imaging And liver fibrosis (diagnosed with a FibroScan> 6 KPa) Exclusion Criteria: Age <18 years Viral hepatitis and other chronic liver diseases Alcohol consumption> 20g / day for women, 30g / day for men Liver biopsy or FibroScan dating more than 6 months before inclusion. History of bariatric surgery Serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship) Solid cancer or progressive hematology or <2 years (except basal cell carcinoma or localized squamous cell carcinoma) Severe and terminal chronic renal insufficiency (estimated GFR <30mL / min) Recent myocardial infarction <6 months

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 |
| --- | --- | --- |
| To compare coffee caffeine consumption in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors. |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the correlation between the degree of hepatic fibrosis assessed by elastometry (FibroScan) or the histological stage and the caffeine consumption from coffee in univariate analysis and after adjustment for potential confounding factors. |  | Day 0 | 
| Comparison of the percentage of regular coffee drinkers in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors. |  | Day 0 | 
| Comparison of total caffeine consumption from all types of drinks in patients with NASH with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors. |  | Day 0 |
Acceptability of a Fixed Combination of Fenofibrate and Metformin

Study Overview
=================
Brief Summary
-----------------
The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

Official Title
-----------------
An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia

Conditions
-----------------
Dyslipidemia/Glucose Metabolism Disorder

Intervention / Treatment
-----------------
* Drug: fenofibrate and metformin fixed combination (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

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

| Intervention/Treatment |
| --- |
|Drug: fenofibrate and metformin fixed combination (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quotation by Visual Numeric Rating Scale before and after 4-week treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by reporting of Adverse Events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Effect Of Clustered Nursing Interventions On Physiological Response In Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
To determine physiological responses related to clustered nursing interventions among critically ill patients.

Detailed Description
-----------------
Clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.The study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of Alexandria Main University Hospital and Damanhour Medical National Institute. The most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. Physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.

Official Title
-----------------
Physiological Responses Related to Clustered Nursing Interventions Among Mechanically Ventilated Patients

Conditions
-----------------
Mechanically Ventilated Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients of both sex, aged 18 years and over mechanically ventilated for ≥ 48 hours. Exclusion Criteria: lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS) pregnancy.

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 |
| --- | --- |
| low intervention group<br>from 0-7 clustered nursing intervention | |
| high intervention group<br>from 8-15 clustered nursing intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in end tidal CO2 in mmHg (EtCO2) change in oxygen saturation (SO2) | measured 5 min before procedure (baseline), 5 min after start, 10 min after, immediately at end procedure, 15 min after end procedure for two weeks | up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clustered nursing interventions
Traditional African Healing Ceremony in a U.S. Population

Study Overview
=================
Brief Summary
-----------------
Pre-agricultural societies almost universally used healing ceremonies that involved reverence, rhythm and dance in the presence of a healer. It is believed that we are wired for such experiences and they foster an integrative mode of consciousness similar to that of mindfulness based stress reduction, which has been shown to have therapeutic effects in a variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has developed a healing ceremony based in sub-Saharan African traditions. The investigators plan is to have 25 subjects with a variety of clinical conditions participate in this ceremony. Subjects will then be asked to write a commentary about their experience and to participate in a focus group discussion. It is anticipated that the study will give us some idea of how promising this approach would be and what kinds of patients might benefit. Safety issues are minimal and include the possibility of injury (though the dancing is not strenuous) and psychological distress.

Official Title
-----------------
Traditional African Healing Ceremony in a U.S. Population

Conditions
-----------------
Chronic Fatigue Syndrome, Anxiety, Depression, Cancer

Intervention / Treatment
-----------------
* Behavioral: Movement to rhythm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 25 to 65 with one of the diagnoses listed above or with 8 visits to their provider in the last year and with no diagnosis of chronic illness. Exclusion Criteria: physical disability making participation difficult and previous experience with a similar ceremony, for instance while growing up in Africa.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Movement with rhythm<br>Subjects will move for 1 hour in time to the Congolese rhythm called Zebola. | Behavioral: Movement to rhythm<br>* Movement to rhythm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report from each participant as to whether they found the experience positive, neutral or negative. |  | During the first hour after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| written narrative of experience |  | During the first hour after the intervention |
Malnutrition in Gastroenterology Patients

Study Overview
=================
Brief Summary
-----------------
Background: Malnutrition is frequently occurring in sick patients and is associated with a higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which leads to a reduced functional status and quality of life. Specific aims: The purpose of the study is to evaluate the effect of a three month nutritional intervention with oral supplements on nutritional status, muscle function and quality of life.

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Drug: Fresubin protein energy Drink (CAVE! nutritional intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malnutrition Benign disease Exclusion Criteria: Malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fresubin protein energy Drink (CAVE! nutritional intervention)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
11C-Choline PET/CT and DWI MRI for Response Assessment of HCC Candidate to TARE

Study Overview
=================
Brief Summary
-----------------
Prospective exploratory study specifically investigating the diagnostic and predictive role of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and candidate to TARE. A minimum number of 20 patients will be considered for the analysis.

Detailed Description
-----------------
For the study, all patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included. In all cases, patients will undergo 11C-Choline PET/CT and DWI MRI before starting radioembolization and will be subsequently restaged 3 months after treatment completion. A minimum number of 20 patients will be considered for the analysis.

Official Title
-----------------
Diagnostic and Prognostic Role of 11C-Choline PET/CT and DWI MRI for Response Assessment in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to TARE

Conditions
-----------------
Hepatocarcinoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included; obtained informed consent Exclusion Criteria: patients age <18 years pregnancy or breast-feeding; patients affected by other malignancies within the last 3 years; disseminated extrahepatic disease; severely abnormal excretory liver function tests or ascites suggestive of liver failure; hepatopulmonary shunt >20%; vascular variants and abnormalities as demonstrated on pre-treatment angiography, which cannot be corrected by embolisation and which lead to reflux of hepatic arterial blood to the stomach, pancreas or bowel.

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 |
| --- |
|Other: No intervention|Observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC |  | Change from Baseline in SUVmax up to 3 months after TARE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocarcinoma, TARE, response assessment
Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Study Overview
=================
Brief Summary
-----------------
Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.

Official Title
-----------------
Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Device: Negative pressure dressing
* Device: Standard wound dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective and emergency abdominal surgery Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure dressing<br>Negative pressure dressing | Device: Negative pressure dressing<br> <br> |
| Active Comparator: Standard dressing<br>Standard wound dressing | Device: Standard wound dressing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection rate |  | 30 days |
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.

Detailed Description
-----------------
Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

Official Title
-----------------
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Conditions
-----------------
Normal Tension Glaucoma

Intervention / Treatment
-----------------
* Procedure: Trabeculectomy
* Procedure: Deep Sclerectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle Glaucoma unstable with current medication assessed by a glaucoma specialist Exclusion Criteria: Secondary Glaucoma e.g. due to previous injury or uveitis Exfoliation syndrome Pigment dispersion syndrome Previous transscleral or endoscopic cyclophotocoagulation Previous other glaucoma surgery Previous retinal detachment Previous intraocular surgery like vitrectomy and other retinal surgery Wet age-related macular degeneration Diabetic retonopathy Previous corneal transplant or previous refractive surgery Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars The patient does not want to participate in the study The patient does not speak Finnish, Swedish or English Dementia Only eye with vision worse than 20/200 or loss of central visual field

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 100 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucoma patient<br> | Procedure: Trabeculectomy<br>* trabeculectomy glaucoma surgery<br>Procedure: Deep Sclerectomy<br>* deep sclerectomy glaucoma surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications | 5 years |
COVID-19 and Psycological Well-being in Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules. No personal data are required.

Detailed Description
-----------------
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19. Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.

Official Title
-----------------
Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context

Conditions
-----------------
Distress, Emotional, Coping Behavior

Intervention / Treatment
-----------------
* Behavioral: well-being assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthworkers of San Raffaele Institution age>18 Exclusion Criteria: all those who do not agree

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 |
| --- |
|Behavioral: well-being assessment|exploration of emotional, cognitive and behavioural resources of healthcare professionals|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of anxiety and depression | Hospital Anxiety and Depression Scale (HADS) Consists of 14 questions, each of which is rated from 0 to 4 according to the severity of the experienced symptoms. | 6 months | 
| Coping strategies | Brief-COPE Consists of 28 items divided into 14 scales, relating to 14 identified coping strategies. Each item is rated on a 4 points Likert scale. | 6 months | 
| Levels of resilience | 14-Item Resilience Scale Consists of 14 items, each rated on a 7 levels Likert scale and evaluates the levels of resilience. | 6 months | 
| Levels of fear of COVID-19 | FEAR OF COVID-19 SCALE Consists of 7 items, each rated on a Likert scale from 1 to 5, with the aim of assessing the levels of fear related to COVID-19 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, resilience, depression, healthcare workers