linjc16/ctgov huggingface dataset:
Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure. Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.). With previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients. The aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis

Official Title
-----------------
Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis

Conditions
-----------------
Liver Cirrhosis, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose of liver cirrhosis by two or more of the following criteria: Albumin < 3.4 g/dL INR ≥ 1.3 Total bilirubin ≥ 2 mg/dL Portal hypertension (esophageal varices, splenomegaly, ascites, etc.) Liver biopsy Ambulatory patients Exclusion Criteria: Personal history of surgery in the last four weeks Thyroid disorders without replacement therapy Pregnancy Active alcoholism with alcohol ingest in the previous 6 months. Acute or chronic renal failure Hepatic or renal transplant

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | It will be assessed by bioelectrical impedance vector analysis | At the time of inclusion, every six months up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioelectrical impedance vector analysis, nutritional assessment, nutritional status, mortality, complications
Vitamin D, Blood Pressure, Lipids, Infection and Depression

Study Overview
=================
Brief Summary
-----------------
There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.

Official Title
-----------------
Vitamin D, Blood Pressure, Lipids, Infection and Depression

Conditions
-----------------
Hypovitaminosis D

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women 30 - 75 years of age low serum 25(OH)D levels Exclusion Criteria: diabetes other serious diseases hypercalcemia

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>vitamin D 40.000 IU per weel | Drug: Cholecalciferol<br>* 40.000 IU cholecalciferol per week for 6 months<br>* Other names: Decristol;|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression score |  | 6 months | 
| Blood pressure |  | 6 months | 
| Lipid profile |  | 6 months | 
| Frequency of infections |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, blood pressure, lipids, infection, depression
Survival Model for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis

Official Title
-----------------
Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)

Conditions
-----------------
Mortality, Morbidity;Newborn

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants born alive at or less than 34 weeks of gestation. Born in Welsh maternity and admitted for care to a Welsh neonatal unit. Mother normally resident in Wales Exclusion Criteria The mother is normally resident in England (detailed maternal data not available) Congenital anomaly noted at birth (alters the natural probability of outcomes) Duplicate episodes for an individual infant

Ages Eligible for Study
-----------------
Minimum Age: 0 Weeks
Maximum Age: 16 Weeks

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|Non-interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-hospital mortality | 40-weeks | 
| Mortality or major morbidity | In-hospital outcomes | 40-weeks |
Revision of the Hip Joint - Prospective Study

Study Overview
=================
Brief Summary
-----------------
Between the years 1999-2011 70 patients went through a revision of the hip joint(revision after not successful Total or Partial Hip Replacement). During the revision the Acetabular implant was found to be stable and it was decided not to replace it. The polyethylene insert was replaced and was fixated using a cement. Our purpose is to evaluate the physical condition of these patients.

Conditions
-----------------
Revision of the Hip Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that underwent a revision of the hip replacement without removing the acetabular implant Insert polyethylene with cement

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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 |
| --- | --- |
| Revison of the hip joint<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life as measured by the SF12 questionnaire. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Function as measured by the Haris Hip Score |  |
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Detailed Description
-----------------
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Official Title
-----------------
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Conditions
-----------------
Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: Ethambutol hydrochloride
* Drug: Clarithromycin
* Drug: Rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Isoniazid for TB prophylaxis ONLY. Patients must have: HIV infection. MAC infection. Life expectancy of at least 16 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded: Antimycobacterial drugs other than the study drugs. Carbamazepine. Terfenadine. Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry: Rifabutin. Rifampin. Ethionamide. Cycloserine. Clofazimine. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Sparfloxacin. Azithromycin. Clarithromycin. Pyrazinamide. Excluded within 14 days prior to study entry: Carbamazepine. Terfenadine. Theophylline.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethambutol hydrochloride|nan|
|Drug: Clarithromycin|nan|
|Drug: Rifabutin|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
-----------------
Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin
Nattokinase Supplementation and Hemostatic Factors

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.

Official Title
-----------------
Nattokinase Supplementation and Hemostatic Factors

Conditions
-----------------
Hypercholesterolemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 69 years Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL) Nondiabetic (fasting blood glucose < 126mg/dL and 2-hour blood glucose < 200mg/dL) Exclusion Criteria: Use of any medication or supplements Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment Women who were pregnant, breastfeeding or intending to become pregnant during the study period Drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nattokinase group<br>A nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal. | Dietary Supplement: Nattokinase<br> <br> |
| Placebo Comparator: Placebo group<br>A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal. | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collagen-epinephrine closure time at baseline |  | baseline | 
| Collagen-epinephrine closure time at 8-week follow-up |  | 8-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prothrombin time at baseline |  | baseline | 
| Prothrombin time at 8-week follow-up | second | 8-week follow-up | 
| Activated partial thromboplastin time at baseline |  | baseline | 
| Activated partial thromboplastin time at 8-week follow-up |  | 8-week follow-up | 
| Fibrinogen concentration at baseline | mg/dL | baseline | 
| Fibrinogen concentration at 8-week follow-up | mg/dL | 8-week follow-up |
Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Study Overview
=================
Brief Summary
-----------------
Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

Official Title
-----------------
Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Conditions
-----------------
Femoral Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 75 years Patient operated on a fracture of the upper extremity of the femur Patient, family or close relative who does not object to participation in the study Patient affiliated to a social security system Patient who can be monitored as part of the protocol Exclusion Criteria: Refusal to participate in the study (patient, family or trusted relative) Patient with support on the operated limb not authorized by the surgeon Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...) Patient with a pathologic fracture Patient included in Category 1 interventional research (involving a drug or medical device) Patient deprived of liberty Patient not affiliated to a social security system

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| Hemoglobin rate |  | 5 days after surgery | 
| Questionnaire Activities of Daily Living | For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points. A loss of autonomy will be defined by the decrease of one or more points in the ADL. | Pre-fractural and 6 months after surgery |
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

Study Overview
=================
Brief Summary
-----------------
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.

Official Title
-----------------
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

Conditions
-----------------
Malignant Biliary Obstruction

Intervention / Treatment
-----------------
* Device: 12-mm metallic biliary stent
* Device: 10-mm metallic biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage age≥ 18 years old; Karnofsky score ≥ 40. Exclusion Criteria: hilar stenosis; coagulation disorder (PT <50%, platelets < 80,000).

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 |
| --- | --- |
| 12-mm diameter metallic billiary stent<br> | Device: 12-mm metallic biliary stent<br>* Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).<br>|
| 10-mm diameter metallic billiary stent<br> | Device: 10-mm metallic biliary stent<br>* Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrent biliary obstruction (RBO) | RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliary stent, malignant biliary stenosis
MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented >80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.

Official Title
-----------------
MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pigmented lesion Exclusion Criteria: No pigmented lesion

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 |
| --- | --- |
| A<br>Subject with pigmented skin lesion suspect for malignant melanoma | |

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
-----------------
Melanoma, SIAscope, pigmented skin lesions