linjc16/ctgov huggingface dataset:
Malnutrition Using GLIM Criteria and Comparing CT and BIA for Muscle Mass Measurement

Study Overview
=================
Brief Summary
-----------------
Evaluation of malnutrition with the help of the GLIM criteria. Muscle mass measurement, as recommended in the GLIM criteria was done with the help of abdominal CT scan and BIA. Both methods were compared and their association to the clinical outcome was assessed.

Detailed Description
-----------------
We retrospectively analysed 260 patients undergoing major abdominal surgery between January 2017 and December 2019. Patients were prospectively screened and assessed for malnutrition with Nutritional Risk Score (NRS) and Subjective Global assessment (SGA). Body composition was analysed with CT scan and BIA within 30 days before surgery. GLIM criteria were retrospectively determined referring to the Fat free Mass from BIA (FFMBIA) and Muscle Mass from axial CT scan at lumbar level 3 (MMCT). The prevalence of GLIM - malnutrition according to BIA and CT was evaluated. Multivariate logistic regression analysis was used to determine association between malnutrition and outcome parameters. ROC-curves specified sensitivity and specificity of the different tools and areas under the curve were calculated.

Official Title
-----------------
Evaluation of Malnutrition in Patients Undergoing Major Abdominal Surgery Using GLIM Criteria and Comparing CT and BIA for Muscle Mass Measurement

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

Intervention / Treatment
-----------------
* Other: BIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 years BIA and CT scan was available within 31 days before surgery patients undergoing major abdominal surgery for gastrointestinal cancer Exclusion Criteria: patients who were not able to agree to the participation missing assessment of the nutritional status leck of quality of the CT scan

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: BIA|nutritional status was evaluated using BIA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall complications | all complications perioperatively including surgical side infections, anastomic leakage, sepsis | 31 days POD | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, sarcopenia, GLIM criteria
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate Measurements in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if blood obtained from a vein (smaller blood vessel) can be used instead of blood obtained from an artery (larger blood vessel).

Official Title
-----------------
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

Conditions
-----------------
Acid-base Analysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the ICU and requiring both an arterial line and central venous line as prt of their clinical care Exclusion Criteria: Patient did not desire to participate

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 |
| --- | --- | --- |
Perioperative Care in Ethiopia

Study Overview
=================
Brief Summary
-----------------
A national cross-sectional survey of surgery and anaesthesia at Ethiopian public hospital facilities.

Detailed Description
-----------------
Incorporating elements from recognized surgical and anesthesia facility assessment tools the survey assesses surgery and anaesthesia at Ethiopian public hospital facilities. The surveys assesses infrastructure, workforce, and availability of resources across all National facilities providing surgery. An online national cross-sectional survey, designed through a consultative process involving senior clinicians - anesthesia providers, surgeons, and obstetricians. Elements incorporated from existing tools, including the Safe Surgery Hospital Assessment Tool, World Federation of Societies of Anaesthesiologists (WFSA) Anaesthesia Facility Assessment Tool and the Lancet Commission on Global Surgery Surgical Assessment Tool. Survey questions grouped into themes: infrastructure, human resources, service delivery, and the availability of medications, equipment, and guidelines. The final quantitative survey includes 77 questions, for distribution to clinicians at a convenience sample of government hospitals providing major surgical services. Private facilities are excluded. The online survey link sent via the N4PCc collaborator network to clinicians at each site. All collaborators and clinicians are perioperative practitioners (anesthesia providers, surgeons, obstetricians, nurses) at their respective institutions. Additional facilities with no N4PCc collaborator contacted via the department of anesthesia at each institution. Telephone follow-up with non-responding hospitals to overcome barriers to completion, including assistance with data input where required.

Official Title
-----------------
Perioperative Care Capacity - an Ethiopian National Cross-sectional Survey

Conditions
-----------------
Perioperative Care

Intervention / Treatment
-----------------
* Other: Observational / Assessment only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinicians working at facilities providing perioperative care Clinicians working in surgery, anaesthesia or obstetrics These will be recruited to provide data on perioperative capacity at all facilities providing surgery nationally Exclusion Criteria: Clinicians working out-with perioperative care Facilities not providing surgical services
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational / Assessment only|The results of this assessment will determine the needs for future interventions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative care capacity | Delivery of perioperative services at national level | 3 months |
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Detailed Description
-----------------
Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis. Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.

Official Title
-----------------
Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells

Conditions
-----------------
Tracheal Stenosis, Laryngeal Stenosis, Mesenchymal Stem Cells

Intervention / Treatment
-----------------
* Biological: Olfactory mucosa-derived mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of chronic laryngeal or tracheal stenosis; absence of cartilage damage. Exclusion Criteria: refuse of patient to participate in the trial; acute infectious diseases; chronic mental disorders with severe manifestations; pregnancy/lactation; intercurrent severe chronic diseases; HIV, Hepatites B/C; active tuberculosis; alcohol use disorder/drug addiction; cachexia of any origin; malignant neoplasms.

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell treated group<br>Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells | Biological: Olfactory mucosa-derived mesenchymal stem cells<br>* Olfactory mucosa-derived mesenchymal stem cells<br>|
| No Intervention: Control group<br>Patients treated according to current clinical protocols | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who didn't require the repeated surgical interventions |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheostomy decannulation | Removal of the tracheostomy tube after the treatment. | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mesenchymal stem cells, Tracheal Stenosis, Laryngeal Stenosis, cell therapy
Association Between Mortality and Diabetes in Elderly Koreans: the South-West Seoul (SWS) Study

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is known to increase the risk of premature death in the general population. In this study, the investigators examine the impact of body mass index (BMI) levels, waist circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in elderly Koreans.

Detailed Description
-----------------
The investigators analyze follow-up data from the South-West Seoul (SWS) Study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea. Briefly, the study population was selected from four urban districts (Guro, Yangcheon, Gwanak and Gangseo) located in the south-west area of Seoul. A total of 1737 apparently healthy individuals (between 60 and 92 years of age) eventually participated in this survey starting in 1999. A follow-up examination was performed in 2002, and an additional 873 subjects who had not participated in the first examination were newly recruited. After a median follow-up of 10 years, each subject's vital status or cause of death as of 31 December 2011 was determined after linking these cohort data with death certificate data from the Korean National Statistical Office. Terminology and codes from the International Classification of Disease, Tenth Revision (ICD-10), were used to classify the underlying cause of death due to cardiovascular disease (ICD-10 codes I00-I79), cancer (ICD-10 codes C00-C97) and others.

Conditions
-----------------
Apparently Healthy Elderly People, (Between 60-92 Years of Age)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy individuals Over the age of 60 years Exclusion Criteria: Those with a mismatched identification number Missing data regarding BMI, waist circumference, and presence of diabetes

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 92 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiovascular mortality in elderly Korean men and women according to BMI, waist circumference, and presence of diabetes |  | A median follow-up of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival probability among study populations |  | A median follow-up of 10 years |
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.

Official Title
-----------------
RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration)

Conditions
-----------------
Schizophrenia, Schizoaffective Disorders, Psychotic Disorders

Intervention / Treatment
-----------------
* Drug: Quetiapine IR (Immediate Release)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor Exclusion Criteria: Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine IR (Immediate Release)|oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable of this study is change from baseline in total PANSS score |  | at Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total PANSS scores |  | on day 5 and 14 | 
| change from baseline in CGI-S and absolute CGI-I |  | on days 5, 7 and 14 | 
| frequency and severity of adverse events; change in vital signs. |  | assessed at each visit | 
| change from baseline in subscale PANSS and PANSS-EC scores |  | on days 5, 7 and 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs

Study Overview
=================
Brief Summary
-----------------
Tuberculosis is a worldwide common infectious disease and effective first line anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation of anti-TB drugs or changing anti-Tb drug regimen. Silymarin has been widely studied for the effect on hepatitis and it has been used in hepatology. Therefore, the investigators hypothesized that prophylactic administration of silymarin with anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB drugs.

Official Title
-----------------
Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: Silymarin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who are diagnosed with tuberculosis based on microbiological, biomolecular, pathological, or radiographical findings and are expecting to be administered with anti-tuberculosis drugs including INH, RFP, or PZA. adults >=35 years old Exclusion Criteria: basal AST >40 IU/uL or ALT >40 IU/uL pregnancy lactating women cases with history of adverse events to silymarin

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silymarin<br>Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs | Drug: Silymarin<br>* Silymarin 140mg 1tab bid for 8 weeks<br>|
| Placebo Comparator: Placebo<br>administration of placebo with anti-TB drugs | Drug: Placebo<br>* Placebo 1tab bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hepatotoxicity | the presence of hepatotoxicity will be evaluated at 2weeks, 4weeks, and 8weeks after initiation of anti-TB drugs. An interim analysis will be done after enrolling first 300 subjects. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hepatotoxicity by genotypic variants |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silymarin, hepatotoxicity, tuberculosis, HREZ
Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis

Official Title
-----------------
Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes

Conditions
-----------------
Hypertriglyceridemia, Acute Pancreatitis

Intervention / Treatment
-----------------
* Biological: insulin
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute pancreatitis triglycerides > 15 mmol/l Exclusion Criteria: diabetes on peroral therapy or insulin blood glucose > 11 mmol/l 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin<br> | Biological: insulin<br>* 5% glucose in 0.9% NaCl with 4 IU of short acting insulin per 500 ml added, infused at a rate determined by the treating physician, treatment duration: 18 hours<br>|
| Placebo Comparator: standard management<br> | Other: standard treatment<br>* infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %triglyceride reduction | change in triglycerides, expressed as % of initial value | after 18 hours of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypoglycemia |  | during treatment with insulin, up to day 5 |
Biomarkers to Measure Treatment Response for Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of the research study of the K23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. We will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. Both men and women between ages 21 and 65 years can join the study. All participants must be of European decent.

Official Title
-----------------
Biomarkers to Measure Treatment Response for Alcohol Dependence

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Other: Alcohol administration; Placebo administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days Exclusion Criteria: DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo alcohol<br><0.05% alcohol | Other: Alcohol administration; Placebo administration<br>* consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days<br>|
| Active Comparator: alcohol middle dose<br>alcohol dose=0.45g/kg for women and 0.5g/kg for men | Other: Alcohol administration; Placebo administration<br>* consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days<br>|
| Active Comparator: alcohol high dose<br>alcohol dose=0.90g/kg for women and 1.0g/kg for men | Other: Alcohol administration; Placebo administration<br>* consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of using serotonin transporter mRNA expression levels | Validity of using serotonin transporter mRNA expression levels in 5 HTTLPR:LL and rs 25531:AA genotype carriers, as a biomarker of alcohol consumption levels. | Within 24 hours of blood sample collection and in archived blood samples from the same participant stores at -80 degrees celsius for a duration of 6 months or more from the collection date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers, social drinkers, alcohol