linjc16/ctgov huggingface dataset:
Comparison of Scoring Systems for Bleeding in Open Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Seven different scoring systems used for prediction of perioperative bleeding were compared regarding patients operated for elective open cardiac surgery in the investigator's study.

Detailed Description
-----------------
Collected data of 500 consecutive patients, operated for elective open cardiac surgery were analyzed retrospectively. Seven different scoring systems were used to predict the probability of bleeding, including TRACK, PAPWORTH, WILL-BLEED, CRUSADE, ACTION, TRUST and ACTA-PORT. The scores are calculated for each of these systems by using their own parameters, and classified into four risk groups as very low, low, moderate and high. Then, these risk groups were compared with patients identified in two groups regarding the use of perioeprative erythrocyte suspension (ES) transfusions or not, as ES positive and ES negative.

Official Title
-----------------
Comparison of Preoperative Scoring Systems for Prediction of Perioperative Bleeding in Patients To Be Operated for Open Cardiac Surgery

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Other: Calculation of scoring systems for bleeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 18 years of age or older, Patients operated for elective open cardiac surgery. Exclusion Criteria: Patients with incomplete data, Patients with an age less than 18 years, Patients operated for emergent surgical procedures.

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: Calculation of scoring systems for bleeding|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding scores | Bleeding scores were calculated in points ranging from 0 to 4.(0 the lowest and 4 the highest risk score for bleeding) | Bleeding risk scores were calculated through study completion, an average of 2 years. | 
| The amount of blood transfusions | The amount of blood transfusions were recorded in units. | The amount of blood transfusions were recorded through study completion, an average of 2 years. |
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.

Official Title
-----------------
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

Conditions
-----------------
Pharmacogenetics of Metformin

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written consent Genotyped in OCT1 for (M420del and R61C) Exclusion Criteria: Daily medication Alcohol abuse Pregnancy Breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Homozygote wildtype OCT1<br> | Drug: Metformin<br>* The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.<br>|
| Active Comparator: Heterozygote OCT1<br> | Drug: Metformin<br>* The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.<br>|
| Active Comparator: Homozygote OCT1 variant<br> | Drug: Metformin<br>* The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous glucose production |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Hypoglycemic Agents, Diabetes Mellitus, Type 2, Gluconeogenesis, Pharmacodynamics, Pharmacogenetics
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.

Study Overview
=================
Brief Summary
-----------------
We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.

Official Title
-----------------
Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.

Conditions
-----------------
Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
* Dietary Supplement: Starch of potato


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who accept not to alter their food habits Exclusion Criteria: Food allergy Regular consumption of probiotics Diabetes Respiratory deficiency Cardiac deficiency Cancer or chronicle disease not stabilized Splenectomy, sickle-cell anemia Immuno depression or immunodeficiency acquired or congenital Immuno depressor or corticoid treatments

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 74 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Subject with active product, not vaccinated against influenza. | Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033<br>* 1 pill per day for 12 weeks<br>|
| Placebo Comparator: 3<br>Subject with placebo, vaccinated against influenza. | Dietary Supplement: Starch of potato<br>* 1 pill per day for 12 weeks<br>|
| Placebo Comparator: 4<br>Subject with placebo, not vaccinated against influenza. | Dietary Supplement: Starch of potato<br>* 1 pill per day for 12 weeks<br>|
| Experimental: 1<br>Subject with active product, vaccinated against influenza | Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033<br>* 1 pill per day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infectious episodes |  | During the study |
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety

Study Overview
=================
Brief Summary
-----------------
Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

Detailed Description
-----------------
ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.

Official Title
-----------------
Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study

Conditions
-----------------
Ventricular Tachycardia

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD Exclusion Criteria: Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,

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 |
| --- | --- |
| Experimental: Exercise training<br>training | Behavioral: Exercise training<br>* 3 months supervised interval training<br>* Other names: ICD, exercise training;|
| No Intervention: Not training<br>No organized training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy delivered from ICD, Anxiety score, functional status |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRV, Endothelial function |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, training
Creatine Supplementation on Cognition in Children

Study Overview
=================
Brief Summary
-----------------
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.

Official Title
-----------------
Effects of Creatine Supplementation on Cognitive Function in Children

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: creatine supplementation
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children age between 10 to 12 years of age Exclusion Criteria: cognitive impairment vegetarian diet use of creatine in the past 6 months chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 12 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 |
| --- | --- |
| Placebo Comparator: placebo<br>placebo (dextrose) | Dietary Supplement: Placebo<br> <br> |
| Experimental: creatine<br>creatine supplementation | Dietary Supplement: creatine supplementation<br>* creatine supplementation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | assessed by a battery of cognitive tests as follows: colors and words attention test, controlled words association test, memory and figures learning, mental flexibility test and inhibitory control, digit span test, and intelligence quotient. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue creatine content | as assessed by 1H-MRS. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

Study Overview
=================
Brief Summary
-----------------
Primary: To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH. Secondary: To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH. To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.

Official Title
-----------------
A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: afuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography Suffering for at least 6 months from lower urinary tract symptoms related to BPH An I-PSS total score ≥ 13 Out patient Exclusion Criteria: Patients previously treated with SL77.0499-10. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology. Isolated bladder neck disease. Diagnosed carcinoma of the prostate. Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH. Patients having an indwelling catheter. A residual urine > 200mL. Patients with Moderate or sever hepatic insufficiency. Known hypersensitivity to alpha1-blockers. Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: afuzosin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One year safety data of SL77.0499-10 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One year efficacy data and plasma concentration of SL77.0499-10 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasiam, Adrenergic alpha-antagonist
Intratracheal Suctioning and Oxygenation at Extubation

Study Overview
=================
Brief Summary
-----------------
Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.

Official Title
-----------------
Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)

Conditions
-----------------
Extubation

Intervention / Treatment
-----------------
* Other: none, does not apply


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval. Exclusion Criteria: Age < 18 years Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database) Patients dying without next-of-kin available

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 |
| --- | --- |
| Extubation with 100% O2<br>for further information please refer to study protocol | Other: none, does not apply<br>* none: does not apply<br>|
| Extubation with 35% O2<br>for further information please refer to study protocol | Other: none, does not apply<br>* none: does not apply<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in proportion of patients with need for ongoing ventilatory support |  | 30 days max follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, critical illness, extubation, respiratory failure
Cytosorb Therapy in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.

Official Title
-----------------
Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis

Conditions
-----------------
Endocarditis, Peri-operative Cytokines Levels, Cardiopulmonary Surgery

Intervention / Treatment
-----------------
* Device: CytoSorb haemoadsorption (HA) device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit Exclusion Criteria: denial of consent for data use

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 |
| --- |
|Device: CytoSorb haemoadsorption (HA) device|CytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital mortality | In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption | during hospital stay for cardiac surgery from admission until discharge (approximately 15 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in intensive care unit (days) | time in intensive care unit (days) | during hospital stay for cardiac surgery from admission until discharge (approximately 15 days) | 
| In-Hospital time (days) | In-Hospital time (days) | hospital stay for cardiac surgery from admission until discharge (approximately 15 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine clearance, cardiac surgery, CytoSorb, cytokine removal
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-36cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-36 cm.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cuff circumference: 22cm-36cm Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 81 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 |
| --- | --- |
| blood pressure monitor<br>Cuff circumference:22cm-36cm | |
| stethoscopy<br>Cuff circumference: 22cm-36cm | |

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
-----------------
BP