linjc16/ctgov huggingface dataset:
Phase Angle and Mortality in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Detailed Description
-----------------
Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. Despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Official Title
-----------------
Phase Angle as a Nutritional Marker Related to Prognosis Inpatients With Cirrhosis: A Cutt-off Value for Mexican Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old ambulatory patients Diagnosis of liver cirrhosis Exclusion Criteria: Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase angle<br>Phase angle obtained from bioelectrical impedance | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Phase angle obtained from bioelectrical impedance | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase angle, liver cirrhosis, mortality, malnutrition
Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

Study Overview
=================
Brief Summary
-----------------
Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable consumption, decreased intake of high energy foods, snacks, sweets, increased intake of water/low energy drinks, decreased intake of high energy drinks. Physical activity should be more than 1 hour/day and TV/media consumption less than 1 hour/day. Main questions are: Do children differ in intervention and control kindergartens according to their nutrition behaviour? Do children in the intervention kindergartens have a higher physical training than such in the control kindergartens? Data were collected with a standardised questionnaire. Do children differ in intervention and control kindergartens according to their body mass index?

Detailed Description
-----------------
The program is based on actual cognitions and methods of the early education science. In the initial phase study part I (2003-2006) we will study over three years in 75 kindergartens of four administrative districts in Bavaria, Germany: Bamberg, Günzburg, Ingolstadt and Schwandorf. The objective of the study part II is to evaluate the effects of the TigerKids intervention program on overweight prevalence in childhood. Data concerning BMI, nutrition behavior and physical activity are assessed both at baseline (September/October 2007) and after 10 months intervention in > 450 control- and intervention-kindergartens in Bavaria.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: attitude change
* Behavioral: adiposity prevention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant of intervention- or control-kindergarten Exclusion Criteria: absence of parenteral consent to participate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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

| Intervention/Treatment |
| --- |
|Behavioral: attitude change|TigerKids: setting based prevention program to reduce obesity risk factors in children|
|Behavioral: adiposity prevention program|The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | 2005, 2006, 2007, 2008 | 
| nutrition behavior |  | 2005, 2006, 2007, 2008 | 
| physical activity |  | 2005, 2006, 2007, 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, kindergarten, obesity, adiposity
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE

Study Overview
=================
Brief Summary
-----------------
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE

Detailed Description
-----------------
Multi-centre trial involving 46 hospitals in the United Kingdom, with patients entered by 137 Consultant Physicians. Consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. Information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. Outcomes were measured as death from DVT/PE, non-fatal extensions or recurrences of DVT/PE and major haemorrhages during and after anticoagulation.

Official Title
-----------------
Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism

Conditions
-----------------
Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis With Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: Duration of anticoagulation
* Drug: Warfarin duration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate. Exclusion Criteria: DVT/PE severe enough to require thrombolysis or pulmonary embolectomy. DVT/PE in the preceding 3 years. Neoplasia diagnosed/treated within previous 3 years. Pregnancy. Known major thrombophilias. Prolonged or continuous immobility or confinement to bed. Previous allergy to heparin or warfarin. Requirement for long-term anticoagulation. Inability to give informed consent.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duration of anticoagulation|nan|
|Drug: Warfarin duration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death due to DVT/PE |  |  | 
| Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment. |  |  | 
| Number of major haemorrhages. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

Study Overview
=================
Brief Summary
-----------------
In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.

Official Title
-----------------
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

Conditions
-----------------
Sepsis, Coagulopathy

Intervention / Treatment
-----------------
* Device: Calibrated Automated Thrombogram (CAT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 sepsis diagnosis Exclusion Criteria: oncology patient. anticoagulant treatment pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Calibrated Automated Thrombogram (CAT)|The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between sofa score and thrombin generation |  | one week |
Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma

Study Overview
=================
Brief Summary
-----------------
The objectives are to: validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia. The objectives are to: validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia. This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and assist clinical outcomes with these miRNAs.

Official Title
-----------------
Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma

Conditions
-----------------
Lymphoma, Hyperplasia Lymphoid Reactive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years and above Has condition related to lymphoma or reactive lymphoid hyperplasia Exclusion Criteria: Age below 18 years Known pregnancy lymph tissue cannot be accessed

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 |
| --- | --- |
| RLH<br>This group includes subjects diagnosed with reactive lymphoid hyperplasia. | |
| Lymphoma<br>This group includes subjects diagnosed with lymphoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma. | The concentration of tissue miRNAs in absolute quantification in comparison to reactive hyperplasia and lymphoma. To investigate the potential prognosis of lymphoma by the expression difference of the miRNA panel. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish hyperplasia and lymphoma and against standard clinical outcome. | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miRNA, biomarker
Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.

Detailed Description
-----------------
In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The CHEOPS pain scale will use to assess postoperative pain.

Official Title
-----------------
Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children

Conditions
-----------------
Postoperative Analgesia

Intervention / Treatment
-----------------
* Procedure: penil or pudendal nerve block in circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients, aged 1-12 years old patient undergoing circumcision, Exclusion Criteria: history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pudendal block group in circumcision<br>Nerve stimulated pudendal nerve block performed under general anesthesia | Procedure: penil or pudendal nerve block in circumcision<br>* regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision<br>|
| Active Comparator: Penil block group in circumcision<br>Penil block performed by surgeon under general anesthesia | Procedure: penil or pudendal nerve block in circumcision<br>* regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain evaluatiom | CHEOPS pain scale | 24 hour |
Oral Misoprostol Before Endometrial Biopsy

Study Overview
=================
Brief Summary
-----------------
An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.

Official Title
-----------------
Oral Misoprostol Before Endometrial Biopsy

Conditions
-----------------
Endometrial Biopsy

Intervention / Treatment
-----------------
* Drug: misoprostol
* Drug: vitamin B6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 19 years and older planned endometrial biopsy Exclusion Criteria: known hypersensitivity or allery to prostaglandins seizure disorder liver disease known abnormal liver function tests pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Vitamin B6 | Drug: vitamin B6<br>* Vitamin B6 50 mg orally 12 hrs prior to procedure<br>|
| Active Comparator: 2<br>misoprostol | Drug: misoprostol<br>* misoprostol 400mcg 12 hrs prior to procedure<br>* Other names: Cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain/discomfort of endometrial biopsy |  | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ease of performing biopsy |  | during procedure | 
| success of obtaining biopsy |  | during procedure | 
| potential side effects |  | time study drug taken until procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain/discomfort, cervical dilatation, side effects
Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
A geriatric assessment is becoming increasingly important in the treatment of patients with a percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal therapy concept is to examine the influence on the postoperative outcome. In addition to a comprehensive assessment of the individual frailty score, the subjective condition before and after TAVI is also evaluated using a standardized questionnaire (Minnesota living with heart failure questionnaire).

Official Title
-----------------
Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

Conditions
-----------------
Influence of Geriatric Functional State on the Outcome After TAVI, Possible Change in Geriatric Assessment After TAVI

Intervention / Treatment
-----------------
* Other: pre- and postinterventional geriatric assessment in patients undergoing TAVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with indication for TAVI according to the current guidelines Exclusion Criteria: no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pre- and postinterventional geriatric assessment in patients undergoing TAVI|geriatric assessment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Live score in the Minnesota living with heart failure questionnaire | self reported quality of life | 6 month | 
| frailty score | multimodal geriatric assessment including cognitive Status (MMST, clock test, Tinetti test, stand up and go-test) | 6 month | 
| mortality after TAVI | phone call follow-up | 6 month |
Dietary Determinants in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.

Official Title
-----------------
Assessment of Dietary Intakes of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Conditions
-----------------
Dietary Intake, NAFLD

Intervention / Treatment
-----------------
* Other: there is no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out Exclusion Criteria: not completing more than 10% of the questionnaire

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 |
| --- | --- |
| Patients with NAFLD<br>Patients with NAFLD are the cases. | Other: there is no intervention<br> <br> |
| control group<br>Healthy people without NAFLD are controls. | Other: there is no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nonalcoholic fatty liver disease diagnosed by Fibroscan | patients with confirmed diagnosis will be asked about their dietary intakes | 6 months |