linjc16/ctgov huggingface dataset:
Epidemiology and Determinants of Short-Term Outcome in Critically Ill Patients With Near-Hanging Injury

Study Overview
=================
Brief Summary
-----------------
Near-Hanging is a catastrophic event that has been merely studied in the literature. We aimed to report the outcomes, and early predictors of hospital survivors in critically ill patients with near-hanging. Patients admitted to 31 university or university-affiliated participating ICUs in France and Belgium between 1992 and 2014 were studied retrospectively. Hospital survival was the main judgment criterion.

Official Title
-----------------
Outcome After Near-Hanging Injury

Conditions
-----------------
Near Hanging

Intervention / Treatment
-----------------
* Other: logistic regression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any of the following code corresponding in the International Statistical Classification of Diseases and Related Health Problems, 10th Revision: Intentional self-harm by hanging, strangulation and suffocation (X70). Local investigators reviewed the medical records of the patients thus identified to select adults admitted to the ICU after successfully resuscitated near-hanging injury. older than 18 years requiring ICU management Exclusion Criteria: -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital survival<br> | Other: logistic regression<br>* To identify associations between factors listed in Table 1 and hospital survival, we used logistic regression<br>|
| No hospital survival<br> | Other: logistic regression<br>* To identify associations between factors listed in Table 1 and hospital survival, we used logistic regression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital survival | Survival rate at hospital discharge | 1 year |
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.

Official Title
-----------------
A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

Conditions
-----------------
Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma

Intervention / Treatment
-----------------
* Drug: LFA102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma Detectable metastases by bone scan, CT-scan, or MRI. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only) Suitable venous access for blood sampling Exclusion Criteria: Prior treatment with any anti-prolactin receptor antibody Major surgery within 28 days before study treatment Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug Prior anaphylactic or other severe infusion reaction to antibody formulations Other protocol-defined inclusion/exclusion criteria may apply

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast & Prostate Cancer Group<br>Dose Escalation | Drug: LFA102<br> <br> |
| Experimental: Breast Cancer Group<br>Dose Expansion | Drug: LFA102<br> <br> |
| Experimental: Prostate Cancer Group<br>Dose Expansion | Drug: LFA102<br> <br> |
| Experimental: Uterine Leiomyoma Group<br>Dose Expansion | Drug: LFA102<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of Dose Limiting Toxicity |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LFA102 serum concentration |  | 6 months | 
| Disease response |  | every 2 to 3 months | 
| Concentrations of antibodies to LFA102 |  | every month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Official Title
-----------------
A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Exclusion Criteria: Other protocol-defined inclusion / exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC-MPS arm<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters and graft function in maintenance renal transplant recipients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, maintenance patients, tolerability, EC-MPS
ICF in Secondary Prevention of Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to develop a practical protocol based on the ICF(The International Classification of Functioning, Disability, and Health) the risk factors of cardiovascular disease (CVD) in secondary prevention.

Detailed Description
-----------------
The original ICF assessment sheet contains CVD risk factor categories, such as comorbidities (depressive disorders, insomnia, heart rhythm and heart rate disorders, carotid artery disease, and hypertension), measures of liver and renal impairment, disorders of carbohydrate and lipid metabolism). The evaluation criteria for each category were determined based on recommendations defined in the ESC, AHA, EFSD, and KIDIGO guidelines.

Official Title
-----------------
The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.

Conditions
-----------------
Cardiovascular Diseases, Secondary Prevention, Risk Factor, Cardiovascular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the first episode of ischemic stroke or hemorrhagic stroke, full medical documentation with a description of the above-mentioned risk factors Exclusion Criteria: another neurological disease: brain tumor, trauma craniocerebral incomplete medical history - no data on assessed risk factors CVD

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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 |
| --- | --- |
| Patients after ischemic stroke<br>The analysis included the presence of CVD risk factors in patients after ischemic stroke durning in the early rehabilitation. | |
| Patients after hemorrhagic stroke<br>The analysis included the presence of CVD risk factors in patients after hemorrhagic stroke durning in the early rehabilitation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional functions | symptoms of depression | first examination on admission | 
| sleep functions | symptoms of insomnia | first examination on admission | 
| heart rate | heart rate per minute | first examination on admission | 
| heart rhythm | heart rhythm interpreting ECG (regular or irregular) | first examination on admission | 
| functions of arteries | carotid stenosis [%] | first examination on admission | 
| increased blood pressure | blood pressure value [mm/Hg] | first examination on admission | 
| functions related to the coagulation of blood. | International Normalised Ratio (INR) testing | first examination on admission | 
| Glycosylated hemoglobin | HbA1c [%] | first examination on admission | 
| lipid metabolism. | LDL [mg/dL] | first examination on admission |
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake

Study Overview
=================
Brief Summary
-----------------
As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.

Official Title
-----------------
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males and females aged 18 to 60 Exclusion Criteria: known disorders of the gastrointestinal tract which can lead to malabsorption intake of medication which could affect the absorption of any nutrients Pregnant or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention (observational study)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty acid composition of red blood cells due to dietary habits | Fatty acid composition of red blood cells due to dietary habits | 1 day ( first visit) |
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to perform perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis (RA) to enable its use among Arabic speaking population and to enhance confidence in its use patients with lower limb amputation.

Official Title
-----------------
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ) in Saudi Lower Amputees

Conditions
-----------------
Filling Out Questionnaires

Intervention / Treatment
-----------------
* Other: Filling out Questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current users of lower limb prosthesis of minum 6 month, to be able to fully understand and appropriately complete the questionnaire, to be unilater amputee. Exclusion Criteria: inability to understand and complete the questionnair (e.g. cognitive or language impairment; not native-Arabic speaker), less the 6 month of using the prosthesis, bilateral and partial lower limb amputees

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Lower extremity amputees | Other: Filling out Questionaire<br>* Filling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rasch analysis | to perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis | Change from baseline answers of questions following 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arabic Activity-specific Balance Confidence, Arabic Prosthetic Mobility Questionnaire, Psychometric
Jakarta Acute Coronary Syndrome Registry

Study Overview
=================
Brief Summary
-----------------
Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of all health centers in Jakarta and the surrounding area.

Detailed Description
-----------------
The JAC registry is an ongoing prospective, multi center, observational study that aims to enroll ACS patients who admitted to the emergency department (ED) of all health centers in Jakarta and the surrounding area. The registry has been collecting data since 2007, and used extensively since 2014. Currently, the JAC registry is the main source of data for measuring the performance of the STEMI network in the region, namely Jakarta Cardiovascular Care Unit Network System. The STEMI network in Jakarta has been introduced as an integral part of the government project since 2010/2011. STEMI was diagnosed based on the typical chest pain and ST segment elevation on two or more contiguos leads. The number of primary PCI, fibrinolytic therapy and non-reperfused patients were recorded.

Official Title
-----------------
Jakarta Acute Coronary Syndrome Registry

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: JAC Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI patients that was diagnosed based on the presence of typical chest pain and ST-segment elevation in two or more contigious leads on the initial ECG Exclusion Criteria: STEMI patients that was under 18 years

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: JAC Registry|patients who received acute reperfusion therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of primary PCI |  | 15 years | 
| In-hospital mortality |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of fibrinolytic therapy |  | 15 years | 
| The number of non-reperfused patients |  | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
system of care, acute myocardial infarction, registry, Primary PCI, Fibrinolytic therapy
Proprioception on Balance and Gait in Hemiparetics

Study Overview
=================
Brief Summary
-----------------
The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.

Official Title
-----------------
Investigation of The Effect of Proprioception on Balance and Gait Functions in Hemiparetic Individuals

Conditions
-----------------
Hemiparesis, Proprioceptive Disorders, Gait, Hemiplegic

Intervention / Treatment
-----------------
* Other: Proprioseption in hemiparetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 20-65 and discharged from the hospital, Diagnosed with hemiparesis at least 4 weeks ago, First time and unilateral hemiparesis, Modified Rankin Score ≤ 3, Hodkinson Mental Test ≥ 6, Individuals who agree to receive treatment will be included in the study. Exclusion Criteria: Having vision and hearing problems, Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis, Medically unstable, Diseases that will affect the lower extremity sense, Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Proprioseption in hemiparetics|Proprioception on balance and gait functions in hemiparetic individuals|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensorial Assessment-1 | Semmes-Weinstein Monoflament | 2 minutes | 
| Sensorial Assessment-2 | Position test for lower extremity | 2 minutes | 
| Sensorial Assessment-3 | Kinestesia (Electrogoniometer) | 2 minutes | 
| Balance assessment | Static balance via SportKAT-550 | 30 second | 
| Gait parameters | BTS G-Walk Spatiotemporal gait parameters | 1 minute |
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.

Official Title
-----------------
A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Group 1 ELND005
* Drug: Group 2 ELND005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete Week 12 visit of AG201 Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests Exclusion Criteria: Is currently using any other investigational or experimental drugs or devices Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 ELND005/ELND005<br>Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks. | Drug: Group 1 ELND005<br> <br> |
| Experimental: Group 2 PLACEBO/ELND005<br>Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks. | Drug: Group 2 ELND005<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment Emergent Adverse Events | To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression. | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agitation, Aggression, AD patients