linjc16/ctgov huggingface dataset:
Registry AutoLog Lipid Removal and Blood Component Characterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: to determine the lipid removal capabilities of the Medtronic AutoLog System. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

Detailed Description
-----------------
Since the in house data strongly suggest that the Medtronic AutoLog is uniquely high performing in lipid removal in-vitro, the Registry AutoLog Lipid Removal and Blood Component Characterization is initiated to determine if the AutoLog system is successful in removing lipids in vivo as it is in-vitro. Therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl. The study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). The study has a single arm, without controls, as it is descriptive in nature.

Official Title
-----------------
Registry AutoLog Lipid Removal and Blood Component Characterization

Conditions
-----------------
Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation. Exclusion Criteria: The use of citrate-based anticoagulant in patients with impaired liver function Gross contamination and/or septic procedures Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system Caesarean sections in presence of amniotic fluid Presence of high concentrations of prostatic fluid Contamination of salvaged blood with drugs not intended for intravenous administration Use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system Coagulopathy Not willing to sign a Patient Informed Consent/Data Release Form
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autotransfusion<br>All patients undergoing surgery which requires routine use of an autotransfusion system | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of reduction of nonemulsified fat | The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog. | after process | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AutoLog, Post market release, Non-interventional
The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress and the incidence of infections, cardiovascular events and mortality.

Detailed Description
-----------------
The mortality rate in patients with end stage renal failure is substantially higher than in the general population, and deaths are mainly attributable to cardiovascular diseases and infections. There is accumulating evidence that supports the role for oxidative stress in damaging the immune system and in the pathogenesis of cardiovascular diseases in hemodialysis patients, therefore antioxidative treatment, which will reduce oxidative stress, may be beneficial. Pomegranate juice contains antioxidants such as soluble polyphenols, tannins and anthocyanins and was shown to have anti-inflammatory, anti- bacterial and anti-atherosclerotic properties in mice and humans. However,the effects of pomegranate juice on oxidative stress, infections and cardiovascular events in hemodialysis patients are still not documented. This is a randomized preventive intervention trial on hemodialysis patients from one dialysis centre in Israel. The patients will be enrolled and randomized to receive pomegranate juice or placebo. Patients will be followed for one year. The objective of this study is to investigate the effects of pomegranate juice (PJ) consumption by hemodialysis patients on the changes in oxidative stress and the incidence of infections, cardiovascular events and mortality.

Official Title
-----------------
A Randomized Clinical Trial for Estimating the Effects of Pomegranate Juice Consumption by Hemodialysis Patients on Oxidative Stress, Infections, Cardiovascular Events and Mortality

Conditions
-----------------
End Stage Renal Disease, Hemodialysis

Intervention / Treatment
-----------------
* Dietary Supplement: Pomegranate juice
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End Stage Renal Disease, stable chronic hemodialysis > 3 months Informed Consent. Man and women over 18 years. Exclusion Criteria: Hemodialysis < 3 months Participation in other clinical trial Not eligible according to physician decision

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG<br> | Dietary Supplement: Pomegranate juice<br> <br> |
| Experimental: PL<br> | Dietary Supplement: Placebo<br> <br> |

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
-----------------
Hemodialysis, Nephrology, Pomegranate Juice, Israel
The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.

Official Title
-----------------
A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: Memantine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: El Escorial Classification of laboratory supported probable, probable,or definite ALS Age 18 - 80 years, ALS symptoms for no more than 3 years, FVC greater than or equal to 60% predicted, Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months, Patients must have the ability to attend monthly study visits in Edmonton or Calgary, Alberta Exclusion Criteria: Presence of significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness Female patients who are breastfeeding Use of concurrent investigational drugs, Patient unlikely to comply with study requirements Poor adherence to study protocol during run-in phase

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine Low Dose<br> | Drug: Memantine<br> <br> |
| Experimental: Memantine High Dose<br> | Drug: Memantine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALS Functional Rating Scale-Revised (ALSFRS-R) |  |  | 
| Forced vital capacity (FVC) |  |  | 
| Manual Muscle Testing (MMT) |  |  | 
| Addenbrooke Cognitive Examination (ACE) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor unit number estimates of hand and foot muscles |  |  | 
| N-acetylaspartate in the motor cortex |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND, Memantine
Brain Computer Interfaces (Mu Rhythm Learning)

Study Overview
=================
Brief Summary
-----------------
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.

Detailed Description
-----------------
As a method of BCI control, Mu rhythms are difficult to learn and involve extensive training. The investigators want to keep users motivated and determine the best way to provide effective training. Healthy users will be trained to control a computer by wearing an electrode cap that is connected to a computer. They will have their levels of motivation and interest measured while learning to use the Mu rhythm. Two different types of learning programs will be used to determine which is most effective for Mu rhythm training. This method will be used for device control by people with severe physical impairments, who may be able to communicate or carry out other desired tasks using a BCI.

Official Title
-----------------
EEG-based Brain Computer Interface and Mu Rhythm for Computer Access

Conditions
-----------------
Mobility Impairments

Intervention / Treatment
-----------------
* Procedure: Brain Computer Interface for Mu Rhythm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Able to read text on a computer screen Able to understand and remember instructions concerning participation Exclusion Criteria: Unable give informed consent. Unable to understand and follow instructions. Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings. Known to have photosensitive epilepsy. Open head lesions or sores

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

| Intervention/Treatment |
| --- |
|Procedure: Brain Computer Interface for Mu Rhythm|Device: Brain Computer Interface Subjects will wear an EEG (electrode) cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate a computer. Subjects will be asked to participate in 4-20 sessions. Arms: Brain Computer Interface Keyboard|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Mu Rhythm Learning | The primary outcome measure is determining the best learning methods by which subjects can learn to use the Mu rhythm to hit targets on a computer screen. | 20 sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain, computer, interfaces, mobility impairments
Optical Coherence Tomography in STEMI

Study Overview
=================
Brief Summary
-----------------
The overall objective of this research proposal is to use OCT to investigate those morphological culprit plaque characteristics associated with the risk of developing MVO in reperfused STEMI patients.

Detailed Description
-----------------
The specific research objectives include: To use OCT to determine the type of plaque (plaque rupture, plaque erosion or calcified nodule) most associated with the presence and severity of MVO (as measured by IMR and cardiac MRI). To use OCT to investigate the relationship between the extent of tissue protrusion and the amount of residual stent thrombus with the presence and severity of MVO (as measured by IMR and cardiac MRI).

Official Title
-----------------
Plaque Evaluation by Optical Coherence Tomography and Its Association With Microvascular Obstruction in Reperfused STEMI Patients - The POMS Study

Conditions
-----------------
STEMI

Intervention / Treatment
-----------------
* Procedure: Optical coherence tomography (OCT)
* Procedure: Index of microcirculatory resistance (IMR)
* Other: Cardiac MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed STEMI as per the in-charge consultant based on presenting history, ECG and angiogram findings. < 12 hours of onset of chest pain. Ability to provide informed consent Exclusion Criteria: Previous myocardial infarction or coronary artery bypass graft surgery Cardiac arrest or cardiogenic shock Inability to advance the OCT catheter or to obtain good image quality Ostial lesions Significant renal impairment Contraindications for cardiac MRI Contraindication for adenosine (for IMR measurement)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 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 |
| --- | --- |
| STEMI patients<br>The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study. All patients to do Optical Coherence Tomography (OCT), Index of Microcirculatory Resistance (IMR) and Cardiac MRI. | Procedure: Optical coherence tomography (OCT)<br>* Special camera to study part of your heart that was affected<br>Procedure: Index of microcirculatory resistance (IMR)<br>* Special wire to study part of your heart that was affected<br>Other: Cardiac MRI<br>* Special scanner if the heart to assess the damage of your heart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Two years |
Population-based Intervention to Promote Health in Elementary Schools

Study Overview
=================
Brief Summary
-----------------
Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness. Main questions of the pilot are: Does health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?

Detailed Description
-----------------
The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein. The long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.

Official Title
-----------------
Rakuns: Setting-based Prevention Program to Promote Positive Experiences in Health Promoting Lifestyle Choices

Conditions
-----------------
Health Promotion

Intervention / Treatment
-----------------
* Behavioral: attitude change, behavioral change
* Behavioral: prevention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: teacher of intervention-school Exclusion Criteria: absence of consent to participate
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: attitude change, behavioral change|nan|
|Behavioral: prevention program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of health related behaviour due to intervention |  | After 6 weeks of intervention period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elementary school, children, health promotion, teachers, prevention
Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.

Detailed Description
-----------------
RNF43 is a cancer testis antigen which express widely in colorectal cancer tissue but not in normal organs. RNF43-721 induces HLA A24 restricted specific cytotoxic T lymphocytes (CTL) against RNF43 expressed target. S-1/CPT-11 chemotherapy is performed unresectable advanced colorectal cancer in Japan and is reported to be obtained almost the same result compared with FOLFOX or FOLFIRI as first-line chemotherapy for advanced colorectal cancer. Because synergistic effect between vaccine therapy and chemotherapy will be expected, we plan phase I study to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.

Official Title
-----------------
Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Biological: RNF43-721


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG performance status 0-1 Life expectancy > 3 months HLA A24 positive Histologically diagnosed as colorectal cancer with measurable lesion Laboratory values as follows:WBC>3000/mm3, Hb>10mg/dl, Plt>75000/mm3, Creatinine<1.2mg/dl, T. bil.<1.5mg/dl, AST, ALT<3x normal limits Able and willing to give valid written informed consent Exclusion Criteria: Active other malignancy Active infection Immune deficiency Current treatment with steroids and immunosuppressive agents Pregnancy and breast feeding Inability oral intake Psychic disease Hepatitis B, C virus HIV infection

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1<br> | Biological: RNF43-721<br>* Doses of 0.5mg, 1.0mg, 3.0mg/body/week<br>* Other names: S-1/CPT-11;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (toxicities as assessed by NCI CTCAE version 3) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific CTL induction in vitro, Objective rate as assessed by RECST criteria |  | 2 months |
Adult Social Interaction

Study Overview
=================
Brief Summary
-----------------
This study will collect vocalization data from healthy adults during regular daily activity.

Official Title
-----------------
Exploratory Study of Wireless, Wearable Sensors at Assessing Social Interaction in Healthy Adults

Conditions
-----------------
Adults

Intervention / Treatment
-----------------
* Device: Wearable sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Subjects willing and able to comply with requirements of the protocol Healthy Exclusion Criteria: Age <18 years old Subjects unwilling and able to comply with requirements of the protocol History of skin allergy to medical adhesive tape Non-English speaking subjects

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

| Intervention/Treatment |
| --- |
|Device: Wearable sensor|Wireless sensor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech detection | Talk time will be measured using computer algorithm made by the researchers in this study comparing signal to controlled, labeled signals with measured talk time. | 2 years | 
| Administration UCLA Loneliness scale. | Administration UCLA Loneliness scale as a proxyu assessment to measure socialization. https://fetzer.org/sites/default/files/images/stories/pdf/selfmeasures/Self_Measures_for_Loneliness_and_Interpersonal_Problems_UCLA_LONELINESS.pdf | 2 years |