linjc16/ctgov huggingface dataset:
Evaluation of Left Ventricular AutoThreshold

Study Overview
=================
Brief Summary
-----------------
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Detailed Description
-----------------
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Official Title
-----------------
Evaluation of Left Ventricular AutoThreshold

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: No intervention is used. Collection of signals only.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion Patients who are willing and capable of participating in all testing associated with this study Patients who are 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads) Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads) Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study Patients with a prosthetic mechanical tricuspid heart valve Women who are pregnant

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 |
| --- | --- |
| 1<br> | Device: No intervention is used. Collection of signals only.<br>* Device received per standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to collect data to characterize the performance of the LVAT feature. |  | Implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, auto threshold, pacing, CRT-P or CRT-D recipients, threshold measurements
Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on admission might be predictive for early neurological deterioration in acute ischemic stroke patients, specifically for the DWI lesion evolution within the first week after stroke onset.

Detailed Description
-----------------
Early neurological deterioration (END ) is a major concern in stroke care, consistently associated with adverse clinical outcomes.END is a heterogeneous complex of pathophysiological and clinical entities. Despite some straight forward causes, DWI lesion growth is reportedly a primary underlying mechanism. Early recognition of END risk would allow for timely identification and proper intervention, improving stroke health care. Thromboelastography (TEG) measures the coagulation process from initial clotting cascade to clot strength, providing an integrated picture of two separate but simultaneously occuring components of coagulation, thrombosis and lysis. It has been reported to be associated with short and long-term outcome in patients with trauma, coronary artery diseases , pulmonary embolism and, most recently, stroke prevention.The purposes of this study is to evaluate how effective TEG is on predicting END, by producing a range of TEG values correlated with clinical and radiological assessment.

Official Title
-----------------
Predictive Significance of Thrombelastography on Early Neurological Deterioration in Patients With Acute Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ischemic stroke within 24 hours after symptom onset first ever stroke give informed consent Exclusion Criteria: receiving thrombolysis cardiogenic embolism contradiction to serial MRI studies taking hemostatic agents (warfarin, oral anticoagulants and etc. )

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| End and non-END groups<br>END was denied as NIHSS score increase of 2 or more than 2 within 7 days after admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| END | increase of NIHSS >=2 | fist week after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DWI lesion growth | Large volume or new lesions on followup DWI than the baseline DWI | 7 days |
A Study of Isoprinosine in Patients With Lymph Node Disease

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include: Signs and symptoms: Lymphadenopathy. Fever. Weight loss. Occurrence of opportunistic infections. Cell-mediated immune system parameters: T-helper cell (OKT4) numbers and proportions. T-suppressor cell (OKT8) numbers and proportions. Natural killer (NK) cell activity. Lymphocyte blastogenic response to phytohemagglutinin (PHA). Lymphocyte blastogenic response to pokeweed mitogen (PWM). Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile. Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora. Safety parameters: Blood chemistry including serum uric acid (PurposeA-12). Complete blood count (CBC). Platelet count.

Official Title
-----------------
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

Conditions
-----------------
Lymphatic Disease, HIV Infections

Intervention / Treatment
-----------------
* Drug: Inosine pranobex


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded. Concurrent Medication: Excluded: Systemic corticosteroids. Cytotoxic immunosuppressive agents. Radiotherapy. Critically ill patients or those with CDC-defined AIDS are excluded. Prior Medication: Excluded within 1 month of study entry: Immunotherapy. Patients with persistent generalized lymphadenopathy (PGL).

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inosine pranobex|nan|

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
-----------------
Inosine Pranobex, AIDS-Related Complex
SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.

Detailed Description
-----------------
Patients are randomly assigned to either ST-IMRT or SW-IMRT.

Official Title
-----------------
Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer

Conditions
-----------------
Swallowing Dysfunction

Intervention / Treatment
-----------------
* Radiation: ST-IMRT SW-IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy. Exclusion Criteria: Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ST-IMRT<br>standard parotid sparing IMRT | Radiation: ST-IMRT SW-IMRT<br> <br> |
| Experimental: SW-IMRT<br>swallowing sparing IMRT | Radiation: ST-IMRT SW-IMRT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of the swallowing function (dysphagia) at regular intervals | Subjective assessment of swallowing function (dysphagia) will be scored on a scale of 0 (no dysphagia) to 4 (life threatening consequences; urgent intervention indicated) each follow-up visit on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE 4). | 6 months | 
| Objective assessment of the swallowing function (dysphagia) at regular intervals | Objective assessment of swallowing will be made by videofluoroscopy and scored by Dynamic Imaging Grade of swallowing toxicity scale (DIGEST) and will be scored on a scale of 0 (no dysphagia) to 4 (life threatening ) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence | 6 months |
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor

Study Overview
=================
Brief Summary
-----------------
Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially presented with brain tumors, and predict the prognosis in the patients diagnosed with primary high graded astrocytoma or oligodendroglioma.

Detailed Description
-----------------
Materials and methods: Simultaneous MRI-PET (FDG) will be prospectively obtained in patients (n = 60) initially presented with brain tumors by using integrated MRI-PET (Biograph mMR, Siemens, Germany). We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies. We will use the imaging protocols including whole body MRI-PET and advanced brain tumor imaging (DWI, PWI and DCE). In addition, we will analyze the imaging parameters to see whether the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas. Expected results: We expect that whole body MRI-PET is useful for the differential diagnosis of primary and metastatic brain tumors, and the multiparametric information from DWI, PWI, DCE and PET can be used for the tumor grading and prognosis prediction of the primary brain malignancies.

Official Title
-----------------
Application of the Simultaneous PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor From Differential Diagnosis to Prediction of Prognosis

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will inculude the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas. Exclusion Criteria: We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor |  | 2year |
The Double Burden of Malnutrition Among Adolescents in Low-income and Middle-income Countries

Study Overview
=================
Brief Summary
-----------------
Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.

Detailed Description
-----------------
We used the most recent Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight. The GSHS is a World Health Organisation (WHO) initiative, designed to assess health behaviours of adolescents through cross-sectional school-based surveys, across several countries using similar standardised procedures. The HSBC study are WHO sponsored cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to examine the physical and mental health of adolescents in the WHO European Region and North America.

Official Title
-----------------
The Double Burden of Malnutrition Among Adolescents: Analysis of Data From the Global School-Based Student Health and Health Behaviour in School-Aged Children Surveys in 57 Low-income and Middle-income Countries

Conditions
-----------------
Stunting, Thinness, Obese

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-income or middle-income countries with completed Global School-Based Student Health Survey or Health Behaviour in School-Aged Children surveys. Adolescents aged 12-15 years Recorded sex, height and weight Exclusion Criteria: - High-income countries

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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 |
| --- | --- |
| Adolescents aged 12-15 years in LMICs<br>No interventions administered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of stunting | Trained survey staff measured the height of each student. Stunting was defined as height-for age < 2 standard deviations below the WHO Child Growth Reference median. | 2003-2013 | 
| Prevalence of thinness | Trained survey staff measured the weight of each student. Thinness was defined as BMI-for-age < 2 standard deviations below the WHO Growth Reference median. Body mass index [BMI (weight in kilograms divided by height in meters squared)] was calculated from height and weight. | 2003-2013 | 
| Prevalence of overweight and obesity | Overweight was defined as BMI-for-age > 1 standard deviation above the WHO Growth Reference median) and obesity was defined as >2 standard deviations above the WHO Growth Reference median. | 2003-2013 |
Change of Lifestyle by Persons in Risk of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).

Detailed Description
-----------------
The intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. They have 7 meetings in groups of 10 persons over 3 months. The controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year. We tell all that small changes are making big differenses (in weight and the chanse of getting ill). Everyone is told that lack of aktivity is the main reason to obesity. Lack of activity also influense in whar you eat. herefore is activity in the center.

Official Title
-----------------
Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Increase in activity to control weight
* Behavioral: Increase in activity to control weight.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes risk score above 9 points. Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Increase in activity to control weight|nan|
|Behavioral: Increase in activity to control weight.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weigtreduction |  |  | 
| Increase in maximum oxygen uptake |  |  | 
| Change in foodintake |  |  | 
| Change in self-reported activity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, lifestyle, obesity
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI

Study Overview
=================
Brief Summary
-----------------
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation. The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.

Official Title
-----------------
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

Conditions
-----------------
Symptomatic Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic aortic valve stenosis patients screened for TAVI written informed consent Exclusion Criteria: unconsciousness, not able to consent < 18 years permanent pacemaker

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of HV interval | HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation. | Changes in Baseline to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AV-block development after 1 month, 6 months and 12 months |  | 1 month, 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAVI, complete AV-block, HV-interval, permanent pacemaker