linjc16/ctgov huggingface dataset:
Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma

Study Overview
=================
Brief Summary
-----------------
The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology). Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies.

Detailed Description
-----------------
The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology). Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies. The register gives recommendations for the therapy of the patients, but these are not mandatory.

Official Title
-----------------
Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, Central Nervous System (CNS)- Primitive Neuroectodermal Tumour (PNET), or Ependymoma

Conditions
-----------------
Medulloblastoma, Childhood, Cerebral Primitive Neuroectodermal Tumor, Ependymoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age at diagnosis 0-21 years histologically proven medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
| Event free survival (EFS) | event free survival probability rates will be calculated | up to 10 years |
Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab

Study Overview
=================
Brief Summary
-----------------
-1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of metastatic colorectal cancer patients. The present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.

Official Title
-----------------
Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma; Measurable metastatic disease according to RECIST criteria; Patients receiving BV plus FOLFIRI as first-line treatment; Written informed consent; Availability of blood samples for genetic analysis.- Exclusion Criteria:
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 |
| --- | --- | --- |
| Progression-Free Survival | Progression free survival (PFS) is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Response Rate (RR) is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) |  | 
| Overal survival | Overall survival (OS) is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VEGF polymorphism Bevacizumab
Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs

Study Overview
=================
Brief Summary
-----------------
The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.

Detailed Description
-----------------
Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

Official Title
-----------------
Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures

Conditions
-----------------
Atypical Femur Fracture

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: Have experienced a confirmed, documented Atypical femur fracture Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Atypical Femur fracture cases | Other: No Intervention<br>* No Intervention<br>|
| Control<br>matched to AFF cases by race, age, length of ART use | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between AFF and clinical Risk Factor | Associations between AFFs and clinical risk factors | baseline | 
| Associations between AFF and common genetic variants | Associations of common genetic variants among patients with AFFs | baseline | 
| Validation of top genetic variants | To validate the top few genetic variants identified in the above case-control study in a separate cohort of 100 cases and 100 controls. | baseline |
Exploring Clinical Trial Experiences of Patients With Migraine

Study Overview
=================
Brief Summary
-----------------
Clinical study participation has historically been heavily biased toward specific demographics. This study will invite several participants to gather a wide range of information on clinical trial experiences for migraine patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of migraine. People with migraine who are invited to take part in medical research will benefit from the analysis of the data.

Official Title
-----------------
An In Depth Study Examining Patterns in the Clinical Trial Experiences of Migraine Patients

Conditions
-----------------
Migraine, Migraine Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is a minimum of 18 years of age Patient has been diagnosed with a type of migraine Patient plans to participate in an interventional clinical trial for the condition of migraine Patient has access to a home internet connection in order to provide regular updates through the course of the study Exclusion Criteria: Patient has an ECOG score of 4 or higher Patient is not able to provide consistent digital updates as per study requirements Patient does not complete or agree to terms outlined in the Informed Consent Form

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who decide to enroll in a migraine clinical trial |  | 3 months | 
| Rate of patients who remain in migraine clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine
Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation

Study Overview
=================
Brief Summary
-----------------
A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Vaporizing humidifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status class I,II Unilateral lung lobectomy Use of one-lung ventilation Exclusion Criteria: COPD CAOD Unstable cardiovascular status Peak inspiratory pressure > 30 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaporizing humidifier<br>Vaporizing humidifier applying during one-lung ventilation | Procedure: Vaporizing humidifier<br>* Vaporizing humidifier applying during one-lung ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial oxygenation | T1,T2,T3,T4: all measurement in lateral position, T1-arterial oxygenation(PaO2), T2-arterial oxygenation(PaO2),T3-arterial oxygenation(PaO2),T4-arterial oxygenation(PaO2) | T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory dynamic parameters | T1,T2,T3,T4: T1-respiratory dynamic parameters, T2-respiratory dynamic parameters, T3-respiratory dynamic parameters, T4-respiratory dynamic parameters | T1,T2,T3,T4 (same as 'primary outcome measure') | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer
Chinese PD-LRRK2 Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland China.

Detailed Description
-----------------
Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. LRRK2 missense mutations are the most common known genetic cause of PD. However, some polymorphisms of LRRK2 such as G2385R and R1628P can also affect the risk of developing PD. The investigators aim to establish a database of PD with LRRK2 variants and characterize the clinical manifestation of these patients in mainland China. Method: Peripheral blood from patients has been tested to have LRRK2 gene variants. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO). The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Official Title
-----------------
The Chinese Parkinson's Disease With LRRK2 Variants Registry

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with positive LRRK2 variants Exclusion Criteria: -
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 |
| --- | --- | --- |
| Database of Parkinson's disease with LRRK2 variants | Establish the database of Parkinson's disease with LRRK2 variants in mainland China. | 10 years | 
| Clinical feature | Characterize the clinical feature in patients of Parkinson's disease with LRRK2 variants | 10 years |
Value of Ankle Pressure Index After Maximal Exercise Tests

Study Overview
=================
Brief Summary
-----------------
Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease. Estimate morbi-mortality of included patients over a 5 years follow up.

Official Title
-----------------
Mesure de l'Index de Pression Systolique de Cheville après Test d'Effort Maximal.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Exercise test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and more Exclusion Criteria: patient with recent cardiovascular event

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise test<br>Ankle pressure Index measure before and after Maximal Exercise Tests | Other: Exercise test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean value of post exercise ABI by age categories | Ankle to brachial index is measured before and after a maximal exercise on a cycle ergometer. results are expressed by age categories of 10 years interval | up to 15min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Morbi-mortality through self completed questionnaires |  | up to 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maximal Exercise Test, Ankle Brachial Index
Combined Triple Procedure in Retinal Vein Occlusion (RVO)

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Detailed Description
-----------------
This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Official Title
-----------------
Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Retinal Vein Occlusion

Conditions
-----------------
Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: triamcinolone and bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic central RVO (CRVO) Non-ischemic CRVO Branch RVO (BRVO) Exclusion Criteria: Visual deterioration due to acute or chronic inflammation Post trauma Macular edema of other origin Intravitreal drug treatment within last 4 months

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Active Comparator: ischemic CRVO<br>treatment was applied to this entity | Drug: triamcinolone and bevacizumab<br> <br> |
| Active Comparator: non ischemic CRVO<br>treatment was applied to this entity | Drug: triamcinolone and bevacizumab<br> <br> |
| Active Comparator: BRVO<br>treatment was applied to this entity | Drug: triamcinolone and bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  | day of exam |
Technique Optimization With Whole-body Diffusion-weighted MRI

Study Overview
=================
Brief Summary
-----------------
Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native diffusion-weighted images and low ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis, the complete absence of cellular organization. This will facilitate water diffusion, leading to absent SI on native diffusion-weighted images and high ADC. The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the whole body diffusion-weighted images which can be used as a reference in further studies with patients scanned with the same whole body diffusion-weighted imaging scan protocol. A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on a 3 Tesla T-MRI system. A total scan session will take about 30 minutes. Contrast administration is not required and patients will not be exposed to radiation.

Official Title
-----------------
Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers

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

Intervention / Treatment
-----------------
* Other: diffusion-weighted MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: no severe illness in the past no current infection/inflammation

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diffusion-weighted MRI<br>MRI | Other: diffusion-weighted MRI<br>* MRI scan without contrast administration and without radiation exposure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal aspect of human anatomy on WB-DWI images/ technique optimization | assessment after all the scans of the healthy volunteers are collected | up to 12 months |