linjc16/ctgov huggingface dataset:
Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).

Study Overview
=================
Brief Summary
-----------------
a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition

Detailed Description
-----------------
The test-retest reliability of the German version of the HDQ will be tested to assess the reproducibility of the test results with a stable condition of the participants over a short period of time. For this purpose, it is planned to administer the questionnaire twice in row at an interval of 48 - 72 hours to headache patients in outpatient physiotherapy. The chosen setting limits the sample to a common intervention measure (physiotherapy), so that primary and secondary headache types can be included and the requirements of the original study can be maintained. In the period between the two tests, subjects should not receive physiotherapy, because it can often have different effects on headache. This can lead to uneven changes in the sample and affect the variance of the test results. However, subjects are allowed to take their usual medications. To avoid recall bias, an online survey tool (RedCAP) to conduct the questionnaire will be used. It is designed so that, only one question appears per slide, no overview of responses is allowed and the questions are displayed in a different order at the second testing. The lower prevalence of headaches after the age of 65 years is taken into account in the inclusion criteria.

Official Title
-----------------
Translation, Trans-cultural Adaptations and Test-retest Reliability of the Headache Disability Questionnaire (HDQ)

Conditions
-----------------
Headache Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within physiotherapeutic care due to headache for no longer than 3 months headache conditions for at least one month and at least once /month live in Switzerland give informed consent Exclusion Criteria: not in physiotherapeutic care in physiotherapeutic care due to other conditions not associated with headache younger than 18 and older than 65 years

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 |
| --- | --- | --- |
| Headache | Nine item headache disability questionnaire (HDQ) | June 21 to July 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache disorder | Migraine, Tension-type headache, other | June 21 to July 22 |
Chronic VEnous dIsorders maNagement and Treatment effectivenesS evaluaTion in Chronic vEnous Disease, an International Program

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD

Official Title
-----------------
A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease

Conditions
-----------------
Chronic Venous Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Patient consulting spontaneously or referred for symptomatic venous disorders Diagnosis of chronic venous disease according to investigator's judgment Exclusion Criteria: Presence of known severe systemic disease likely to interfere with the study evaluation Patients with lower limb arterial disease Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema Patient consulting for an emergency not related to venous disease Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery Procedure or surgery for venous disease planned during the study Pregnant or breastfeeding woman

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 |
| --- | --- | --- |
| Global leg symptoms severity | Measured by visual analogue scale (VAS) and questioning with 4 points rate | week 4 | 
| Global improvement | Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement. | Week 4 | 
| Disease severity | Measured by VCSS (Venous Clinical Severity score) | Week 4 | 
| Quality of Life | Measured by CIVIQ-14 questionnaire | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
observationnal, QoL
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

Official Title
-----------------
A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects

Conditions
-----------------
Hyperlipidemia, Hypertension

Intervention / Treatment
-----------------
* Drug: Pitavastatin, Valsartan
* Drug: Livalo® fixed combination drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers Age 20-55 years at the time of Screening BMI 19-26 kg/m2 at the time of Screening Exclusion Criteria: Received other investigational drug within 90 days prior to the first dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pitavastatin + Valsartan<br>Intervention: Drug: Pitavastatin, Valsartan | Drug: Pitavastatin, Valsartan<br>* Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)<br>* Other names: Livalo, Diovan;|
| Experimental: Livalo fixed combination drug<br>Intervention: Drug: Livalo® fixed combination drug | Drug: Livalo® fixed combination drug<br>* Livalo® fixed combination drug(1 tablet)<br>* Other names: Livalo, Diovan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of study drugs after single oral administration |  | 0-48hrs | 
| AUClast of study drugs after single oral administration |  | 0-48hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax and t1/2β of study drugs after single oral administration |  | 0-48hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pitavastatin, Livalo
Galectin-3 and Placenta Accreta

Study Overview
=================
Brief Summary
-----------------
Galectins are a family of carbohydrate-binding proteins that have a high affinity to galactosides, its protein portion is located in the nucleus and the cytoplasm with its carbohydrate recognition domain which has high ability to be glycosylated inside or outside the cell. They are expressed by vascular endothelium, immune cells (macrophages, neutrophils, and mast cells), uterus, placenta, cardiac muscle, liver, epithelium of the gastrointestinal tract, and many other tissues. Although some galectins have intracellular functions, the majority of them have extracellular activities, which facilitate their contribution to cell adhesion, cell activation, and inflammation. Galectin-3 (Gal-3) is a unique pentamer of the galectins family and it is involved in both physiological functions; cell growth and differentiation, and pathological conditions; inflammation, fibrosis, and metastasis. Regarding pregnancy, Gal-3 is proved to participate in angiogenesis, embryo developmental processes, and modulation of maternal immunity.

Official Title
-----------------
The Role of Galectin-3 in the Pathogenesis and Prediction of Placenta Accreta

Conditions
-----------------
Placenta Accreta

Intervention / Treatment
-----------------
* Diagnostic Test: Galectin-3
* Diagnostic Test: Placental Galactin-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 28-32 weeks. Age between 20-40 years. Singleton pregnancy. Women with suspicion of placenta accreta Cases with mild vaginal bleeding or not having any vaginal bleeding. Exclusion Criteria: Women are known to have any medical disorders. Patients with known bleeding disorders or on anticoagulant therapy. Patients refuse to participate.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal pregnancy group<br> | Diagnostic Test: Galectin-3<br>* Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R&D Systems, Minneapolis, MN, USA).<br>Diagnostic Test: Placental Galactin-3<br>* Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA<br>|
| Placenta accreta at 24-32 weeks group<br> | Diagnostic Test: Galectin-3<br>* Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R&D Systems, Minneapolis, MN, USA).<br>Diagnostic Test: Placental Galactin-3<br>* Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Galactin 3 level in the blood | measured by ng/ml | 6 weeks |
Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia. The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.

Detailed Description
-----------------
Community-acquired pneumonia (CAP) is a acute illness with a considerable morbidity and mortality, especially patients with severe CAP. In the past decennia, in spite of many investigations, little reduction is seen in morbidity an mortality. Corticosteroids have a immune-modulation effect, which is not completely elucidated. Most likely the immune modulation effect is due to down-regulation of pro-inflammatory cytokines. The use of corticosteroids next to antibiotics in CAP could lead to shorter time to clinical stability, length of stay and costs. Comparison: Hospitalized patients with CAP treated with antibiotics and prednisolone versus hospitalized patients with cap treated with antibiotics and placebo

Official Title
-----------------
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms of community-acquired pneumonia: Fever, cough, sputum, pleural pain, dyspnoea Radiological symptoms of pneumoniä Exclusion Criteria: Any conditions wich requires corticosteroid therapy. Pregnancy of lactation Malignancy Immune-compromised patients (eg chemotherapy or AIDS) Pre-treatment with macrolide for >24 hours

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prednisone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy at the end of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy at follow up |  |  | 
| Inflammation response (serummarkers) |  |  | 
| Length of Stay |  |  | 
| Time to clinical stability |  |  | 
| Mortality |  |  | 
| Time to defeverescence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumonia, corticosteroids
Endurant for Challenging Anatomy: Global Experience Registry

Study Overview
=================
Brief Summary
-----------------
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database. This study aims at answering two major questions: Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm? Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?

Official Title
-----------------
EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience

Conditions
-----------------
Abdominal Aortic Aneurysms With Challenging Anatomy

Intervention / Treatment
-----------------
* Device: Endurant Stent Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations Indication for elective EVAR Challenging AAA anatomy Intention to electively implant the Endurant or Endurant II Stent Graft System© Signed informed consent form Exclusion Criteria: Subjects with intolerance to contrast media Chimneys or fenestrated device procedures High probability of non-adherence to physician's follow-up requirements Current participation in a concurrent trial that may confound study results

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 |
| --- | --- |
| Abdominal Aortic Aneurysm (Challenging anatomy)<br>Endovascular aneurysm repair | Device: Endurant Stent Graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Freedom from: Increase of AAA diameter > 5 mm (1 month measurement as baseline) Type I&III endoleaks Aneurysm rupture Conversion to surgery Stent graft migration (>10mm) resulting in SAE or reintervention Stent graft occlusion | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helath Related Quality of Life Scores | EQ-5D VAS EQ-5D index | 12 months |
The Relation Between Periodontal Disease and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.

Official Title
-----------------
The Relation Between Periodontal Disease and Metabolic Syndrome

Conditions
-----------------
Periodontal Disease, Metabolic Syndrome

Intervention / Treatment
-----------------
* Procedure: Periodontal therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with periodontal disease Exclusion Criteria: Patients with malignant disease Pregnant women

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

| Intervention/Treatment |
| --- |
|Procedure: Periodontal therapy|Normal periodontal therapy is performed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| features of periodontal disease and metabolic syndrome |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal disease, Metabolic Syndrome
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are (1) to evaluate the feasibility of using a combined spin- and gradient- echo (SAGE) sequence in dynamic susceptibility contrast magnetic resonance imaging (DSC MRI) and (2) to determine quantitative estimates of vessel density and size to differentiate between areas of radiation necrosis and tumor recurrence.

Official Title
-----------------
Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions

Conditions
-----------------
Brain Tumor, Brain Metastases

Intervention / Treatment
-----------------
* Diagnostic Test: Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with a brain metastasis or primary brain tumour and who will undergo MRI with contrast. Exclusion Criteria: Subject or subject's legally authorized representative is unable or unwilling to consent to the study. Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (DSC MRI)<br> | Diagnostic Test: Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)<br>* A dye, known as a contrast agent, will be injected through a needle that is inserted into a vein in the arm or hand. Subsequent magnetic resonance imaging will follow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of perfusion parameter: cerebral blood volume (CBV) | Measurements of cerebral blood volume (CBV) will be calculated. | Baseline to end of study (up to 2 years) | 
| Measurement of perfusion parameter: vessel size index (VSI) | Measurements of vessel size index (VSI) will be calculated. | Baseline to end of study (up to 2 years) |
Associative Memory in Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.

Official Title
-----------------
Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Other: Electroencephalography
* Behavioral: Neuropsychological assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed children from 10 to 18 years old Informed consent signed by the legal representative and adolescent himself. Medical Examinations, psychopathology, and cognitive examination in accordance with inclusion and exclusion criteria specific to each population: People with ASD: Participants with ASD without mental retardation with a diagnosis in reference to the DSM V criteria Controls : Participants without ASD Main exclusion criteria: mental retardation, schizophrenia, ADHD, head injury with lost of consciousness

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Electroencephalography and neuropsychological tests in children with autism | Other: Electroencephalography<br>* EEG recordings during memory tests<br>Behavioral: Neuropsychological assessment<br>* patterns of eye gaze during cognitive tests<br>|
| Experimental: Control<br>Electroencephalography and neuropsychological tests in children without autism | Other: Electroencephalography<br>* EEG recordings during memory tests<br>Behavioral: Neuropsychological assessment<br>* patterns of eye gaze during cognitive tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of discrimination obtained with the task of associative memory |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorder, Development, Memory, ERD