cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback Training of Alpha-band Coherence After Stroke

Background: The technology of brain-computer interfaces (BCI) enables the monitoring of brain activity and the generation of a real-time output about specific changes in activity patterns. The recorded subject receives a feedback about the neural activity associated his/her efforts and can thus learn to voluntarily modulate brain activity. There is accumulating evidence that training of motor cortex activations with brain-computer interface systems can enhance recovery in stroke patients. Here we propose a new approach which trains resting-state correlates of motor performance instead of activations related to movements. Previous studies have shown that the more resting-state alpha oscillations in the motor cortex are coherent with the rest of the brain, the better stroke patients perform in motor tasks. Furthermore, observational studies have suggested that training of alpha-band coherence in the motor cortex with neurofeedback has beneficial effects on motor performance.

Objective : This randomized controlled study aims to test the usefulness of training functional connectivity between the motor cortex and the rest of the brain with a brain-computer interface in patients with chronic stroke. We hypothesized that this network variant of neurofeedback training will lead to region and frequency specific increases in functional connectivity and to an improved function of the affected upper extremity.

Methods : 10 patients with chronic stroke and significant unilateral deficit of upper extremity motor function will perform two periods of neurofeedback training in a randomized cross-over design. In one period, they will train alpha-band coherence between intact areas around the affected motor cortex and the rest of the brain. In a control period, they will train alpha-band coherence between a control region not directly related to motor function (the medial prefrontal cortex of the healthy hemisphere) and the rest of the brain. In each period, two training sessions per week will be performed for 4 weeks. The periods are separated by at least 4 weeks. Oscillations in the brain will be reconstructed from 128 EEG channels using an adaptive spatial filter and the coherence between the target area and the rest of the brain will be calculated in real time. Coherence magnitude will be displayed in the form of a cursor on a computer screen.

Significance: This study may provide causal evidence for a role of functional connectivity in motor learning and may lead to new strategies for rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke in chronic stage (at least 9 months after onset)
* unilateral deficits in motor function with significant impact on independence and daily activities

Exclusion Criteria:

* inability to participate in long treatment sessions
* inability to concentrate for prolonged periods
* metallic objects in the brain
* presence of implants or neural stimulators
* persistent delirium or disturbed vigilance
* moderate or severe language comprehension deficits
* skull breach
* new stroke lesions during treatment
* medical complications
The Use of Public Messaging for the Promotion of Firearm Safety to Veterans

This pilot study seeks to determine if exposure to the firearm safety public service announcement (PSA) developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in related beliefs and safe storage practices. Participants are randomly assigned to message exposure or control conditions. Data from this project will inform injury prevention outreach efforts targeted towards Veteran populations.


Eligibility Criteria:
Inclusion Criteria:

* Veterans of all gender/sex, race/ethnicities
* Living in United States
* Fluent in English language
* Capable of understanding the goals of the study
* Possess computer/internet access

Exclusion Criteria:

* Not a U.S. Veteran living in the United States
* Determined to be cognitively impaired
* Currently institutionalized (e.g., hospitalized; incarcerated, etc.)
* Do not possess computer/internet access
Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).


Eligibility Criteria:
The inclusion criterion:

A. 18 years or more of age requiring a test for COVID-19.

The exclusion criteria are :

A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.

B. Do not understand oral or written Danish
A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers

A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers


Eligibility Criteria:
Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history
Geniculate Artery Embolization for Treatment of Osteoarthritis

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.

Eligibility Criteria:
Inclusion Criteria:

1. 30-80 years of age of any gender;
2. Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
3. Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
4. Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
5. Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.

Exclusion Criteria:

1. Active systemic or local knee infection;
2. Active malignancy;
3. Life expectancy less than 12 months;
4. Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
5. Ipsilateral knee intra-articular injection in the last 3 months;
6. Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
7. Pregnant during the study period;
8. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 on blood tests obtained within 30 days of procedure;
9. Body weight greater than 200 Kg;
10. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.5 within 30 days of procedure;
11. Known history of contrast allergy resulting in anaphylaxis;
12. Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);
13. Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
14. Known avascular necrosis in the target knee;
15. Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)

The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the development of a better outcome models for the clinicians in facilitating effective community re-integration in Veterans with TBI

Examine if there are associations among balance, cognitive and affective function during multitasking activities in Veterans with the diagnosis of TBI.

To determine if an association exists between balance performance and the degree of community re-integration in Veterans with TBI.

To determine which of the three systems, balance performance, cognitive dysfunction or affective dysregulation, is the strongest predictor of community re-integration in Veterans with TBI.

Eligibility Criteria:
Exclusion-inclusion criteria Inclusion Criteria: Enrolled participants will be Veterans with TBI between18 to55 years of age. We identified a wide age range in order to include Veterans from the Iraq and Afghanistan conflicts, as well as Veterans of the Vietnam War. This feature of the inclusion criteria is important since barriers to community re-integration may be affected by impaired balance, cognitive dysfunction, affective dysregulation, across the age spectrum. Consequently, the study findings will potentially benefit not only young Veterans, but also middle aged Veterans.

The Military Acute Concussion Evaluation (MACE): We will use MACE scores of 21/30 to ensure the participants have the cognitive ability to understand our study protocol, and therefore, participate voluntarily in the study. 62 Exclusion Criteria: We will use an exclusion criteria of 12/24 on the Dynamic gait index (DGI) to ensure that patients are ambulatory either with or without the use of assistive device to be able to measure dynamic balance accurately.16 Past Medical History: The following diagnoses will be cause for exclusion -- peripheral neuropathy, Parkinson syndromes, multiple sclerosis; bipolar, schizophrenia, seizure or psychiatric illnesses.

Medically stable patients: It is essential to minimize future medical adverse conditions and minimize the risk of drop out. Therefore, no patient shall be considered for enrollment if they do not meet inclusion/exclusion criteria or have not been recommended by the polytrauma staff at VA DCMC.

The result of VHA TBI Comprehensive Evaluation electronic template will be reviewed following IRB approved and HIPAA compliant data collection procedures. The TBI diagnosis will be obtained from patient's chart review of problem section and physician's notes.

-
Korea Atherosclerosis Study-3

Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Especially,the investigators will evaluate the relationships between the pericardial fat and severity of stenosis as well as plaque characteristics using logistic regression models.


Eligibility Criteria:
Inclusion Criteria:

* Korean capable of Multidetector-Row Cardiac Computed Tomography (MDCT)

Exclusion Criteria:

* malignancy
* infection
* shock
Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven gastric cancer
* aged 75 years or less
* performance status 0 to 2
* no prior chemotherapy
* inoperable, recurrent, or metastatic
* normal marrow, hepatic and renal functions

Exclusion Criteria:

* active infections
* severe co-morbidities
* pregnant or lactating women
* active brain metastasis
* neuropathy of grade 2 or higher
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)

It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who agree to the terms described in IC;
* Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
* Subjects with CVI ranked 3 to 5, according to CEAP scale;
* Patients complaining of pain and swelling in the lower limbs secondary to IVC;
* Subjects with good mental health that can respond adequately to the study questionnaires;
* Subjects who agree to make any return visits for evaluation;

Exclusion Criteria:

* Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
* Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
* Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
* Pregnant or nursing women;
* Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
* Participation in clinical trials in the twelve months preceding the study;
* Patients with serious illnesses and uncontrolled that need multidrug treatment;
* Patients on diuretics of any kind, regardless of pathology (hypertension, renal or liver disease);
* Values of laboratory tests appropriate security; the Hemoglobin \<10 mg / mL the creatinine\> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
* past medical history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction

The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.

This study evaluated The Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5_8 years old.
* Moderate or severe dental anxiety based on the (CDAS).
* Good general health, free from any systemic diseases or psychological disorders.
* Teeth indicated for restoration treatment under local anesthesia.
* No allergy to anesthetic drugs

Exclusion Criteria:

* Use of analgesics before treatment.
* Presenting with acute pain and requiring emergency dental treatment.
Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself, but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst...). This discomfort is real, and can be associated with psychological consequences. The investigators hypothesized that the use of immersive virtual reality (IVR) with HypnoVR® is feasible and can help reduce discomfort in intensive care.The ZION trial is a prospective, monocentric trial, randomizing 194 patients admitted in a surgical intensive care unit after a major surgery. The inclusion criterion are patients admitted in a surgical intensive care for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR®, twice a day, during the ICU stay (2 to 5 days). In the control group, postoperative care will be conducted according to standard cares without IVR. The primary endpoint will be the 18-items IPREA questionnaire on the day of ICU discharge or at day 5 after IVR initiation. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnea, thirst and sleep deprivation), the 18-item IPREA questionnaire assessed daily from randomization to V1 follow-up visit (ICU discharge or at day 5 after IVR initiation), incidence of delirium, cumulative morphine consumption at ICU discharge, length of ICU stay, and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* scheduled for a major surgery (cardiothoracic surgery or a major abdominal surgery)
* Written informed consent from patient or next of kin.
* Admitted in a surgical ICU for a postoperative care for at least 48 hours.
* Absence of delirium at inclusion (RASS and CAM-ICU scale)

Exclusion Criteria:

* Missing informed consent
* Patient strictly under 18 years old
* Inclusion in other study within the last 30 days
* Pregnancy
* Emergency hospitalization
* Progressive sepsis
* Patient transferred from another intensive care unit
* Short-term life-threatening condition
* Active psychiatric illness requiring antidepressant, antipsychotic or anxiolytic treatment
* Mechanical ventilation \> 48 hours
* Patient known to have cognitive disorders.
* Unbalanced epilepsy
* Visual problems (absence of binocular vision, blindness) and/or auditory problems (deafness) preventing the use of virtual reality
* Pregnant or breast-feeding women
* Patients under guardianship or deprived of their liberty
* Patients not registered with the national social security system
Improving Cancer Foci Detection in Prostate Cancer Using Multiparametric MRI/MRS

The investigators' goal is to develop a non-selective and non-invasive procedure to identify aggressive tumors and simultaneously identify their exact location in Prostate cancer patients undergoing radical prostatectomy by combining multiparametric MRI and machine learning techniques. The combination of multi-parametric MRI and machine learning (validated using histopathology) can lead to increased sensitivity and specificity of cancer foci in the prostate, and help in isolating aggressive from indolent tumors. This increased sensitivity and specificity may eventually lead to: a) a reduction in the number of patients that undergo unnecessary treatment, and b) enhance current treatment options by enabling the use of focused therapies. The investigators will recruit 15 patients with prostate cancer that are currently scheduled to undergo radical prostatectomy into the study. All patients will obtain an advanced MRI study prior to the radical prostatectomy. MRI scans will include a) high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based on standard of care (Gleason grading system). Correlations will be generated between the parameters obtained from scans and from clinical assessments.


Eligibility Criteria:
Inclusion Criteria:

1. All male patients that have opted for radical prostatectomy
2. Subjects must be capable of giving informed consent.
3. Subjects must not be claustrophobic.

Exclusion Criteria:

1. Subjects with pacemakers.
2. Subjects who have metallic ferromagnetic implants or pumps.
3. All females are excluded from this study.
4. Subjects with kidney disease of any severity or on hemodialysis.
5. Subjects with known allergies to gadolinium-based contrast agents.
6. Subjects incapable of lying on their backs for up to an hour at a time.
Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia

Respiratory problems in neonates are one of the leading causes of neonatal morbidity and mortality in developing countries. These respiratory problems are seen in premature neonates, which mainly include respiratory distress syndrome (RDS), pneumonia, requiring ventilatory assistance or oxygen support

The purpose of this study is to compare between the effect of reflex rolling and lung squeezing techniques on pulmonary functions in premature neonates with pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* 1) Preterm neonates with pneumonia. 2) Neonates with 30-37 weeks of gestation admitted to NICU. 3) They were free from any major congenital malformation. 4) They were clinically and thermodynamically stable.

Exclusion Criteria:

* 1) Treatment with neurotropic drugs. 2) Interventricular hemorrhage. 3) Temperature \>38 4) Respiratory and cardiac congenital anomalies. 5) Seizures. 6) Surgical procedures. 7) Genetic Disorders 8) Any segmental or lobar collapse confirmed on chest x-ray. 9) Major airway interventions including change of endo-tracheal tube, hand ventilation or bronchial lavage in the previous 12 hours.