cyrilzakka/clinical-trials huggingface dataset:
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.

This study aims to demonstrate the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a diagnostic aid for healthcare providers in diagnosing ADHD in youth ages ≥ 6 to ≤17 years.

The study aims to demonstrate the accuracy of the MT1 algorithm. The output of the MT1 algorithm will be compared to a Gold Standard clinical diagnosis made by specialist clinician diagnosis supported by the Kiddie SADS Present and Lifetime semi-structured interview (K-SADS-PL) and norm-referenced measures of current ADHD symptom frequency and severity using the ADHD-RS-5 rating scale. Diagnosis will be scaled according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5) criteria, and made with agreement between two licensed specialists in ADHD (a Clinical Psychologist and a Psychiatrist).

Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.

Eligibility Criteria:
Inclusion Criteria:

1. Parent provision of signed and dated informed consent form
2. Child stated willingness to comply with all study procedures and availability for the duration of the study
3. Any gender, aged 6 to 17 years
4. Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA)
5. ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
6. Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.

Exclusion Criteria:

1. Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
2. Known current seizure disorder (history of febrile seizure allowed).
3. Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
4. IQ\<70 by clinician judgment
5. Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia
6. Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
7. Inability to complete the assessments.
8. Any other concerns in the judgment of the PI.
AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation

Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF).

In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice.

In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke.

To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously.

The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.


Eligibility Criteria:
Inclusion Criteria:

* Male, atrial fibrillation.
* 40-64 years of age at the time of enrolment.
* Primarily (≥50% of competition) competes in an endurance type sport as defined by European Society of Cardiology 2020 guidelines.
* Competitive athlete\*
* CHA2-DS2-VAsc =0/1 (excluding previous stroke).

  * Competitive athlete defined by having trained ≥10 years, 6 hours per week as a self-reported average and having participated in at least one competitive event at regional level or above.

Exclusion Criteria:

* History of pre-existing cardiovascular disease
* Previous myocardial infarction, peripheral arterial disease
* Left ventricular systolic dysfunction (EF \<45%)
* Heart muscle disease
* Complex congenital heart disease.
* Moderate or severe valvular disease.
* Uncontrolled hypertension (180/100mmHg)
* Clotting or bleeding disorders, vasculitis
* Inherited cerebral disease
* Known to have an estimated glomerular filtration rate \<30 ml/min/1.73m2.
AVAPS-AE Efficacy Study

The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS).

The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years of age; less than or equal to 70 years of age
* Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy

  * BMI greater than or equal to 30 kg/m2
  * Daytime PaCO2 greater than or equal to 45 mmHg
  * Apnea Hypopnea index (AHI) \> 5
* Daytime pH \> 7.35
* Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) \> 70%

Exclusion Criteria:

* Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator
* Respiratory alkalosis (pH \> 7.45), per investigator discretion
* Emergency admissions on chronic respiratory failure
* Hospitalization for respiratory exacerbation \< 6 weeks prior to screening visit
* Participants in whom PAP therapy is otherwise medically contraindicated
* Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV)
* Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.
Microcirculatory Oxygen Uptake in Sepsis

Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for prognostic value and for associations with tissue hypoxia markers and high central venus saturations.

Sepsis remains a common entity in critical care patients with remarkable mortality. Microcirculatory dysfunction plays a pivotal role in the pathophysiology of sepsis and organ dysfunction. The main causal mechanisms are vasoactive substances such as nitric oxide and endothelin, destroyed endothelial surfaces and microvascular occlusion by activated coagulation and leucocytes. Furthermore there is some knowledge from vasooclussive testing (VOT) based on near-infrared spectroscopy (NIRS) and assessing the proportion of perfused vessels determined with orthogonal polarization spectral and sidestream darkfield imaging techniques (SDF) that impaired microcirculation is associated with organ dysfunction and increased mortality. Despite these well-recognised evidence previous trails proving therapy guidance with microcirculatory parameters failed in demonstrating optimised outcome . Recent guidelines still recommend fluid therapy based on central venous pressure, mean arterial pressure, urine output and or blood lactate concentration. But especially the parameter central venous oxygen saturation (ScvO2) seems to be not unproblematic. Retrospective data analysis found higher mortality rates if ScvO2 is elevated.

In the present study patients with sepsis, severe sepsis and septic shock will be evaluated on day 1 and day 4 and a follow up will be performed on day 180.

Additional to clinical parameters of organ function, infection markers, global parameters of tissue hypoxia will be captured by measurements of adenosine and whose metabolites.

Macrocirculatory cardiovascular function delivered by transpulmonary thermodilution technique will be assessed and local tissue perfusion and oxygen uptake will be measured with a transcutaneous laser-doppler spectrophotometry system in VOT.

The aim of this study is to check:

1. Is microcirculatory oxygen uptake a prognostic value in sepsis?
2. Is it correlated with biomarkers of hypoxia?
3. Are high levels of ScvO2 caused by microcirculatory impairments or by hyperdynamic macrocirculation?

Eligibility Criteria:
Inclusion Criteria:

* Criteria according to the SSC for sepsis, severe sepsis and septic shock
* Admission to the ICU within 24 hours

Exclusion Criteria:

* Pregnancy
* Cardiopulmonary resuscitation within the last 5 days
A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis (Study P04459)

This study examined the safety and effectiveness of long-term administration of mometasone nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12 weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be decreased or increased during the study based on patient's response.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe perennial allergic rhinitis, \>16 years of age

Exclusion Criteria:

* Patients with coexisting tuberculous disease or lower respiratory tract infection and patients who have acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis judged by the investigator to require treatment
* Patients with coexisting infections or systemic mycosis for which there are no effective treatment
* Patients with coexisting mycosis in the nasal and paranasal cavities
* Patients who are judged to require prohibited concomitant drugs during the clinical study
* Patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma, which have not yet healed
* Patients with a history of hypersensitivity to steroids or mometasone furoate
* Patients who are pregnant or nursing or who may be pregnant and patients or whose partner desires to become pregnant during the study period
* Patients with severe hepatic disorder, renal disorder, cardiac disease, diabetes mellitus, hypertension, or hematological disease or other serious coexisting diseases and whose general condition is poor as judged by the investigators.
* Patients allergic to pollen and the pollen release season occurs in the 7 days before the start of treatment
* Patients diagnosed with vasomotor rhinitis or eosinophilic rhinitis
* Patients with nasal conditions which may interfere with efficacy evaluation of the study drug
* Patients who develop a disease which may affect nasal symptoms in the 7 days before the start of treatment
* Patients who are participating or have participated in a clinical trial of an investigational drug within 120 days before the day of obtaining informed consent
* Patients for whom the period of discontinuation of previous treatment before the start of study drug administration indicated Table 2 is not adequate or who cannot avoid the use of these drugs
* Patients undergoing specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapy within 90 days prior to obtaining informed consent. (However, patients need not be excluded if therapy has been ongoing for at least 180 days before obtaining informed consent and maintenance therapy is now being conducted.)
Personalized Interactive Laser Therapy of Port Wine Stain

Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a PWS
* At least one visible PWS measuring greater than or equal to 15 mm in diameter.
* Information provided regarding alternative treatment methods, includig no treatment.
* Reading, understanding, and signing of an informed consent document.
* Children age 7 years or older has read, understood, and signed an assent document.
* Agreement to participate in the study.
* Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
* Zubrod performance status of 0 or 1 at screening.

Exclusion Criteria:

* Inability or unwillingness of subject to participate in the study.
* Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
* Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia

Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 40 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid

1. Background:

   Preliminary studies have suggested that valproate acid (VPA) may promote neuron survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia, and promote the brain functional recovery after traumatic brain injury (TBI). Besides, in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than 7 days).
2. Objectives:

   Our main objective was to evaluate whether VPA could protect brain and improve recovery of brain function after severe TBI. The secondary objective was to explore whether VPA could prevent late epilepsy after severe TBI (more than 7 days).
3. Methods:

We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16 weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the treatment was discontinued. The rate of functional recovery on the Disability Rating Scale (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the 4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of mixed-effects regression models.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were 16 to 65 years of age with all genders.
* The patients had sustained a nonpenetrating traumatic brain injury 4 to 16 weeks before enrollment, with the confirmation of CT or MRI.
* Additional eligibility criteria were a vegetative state or a minimally conscious state, as indicated by a Disability Rating Scale (DRS) score greater than 11.
* There was an inability both to follow commands consistently and to engage in functional communication, as assessed by the score on the Coma Recovery Scale-Revised (CRS-R)
* All the patients had provided written informed consent.
* The patients were receiving usual inpatient rehabilitation and treatment at each site.

Exclusion Criteria:

* unstable health state,including:Be allergic to VPA, or with serious allergic diseases or allergic constitutions;With serious cardiovascular diseases, hepatic, renal, or psychiatric diseases;With serious respiratory, endocrine, or blood system diseases;With serious infections or malignant tumors; With weakened immunologic status;Addison's diseases;With alcohol or drug abuse.
* Any disability related to the central nervous system that predated the traumatic brain injury.
* Pregnancy or breastfeeding females.
* More than one seizure in the previous month.
* Prior treatment with VPA
* In the case of patients who were undergoing evaluation for ventricular shunt placement or receiving a psychoactive medication, enrollment was deferred until shunt placement had been completed or psychoactive medications discontinued.
* The patients had enrolled the other studies in the past three months or are engaging the other studies.
* The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating and exhaustion, which may potentially allow many more people with multiple sclerosis to participate in and benefit from exercise. The design is double-blind, within-subject, with three arms: participants will receive one of three treatments at three separate study visits: aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.

Persons with multiple sclerosis benefit from exercise, but many avoid it because of exhaustion and overheating. This randomized controlled trial (RCT) tests aspirin as a method to increase time to exhaustion for persons with MS, through its antipyretic mechanism. Participants will be seen at our laboratory for maximal exercise tests on three separate days. At each session, they will be given one of three treatments: aspirin, acetaminophen (a drug that is anti-inflammatory but not antipyretic, thereby allowing for isolation of the antipyretic action of aspirin), and placebo. Primary outcome is increased time to exhaustion, secondary outcome is reduced body temperature increase during exercise.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting MS
* self-reported heat-sensitivity to exercise
* Expanded Disability Status Scale (EDSS) total score ≤ 6.0
* exacerbation-free (and no use of corticosteroids) for 6 weeks prior
* BMI ≤ 40

Exclusion Criteria:

* prior history of significant head injury, stroke, or other neurological disease/disorder
* current daily use of antipyretics or pain medication
* currently in a major depressive episode
* vascular disease of the legs, uncontrolled high blood pressure
* uncontrolled diabetes mellitus or problem with blood sugar levels
* contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)
* tarry stool or known fecal occult blood
* uncontrolled syndrome of asthma, rhinitis, or nasal polyps
* contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.


Eligibility Criteria:
Inclusion criteria:

* Narcolepsy patients
* Body mass index between 18 - 32 kg/m2
* Females may be of child bearing or non-child bearing potential.
* Agreement to refrain from driving or operating heavy machinery for the duration of the study.
* Must be able to withdraw from medication for the treatment of daytime sleepiness and must not be living on their own.

Exclusion criteria:

* History or presence of major psychiatric disorder or depression.
* History of significant head trauma in the previous 12 months.
* Participation in a clinical trial in the previous 3 months.
* Patient has significant and recent (within 1 year) history of drug or alcohol abuse.
* Patient is pregnant or breast-feeding.