cyrilzakka/clinical-trials huggingface dataset:
Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis

The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.

Respiratory syncytial virus associated bronchiolitis is a leading cause of global infant morbidity and mortality \[1\], yet care remains largely supportive. Several recent studies show that a helium-oxygen gas mixture (heliox) improves outcomes in children with moderate to severe bronchiolitis \[2-5, 7\]. Heliox is a safe, inert gas with no biological effects and very low density \[6\]. By improving laminar flow, heliox improves gas exchange in conditions where airway resistance is increased, such as asthma, croup and bronchiolitis \[6\].

Recent data shows that infants with moderate to severe bronchiolitis have a reduced length of hospital stay when heliox is delivered via facemask or CPAP, as compared to heliox via nasal cannula \[2\]. Limitations to this study include the small number of patients (84/319 \[26%\]) who tolerated the facemask therapy and the fact that nasal cannula heliox was delivered at low flows (3 LPM). Oxygen is increasingly being delivered with a heated, humidified, high flow nasal cannula (HFNC) system to infants with moderate to severe bronchiolitis in our PICU. To date, there are no definitive randomized controlled trials that show the HFNC system is an effective treatment in bronchiolitis. However, there are several retrospective, prospective and pilot interventional studies showing clinical improvement in this patient population treated with the HFNC system \[8-11\]. We hypothesize that delivering heliox via a heated, humidified, high flow nasal cannula will be well tolerated, safe and effective.

Specific Aim #1: The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.

Hypothesis #1: Clinical and physiologic markers of respiratory distress will be improved in patients receiving heliox via HFNC compared to standard therapy following separation from mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-24 months
* Admission to the Pediatric Intensive Care Unit
* Diagnosis of bronchiolitis, with respiratory syncytial virus infection confirmed by laboratory testing
* Mechanical ventilation

Exclusion Criteria:

* Inclusion in another clinical trial
* Significant cardiac disease
* Anatomically abnormal airway
* Neurologic disease
* Immunodeficiency
* History of chronic lung disease
* Craniofacial anomaly
* Chromosomal anomalies
* Known or suspected dysphagia
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.

The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18)
* Diagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
* The patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein
* Patient or legally authorized representative provides written informed consent to enroll in this study
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.

This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Written informed consent
* Patients with one or more of the following:

  * Syncope of uncertain etiology; or
  * Pre-syncope of uncertain etiology; or
  * Palpitations of uncertain etiology; or
  * Management of known AF/SVT patients

Exclusion Criteria:

* Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
* A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment.
* Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
Duke Lupus Registry

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.

The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic.

The Duke Lupus Registry has two main purposes:

1. Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic.
2. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression.

At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus
* Patient of a rheumatologist at Duke University Medical Center

Exclusion Criteria:

* Inability to travel to Duke for follow-up visits
* Inability to speak English
* Not able to provide informed consent
Qualitative Study on a Psychoeducation Group for Juvenile Sex Offenders

Some sexual violence is committed by minors but how to take care of them ? Despite heterogeneous profiles, some characteristics are common in these adolescents and can be used in psychoeducation group. CRIAVS-LR team has therefore decided to create a psychoeducation group on emotional and sexual life specific for this population of young adult/adolescents in order to improve their skills and find alternative solutions to violence, particularly in the area of sexual violence The qualitative aspect of this study would make it possible to provide data in this still little explored field, to try to understand the experience of the young people participating in this group and to improve its structure and content so that it reaches best its goals.

In France, 25% of perpetrators of sexual offenses are minors. Faced with this increasingly present problem in our society, the answer seems to be more on the side of education and care. However, this new problem confronts us with the limits of our care and forces us to reconsider the organization of care. Indeed, to date, there is no specific support for juvenile sex offenders. Little research exists on the subject because of the many difficulties in setting up this type of study: low power, problem of definition, variables that are difficult to compare, few therapists specialized in this field... In fact, studies must continue to demonstrate the effectiveness of psychoeducational treatment. Although there is no consensus on the profiles of juvenile sex offenders in the literature, there are common characteristics among these individuals. Indeed, the lack of social skills, relationship difficulties, empathy, self-esteem, sex education, impulse control and therefore self-control are issues that can be worked on by psychoeducation.

CRIAVS-LR's team have therefore decided to create a specific psychoeducation group for minors and young adults who are perpetrators of sexual violence. The objective is to improve their skills of knowing, knowing how to be and knowing how to do in the areas of affective and sexual interpersonal relationships and thus find alternative solutions to violence, particularly sexual violence. The qualitative aspect of this study would make it possible to provide data in this still little explored field, to try to understand the experience of the young people participating in this group and to improve its structure and content so that it reaches best its goals.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 14 to 20
* commit a sexual offense
* takes part to CRIAVS-LR psychoeducation group

Exclusion Criteria:

* severe intellectual disability, decompensated psychiatric disease
* Illiterate or unable to understand the purpose and methodology of the study
* Patient not affiliated to a French social security scheme or not a beneficiary of such a scheme
* Person unable to give consent
* Refusal of consent after information
* Adult protected by law (guardianship, curatorship)
* Person under psychiatric care
* Person participating in another research project with an exclusion period still in progress,
Genetics of Ischemic Cardiomyopathy

Background:Ischemic heart disease is one of the heaviest health-related burdens worldwide.We aimed to identify the common hub mRNA and pathways that are involved in pathological progression of ischemic cardiomyopathy. Methods: To explore potential differentially expressed genes (DEGs) of all ischemic heart disease stages, we used chipster and GEO2R tools to analyze of retrieved eight high throughput RNA datasets obtained from GEO database. Gene Ontology functional annotation and Pathways enrichment analyses were used to obtain the common functional enriched DEGs which were visualized in protein-protein interactions (PPI) network to explore the hub mRNA according to the interaction scores. Validation qRT-PCR was carried out for blood and cardiac biopsies compared with controls to validate the determined four hub mRNAs and subsequently reviewed inside comprehensive published meta-analysis database. The validated mRNAs were visualized in two interaction modules. Finally screening of approved drugs was applied.


Eligibility Criteria:
Inclusion criteria The enrolled patients aged 20-80 years with stable coronary artery disease undergoing elective PCI or patients with unstable angina or myocardial infarction undergoing rescue PCI and admitted to the cardiology hospital (Asyut University, Asyut, Egypt) were recruited in this study.

Exclusion criteria Patients with dilated cardiomyopathy were execluded from this study.
The Management of Asymptomatic Carotid Stenosis

Carotid stenosis are asymptomatic if no hemispheric or retinal symptoms have appeared in the 6 months preceding the discovery of the stenosis. Asymptomatic carotid stenosis (ACS) accounts for about ¾ of all carotid lesions. The goal of treating carotid stenosis is to prevent a stroke. While carotid surgery is recommended in the elderly patients in cases of symptomatic carotid stenosis, that of ACS in patients over 75 years old, even when tight, remains subject to many controversies. Indeed, the debate, concerning the benefit to be expected from a surgical procedure or a possible angioplasty procedure, is not yet closed. The aim of our study, through a retrospective evaluation of the results of all consecutive carotid endarterectomy (CEA) and stenting in the participating center.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic carotid stenosis
* Patient with degree of carotid stenosis greater than 80% measured by the maximum systolic velocity at the site of the stenosis which must have been greater than 250 cm/s
* Ultrasound characteristics of a possibly unstable plaque

Exclusion Criteria:

* Symptomatic carotid artery stenosis
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:

  * is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
  * is willing and able to complete the follow-up requirements of this study, and
  * signs the informed consent (or a legal representative signs the informed consent).
Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease

The main purpose of this study is to assess changes in exercise capacity in people with Parkinson's disease before and after an exercise training program with ketone ester supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease

Exclusion Criteria:

* Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise
* Inability to use a step, stand, walk, or use a stationary cycle ergometer
* History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects
* History of symptomatic cardiovascular or pulmonary disease interfering with exercise
* History of active rheumatoid arthritis
* History of uncontrolled chronic pain syndrome
* Any other history of medical or psychiatric comorbidity precluding safe participation in the project
* Poorly controlled diabetes
* Pregnancy or breastfeeding
* Clinically significant dementia
* Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)
Prevalence of Sleep Apnea in Women

To identify the prevalence of sleep apnea (SA) in women and its relationship to age; to predict those women at risk for sleep apnea; and to define the natural history of those with sleep apnea.

BACKGROUND:

Often sleep apnea is accompanied by considerable morbidity; the associated excessive daytime sleepiness, cardiovascular abnormalities and cognitive impairment impact greatly on daytime functioning. The obese, hypertensives, elderly and postmenopausal women are reported to be at increased risk for sleep apnea. The investigators published on the prevalence of sleep apnea in several special populations: elderly subjects without sleep complaints and insomniac, narcoleptic, hypertensive and obese patients. They established the prevalence of sleep apnea in men based on the sleep laboratory evaluation of approximately 1,000 men randomly selected from a randomly generated telephone sample of 4,364 men from the general population. Their preliminary estimate of prevalence was that about 2.2 percent of the adult male population have clinically diagnosable sleep apnea. Further, in the male sample, the age distribution was not linearly related to age. Rather, it peaked at approximately age 55. Finally, the major risk factors appeared to be obesity and snoring. The differences in the male/female ratio in clinical and selected populations ranged from 10.0:1 to 1.9:1. One recent study suggested that the prevalence of sleep apnea in women was about two-fold less than in men. However, this study did not sample the general population and used only a restricted age range (30 to 60 years) which did not allow the assessment of the influence of menopause. Thus, the prevalence of sleep apnea in women in the general population remained largely undetermined.

DESIGN NARRATIVE:

In order to establish the prevalence in women with reasonable precision, the prevalence study employed a two-stage sample modified from the prevalence study in men in the following two ways: an expanded telephone sample (N=12,219 women) selected randomly from the general population was evaluated, for clinically relevant risk factors for sleep apnea; and 2) a second sample (N=1,000) selected randomly from the first sample based on higher risk for sleep apnea (including the additional risk factor of menopause) was evaluated in the sleep laboratory to determine the presence of sleep apnea. This strategy yielded an adequate power in order to establish the prevalence of sleep apnea requiring treatment and sleep disordered breathing in women in the general population as well as result in a large enough sample to establish the association between risk factors and sleep apnea in women. In order to perform gender analyses, the study compared previously published data from a total of 4,364 men interviewed in an expanded telephone sample and 741men evaluated in the sleep laboratory.

Eligibility Criteria:
Stratified random sample based on risk severity obtained during phone interview
Study to Examine the Effects of ATP Supplementation on Muscle Excitability and Reaction Time During and Following a Repeated Sprint Bout

We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance motor unit recruitment while simultaneously blunting the decline in power and reaction time that is typically seen during repetitive sprints. This will give researchers a better understanding of the mechanism by which ATP supplementation can augment power, especially under high fatiguing conditions.

Healthy participants of similar training status as previously tested will be enrolled into the study. The participants will be randomly assigned to either placebo supplementation or to 400 mg ATP per day for 14 days. The supplements will be taken in the morning and the last dose will be taken 30 min prior to testing on the last day. Testing will be performed at baseline and after the 14 days of supplementation. Ten successive sprints will be conducted on the Wingate apparatus as this has been previously demonstrated to decrease muscle excitability. After the sprints, muscle excitability, reaction time, and vertical jump power will be measured. In addition a blood sample will be obtained before and after supplementation and complete blood hematology and chemistry analyses will be performed. It is expected that ATP supplementation may help maintain muscle excitability and power after the successive sprint sessions.

Eligibility Criteria:
Inclusion Criteria:

* Agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
* Must not have taken performance enhancing supplements for at least 3 months prior to the study start,
* Must be a non-smoker.
* Must not be taking amino acid supplements.
* Must not be using anabolic or catabolic hormones.
* Must not be taking any medications known to influence variables to be measured in the study.

Exclusion Criteria:

* Will not agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
* Has taken performance enhancing supplements for at least 3 months prior to the study start,
* Is currently a non-smoker.
* Is currently taking amino acid supplements.
* Is currently using anabolic or catabolic hormones.
* Is currently taking medications known to influence variables to be measured in the study.