cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal Pain in Cancer Patients,

Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and intervention related side effects.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status of I or III (ASA), of both sex
* cancer-related anal or perineal pain

Exclusion Criteria:

* coagulopathies
* allergies to the contrast dye
* patients with moderate or significant cardiac/respiratory disease or hepatic
Project Sueño: Sleep & Understanding Early Nutrition in Obesity

The purpose of the study is to understand how mothers think and feel about feeding their babies and putting them to sleep, understand more about programs that can support mothers taking care of babies, and how professionals can be most helpful in helping mothers make decisions about their baby's feeding and sleeping. The overarching goal is to prevent early life obesity and progression to metabolic syndrome in high-risk populations, starting with healthy toddler weights by age 2 years.

This study seeks to intervene just in time for families at highest risk of early life obesity and obesity-related comorbidities (such as Type 2 diabetes), to prevent intergenerational obesity and metabolic syndrome for Hispanic families. For those children exposed to gestational diabetes (GDM) or maternal overweight/obesity in utero, there is a critical need for effective early life strategies for secondary prevention of obesity, to interrupt intergenerational transmission. This study will offer community-embedded coaching to families learn how to responsively feed their babies using 2 models: group visits and text-based. The investigators will also assess responsive sleep practices; i.e. paying attention to an infant's sleep cues as well as hunger cues, breaking the feeding to sleep association, and not overfeeding at night. Infant and toddler sleep, both duration and quality, has not been well studied in this population for early life obesity prevention. This study is specifically exploring pathways from prenatal gestational diabetes and maternal overweight/obesity to dysregulated infant feeding and sleep. Few interventions around infant sleep exist for the Hispanic population, or resources in Spanish-language around sleep coaching; let alone analyses on parents' self-efficacy and behavior change. In this study, the investigators aim to better understand the complex socioenvironmental drivers of infant sleep and feeding behaviors, and the prenatal risks related to infant rapid weight gain, in order to target modifiable factors in this population.

Eligibility Criteria:
Inclusion Criteria:

* Mother to infant born full term \> 37 weeks, and are under 1 month of age
* Infant is singleton
* Infant has no identified health problems
* Infant is patient of CommUnityCare
* Mother is 18 years of age
* Mother is Latino/Hispanic ethnicity
* Mother is willing to commit to study follow-up visits

Exclusion Criteria:

* Mother smokes
* Mother works primarily at night
* Infant has metabolic or chromosomal disorders, chronic neurological or respiratory conditions, or developmental disability
Mindfulness Meditation in Chronic Stress

The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.

Subjects will first undergo a phone screening, and if eligible, they will complete three study visits at Week 1, Week 8, and Week 15. The study visits involve at-home surveys, voice recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), EEG recordings (including recordings of electrodermal activity and heart rate variability), computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device that randomly administers eight short assessments in the subjects' natural environment. Subjects will be randomized to receive a 6-week mindfulness meditation course either between the first and second study visits or between the second and third study visits. Participants who receive training during the first and second visits will continue meditating until the third visit. The one-on-one instruction occurs once a week for 1 ½ hours, and participants are asked to listen to guided meditations and do other mindfulness-based tasks on a daily basis between sessions.

Eligibility Criteria:
Inclusion Criteria:

* Ages 50-85
* Good General Health
* Experiencing Stress
* No current meditation practice
* English speaking

Exclusion Criteria:

* Cognitive Impairment
* Neurological Disease
* Major Untreated Depression
Effects of Change in Insulin Resistance and Systemic Inflammation on Brain Structure and Function

Obesity is associated with alterations in brain structure and cognitive impairment and is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this project is to understand how obesity affects cognitive function, with the aim to develop new ways to prevent and treat obesity related cognitive decline

A growing body of evidence suggests that obesity is associated with alterations in brain structure and cognitive impairment. Mid-life obesity is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this research is to identify how obesity, insulin resistance (IR), and their treatment impact brain structure and function. The investigators propose that IR and obesity related inflammation are two modifiable factors that affect neuronal integrity and lead to cognitive dysfunction. In this proposal, investigators will test two hypotheses: 1) among obese patients planning to undergo bariatric surgery (specifically vertical sleeve gastrectomy), baseline IR and systemic and brain markers of inflammation will inversely correlate with performance on cognitive testing and correlate with abnormalities in brain structure and 2) following bariatric surgery subjects who experience the greatest reduction in IR and obesity related inflammation will have the greatest improvement in cognitive function and brain structure. To address these hypotheses, investigators will use a comprehensive battery of tests to evaluate cognition and state of the art magnetic resonance imaging (MRI) techniques to assess brain structure and neurochemistry before and six months after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

Obese Group

* Undergoing VSG-type bariatric surgery
* BMI \> 30
* Current weight less than 400 lbs

Non-Obese Group

* Age 30-50
* BMI \< 25

Exclusion Criteria:

Both Groups

* History of type 1 or type 2 diabetes
* History of stroke
* History of epilepsy
* History of Neurosurgical procedures
* Past or current history of severe psychiatric illness
* Pass or current history of alcohol or substance abuse
* Absence of metallic substances in body or ability to remove before imaging procedure
* History of claustrophobia or known inability to tolerate MRI
* Inability to consent
Screening Questionnaire for Depression

Depression is common in primary care and general medical settings, but is often unrecognized and untreated by physicians working in those settings.

The Patient Health Questionnaire for depression (PHQ-9) is well validated and widely used screening instrument.


Eligibility Criteria:
Inclusion Criteria:

* \>18 yrs
* Primary care and general medical patients
* Understand the IC
* Speaks Hebrew
* No significant cognitive impairment
App-supported Vestibular Rehabilitation (RCT)

A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes

Vestibular Rehabilitation (VR) home exercises, prescribed by physiotherapists, are the main treatment for vestibular dysfunction. However, reports by clinicians indicate that patients do not fully comply with the treatment. Advances in technology and tele-rehabilitation have the potential to facilitate adherence to home exercise, if they are designed to overcome the barriers for practice. We plan to continue and expand our previous feasibility study with the vestibular phone app, in order to examine the effects of an app-assisted VR program on adherence and treatment outcomes. The patients in this study will be randomly assigned to the intervention (app-assisted vestibular rehabilitation) or the control group (standard vestibular rehabilitation, no app).

Tests and measurements for both groups will be done at three time points:

1. Preliminary assessment session (Session 1)- An initial assessment test on the first visit;
2. Secondary assessment session (Session 2)- After 5-6 weeks;
3. Follow-up evaluation session (Session 3)- One month after the secondary assessment session.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and over
* Diagnosis with any vestibular disorder that requires a vestibular rehabilitation exercise program
* Physical and cognitive ability to perform vestibular physiotherapy

Exclusion Criteria:

* A physical disability that does not allow for the performance of vestibular physiotherapy
* A diagnosis of a central vestibular disorder caused by structural damage to the brain
* Individuals who are not qualified to give informed consent
Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.

The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.

Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe ARDS (Berlin Definition)
* Acute beginning \<1 week
* PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
* Bilateral opacities on chest X-ray
* Respiratory failure not fully explain by cardiac failure or fluid overload
* Informed consent signed by the next of kin and secondarily by the patient when awake
* Patient with social insurance

No Inclusion criteria

* Age \< 18
* Pregnancy a pregnancy test will be done to women of childbearing age
* Chronic obstructive pulmonary disease
* Severe hypoxemia PaO2/FiO2 \<50% with high PEEP
* Immunosuppressive treatment
* Immunodeficiency onco-hematology, HIV
Digital Interventions to Understand and Mitigate Stress Response

Stress, anxiety, distress, and burnout are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. The understanding of factors underlying distress and resilience in complex workplace contexts is limited, and there are limited evidence-based interventions for stress and moral distress among frontline healthcare workers. The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality \[VR\], a web-based platform, and a wearable \[Oura Ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals.

The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality \[VR\], a web-based platform, and a wearable \[Oura Ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals. This study involves participation in an in-person VR setup and the use of an app and a wearable device over the duration of the study (14+ weeks). The immersive VR component of the study involves a virtual experience of navigating a challenging workplace scenario to understand stress response and provide an overview of interventions that can be used to reduce workplace stress. Upon completion of the in-person VR visit, participants will continue to use the app and the wearable for the study duration to understand stress responses in their actual workplaces. Participants will have real-time access to their essential data on wellness collected through the app and wearable (e.g., sleep, activity, physiological signals, anxiety symptoms). The Digital Intervention Suite (combined use of these three components: VR, app, and wearable) is essential for a thorough understanding of stress and moral distress. This is a de-identified study, and the team will only have access to de-identified data for analysis at the end of the study.

Eligibility Criteria:
Inclusion criteria:

1. Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
2. Ownership of a smartphone.

Exclusion criteria:

1. History of seizures (except febrile seizure).
2. Use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators).
3. A score of ≥ 15 on the Generalized Anxiety Disorder (GAD-7) scale
4. A score of ≥ 20 on the Patient Health Questionnaire (PHQ-9).
Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.

Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.

Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy.

Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.

Eligibility Criteria:
Inclusion Criteria:

* Available history and physical exam findings
* Available complete blood count and tympanometry at admission

Exclusion Criteria:

* Previous tonsillectomy and/or adenoidectomy.
* Previous ear surgery.
* Acute infection during the past month.
* Active severe systemic disease.
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ, null or other rare geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM
* FEV1 ≥20% predicted
* Computerised tomography (CT) scan evidence of emphysema
* Non-smokers

Exclusion Criteria:

* Primary diagnosis of bronchiectasis
* An ongoing acute exacerbation of the underlying lung disease
* Underlying liver disease or abnormal liver function tests
* Previous augmentation therapy within 6 months of dosing
Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus

Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and neglect. While cognitive and psychiatric issues have been described in HIV-infected children, and even more so in HIV-positive adults, there have been no reports on neuropsychiatric interventions that can improve cognitive and psychiatric states in this highly vulnerable population. Without these needed data, Pediatric HIV providers have not been able to advocate for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who has suffered the additional risk of being internationally adopted. In the proposed study, the investigators will report on the neuropsychological profiles and outcomes in a cohort of internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who have not previously undergone neuropsychological testing or treatment. Data obtained from this study will provide important contributions to the literature by building understanding of the complex needs of this population as well as guiding future intervention efforts. The investigators predict that intervention efforts aimed at helping educators understand the learning and cognitive challenges for many of our patients will guide targeted academic supports in the school setting and lead to gains in academic skills. The detailed information obtained during the comprehensive neuropsychological assessment and follow-up care will be shared with the child's key educators at school so that individualized educational strategies can be developed, while maintaining confidentiality regarding the child's HIV status.


Eligibility Criteria:
Inclusion Criteria:

* Perinatally infected with HIV, internationally adopted

Exclusion Criteria:

* Prior neuropsychological testing
Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.

Systemic Inflammatory Response Syndrome (SIRS), sepsis, septic shock and concomitant multiorgan failure are major causes of morbidity and mortality in intensive care units. During SIRS and septic shock the role of the gut seems to be uncertain. As it serves as an intestinal barrier which allows the symbiotic relationship between man and enteric bacteria, increased gut permeability during critical illness is accused to promote sepsis. Brush border enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion across the gut mucosal barrier. A reduced brush border enzyme function could contribute to the gastrointestinal intolerance in critically ill patients, which is frequently observed. The aim of this study is to assess the influence of SIRS and septic shock on brush border enzyme morphology and function in men.

Eligibility Criteria:
Septic Shock:

Recruitment and inclusion criteria

* 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR \> 20/min, HR \> 90/min, Temp. \> 38°/\< 36°, 12G/l\< WBC \< 4G/l; assumed or proven infection, persistent hypotension refractory to fluid therapy and need for vasopressors.
* Time window for inclusion: up to 72h after onset of symptoms

Exclusion criteria

* PLT \< 50G/l,
* PT \< 50%,
* Continuous therapeutic anticoagulation,
* DIC, st. p. MCI within 14 days,
* Gastrointestinal perforation,
* Age \< 18 years,
* Age \> 80 Years

SIRS:

Recruitment and inclusion criteria

* 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR \> 20/min, HR \> 90/min, Temp. \> 38°/\< 36°, 12G/l \< WBC \< 4G/l; assumed or proven infection
* Time window for inclusion: up to 72h after onset of symptoms

Exclusion criteria:

* PLT \< 50G/l,
* PT \< 50%, continuous therapeutic anticoagulation,
* DIC, st. p. MCI within 14 days,
* Gastrointestinal perforation,
* Age \< 18 years,
* Age \> 80 Years

Healthy/controls:

* 15 control subjects will be recruited from the outpatient ward referred to the endoscopy of the Department of Medicine III - Division of Gastroenterology and Hepatology for upper GI-endoscopy because of epigastric pain or reflux symptoms.

Inclusion criteria:

* Signed informed consent

Exclusion criteria:

* Patients with diarrhea of unknown origin, IBD or known celiac disease
* Age \< 18 years
* Age \> 80 Years
* PLT \< 50G/l, PT \< 50%
* Therapeutic oral anticoagulation
Pain Control in Dentin Hypersensitivity in Patients With MIH

This study aims to evaluate the effectiveness of different protocols in controlling dentin hypersensitivity in patients with teeth affected by MIH. The subjects will be randomly designated in four experimental groups, according to different treatments. Pain will be assessed with the visual analog scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and and an exploratory probe at the time of (initial) recruitment, immediately after treatment, after 1 week and 1 month, 3 and 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 35 years old;
* Present good general health;
* Present at least one tooth with dentin hypersensitivity reported in the cervical region, which must have a graduated sensitivity equal to or greater than 4 in the VAS scale.

Exclusion Criteria:

* Present active caries lesions or restoration defects in the tooth to be analyzed;
* Present sufficient dentin loss that requires restorative treatment or periodontal surgery;
* Volunteers who underwent any professional desensitizer treatment in the last 6 months;
* Volunteers who used desensitizing pastes in the 3 months;
* Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
* Volunteers who are pregnant or breastfeeding.