rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
eGPA and Local Inflammation Within the Ear, Nose and Throat Area
Status: Recruiting

Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age  able to give informed consent In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan In Severe asthma group: clinical diagnosis of asthma with forced expiratory volume at one second(FEV1) <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml) In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017) In GPA group: fulfilling the American College of Rheumatology (ACR)/EULAR GPA criteria (Robson et al., 2022) In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness  Exclusion Criteria:  unable to give informed consent Active smoking < (less than) 6 months from baseline visit Concomitant use of dupilumab within 6 months of baseline visit pregnant or breastfeeding woman in CRSwNP group: current use of asthma medication, eGPA in healthy controls: chronic use of local anti-inflammatory agents in healthy controls: use of immunosuppressive medication in healthy controls: use of antibiotics within the last month (before start study/screening/) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment - SamplingMethod: Non-Probability Sample
Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements
Status: Not yet recruiting

• Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.

Main research question

To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.
Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes.

Eligibility:
- EligibilityCriteria: Inclusion criteria: Adult patients having undergone surgery under general anesthesia with Intermittent Positive Pressure Ventilation in the UMCG between 01-01-2018 and 01-04-2023. Exclusion criteria: age <18 years; no use ofIntermittent Positive Pressure Ventilation; not under general anesthesia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Inclusion criteria: Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023.  • - SamplingMethod: Non-Probability Sample
Oxygen Saturations Across Tones of Skin
Status: Recruiting

Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  >18 years old Any gender Any ethnic background Admitted to UC San Diego La Jolla or Hillcrest campus ICU Mechanically ventilated Has a clinical ABG ordered by the critical care team responsible for clinical care  Exclusion Criteria a. <18 years old b. Medical history of or acute diagnosis of sickle cell disease c. Normally protected individuals under 45 CFR 46 (pregnant individuals, prisoners, and children)  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Critically ill patients on mechanical ventilation. - SamplingMethod: Probability Sample
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
Status: Recruiting

We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit. ASA Classification 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Positive for at least one clinical symptom consistent with SIBO. Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria. Prescribed, but has not started, a two-week course of Rifaximin for SIBO.  Exclusion Criteria:  History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia. Actively taking a proton-pump-inhibitor medication within 30 days of enrollment Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: SIBO patients - SamplingMethod: Non-Probability Sample
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
Status: Not yet recruiting

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422) At least three months after activation of the cochlear implant. Eighteen years or older at the time of consent. User of 900Hz ACE (Advanced Combination Encoder) strategy MAP. Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear. Fluent speaker in English. Willing and able to provide written informed consent.  Exclusion Criteria:  One or more electrodes turned off in the MAP used regularly. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain
Status: Not yet recruiting

Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with symptomatic irreversible pulpitis. Patients with active pain (moderate-to-severe) in mandibular molars. Males and females. Patient with the ability to understand and use pain scales. Patient who accepts to enroll to the study  Exclusion Criteria:  Patients' allergies or any other contraindication to any of the used medications or mepivacaine. Pregnant and lactating females. Patients have been taking pain medication 12 hours earlier. Patient has more than one symptomatic mandibular tooth in the same quadrant. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. Patients with contributory medical history (ASA>II). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty
Status: Recruiting

This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged between 18 and 90 years American Society of Anesthesiologists (score ranging from 1 to 4) Anterior hip arthroplasties  Exclusion Criteria:  Patients with a history of opioid addiction Individuals under the age of 18 Those aged 90 and above Allergies to morphine, fentanyl, bupivacaine, or tramadol Coagulopathy Infection at the injection site Severe cardiac, renal, or hepatic dysfunction Cases unable to provide informed consent Body Mass Index >40 kg/m2 Known neurological or anatomical deficits in the lower extremities Patients requiring a transition from spinal anesthesia to general anesthesia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
Status: Not yet recruiting

This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  >7 years of age medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant a caregiver who can assist the child with the study procedures  Exclusion Criteria:  complete blindness or deafness inability to operate the hand-held controllers susceptible to motion sickness in virtual reality inability to communicate in English - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - StdAgeList: Child, Adult, Older Adult
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
Status: Not yet recruiting

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 6 months - 18 years. Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria. Patients who will undergo intervention with transcatheter closure.  Exclusion Criteria:  Patients who experienced acute infections before the procedure. There are other heart defects that require surgery. There is a hereditary, genetic disorder, syndrome or other chronic disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult
Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
Status: Not yet recruiting

The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 18-65 Diagnosed with chronic constipation according to Rome IV criteria No new treatment for constipation in the last 3 months Absence of any condition that would prevent compliance with the interventions and assessments in the study  Exclusion Criteria:  Presence of secondary constipation ( uncontrolled metabolic disease (uncontrolled DM, hypothyroidism), hyperparathyroidism, neurologic disease or use of anticoagulants, anticholinergics, antihistamines, antipsychotics or opioids) In individuals over 50 years of age, the presence of alarm symptoms (new-onset constipation, rectal bleeding, involuntary weight loss, nausea and vomiting, fever and anemia) having BMI > 30 kg/m² having cancer diagnosis being pregnant or breastfeeding, being within the first year postnatally having irritable Bowel Syndrome, Hirschprung's Disease, Crohn's Disease, Inflammatory Bowel Disease, Megacolon diagnosis, Megarectum diagnosis, Rectocele and enterocele stage 3 and above presence of advanced systemic disease (e.g. cardiovascular, respiratory, renal or hepatic diseases) history of abdomino-pelvic or gastrointestinal surgery in the last 6 months presence of open wound, disruption of skin integrity, local tumor, cholestomy or abdominal hernia at the massage site Presence of orthopedic (e.g. lumbopelvic pain, advanced knee joint degeneration) and cardiovascular diseases (e.g. acute coronary syndrome, stage 3-4 heart valve diseases) that may prevent aerobic exercise training - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Metabolic Changes in Healthy Subjects With Acute Binge Drink
Status: Recruiting

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:

1. if acute binge drink could alleviate liver injury and hepatic steatosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sign informed consent  Exclusion criteria  a. Neurological disorders b. Alcohol allergy c. Alcohol addiction d. Gastrointestinal diseases e. Liver, kidney, cardiovascular or systemic diseases f. Antibiotics were administered within 2 weeks prior to the trial g. Participants who ate a vegetarian diet h. Unable to use a smartphone or computer with Internet access i. Participate in another intervention study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies
Status: Not yet recruiting

The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of Tyrosinaemia type I, II III or Alkaptonuria requiring a tyrosine- and phenylalanine-free protein substitute. Diagnosis of Homocystinuria requiring a methionine-free, cystine-enriched protein substitute. Diagnosis of MSUD requiring a valine-, leucine- and isoleucine-free protein substitute. Subjects who are already taking a protein substitute for one of the specified rare metabolic disorders and are willing to try the study product for 7 days. Children aged 7 years and over. Written informed consent obtained from parental caregiver.  Exclusion Criteria:  Presence of serious concurrent illness Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Any children having taken antibiotics over the previous 2 weeks leading up to the study. Children less than 7 years of age. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: 15 children out of a patient pool with proven tyrosinaemia type I, II, III or alkaptonuria, homocystinuria, or MSUD will be recruited from two specialist metabolic centres. - SamplingMethod: Non-Probability Sample
Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel
Status: Not yet recruiting

This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 18 years of age Current or former public safety personnel (or public safety personnel trainee) Residing in Canada at time of enrollment Has regular access to the internet Confirms intent to participate in study  Exclusion Criteria:  Not 18 years of age or older Not a current or former public safety personnel (or public safety personnel trainee) Not residing in Canada at time of enrollment Does not have regular access to the internet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2
Status: Not yet recruiting

This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Food pantries enrolled in the study will be partner agencies of the Greater Boston Food Bank that are maximum client choice, are located within approximately 1 hour driving time of Boston (for logistical feasibility), and are not actively using traffic-light nutrition ranking. Food pantry clients that complete assessments must be 18 years or older and speak English or Spanish.  Exclusion Criteria:  Food pantries that are not affiliated with the Greater Boston Food Bank and are not maximum client choice. Food pantry clients that do not speak English or Spanish. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult