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About This Study

The overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (T2D) in childhood.

Design

Interventions / Regimen

• Other: Observational screening study

Primary Outcomes

• Obesity (18 years)
• Type 2 Diabetes (18 years)

About This Study

As the U.S. population ages, future physicians must be prepared to care for older adults with multiple health conditions and complex needs. This study will test whether cinematic virtual reality (VR)-an immersive, interactive learning tool-is more effective than traditional lectures in helping medical students learn about geriatric care. Students who complete the VR training will experience realistic patient scenarios that show what can go wrong in medical care and learn how to apply osteopathic principles to improve outcomes. Researchers will compare students' performance on a clinical skills assessment and explore their experiences with the VR training. The goal is to determine whether cinematic virtual reality can better prepare students for residency and improve their ability to provide compassionate, high-quality care for older adults.

Design

Interventions / Regimen

• Behavioral: Cinematic Virtual Reality Training — The participants randomly assigned to the cinematic virtual reality training will view 6 virtual reality episodes of an older adult, Mr. Chen, with multiple geriatric syndromes, chronic health conditions, disabilities, and significant social needs, who is also vulnerable to elder abuse and neglect. The content will cover medication, mentation, mobility, what matters most for older adults, nutrition and hydration, and osteopathic tenets.
• Behavioral: Traditional Didactic Lecture — Participants randomized to the traditional didactic lecture will receive a lecture on geriatric care that includes medication, mentation, mobility, what matters most for older adults, nutrition and hydration, and osteopathic tenets.

Primary Outcomes

• Number of Participants with Passing Score on Graduate Medical Education Readiness Assessment (From enrollment to the end of the graduate medical education readiness assessment at 6 weeks.)

About This Study

The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate. The main questions this study aims to answer are: Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends. Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part. What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time. Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).

Design

Interventions / Regimen

• Dietary Supplement: Normast® 3 - a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin and hydroxytyrosol. It is designed to support the management of diabetic polyneu — Normast® 3 is a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin (5:1) and hydroxytyrosol. Each tablet provides 360 mg PEA/rutin and 15 mg hydroxytyrosol. The product is formulated to target neuroinflammation and vascular dysfunction involved in diabetic polyneuropathy. In this study, participants will take one tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.
• Dietary Supplement: Placebo — Placebo tablets are visually and taste-matched to Normast® 3 but contain no active ingredients. Each tablet is composed of inert excipients (mainly microcrystalline cellulose and other standard tablet components). Participants will take one placebo tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.

Primary Outcomes

• Change in average daily pain intensity (Time Frame: Baseline to Week 12)

About This Study

β2-Agonists, commonly used to treat asthma, have also been used by athletes to enhance performance, leading to their ban by the International Olympic Committee in 1972. Research has shown non-asthmatics receive no benefit from these drugs at therapeutic dosages; however, many elite athletes still use them, and asthmatic athletes often win more Olympic medals. In some non-asthmatics, β2-agonists may improve breathing limitations during high intensity exercise, which may improve performance. Therefore, we aim to examine if there is a select group of non-asthmatic individuals who experience breathing limitations that may receive benefit from β2-agonists.

Design

Interventions / Regimen

• Drug: Salbutamol — Meter-dose inhaler of salbutamol performed using large-volume spacer
• Drug: Placebo — Meter-dose inhaler of placebo performed using large-volume spacer

Primary Outcomes

• Difference in time to exhaustion following salbutamol inhalation compared to placebo inhalation. (Up to 2 weeks)
• Sex differences in time to exhaustion following salbutamol inhalation (Up to 2 weeks)

About This Study

Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA. The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Design

Interventions / Regimen

• Device: Lung Master (Pulmonary Exerciser) — During the one-month using the Lung Master at their house, the participant will be using it at least one time every day, either in the morning or in the evening before going to sleep. During the session, the participants will sit upright and try to prolong the inhalation and exhalation breaths through the Lung Master device for at least three seconds. For each session, the participants will try to concentrate on 35-50 breaths in and breaths out which is about 2-5 minutes. Every session can involve using the Pulmonary Exerciser for a minimum of 5 minutes and a maximum of 20 minutes. After each session, participants will be asked to note how long they have used the device and when they have used it. Information from each session will be recorded on the Participant Device Log that will be provided.

Primary Outcomes

• Inspiratory Capacity (baseline and after one month of device use)
• Tidal Volume (baseline and after one month of device use)

About This Study

Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.

Design

Interventions / Regimen

• Behavioral: Hospital to Home Transition (H2H) — The intervention for this study is a multi-component navigation-supported intervention for children hospitalized with asthma. Navigators will work with families for 12-months post-discharge. Trained asthma educator/navigators will work to address challenges with asthma care after discharge; will include maximum 15 contacts/12 months. The asthma navigators within this study will attempt to maintain direct contact with participants primary care doctors through email, fax, and/or postal mail as means for delivering asthma action plans, prescription updates, and patient appointment scheduling. The asthma navigators for intervention participants will attempt to maintain contact with the school nurse in efforts to have a line of communication with the school. Asthma navigators will assist families in all home-based needs pertaining to their child's asthma.

Primary Outcomes

• Number of Re-admissions (3, 6, 9, 12 months)

About This Study

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Design

Interventions / Regimen

• Biological: 10,000 MM09 — Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
• Biological: 30,000 MM09 — Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
• Biological: Placebo subcutaneous — The same solution and presentation as the active treatment, but without active ingredients.

Primary Outcomes

• CSMS: Combined Symptoms and Medication Score (12 months)

About This Study

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions. Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment. These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

Design

Interventions / Regimen

• Genetic: Biobanking with genetic analysis — Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.
• Other: SF-12 questionnaire — Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Primary Outcomes

• Change of SLEDAI for lupus (once a year for 10 years)
• Change of Medsger score (once a year for 10 years)
• Change of EDSS for multiple sclerosis (once a year for 10 years)
• Change of BASDAI for psoriatic arthristis (once a year for 10 years)
• Change of Longhurst criteria for hereditary angioedema (once a year for 10 years)
• Change of number of flares for atopic dermatitis (once a year for 10 years)
• Change of number of exacerbations for severe asthma (once a year for 10 years)
• Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale (once a year for 10 years)

About This Study

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.

Design

Interventions / Regimen

• Drug: Celestone + placebo — After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
• Drug: Celestone + Celestone — After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

Primary Outcomes

• Perinatal Mortality or Substantial Neonatal Morbidity (approximately 1 month)

About This Study

The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients

Design

Primary Outcomes

• Asthma exacerbations (36 months)

About This Study

The diagnosis of either asthma or chronic obstructive pulmonary disease (COPD) is currently based on a combination of symptoms, different lung tests and sometimes a 'trial by treatment'. Both COPD and Asthma tests currently include forced breathing using a test known as spirometry which can be difficult and uncomfortable for people to perform and needs expert interpretation. Asthma can require multiple tests in sequence which can make the process of diagnosis long and inconvenient for patients. In the UK, there have been challenges providing enough testing for COPD and asthma, in part because the tests are challenging to provide in the community to everyone who needs one. The STARDUST study aims to test and develop new ways of diagnosing asthma and COPD that are quick, accurate and easy for patient and healthcare professionals to perform. People who have been referred for routine lung testing will breathe normally in and out into a handheld device called the N-Tidal Handset for 75 seconds. This device measures how the level of carbon dioxide (CO2) changes in the breath as people breath through it. The information gathered on the N-Tidal Handsets, called breath records or capnograms, will not be used to alter the diagnosis of any participants in the study. After the capnograms have been collected, the research team will test 'algorithms' that have been developed using artificial intelligence, to see if they can accurately identify the correct diagnosis. Information collected in the study will also be used to make improvements in these algorithms. If confirmed to be accurate, these algorithms could be used in clinical practice to help healthcare professionals make faster, more accessible and accurate diagnoses, especially in settings like GP clinics in the community where access to specialist tests may be limited.

Design

Interventions / Regimen

• Diagnostic Test: Partial pressure of CO2 during tidal breathing — Partial pressure of CO2 during tidal breathing for diagnosis of asthma or COPD
• Diagnostic Test: FENO — Fractional exhaled nitric oxide
• Diagnostic Test: Spirometry — Spirometry with or without bronchodilation (if indicated)

Primary Outcomes

• Diagnostic accuracy of the diagnostic algorithms of N-Tidal Diagnose 1 (At time of testing)
• Diagnostic accuracy of prototype diagnostic algorithms (At time of testing)

About This Study

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Design

Interventions / Regimen

• Combination Product: BDA MDI — Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
• Combination Product: AS MDI — Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

Primary Outcomes

• Annualized rate of severe asthma exacerbations (AAER) (From Randomization (Day 1) to Week 52 (EOT))