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About This Study

The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico. The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.

Design

Interventions / Regimen

• Behavioral: CASE in person version (High Intensity Package) — Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.
• Behavioral: CASE-V remote version (Low Intensity Package) — CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).
• Behavioral: CASE and HARP in person (High Intensity package) — Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.
• Behavioral: CASE-V and HARP-V remote version (Low Intensity package) — HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.

Primary Outcomes

• Change in Child Asthma Control (Individual Level, ages 2-4 years) (Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.)
• Change in Child Asthma Control (Individual Level, ages 5-11 years) (Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.)
• Change in Child Asthma Control (Individual Level; ages 12 and up) (Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.)
• Health Care Utilization-ED visits (Community Level) (12 months pre- and post-intervention year)
• Health Care Utilization-Hospitalizations (Community Level) (12 months pre- and post-intervention year)
• Health Care Utilization-Urgent Care Visits (Community Level) (12 months pre- and post-intervention year)

About This Study

This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.

Design

Interventions / Regimen

• Drug: SKB575 — Subcutaneous
• Drug: Placebo — Subcutaneous

Primary Outcomes

• Incidence of participants with adverse events (AEs), serious adverse events (SAE) (From baseline to week 32)
• Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at week 8 (Week 8)

About This Study

This is a registry of participants who are interested in being screened for clinical trials at a single site.

Design

Interventions / Regimen

• Other: There is no intervention — There is no intervention

Primary Outcomes

• Registry to provide a list of interested individuals in clinical trials at a single site (4 years)

About This Study

Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.

Design

Interventions / Regimen

• Other: Exercise — effect of exercise after three months (comparison of the patient with himself)

Primary Outcomes

• Functional Capacity (three months)
• Inspiratory muscle strength (three months)
• Expiratory muscle strength (three months)

About This Study

This study investigates the effects of a tele-rehabilitation-guided Qigong exercise program on pulmonary function, functional exercise capacity, and symptom control in children and adolescents with mild-to-moderate asthma. Participants aged 8 to 18 years will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week, home-based, tele-rehabilitation-supervised Qigong exercise program in addition to standard medical care. The control group will continue receiving standard medical treatment and routine follow-up. The primary aim of the study is to evaluate changes in pulmonary function (spirometric parameters such as FEV1 and FVC) and functional exercise capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include asthma symptom control assessed via the Asthma Control Test (ACT/c-ACT) and health-related quality of life.

Design

Interventions / Regimen

• Behavioral: Tele-rehabilitation-guided Qigong — An 8-week home-based Qigong exercise program delivered and supervised via tele-rehabilitation sessions in addition to standard medical asthma care.

Primary Outcomes

• Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) (Baseline and Week 8)
• Change from Baseline in 6-Minute Walk Distance (6MWD) (Baseline and Week 8)

About This Study

The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.

Design

Interventions / Regimen

• Drug: Benralizumab — Accessorized Pre-Filled Syringe (Solution for injection).

Primary Outcomes

• Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab (From baseline until 8 weeks after the last dose of benralizumab)

About This Study

The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and mortality. A group of people with chronic respiratory disease who are being followed in respiratory outpatient clinics and a healthy control group without lung disease will also take part. The main questions it aims to answer are: * Which clinical, physical, functional, and biological characteristics are associated with short-term outcomes after hospitalisation, including 30-day hospital readmission, length of hospital stay, and 30-day mortality? * Which characteristics are associated with longer-term recovery, future exacerbations, hospital readmissions, healthcare use, and mortality? * Can measurements taken during or around the time of hospitalisation be used to identify people at greater risk of poor outcomes who may benefit from targeted interventions? Participants will undergo clinical assessments that may include questionnaires, measurements of physical function and muscle strength, lung function tests, physical activity monitoring, and collection of biological samples. Some participants may also undergo additional assessments of body composition, muscle size and function, imaging, or muscle metabolism, including through nested sub-studies. Participants will be followed for up to 36 months to assess recovery and longer-term clinical outcomes.

Design

Primary Outcomes

• 30 days hospital re-admission rate (30 days)
• Length of index hospital admission stay (Variable (up to 52 weeks))
• 30 days mortality rate (30 days)

About This Study

Lung health is negatively affected during wildfire season by increased smoke pollution. Wearing N95 masks protects lung health in the short-term. The purpose of our study is to assess whether wearing of N95 facemasks on days with moderate to high air pollution in people who go outside to golf on a regular basis (two or more times per week) for two months during the wildfire season projects lung health.

Design

Interventions / Regimen

• Device: N95 mask — N95 mask to be worn outside when golfing when Air Quality Health Index reading indicates moderate risk or higher

Primary Outcomes

• Change in compliance with wearing of N95 masks (number of times divided by days with moderate or higher air pollution) (8 weeks)

About This Study

This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight/obesity and chronic conditions, including type 1 diabetes (T1D) and asthma. The intervention combines personalized educational content, wearable-device monitoring, psychometric assessments, and explainable artificial intelligence (AI) to improve mental well-being, quality of life, and adherence to healthy lifestyle behaviors. A total of 280 families will participate in a 3-month intervention with remote monitoring and follow-up assessments.

Design

Interventions / Regimen

• Behavioral: Adhera Caring Digital Program-Obesity (ACDP-O) — The Adhera Caring Digital Program-Obesity (ACDP-O) is a mobile-based digital health intervention that provides personalized educational content, cognitive behavioral approach-based support, psychometric monitoring, wearable-device integration, remote monitoring, and explainable artificial intelligence tools. The intervention is designed to support weight management, healthy lifestyle behaviors, mental well-being, quality of life, and family engagement in adolescents and young adults with obesity and chronic conditions

Primary Outcomes

• Feasibility of the ACDP-O Intervention (Baseline to Day 90)
• Acceptability of the ACDP-O Intervention (Day 90)
• Change in Mental Well-being (DASS-21) (Baseline and Day 90)
• Change in Family Well-being (Baseline and Day 90)
• Change in Quality of Life (Distress) (Baseline and Day 90)
• Change Quality of Life (KIDSCREEN-10) (Baseline and Day 90)

About This Study

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Design

Interventions / Regimen

• Device: Spinal Cord Stimulation — Implantation of a Spinal Cord Stimulation system

Primary Outcomes

• ACT score (3 months)

About This Study

Alcohol use disorders (AUDs) and depressive disorders frequently coexist, complicating the clinical management of patients suffering from them. Taken separately, these two disorders have a significant prevalence in the population, and a recent meta-analysis concluded that coexistence could reach 1 in 5 patients (20.8%). This comorbidity represents a considerable challenge, particularly in cases of treatment-resistant depression (TRD), where patients do not respond to conventional pharmacological interventions. Since alcohol can act as a powerful trigger for depressive symptoms, and conversely, a depressive state increases the risk of alcohol abuse, the question of intervention sequence is also of clinical interest: should priority be given to treating TRD, AUD or both simultaneously? This question raises a major issue for healthcare professionals, as current conventional therapeutic approaches present limitations in the concomitant management of these complex disorders. Thus, in certain clinical settings, ketamine has emerged as a promising intervention to treat both TRD and AUD. In fact, ketamine has been shown to produce rapid but only transient antidepressant effects, and is part of the possible treatment arsenal for TRD. The potential of ketamine in the treatment of AUD has also been explored in recent studies, with a few small randomized controlled trials. In these trials, the combination of ketamine with psychotherapy, versus placebo, was investigated as a means of alleviating AUD. Ketamine was shown to increase abstinence rates, time to relapse and decrease the number of heavy drinking days. Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioural therapy that emphasizes psychological flexibility and acceptance of difficult emotions and thoughts without judgment, a type of psychotherapy particularly relevant to AUD. Thus, adding ACT to ketamine treatment could increase the duration of ketamine's effect on depressive symptoms, while reducing AUD. In view of this accumulated evidence of the potential benefit of ketamine and ACT, adding acceptance and commitment therapy to ketamine appears to be a promising option for improving outcomes in patients diagnosed with TRD comorbid with AUD. This study will not only verify the feasibility of this type of intervention in this particular patient population, but also the preliminary effects on their alcohol consumption and depressive symptoms.

Design

Interventions / Regimen

• Behavioral: Acceptance and Commitment Therapy — The ACT intervention consists of eight weekly 50 minute sessions, delivered in person when possible, with virtual options available. ACT targets psychological flexibility by addressing fusion, evaluation, avoidance, and reason giving through six core processes: acceptance, values, committed action, present moment awareness, cognitive defusion, and self as context. Sessions combine didactic content and experiential exercises following a standardized manual, with therapists trained in ACT. Participants receive a workbook to support practice. Each session begins with a brief mindfulness exercise that evolves across weeks, starting with grounding and simple emotional labeling, then progressing to neutral sensory descriptions and openness to challenging sensations.
• Drug: Ketamine — The protocol includes 6 IV ketamine infusions over 4 weeks at the CHUM Neuromodulation Unit, following the Montreal Model integrating psychotherapeutic and contextual elements (e.g. preparation, music, and integration). Infusions occur twice weekly in weeks 3 and 4 of the treatment protocol, then once weekly in weeks 5 and 6. The first dose is 0.5 mg/kg in 250 mL saline over 40 minutes, with possible titration up to 1.0 mg/kg based on tolerability, clinical response, and participant preferences. Blood alcohol level is measured by breathalyzer before each session, and if any detectable alcohol is present (i.e., BAC ≠ 0%), the infusion will be postponed and rescheduled. Infusions occur in a quiet, dim room with continuous monitoring. Before each infusion, a brief mindfulness exercise promotes openness to internal experience. During the infusion, participants listen to a curated 60 minute instrumental playlist to support emotional exploration.

Primary Outcomes

• Study completion AND Adherence to ketamine infusions and ACT psychotherapy sessions (From enrollment to the end of the follow-up at 12 weeks (phase 1, weeks 0 to 12) and from week 1 to week 8)

About This Study

Background: Loss of the sense of smell can seriously affect a person's quality of life. The ability to smell can be damaged by many factors, including illnesses, injuries, and exposure to toxic chemicals. The effects can vary, including complete loss of smell, partial loss, and parosomia, which is when things smell differently than they should. Objective: To study how brain function changes in people with different types of smell disorders. Also, to look at how smell loss affects quality of life over time. Eligibility: People aged 18 years or older with a disorder that affects their sense of smell. Healthy volunteers are also needed. Design: Participants will have 5 study visits over 1 year. They will have various tests and procedures: Smell tests. They will have several tests that involve smelling different items and answering questions. Questionnaires. They will answer questions about their health, mood, sense of smell, and daily habits. Magnetic resonance imaging (MRI) scans. They will lie on a bed that slides into a tube. Padding will hold their head still. They will smell different odors while in the scanner. Electrobulbogram (EBG). They will wear a soft cap with sensors that measure brain activity. They will smell different odors while wearing the cap. Nasal endoscopy. A flexible tube will be inserted into a nostril to view the inside of the nose. Biopsy. A numbing substance will be sprayed into the nose. Then a scissor-like tool will be used to collect a sample of tissue from one or both nasal passages. Samples of blood, urine, and nasal fluid will be taken.

Design

Primary Outcomes

• Functional Connectivity Differences in Olfactory Dysfunction (baseline, 3, 6, 9 and 12 months)