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About This Study

People with severe mental illness have a substantially increased risk of undiagnosed and insufficiently treated somatic disease. Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) is a service-level intervention implemented in psychiatric outpatient clinics in the Capital Region of Denmark to improve the detection and follow-up of somatic disease among patients with psychotic and affective disorders. This study evaluates whether integrating structured somatic screening into mental health services leads to improved identification and management of somatic disease compared with care as usual. Using a quasi-experimental controlled design with a matched cohort, outcomes among patients exposed to the SomaScreen intervention are compared with those of patients receiving usual care in comparable psychiatric outpatient clinics outside the Capital Region.

Design

Interventions / Regimen

• Diagnostic Test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) — SomaScreen is a structured somatic health screening program for adults in psychiatric outpatient care (F-ACT and OPUS clinics). Trained somatic nurses and general practitioner consultants systematically assess patients for cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, and may detect other somatic conditions. Patients with identified conditions are referred to their own general practitioner for follow-up and management. The intervention is distinguished from usual care by its systematic, multi-condition screening and structured referral process.

Primary Outcomes

• Previously Undiagnosed Somatic Illness (2 years from start of intervention)
• Management of Somatic Conditions (2 years from start of intervention)

About This Study

The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.

Design

Interventions / Regimen

• Drug: GB-0895 — Study Drug
• Drug: Placebo — Placebo

Primary Outcomes

• To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma. (From Day 1 (randomization) to Week 52)

About This Study

This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma. The main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.

Design

Interventions / Regimen

• Drug: KT-621 — Oral drug
• Other: Placebo — Oral placebo matched to KT-621

Primary Outcomes

• Change from baseline in pre-bronchodilator FEV1 (From baseline to Week 12)

About This Study

The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

Design

Interventions / Regimen

• Behavioral: CHAMPION — The CHAMPION program is an intensive health behavior and lifestyle treatment (IHBLT), formed through the integration of the Healthy Weight Clinic IHBLT and with MGB's pediatric Asthma Population Health Management Program. It consists of 30 hours of contact time with the CHAMPION team (physician, dietician, community health worker), consistent with the USPSTF and AAP recommendations, monthly individual clinic visits with the team (in person or virtual, per randomization), health coaching calls with a community health worker and/or registered dietician, monthly group sessions (in the first six months), and educational materials for families that reinforce healthy lifestyle behaviors and provide self-management education. In this study, all participants will participate in CHAMPION, but one arm will receive the experimental form (delivery via telehealth) and the other arm will receive the active comparator (delivery via telehealth).

Primary Outcomes

• Change in Child Body Mass Index (BMI) (0-12 months)
• Change in Child BMI z-score (0-12 months)
• Change in Asthma Control Test (0-12 months)
• Change in Asthma and Obesity Specific Quality of Life (0-12 months)

About This Study

This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD). The aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials. Participants will attend a study visit at the clinical trials unit, where they will receive a guided tour of the facilities and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available. The information collected will help establish a clinical baseline and improve understanding of how respiratory diseases affect people in everyday life. The study will also explore how symptoms and quality of life relate to clinical measurements and other health information. Participants will be contacted after their visit to discuss any clinically relevant findings and to answer any questions they may have. If a previously unrecognised condition is identified, participants will be advised appropriately and, with their consent, their GP may be informed to support any further care that may be needed. The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.

Design

Primary Outcomes

• Number of patients indicating willingness to be re-contacted for future clinical trials (Until the end of the study (up to 5 weeks)])
• Participation feedback questionnaire results using Participant Feedback and Clinical Research Experience Questionnaire (Until the end of the study (up to 5 weeks)])

About This Study

Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia. To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available. Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.

Design

Interventions / Regimen

• Behavioral: ED Clinical Decision Support (CDS-ED) — The ED-CDS intervention is designed as a discrete decision support aid to influence initial antibiotic decision-making in the ED. This intervention will feature a clinician-facing LRTI dashboard for end-users that assimilates relevant clinical data (e.g., vital signs, select diagnostic tests, links to reference information) and offers tailored suggestions for antibiotic initiation, related diagnostic testing, and in those receiving antibiotics, preferred options and alternatives for antibiotic choice, route, dose, and duration.
• Behavioral: Transitions Clinical Decision Support (CDS-Tr) — The CDS-Tr intervention is designed as a longitudinal decision support aid to influence initial and ongoing (i.e., continuation, discontinuation, escalation, or de-escalation) antibiotic decision-making in the hospital setting. This intervention will also feature the LRTI dashboard along with additional tailored suggestions and recommendations for antibiotic decision-making upon hospital admission, and for those receiving antibiotics, at the time of discharge. Additionally, CDS-Tr will be active at the time of any service transition (i.e., hospital to intensive care or vice versa) and at pre-specified time points (e.g., approximately 48 hours and 120 hours following ED triage for encounters remaining in the hospital).

Primary Outcomes

• Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index (10 days)
• Primary Safety: Proportion of Participants Experiencing Escalation in Treatment (10 days)

About This Study

This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called "remission") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage. This study explores whether treating high-risk patients earlier could prevent asthma attacks and lung function decline, potentially achieving remission before permanent damage occurs. The study is looking for adults aged 18-79 with moderate asthma who have had at least one asthma attack requiring steroid pills in the past 2 years, use medium or high-dose inhaled steroids regularly, have high levels of inflammation markers in their blood and breath tests, but don't yet meet criteria for severe asthma requiring biologic therapy. Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications. They attend clinic visits every 3 months for breathing tests, questionnaires, and safety monitoring. Neither participants nor doctors know who receives the real medication until the study ends. The goal is to learn whether early treatment with dupilumab helps more people achieve complete asthma control compared to standard care alone, potentially changing how asthma is treated from "waiting until severe" to "preventing severe disease." The study runs in Canada, the United Kingdom, and Australia, involving 150 participants

Design

Interventions / Regimen

• Drug: Dupilumab Prefilled Syringe — Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks
• Drug: Placebo Injection — Volume-matched placebo injected subcut every 2 weeks

Primary Outcomes

• Win ratio based on remission criteria (Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline))

About This Study

The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.

Design

Interventions / Regimen

• Procedure: Repetitive transcranial magnetic stimulation (rTMS) — The theta burst stimulation (TBS) technique consists in administering bursts of transcranial magnetic stimulation (TMS) at very high frequency (50Hz) for 5 minutes (3 pulses of stimulation given at 50 hz; 10 bursts/1 s train; inter-train interval : 8 s; number of trains : 30; 100% resting motor threshold; number pulses/session : 900). Total number of sessions : 20 sessions (single daily session).

Primary Outcomes

• 17-item Hamilton Depression Scale (HAMD) (Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions))

About This Study

This study will explore the effects of esketamine (Spravato®), an FDA-approved nasal spray, on adults diagnosed with treatment-resistant depression (TRD). All participants will receive esketamine as prescribed by a healthcare professional in a clinical setting. The purpose of this research is to understand whether adding therapeutic support in the form of preparation and integration sessions - before and after the esketamine doses - can enhance the treatment experience and lead to longer-lasting improvements in mood and functioning. Participants will be randomly assigned to one of two groups: Esketamine with therapeutic support sessions (integration group) Esketamine without additional support (standard care group) Both groups will receive standard monitoring and psychiatric evaluation during the study. The support sessions offered in the integration group are designed to help participants prepare for their treatment sessions and make sense of their experiences afterward, using a structured, evidence-based approach. The study will last approximately 8 weeks per participant, with follow-up assessments. The goal is to learn whether integration therapy can improve treatment outcomes, safety, and satisfaction for individuals with depression that hasn't responded to other treatments.

Design

Interventions / Regimen

• Drug: Esketamine hydrochloride (intranasal) — Intranasal esketamine (Spravato®), administered under medical supervision in accordance with FDA guidelines for treatment-resistant depression. Dosing schedule includes twice-weekly administration during weeks 1-4 (acute phase), followed by weekly or biweekly administration during weeks 5-8 (maintenance phase), based on clinical response and tolerability. All dosing occurs in a clinical setting with standard monitoring for at least two hours post-administration.
• Behavioral: Integration Therapy — Brief, structured psychotherapeutic sessions delivered before and after each esketamine dose, based on psychedelic-assisted therapy principles. Sessions are designed to support emotional safety, preparation for the treatment experience, and integration of psychological content that may arise. Conducted by trained clinicians following a standardized framework developed for this study. Only participants in the experimental arm receive this intervention.

Primary Outcomes

• Change From Baseline in Depression Severity as Assessed by MADRS (Baseline and end of acute treatment at 8 weeks)

About This Study

The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.

Design

Interventions / Regimen

• Drug: Esketamine — Esketamine will be administered as intranasal solution.
• Drug: Midazolam — Midazolam will be administered as oral solution.
• Other: Oral Placebo — Placebo will be administered as oral solution.
• Other: Intranasal Placebo — Intranasal placebo will be administered as nasal solution.

Primary Outcomes

• Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2))

About This Study

The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs and those with depression who are prescribed and taking SNRIs.

Design

Primary Outcomes

• Skin blood flow (Monitored continuously during the passive heating experimental trial, about 2 hours.)
• Local Sweat Rate (Monitored continuously during the passive heating experimental trial, about 2 hours.)
• Core Temperature (Monitored continuously during the passive heating experimental trial, about 2 hours.)

About This Study

The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone. We aim to find out whether participants who receive both treatments: 1. Have greater reductions in depression symptoms than those who receive ketamine only 2. Have better response and remission rates than those who receive ketamine only 3. Experience better overall functioning, including mood, anxiety, quality of life, and physical activity than those who receive ketamine only Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone. * All participants will undergo IV ketamine infusions administered twice weekly for three weeks. * Half of the participants in will also undergo BA therapy sessions twice weekly for three weeks. * Individuals with a sufficient treatment response after 3 weeks will proceed to undergo an additional 12 weeks of ketamine infusions (and those receiving BA therapy will continue to receive therapy for an additional 12 weeks).

Design

Interventions / Regimen

• Drug: Ketamine (0.5 mg/kg) — IV ketamine will be administered under medical supervision at a fixed dose of 0.5 mg/kg infused over 40 minutes. Treatments will be administered twice weekly for three weeks during the Induction Phase (6 treatments). Participants' response to ketamine will be assessed after the Induction Phase. Those who do not meet response criteria (\<50% reduction in MADRS score) will be deemed Nonresponders and will conclude receiving ketamine at that time. Those who meet the response criteria (≥50% reduction in MADRS score) will be deemed Responders and will proceed to the Maintenance Phase. During the Maintenance Phase, ketamine treatments will be administered once weekly for 8 weeks (8 treatments), followed by once biweekly for four weeks during the Discharge Preparation Phase (2 treatments). Responders will receive a total of 16 ketamine infusions over 15 weeks.
• Behavioral: Behavioural Activation Therapy — BA therapy is a structured, primarily talk therapy that focuses on helping people with depression increase engagement in positive, meaningful activities and reduce avoidance behaviors that reinforce low mood. The BA therapy protocol will be based on the approach described by Martell et al. (2022). Therapy sessions will be delivered virtually or in person according to participant preference. Participants in Arm 1 will receive a total of 16 BA sessions at a frequency of twice weekly for 3 weeks during the Induction Phase (6 sessions), once weekly for 8 weeks during the Maintenance Phase (8 sessions), and once biweekly for 4 weeks during the Discharge Preparation Phase (2 sessions). BA therapy sessions can occur on the same day as ketamine infusions, but not during or after the infusion.

Primary Outcomes

• Change in MADRS from Baseline (Week 0 to end of Week 3 and end of Week 15)