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NCT ID: NCT05652439 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)

TRIBE
Start date: December 2, 2022
Phase:
Study type: Observational

The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized Metered Dose Inhaler (pMDI). Data from clinical practice from different European data sources will be collected. The baseline hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.

NCT ID: NCT05652335 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Start date: November 22, 2022
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

NCT ID: NCT05652205 Recruiting - Clinical trials for Functional Constipation (FC)

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05651711 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

ROCKET-Horizon
Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The co-primary objectives of the study are to: - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

NCT ID: NCT05651126 Recruiting - Clinical trials for Autism Spectrum Disorder

Psilocybin in Adults With and Without Autism Spectrum Disorder

PSILAUT
Start date: December 12, 2022
Phase: N/A
Study type: Interventional

This study will test the hypothesis that brain systems are differentially regulated by serotonin in individuals with and without Autism Spectrum Disorder.

NCT ID: NCT05651113 Recruiting - Clinical trials for Severe Combined Immunodeficiency

The Experience of Screening for SCID

Start date: November 9, 2022
Phase:
Study type: Observational

This project will evaluate the impact of including Severe Combined Immunodeficiency into the newborn bloodspot screening panel. It will recruit parents and health professionals primarily from the sites where this new form of screening is being trialled well as additional sites where clinicians will be involved in the care of these babies and comparator groups are needed. The proposed work will consist of two work packages. The first, a mixed-methods study conducted with families from the point of screening information being returned through to the child's fifth birthday. The second, a qualitative interview study conducted with health professionals during the clinical evaluation phase of the national pilot programme.

NCT ID: NCT05650762 Not yet recruiting - Wound Clinical Trials

Controlling Malodour In Fungating Wounds Using A Cinnamon-Based Dressing: Observational Study

Start date: February 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to observe the contribution of the cinnamon dressing to the reduction of the discomfort associated with the odour felt by the patient and carers. This prospective study aims to collect data on patients living with a malodorous fungating wound. Quality of life tools will be used to assess the impact of the cinnamon dressing on managing malodorous fungating wounds.

NCT ID: NCT05650632 Recruiting - Multiple Myeloma Clinical Trials

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

NCT ID: NCT05650567 Recruiting - Dermatomyositis Clinical Trials

Study of M5049 in DM and PM Participants (NEPTUNIA)

Start date: January 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

NCT ID: NCT05650229 Active, not recruiting - Clinical trials for Primary Mitochondrial Disease

Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

FALCON
Start date: December 13, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.