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NCT ID: NCT06121739 Recruiting - Child Mental Health Clinical Trials

Child and Adolescent Mental Health Literacy for Primary Schools Teachers. A Multicomponent Intervention

Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Child mental health (CMH) is crucial for lifelong well-being. Early prevention and intervention are vital for public health, yet Chile faces a high prevalence of CMH issues, particularly in children aged 4 to 11. Schools play a key role in addressing these problems, but there's a lack of coordination within the systems (Schools and Health Centers). This project aims to enhance children's mental health and the school community through a biopsychosocial approach, emphasizing social support. The intervention consists of two parts: 1. Developing an online CMH literacy program for primary school teachers in Public Educational Establishments (EEPs). It's designed through collaboration with stakeholders, focusing on the specific needs of participating schools. 2. Enhancing the coordination of the CMH network in Valparaíso, involving community, health, and education stakeholders in two neighborhoods. This will be done by using "ECO Barrio Solidario" program and aligning it with local health initiatives. The project spans two years and focuses on four EEPs in Valparaíso. In the first year, the literacy intervention is constructed in partnership with each school, including program objectives, methodology, and scope. An online platform with educational videos will be created. The "ECO-Barrio Network" will connect with local agencies involved in child MH. In the second year, the intervention will be implemented in four of the eight recruited schools, while the other four serve as a control group. Subsequently, the remaining four schools will receive the intervention. Evaluation will consider acceptability, feasibility, and effectiveness, assessing faculty CMH knowledge, timely research, and reduced wait times for healthcare and child protection services.

NCT ID: NCT06120491 Recruiting - Clinical trials for Metastatic Castration-Sensitive Prostate Cancer

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

EvoPAR-PR01
Start date: November 21, 2023
Phase: Phase 3
Study type: Interventional

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

NCT ID: NCT06118099 Recruiting - Hidradenitis Clinical Trials

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Start date: November 1, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment. Study details include: - The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period. - All participants who complete the 16-week DBT period will be offered entry into an optional LTE. - Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period. - The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.

NCT ID: NCT06113328 Recruiting - Clinical trials for Non-segmental Vitiligo

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The primary hypothesis is that at least 1 MK-6194 dose is superior to placebo with regards to percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.

NCT ID: NCT06102005 Recruiting - Asthma Clinical Trials

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

AIRCULES
Start date: October 16, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

NCT ID: NCT06101134 Recruiting - Melanoma Clinical Trials

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

NCT ID: NCT06099782 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

Start date: December 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab (MK-3475A) administered subcutaneously (SC) over pembrolizumab (MK-3475) administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.

NCT ID: NCT06097364 Recruiting - Clinical trials for Follicular Lymphoma (FL)

A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma

OLYMPIA-2
Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma in Part 2, as well as participants with lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"), in Part 1. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on your quality-of-life and ability to complete routine daily activities

NCT ID: NCT06097260 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

Start date: November 16, 2023
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

NCT ID: NCT06094296 Recruiting - NSCLC Clinical Trials

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).