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NCT ID: NCT06150183 Recruiting - Clinical trials for Advanced Malignant Solid Tumor

Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors

Start date: November 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone and when it is used together with another antibody cancer drug (pembrolizumab) in patients with different types of cancer. Patients will receive either BNT314 alone or BNT314 combined with pembrolizumab. Phase 1 of the study consists of a dose escalation part, and a safety run-in (SRI) and expansion part: Dose escalation: In this part of the study, patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose (MTD) which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose (MAD) will be investigated. At the end of this part, the Recommended Phase 2 Dose (RP2D) which is the dose to be tested in Phase 2 will be decided. Safety Run-In: In this part of the study, BNT314 will be combined with pembrolizumab. Before starting the expansion part, the combination will be tested in another small group of participants (12-28) to find out how safe this combination is. Expansion: In this part of the study, BNT314 will be combined with pembrolizumab. After the SRI is completed, the study will continue with the expansion part where up to 199 participants with different types of cancer will be included. The Phase 2 part of the study will be introduced via an amendment to the study protocol.

NCT ID: NCT06150157 Recruiting - Neoplasms Clinical Trials

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Start date: December 20, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968, in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s), in part 2 (Cohort Expansion).

NCT ID: NCT06149494 Recruiting - Copd Clinical Trials

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

NCT ID: NCT06149403 Recruiting - Clinical trials for MPS-IH (Hurler Syndrome)

A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT

HURCULES
Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).

NCT ID: NCT06149286 Recruiting - Clinical trials for Marginal Zone Lymphoma (MZL)

A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma

OLYMPIA-5
Start date: December 28, 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 patients who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (the current standard-of-care treatment for FL and/or MZL). 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 in combination with lenalidomide - 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: NCT06147830 Recruiting - Major Bleeding Clinical Trials

A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment

REVERXaL
Start date: December 4, 2023
Phase:
Study type: Observational

REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

NCT ID: NCT06147323 Recruiting - Pre-diabetes Clinical Trials

Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients

PreVegDiet
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

The research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. The rationale of this project is to study the influence of beneficial diets on the immune system of pre-diabetic patients and its potential to counteract infections. A clinical, an in vitro (cell systems) and an in vivo (animal model) approach will be used to study the influence of a seaweed bioactive supplement and a diet rich in components from a Mediterranean diet on a Salmonella typhimurium infection in prediabetic subjects. At the end of this project, we will provide evidence on the potential of these nutritional interventions to counteract infection, which are of high relevance to the society to reduce the burden of type 2 diabetes (T2DM) and obesity. This research is part of an ongoing research project funded by the Research State Agency (Spain), Health Research Board (HRB, Ireland) and the Medical Research Council (MRC-UKRI, UK) via the NUTRIMMUNE' Grant of the Joint Programming Initiative a Healthy Diet for a Healthy Life (JPI-HDHL).

NCT ID: NCT06146647 Recruiting - Body Image Clinical Trials

The Evaluation of Two Positive Body Image Micro-interventions for Children Aged 4-6 Years

Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The goal of this 4-arm randomized controlled trial is to test the effectiveness of two positive body image media micro interventions (a tv show and a music video) in improving body image related constructs. The main questions this study aims to answer are: 1. Relative to time-matched active controls, are the two positive body image media micro-interventions effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes? 2. Are the two positive body image media micro-interventions acceptable to children and their participating parent/guardian? An additional five secondary exploratory research questions are described below [in the description section]. Participants will be recruited into the trial by a research agency via their parents/guardians. Once recruited, they will be randomised into one of 4 conditions: - 15-minute TV intervention - 15-minute active TV control - 3-minute music video intervention - 3-minute active music video control Children (and their parent or guardian) will visit a testing centre in groups of approximately 12 dyads. Children will complete T1 assessment interviews one-on-one with a researcher, before watching their assigned media with their parent. After watching their assigned media, children will complete their T2 assessment, again one-to-one with a researcher, while parents complete a survey regarding their acceptability of the media they watched. Parents/guardians will be given a link to rewatch their assigned media and encouraged to rewatch with their child before returning to the testing centre approximately one week later. When children and parents/guardians return one week later, the child will complete T3 assessment interviews one-to-one with a researcher, and parents will complete a short survey regarding their rewatch habits. Researchers will compare the two positive body image media micro-interventions with their time-matched active controls to examine if they are effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes.

NCT ID: NCT06146530 Recruiting - Treatment Adherence Clinical Trials

Cerina-A Pilot Randomized Controlled Trial

Cerina
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot Randomized Controlled Trial is twofold: 1) To learn about the feasibility and usefulness of a mobile application for generalised anxiety symptoms (Cerina); 2) To test the preliminary effects of Cerina in reducing generalized anxiety symptoms compared to a waitlist-control group among Ulster University students presenting mild to moderate symptoms of Generalized Anxiety Disorder (GAD) symptoms. The main research questions are: Is the Cerina app usable and feasible among Ulster University students reporting mild to moderate GAD symptoms? Is there an indication of the effectiveness of the Cerina app in reducing GAD symptoms compared to a wait-list control group among Ulster University students? - After the baseline assessment, eligible and consenting participants will be randomized to either intervention or to the wait-list control group. - Those who are allocated to the intervention group will have access to the Cerina app for 6 weeks. - Those who are in the wait-list control group will wait for 6 weeks until the intervention group finishes the intervention for their access. - The wait-list control group will have access to the services offered by the Ulster University Student Wellbeing team. - Participants in both groups will do mid- (at week 3 after their randomization) and post-assessment (At week 6 after their randomization). - All participants will also be invited to the post-assessment feedback interviews once they complete their post-assessments. The purpose is to have more in-depth information on their views of the Cerina app, the User Interface, the clinical content, the potential facilitators, and barriers to using it in daily life.

NCT ID: NCT06145971 Recruiting - Insomnia Clinical Trials

Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED

CBTi 4 DS:SCED
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties. The main questions this study aims to answer are: 1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures? 2. Does bCBTi reduce the frequency of dissociative seizures? 3. Does bCBTi reduce self-reported levels of dissociation in participants? 4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels? 5. Is bCBTi a feasible intervention to administer in an inpatient setting? This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting. Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.