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NCT ID: NCT06151366 Not yet recruiting - Clinical trials for Non-cystic Fibrosis Bronchiectasis

Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis

Bronch-EX
Start date: March 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the use of equipment to monitor health at home in participants who have non-cystic fibrosis bronchiectasis. The main question[s] it aims to answer are: - How acceptable participants find using home monitoring equipment. - To find out if the data collected from home monitoring can help to detect chest infections (exacerbations) before participants get symptoms they are aware of. Participants will be provided with - - a handheld spirometer to record FEV1 (lung function) - a Fitbit, or other compatible activity monitor, to record activity and heart rate - a saturation monitor that fits painlessly on the end of the finger to record oxygen levels - weighing scales to record weight - a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary. Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week. Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor,) which is free to download, via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day. Participants will be asked to record in the app - - episodes of pulmonary exacerbation that require antibiotic treatment - their coughing and wellness scores daily

NCT ID: NCT06151353 Enrolling by invitation - Bone Densitometry Clinical Trials

Performance of REMS Bone Densitometry in a British Population

Start date: November 21, 2023
Phase:
Study type: Observational [Patient Registry]

Radiofrequency echographic multispectrometry (REMS) is a recently developed technology that uses ultrasound to assess bone density and bone quality. It was launched in 2018 since when OsteoscanUK Ltd has offered a clinical bone health service using a REMS scanner. REMS is an alternative to x-ray based dual energy x-ray absorptiometry (DEXA) scans which are considered the "Gold Standard" for clinical densitometry. REMS is unique in offering not only bone density but also bone quality assessments in real time for both the spine and hip.

NCT ID: NCT06151015 Not yet recruiting - Healthy Clinical Trials

The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.

CRNitrateMRI
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This pilot study will compare the effect of combining dietary nitrate and caloric restriction versus dietary nitrate alone. The participant will be contacted, having responded to an advertisement on social media and posters, to attend the screening visit. They will be asked about their health status, suitability for MRI and availability. The investigators will use physical activity and eating attitude questionnaires. The investigators will also measure their height, weight, body mass index (BMI), and blood pressure (BP) and undertake blood tests. If they are eligible, they will be randomised to one of the two arms. The first group will consume nitrate-rich beetroot juice with a calorie-restricted diet for 28 days. The second group will drink the same juice with a weight-maintenance diet for the same period. The food and drinks will be provided. The outcome measures will be measured twice (at the baseline and end visits) to evaluate the change. The primary outcome is the cognitive function. The secondary outcomes are peripheral vascular health (BP and microvascular perfusion), cerebral vascular health (brain blood flow), anthropometry, body composition, and exhaled NO and nitrate concentrations. Also, the feasibility and accessibility of the study will be assessed.

NCT ID: NCT06151002 Recruiting - Parkinson Disease Clinical Trials

PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

PD Frontline
Start date: February 15, 2020
Phase:
Study type: Observational [Patient Registry]

PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.

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.