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NCT ID: NCT06290102 Recruiting - Asthma Clinical Trials

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

Start date: May 7, 2024
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are: - To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma - To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI) - To compare the PK profiles of ABS between the 2 different strengths of TEV-56248 The secondary objective is: • To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

NCT ID: NCT06290089 Recruiting - ETEC Diarrhea Clinical Trials

Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine. The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States.

NCT ID: NCT06290063 Recruiting - Depression Clinical Trials

Cannabidiol and Older Adult Cannabis Users

QUARTz
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

NCT ID: NCT06290050 Completed - Healthy Volunteers Clinical Trials

A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

Start date: March 29, 2024
Phase: Phase 1
Study type: Interventional

The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).

NCT ID: NCT06289699 Recruiting - Clinical trials for Postoperative Complications

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

Start date: February 26, 2024
Phase:
Study type: Observational

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

NCT ID: NCT06289686 Not yet recruiting - Surgery Clinical Trials

MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Start date: July 2024
Phase: Phase 4
Study type: Interventional

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

NCT ID: NCT06289673 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Start date: July 2024
Phase: Phase 4
Study type: Interventional

The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment. Primary Objectives - To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies. - To develop a central database of genomic and clinical findings. Secondary Objectives - To assess event free and overall survival data of patients enrolled on this study.

NCT ID: NCT06289582 Not yet recruiting - Parkinson Disease Clinical Trials

Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

Start date: June 2024
Phase: Early Phase 1
Study type: Interventional

The overall goal of this protocol is to investigate [18F]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in [18F]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives - To compare [18F]DPA-714 binding in prodromal and manifest PD and healthy volunteers. - To determine the longitudinal change in [18F]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives - To evaluate the correlation between baseline [18F]DPA-714 and PPMI clinical and biomarker outcomes. - To evaluate the correlation between the longitudinal change of [18F]DPA-714 and PPMI clinical and biomarker outcomes - To acquire safety data following injection of [18F]DPA-714

NCT ID: NCT06289413 Recruiting - Clinical trials for Autonomic Dysfunction

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Start date: March 2024
Phase:
Study type: Observational

Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS.

NCT ID: NCT06289192 Enrolling by invitation - Tobacco Dependence Clinical Trials

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Start date: April 30, 2024
Phase: Phase 4
Study type: Interventional

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT). The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.