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NCT ID: NCT04759131 Completed - Hemophilia A Clinical Trials

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

XTEND-Kids
Start date: February 19, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the safety of BIVV001 in previously treated pediatric participants with hemophilia A. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001.

NCT ID: NCT04758962 Completed - Virus Diseases Clinical Trials

A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults

Start date: February 15, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immune response of a self-amplifying mRNA (SAM) lipid nanoparticle (LNP) platform with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike antigen (CoV-2 SAM [LNP] vaccine) in ascending doses when administered intramuscularly (IM) on a 0,1-month schedule to healthy adults 18 to 50 years of age. There will be no administration of escalated doses of the study vaccine.

NCT ID: NCT04758702 Completed - Clinical trials for Lack of Keratinized Gingiva

The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.

Start date: February 24, 2021
Phase: Phase 1
Study type: Interventional

A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.

NCT ID: NCT04758637 Completed - Opioid Abuse Clinical Trials

AESOPS Trial 2 (AESOPS-2): Availability of Opioid Harm

AESOPS-2
Start date: January 23, 2023
Phase: N/A
Study type: Interventional

The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.

NCT ID: NCT04758403 Completed - Lung; Node Clinical Trials

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Start date: March 5, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

NCT ID: NCT04758312 Completed - Chronic Disease Clinical Trials

A Mobile Intervention Merging Yoga and Self-Management Skills

MYSkillsMobile
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Chronic disease self-management interventions and meditative movement approaches (.e.g., yoga) can independently improve depressive symptoms. However, to our knowledge there are no interventions integrating evidence-based chronic disease management strategies with yoga to maximize physical, psychological or social outcomes, nor are mobile health platforms commonly used to improve the reach of these integrated interventions. Therefore, we developed Merging-Yoga for Self-Management Skills Mobile (MY-Skills Mobile). Our first aim is to adapt the MY-Skills Mobile to tailor the intervention to older adults with multiple chronic conditions (MCC) by convening a panel of patient and care-partner stakeholders. We will convene four patient and care-partner dyads (N=8) to serve as study partners for three longitudinal focus groups to suggest and review MY-Skills Mobile adaptations. We will then conduct a usability study of MY-Skills Mobile with older adults with MCC and their care-partners. We will conduct two waves of rapid-cycle prototyping with 5 dyads in each wave (N=20). Dyads will participate in MY-Skills Mobile modules. We will then use acceptability surveys and use data in each wave to iteratively adapt MY-Skills Mobile to optimize usability and acceptability.

NCT ID: NCT04758299 Completed - Decision Making Clinical Trials

Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits

Start date: March 13, 2021
Phase: N/A
Study type: Interventional

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

NCT ID: NCT04758247 Completed - Overactive Bladder Clinical Trials

Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

NCT ID: NCT04758234 Completed - Healthy Clinical Trials

A Study of LY3549492 in Healthy Participants

Start date: February 22, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in healthy participants. The blood tests will be performed to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study includes two parts and will last up to approximately 76 days for each participant, including screening.

NCT ID: NCT04757974 Completed - HIV Infections Clinical Trials

Low-dose Fostemsavir Extended Release Relative Bioavailability Study

Start date: March 5, 2021
Phase: Phase 1
Study type: Interventional

This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.