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NCT ID: NCT05468736 Active, not recruiting - COVID-19 Clinical Trials

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

COVID-19
Start date: July 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses and a booster dose of NVX CoV2373 given 21 days apart in pediatric participants (3 age cohorts; 6 to < 12 years, 2 to < 6 years, and 6 to < 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to < 12 years of age).

NCT ID: NCT05467293 Active, not recruiting - Dry Eye Clinical Trials

Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)

Start date: June 27, 2022
Phase: Phase 2
Study type: Interventional

The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

NCT ID: NCT05467098 Active, not recruiting - Shoulder Pain Clinical Trials

Dry Needling and Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity

Start date: June 30, 2022
Phase: N/A
Study type: Interventional

Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. It has been suggested that the presence of myofascial trigger points (MTrPs) may contribute to the chronicity of shoulder symptoms. An MTrP is a hyperirritable taut band of tissue within a muscle that produces pain when stimulated MTrPs are common in patients with shoulder disorders and occur most often in the infraspinatus muscle of a painful shoulder MTrPs were associated with an acidic biochemical environment with elevated levels of inflammatory mediators, neuropeptides, and proinflammatory cytokines such as bradykinin and calcitonin g-related peptide. It was hypothesized that metabolic demands on muscle and capillary constrictions may contribute to the development of MTrPs. To date, only a few studies have examined the vascular environment of MTrPs and surrounding areas before and after dry needling. No studies have yet examined whether dry needling would change blood flow in patients with shoulder pathology. Therefore, the purpose of this pilot study is to examine the effect of dry needling on blood flow of the infraspinatus muscle using color Doppler imaging in individuals with and without shoulder pain.

NCT ID: NCT05466942 Active, not recruiting - Hypoxia Clinical Trials

RDS MultiSense® SpO2 Calibration

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.

NCT ID: NCT05466032 Active, not recruiting - Mind Body Awareness Clinical Trials

Evolution of the Mind-body Connection While Learning About Common Osteopathic Dysfunctions

Start date: September 29, 2022
Phase:
Study type: Observational

Anecdotally, as first-year medical students learn about common osteopathic dysfunctions, they seem to become more aware of possible dysfunctions in their own bodies. This study will explore whether this new awareness is because of a strengthened mind-body connection, leading to increased proprioceptive awareness, or whether these students are experiencing "medical student syndrome." Medical school syndrome is a common phenomenon, especially in the first years of medical school, defined as experiencing "vague bodily symptoms in terms of the latest disease they have learnt about." This study will be conducted in multiple phases throughout 2022- 2023, based around the first year Osteopathic Manual Manipulation (OMM) exam schedule. After study recruitment during orientation week, first year students will be given the baseline participant survey. This survey asks participants to report pain/discomfort in the thoracic, lumbar, or rib/chest areas, as well as what this sensation may be attributed to (ex: somatic dysfunction, muscle soreness, traumatic injury, etc.). After completing the surveys, participants will undergo an osteopathic evaluation to confirm their stated symptoms. Researchers will not be aware of the participants' survey answers for the duration of the data collection portion of the study to reduce unintentional bias during the osteopathic evaluations. After the first-year students complete each OMM module (thoracic spine, lumbar spine, ribs/chest), they will be given the same survey and osteopathic evaluation. Timing is of particular importance in this study-- conducting the survey and evaluation at a time when students are acutely aware of somatic dysfunctions specific to each region will allow us to link acquisition of this knowledge to the mind-body connection. If a participant reports new or increased pain/discomfort in the region just taught, it is likely to be linked to an increased awareness of the region. The osteopathic evaluation, in conjunction with the participant's attribution of the sensation, will determine if the student is experiencing increased proprioception, or a case of medical school syndrome.

NCT ID: NCT05465616 Active, not recruiting - Diabetes Clinical Trials

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

NCT ID: NCT05465018 Active, not recruiting - Healthy Humans Clinical Trials

Performance Assessment Study VitalSigns Camera

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers. The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.

NCT ID: NCT05463900 Active, not recruiting - Ulcerative Colitis Clinical Trials

Microbial and Human Determinants of the Onset of IBD Flares

Start date: August 1, 2022
Phase:
Study type: Observational

This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.

NCT ID: NCT05463705 Active, not recruiting - Diabetes Clinical Trials

Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications

Start date: May 4, 2023
Phase: N/A
Study type: Interventional

This study will test the impact of addressing diffusion of responsibility with and without additional reduction of prescribing burden on SGLT-2i and GLP-1RAs prescribing compared to usual care. Population: MGH primary care physicians caring for at least 2 eligible patients. Eligible patients are individuals age18 years or older with type 2 diabetes and HbA1c >7.5% and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies. Intervention: PCPs will be randomized to one of three arms: 1) intervention to address diffusion of responsibility, 2) Intervention to address diffusion of responsibility with additional simplification of prescribing, 3) usual care.

NCT ID: NCT05463029 Active, not recruiting - Clinical trials for Disorders of Consciousness

Resting State fMRI in Disorders of Consciousness

Start date: August 1, 2022
Phase:
Study type: Observational

Disorders of consciousness (DoC) remain a major clinical challenge in which high rates of misdiagnosis and difficult prognostication stem from limitations in the ability to access the disordered physiological processes mechanisms of coma in real world clinical settings. There is a great need to develop, validate, and translate to clinical use reliable diagnostics to detect brain recovery potential not evident on neurobehavioral assessment. While resting state fMRI (rs-fMRI) has demonstrated potential to improve the diagnostic evaluation of DoC by detecting features of consciousness that are occult at bedside evaluation, this technology has yet to achieve widespread clinical utility. The investigators propose that recent advancements in rs-fMRI capabilities can be combined with streamlined analysis and interpretation approaches to overcome persistent intensive care unit to perform rs-fMRI in patients with prolonged impaired consciousness due to several causes including TBI, cardiac arrest, stroke, seizures, and severe CNS infection. The investigators will determine the optimal methods of data acquisition, analysis and interpretation for predicting recovery of consciousness in these patients. Our expectations are that this approach will produce highly reliable functional connectomic characterization of individual DoC patients, thereby allowing for more accurate outcome prediction. The investigators will additionally investigate the utility of a novel, simplified radiological approach to rs-fMRI data interpretation in comparison to computationally intensive connectomic approaches. This exploratory/developmental project is expected to provide critical data needed to design and appropriately power future R01 studies validating the efficacy of fMRI-based network integrity in the clinical evaluation of DoC.