373 Clinical Trials for Various Conditions
This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Cardiac arrhythmia in the upper chamber of the heart (atrial fibrillation) can be cured by burning. Physicians burn very small pieces of abnormal tissue. It is important to know where to burn. The investigators propose a new way to find out where to burn. The investigators will use a new way to analyze electrical signals inside the heart and build a new electric map. The study may lead to the development of new technology. In the future, novel technology may increase the success rate and the number of cured atrial fibrillation patients. This study is a retrospective study of data collected during routine clinical care: atrial fibrillation ablations. The investigators will compare intracardiac electrograms and atrial activation maps in patients who had successful ablation outcomes (no recurrence within 1 year) and those who experienced a recurrence of arrhythmia within 1 year after the procedure.
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.
Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner. During this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.
The purpose of this study is to demonstrate the feasibility of augmenting existing/traditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.
Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.
Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case. Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method. The main questions it aims to answer are: * Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side? * What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups. Participants will: * Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively * Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation. * Complete postop questionnaires (PROMs) at the prescribed follow-up intervals
The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are: * Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities? * Can the investigator successfully collect information from participants throughout the study? * How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves? Researchers will compare ALIGN to care as it is usually delivered. Participants will: * Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician. * Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA (Comunidad, Alimentacion, Seguridad y Amen). Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (the CASA) in collaboration with Hispanic churches and their congregants. SA2. To conduct the CASA intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention. SA3. To assess the impact of the CASA intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child). The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors. Participants will: 1. Participate in cooking workshops and one to one learning activities 2. Report on diet and physical activity 3. Will measure fruit and vegetable intake
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older. It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator. The main objectives are: * Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position) * Comparison between the two groups concerning the incidence of device or dental related AEs. * Overall dentist and participant satisfaction with the treatment. Participants will: * Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned) * Attend approximately 5 study during approximately 8-10 months
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
Optical coherence tomography (OCT) is a 3D imaging technology that has seen wide adoption within ophthalmology. However, optical access to the retinal periphery remains a challenge for conventional OCT systems. The study team plans to innovate peripheral retinal OCT imaging technology by first developing the first robotic OCT system capable of autonomously assisting the operator during imaging of the human peripheral retina using 3D active tracking and compensation and then by developing of the first OCT system designed for treatment of the retinal periphery.
This randomized clinical trial aims to assess the effectiveness of optimized attachments, IPR and a combination of the two techniques on the rotational accuracy of canines with clear aligners
This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens. Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b
The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners. The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP. The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.
The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System (DSS) in Patient Aligned Care Teams (PACT) teams and its ability to increase sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like-1 peptide (GLP-1) use in Veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
The purpose of this study is to compare patient priorities care (PPC) and usual care (UC) patients to identify differences in post-encounter medication changes, treatment burden (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care (OPACIC), to understand PPC participant's sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities and to identify and categorize adverse drug withdrawal events (ADWEs)
Postural alignment is often intervened upon in health, fitness, and physical medicine settings. Despite a long tradition in this area, current notions of optimal or normal posture are superficial and often logically inconsistent. A recent attempt to reconcile diverging opinions about good posture proposes that alignment be considered in relation to individual joints' natural tendencies to collapse under gravity. This theory allows different maladaptive postures to be described in terms of functional deficits and compensatory adaptations at the muscular level. Working within this type of theory, postural interventions may be able to account for comparative advantages in maintaining alignment between different muscle systems. This would represent a step forward from current practices, which usually attempt to force arbitrary alignment patterns indiscriminately. The current study presents motion capture and electromyography (EMG) data evaluating the effects of two interventions on individual participants' bipedal standing alignment patterns with respect to the gravitational collapsing tendencies referenced above. Additional outcomes included functional grouping of muscle activation signals (via intermuscular coherence) and kinetic chain continuity. The interventions include 1) an experimental intervention purported to engage muscles that naturally resist the collapsing effects of gravity, and 2) a control intervention designed to inhibit other muscle groups that are sometimes involved in maintaining bipedal alignment in a compensatory role. Study outcomes are measured before and after both interventions to quantify the acute effects of each. All participants complete both interventions in random order, crossing over after a one-week washout period. This research will provide insight into the acute effects of studied interventions, specifically those relating to maintenance of bipedal alignment with respect to gravitational collapsing tendencies.
The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system
The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
The goal of this 2-arm cluster randomized clinical trial is to test whether an evidence-based staff training and coaching model specifically designed as a response to legal system-involved youths' and frontline staff's mental health needs can improve the safety and suicide outcomes, mental health challenges, and wellness and facility climate for youth and staff in facilities assigned to the intervention condition. Staff in facilities assigned to the intervention are eligible to receive evidence-based programming in suicide detection and prevention (Shield of Care; SOC) and wellness skill-building (Skills for Life) through training and personalized coaching. Multiple training sessions will be offered to small groups of staff in-person in residential facilities and paired with personalized in-person and virtual coaching. Staff and youth in all facilities will be asked to complete periodic surveys assessing experiences in the facility, suicide and safety knowledge and risk, and their mental health and wellness. Researchers will compare outcomes of staff in youth in facilities assigned to the intervention compared to facilities in the training-as-usual condition.