32 Clinical Trials for Various Conditions
When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
Older sexual and gender minority (SGM) patients are at risk for receiving inequitable end-of-life care; those with Alzheimer's disease and related dementias (ADRD) are at particularly high risk. Failure to collect and integrate sexual orientation and gender identity (SOGI) data to identify patients' informal support systems may have adverse health consequences for SGM older adults, particularly for those dependent on informal caregivers to provide in-home support and assist with activities of daily living. The goal of this K01 is develop a novel training for hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers.
Sexual and gender minority (SGM) individuals experience significant cancer-related health disparities across the cancer continuum. The overall goal of this proposal is to assess multi-level barriers associated with sexual orientation and gender identity (SOGI) data collection in the health record as well as implementation factors including feasibility, acceptability, and data completeness. The results of this study will make a significant impact by making SOGI data available for research, addressing barriers to SOGI data collection in a large comprehensive cancer center, and informing compassionate cancer care for SGM people.
Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood. Recent studies on mice found a specific microbe-produced molecule, 4-ethylphenyl sulfate (4EPS), can induce anxious behavior. 4EPS is produced by gut microbes in mice and humans. Research suggests higher 4EPS levels may strongly be associated with anxiety levels. However, anxiety is far more complicated than changes in a single molecule. There are many more factors to consider when it comes to anxiety, including various aspects of one's lifestyle and how humans perceive their environment (cognitive orientation). The primary research goal is to better understand the effects 4EPS has on human anxiety behavior and the role cognitive orientation has in connection to anxiety.
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation. The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O\&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O\&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O\&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
The human subject research is a randomized, controlled training trial that tests the effectiveness of three Virtual Reality-based Intelligent Orientation and Mobility Specialists (VR-IOMSs) in teaching orientation and mobility (O\&M) task skills to low vision patients. It will be conducted on two sites, University of Alabama at Birmingham (UAB) and Alabama Institute for Deaf and Blind (AIDB). The same protocol will be used on both sites. UAB will be the sIRB for the trial. Three O\&M tasks will be studied, timing to cross a signalized street using the near lane parallel traffic surge skill, timing to cross an uncontrolled street using the traffic gap judgment skill and learning outdoor numbering system. A VR-IOMS will be develop for each task. The training does not involve research subjects walking into street traffic. Low vision subjects who have difficulties with these O\&M tasks due to their impaired vision will be randomized into three groups, learning the task from a VR-IOMS (experimental group), from a human Certified Orientation \& Mobility Specialist (COMS) in real streets (active control group) and not learning the task but spending the same amount of time watching low vision education videos (placebo group). All subjects will be evaluated by COMSs in real streets around the two study sites before training (pre-training), within 3 days after the completion of training (post-training) and 3 months after the completion of training (follow up). Their ability to perform the O\&M tasks will be assess quantitatively using objective methods. COMSs who conduct these evaluations will be blinded for subject training assignment. The primary outcome measure is the training effect, the difference in task performance between the pre-training and post-training real street evaluations. The training effects of the 3 groups will be compared to determine the training effectiveness of the VR-IOMS relative to human COMS. Secondary outcome measures include the retainment of the training effect. Objective assessment of the VR-IOMS training process and trainee subjective evaluation of the VR-IOMS training will also be analyzed.
All patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Elkins Park will be offered participation into the study. Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. Risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. If the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of Steri-Strips based on the patient's computer-generated randomization assignment. The patient's chart will be reviewed to determine the patient's age and comorbid conditions including obesity (pre-operative BMI), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. This information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. Additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. Steri-Strips will not be removed and will be allowed to fall off naturally. At regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. These photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings.
This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. The researchers will use the new tests and treatments with adults who are affected by visually-induced dizziness. Testing is done twice before and once after treatment. The total time participants are involved in the study is approximately two weeks.
The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.
The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of narcotics. The secondary outcomes focus on safety which includes technical procedure duration time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure pain scores, administrations of analgesia until discharge. The final analysis will focus on determining whether there is a statistically significant difference in the amount and severity of pain in the Anterior versus Posterior myotomy subject populations. Additional analysis will be the collection of analgesic type (narcotic versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure in the endoscopy recovery suite until the subjects are discharged.
In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on the development of fiberoptic intubation skills? Is it necessary to teach both orientations or is the supine view transferable to the upright position? Which method demonstrates longer skill retention? The hypotheses: Both orientations must be practiced and the upright skill is harder to learn but is retained for longer.
The purpose of this study is to apply a recently developed screening test for dementia, the Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of 150 elders who do not have dementia and are residing in the community so that we can determine what is a "normal" MOST score. These subjects will also be individually administered a one-hour battery composed of other commonly used tests of memory and information processing. Group two is composed of 150 elders who are administered the MOST by a nurse as part of their regular visit to the primary care doctor's office, and their scores will be compared against a rating of their cognitive ability made independently by the doctor or another nurse. Their scores will also be compared with a list of their medical problems and medications. Our hypothesis for the first group is that the MOST scores will be higher in the normal group than in the previous clinical groups and that MOST scores will correlate significantly with other neurocognitive tests. Our hypothesis for the second group is that the MOST can be administered quickly and easily by briefly trained nurses, that it will compare highly with doctor opinions, and that patients with known medical conditions related to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in better health.
The purpose of this pilot study is to characterize changes in postural orientation and equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.
We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function.
The overall aims of the 5-year University of Maryland Prevention Research Center (UMD-PRC) Core Research Project are to identify, refine, implement, evaluate, translate, disseminate, and communicate approaches and tools that can be used to improve the competency of mental health care for LGBT persons which is a social determinant of LGBT health disparities. The UMD-PRC research team, in collaboration with the community advisory board (CAB), have identified 5 evidence based resources (Tools) to improve health care competency with sexual and gender minority populations (lesbian/gay, bisexual, and transgender \[LGBT\] people). The UMD-PRC will use the Sexual and Gender Diversity Learning Community (SGDLC) program (Strategy) and these tools along with technical assistance (TA) to improve LGBT mental health care. The following hypothesis will be tested. The study intervention group will show an increase in a) organization-level LGBT-friendly policies and environment as observed by the researchers and b) LGBT competent clinician practice assessed through clinician self-reported preparedness, awareness, and knowledge as well as referral for co-occurring client health needs; client-reported satisfaction with therapy and health literacy; and research team assessment of clinician performance providing consultation to a standardized LGBT patient actor.
The objective of this study is to establish reference values for non-invasive hydration status markers. Although there are no hypotheses associated with this study, the outcome will help advance the development of non-invasive hydration status monitors (described above and in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The outcome that this research effort supports what is recognized by the military community as a high priority medical technology gap (MOM ICD v1.3, 2008).
The National Eye Institute estimated about 3 million people over age 40 in the US had low vision in 2010 and projects an increase to nearly 5 million in 2030 and 9 million in 2050. Current assistive technologies are a patchwork of mostly low-technology aids with limited capabilities that are often difficult to use, and are not widely adopted. This shortfall in capabilities of assistive technology often stems from lack of a user-centered design approach and is a critical barrier to improve the everyday activities of life (EDAL) and the quality of life (QOL) for individuals with low vision. An intuitive head mounted display (HMD) system on enhancing orientation and mobility (O\&M) and crosswalk navigation, could improve independence, potentially decrease falls, and improve EDAL and QOL. The central hypothesis is that an electronic navigation system incorporating computer vision will enhance O\&M for individuals with low vision. The goal is to develop and validate a smartHMD by incorporating advanced computer vision algorithms and flexible user interfaces that can be precisely tailored to an individual's O\&M need. This project will address the specific question of mobility while the subject crosses a street at a signaled crosswalk. This is a dangerous and difficult task for visually impaired patients and a significant barrier to independent mobility.
Critical narrative interventions (CNIs) have not been examined for addressing psychological outcomes (e.g., depression, anxiety, self-esteem, empowerment, psychological well-being) within sexual and gender minority emerging adults (SGM EA) of color; therefore, this pilot study will examine the use of CNIs to impact SGM of color psychological outcomes. Prior literature has shown that CNIs have the potential to increase empowerment, self-efficacy, and social support as a prevention strategy for mental health. The research study is being conducted to see if telling your story through photographs or video can improve the mental health and well-being of emerging adults that identify as a member of a sexual and/or gender minority and a racial and/or ethnic minority. Participants will be asked to complete the following research procedures: 1. take a survey online (about 20-30 minutes), then an interview about everyday experiences as sexual/gender minority of color and your experiences in seeking out mental health services. 2. After the interview, participants will have one month to tell their story, answering two prompts "Tell us a time you have felt seen" and "Tell us a time when you have felt unseen." You will be randomized to one of two formats of telling your story: taking photographs or making two short videos. 1. Photographs: Those that are randomized to the photograph condition will be asked to take 12 photos total telling your story and answering the prompt. 2. Videos: Those that are randomized to the video condition will be asked to create two (1-3 minute) videos telling your story and answering the prompts. 3. At the one-month time frame, participants will be asked to fill out another survey (about 20-30 minutes) and then complete an interview about the photos or videos created.
Study Rationale: Older adults who identify as lesbian, gay, bisexual, transgender, or queer (LGBTQ+) have worse health than non-LGBTQ+ older adults. They and their care partners face greater barriers to getting healthcare and support from friends and family. This is because of lifelong stigma, discrimination, and isolation often separated from their families. Parkinson disease (PD) is a disease that usually appears in older age, so there may be many LGBTQ+ elders with PD, but there is currently no information on how people with PD who are LGBTQ+ are coping with their disease and aging. This study will begin to clarify their needs. Hypothesis/Research Question: What are the experiences and perspectives of LGBTQ+ people living with PD, their care partners, and physicians managing people with PD? Study Design: The investigators will interview 20 people with PD, half who identify as LGBTQ+ and half who are not. The investigators will also interview their care partners and physicians who treat people with PD. From the responses to the interview questions, investigators will create a survey that will be sent to people across the country. Impact on Diagnosis/Treatment of Parkinson's Disease: By understanding what LGBTQ+ people with PD need, and what ideas they have for improving their healthcare, better systems for meeting their needs can be built. Next Steps for Development: With this understanding, future work can focus on educating healthcare providers and clinics to improve the ways they talk with and treat LGBTQ+ people with PD.
The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).
The primary goal of this PCORI proposal is to evaluate the impact of enhanced provider and clinical staff training to address the health disparities of SGM CHC patients to ultimately improve their health outcomes because CHCs are a key part of the U.S. health care delivery system for underserved populations. The current application proposes to test an intervention designed to understand how CHCs, including front line staff and safety net clinical providers, can identify and provide optimal care for their SGM patients, and will determine whether enhanced training of CHC staff in best practices for the provision of primary care for SGM patients will improve their clinical outcomes. The time is right for routinization of SOGI measures in EHRs and evaluation of the optimal methods to train primary care providers in the best practices for the care of SGM patients.
This study will develop and test the efficacy of an online, family-based intervention (MySTYLE) tailored to the relevant sexual health needs of non-heterosexual adolescent males and their parents/caregivers compared waitlist control group. Adolescent males and their parents will be recruited from community organizations, medical clinics and schools in Jackson, MS. Interviews with youth, parents, and relevant community leaders will inform the development of the interventions. Youth and their parents/caregivers in both intervention arms will complete three assessments in the four months after enrolling. This study will provide a wealth of information about the degree to which this intervention may be disseminated for this highly vulnerable population of young people.
The proposed research will further develop the CHAMPS intervention which is self-management intervention to learn new skills, despite current health status of experience a stroke. The study seeks to determine feasibility and compare pre- to post-intervention change including cardiovascular risk, quality of life, self-efficacy, recurrent stroke, hospital readmission, and perceived decline in health and function.
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and neuro-restorative dietary supplement (Braini®) on standardized memory and cognitive performance parameters. The principal active ingredients in the Braini® supplement have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) in 2018, with no adverse events reported to the FDA. A 28-day randomized, double-blinded, placebo-controlled dietary supplement study will be conducted with a cohort of younger and a cohort of colder adults to achieve the purpose of this study. The research team hypothesizes that Braini® will improve standardized performance scores measured by CNS Vital Signs standard memory and cognitive performance assays more effectively than placebo.
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.