Treatment Trials

132 Clinical Trials for Various Conditions

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COMPLETED
Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
Description

The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to: 1. assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective), 2. investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective), 3. report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).

RECRUITING
Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
Description

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

RECRUITING
Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic
Description

Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic.

Conditions
COMPLETED
Social Determinants of Health in Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
Description

Investigators report on the impact of the COVID-19 stay-at-home order concerning penetrating violence and its association within different socioeconomic regions within the county. The distribution and volume of violent offenses prior to the stay-at-home order was compared to during the stay-at-home order. This bears a crucial significance in our injury prevention and education efforts within our community.

ENROLLING_BY_INVITATION
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Description

Since the "National Partnership to Improve Dementia Care" debuted in 2012, almost all long-stay psychoactive prescribing has been graded by CMS, which has correlated to decreased use. However, some national data suggest that while these psychoactive medications are being used less, prescriptions of mood-stabilizing antiepileptic drugs (AEDs) have increased. Unlike all other psychoactive medications, AEDs prescribed in nursing homes are not mandatorily reported to CMS or graded in a quality-measure.

Conditions
COMPLETED
COVID-19 Pandemic Induced Stress and Symptoms
Description

The previous survey of oncology patients at University of California, San Francisco in 2020-2021 found an alarmingly high symptom burden and high levels of stress and loneliness among respondents. This is a follow-up study with the same sample of oncology patients and survivors who participated in the previous study

ACTIVE_NOT_RECRUITING
The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Description

Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures \[1\]. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

RECRUITING
Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?
Description

Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood pressure assessment by physical therapists is inadequate or lacking despite prior training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory function may become more critical as the manifestation of long COVID has become a concern. The purpose of this study is to determine whether physical therapists' attitudes and beliefs towards vital sign assessment have changed following the COVID-19 pandemic.

Conditions
COMPLETED
Improving College Students' Mental Help-Seeking Intention During the COVID-19 Pandemic
Description

This study aimed at testing the effectiveness of a longitudinal intervention in increasing college students' intention to seek mental help during the pandemic.

RECRUITING
A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic
Description

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

ENROLLING_BY_INVITATION
Health System Methods to Improve Nursing Retention Amidst Ongoing COVID-19 Pandemic: a Mixed Method Study
Description

This study is a mixed-method exploratory study with the aim to determine an objective compensation or mechanism of support from a healthcare system standpoint to aid in retention of nursing staff amidst the ongoing COVID-19 pandemic. It will include semi-structured qualitative interviews of current and prior nursing staff from the Trauma/Surgical floor, Progressive Care Unit, and ICU, in addition to Trauma/Surgical unit and system administrators; the second portion of the study will include a quantitative survey distributed via email to current nurses on the Trauma/Surgical floor, Progressive Care Unit, and ICU to assess ranked priority of additional mechanisms of support to improve intention of retention.

COMPLETED
Anxiety Level Assessment of Anesthesia Providers During COVID-19 Pandemic
Description

Healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. Depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care the patients receive. The Severe Acute Respiratory Syndrome Coronavirus 2 infection created a sudden and deep crisis involving every sector worldwide not only affecting sick patients and the healthcare system but also the economy, politics, food, and drugs and social interactions. Hospital workers have experienced the crisis first-hand and have witnessed constant death, a decrease in personal protective equipment supplies, exposure to contracting the virus, risk of contagion to others, and overburdened hospital capacity. The aim of this study is to evaluate how the coronavirus disease 2019 (COVID-19) pandemic has affected healthcare workers. Specifically, to evaluate levels of anxiety and identify factors contributing to anxiety on faculty, residents, and nurse anesthetists in our institution.

Conditions
ACTIVE_NOT_RECRUITING
Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic
Description

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

Conditions
ENROLLING_BY_INVITATION
Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2)
Description

This project capitalizes on a natural experiment imposed by the COVID-19 pandemic in conjunction with an extensive set of cognitive, emotional, biological, and neuroimaging variables already collected at multiple time points in older adults participating in a clinical trial of exercise and mindfulness. This project will elucidate the effects of stress on cognitive function and emotional health in later life, including biological measures of Alzheimer Disease risk, stress, and aging, with the ultimate goal of discovering how to mitigate these effects, among older adults who have made and maintained a lifestyle change.

ACTIVE_NOT_RECRUITING
Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During the COVID-19 Pandemic
Description

This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE.

ACTIVE_NOT_RECRUITING
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Description

This study tests the effectiveness of a community-based peer advocacy, mutual learning, and social support intervention (Refugee and Immigrant Well-being Project) to reduce several negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx and Black populations: psychological distress, financial problems, and daily stressors. In partnership with five community-based organizations that focus on mental health, legal, education, and youth issues with Latinx immigrants and African refugees, we will also be able to examine the effects of people's involvement with community-based organizations and local and state policy changes on their mental health, economic stability, stressors, and social support. This is important not only for Latinx and Black populations and the large number of immigrants and refugees in the United States and worldwide, but also because the intervention model and what we learn from this study have the potential to alleviate mental health disparities experienced by other marginalized populations who face unequal access to social and material resources, disproportionate exposure to trauma and stress, and worse consequences of the COVID-19 pandemic.

TERMINATED
Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
Description

The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.

Conditions
COMPLETED
Examine the Psychosocial Impacts of COVID-19 Pandemic.
Description

This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The data was obtained on standardised measures of wellbeing (WHO Well-Being Index), psychological distress (Kessler 10), post-traumatic stress (PTSD Checklist for DSM-5), post-traumatic growth (Posttraumatic Growth Inventory), and a novel pandemic-related stress (COVID Psychosocial Impacts Scale). Data was collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from participants (N=2574) aged 18 and above using a non-probability convenient sampling. The findings enabled us to examine the psychosocial impacts of COVID-19, validate the translations of the CPIS and standardized measures; and determine the trajectory of study variables with pandemic exposure.

COMPLETED
A Novel Cognitive Remediation Intervention Targeting Poor Decision-making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic
Description

Despite large-scale, nationwide efforts to better address suicidal behavior in Veterans at high risk, the development of interventions that target some of the key risk factors associated with suicide remains limited. This study aims to collect pilot data to test feasibility/acceptability of a novel adjunctive evidence-based cognitive remediation (CR) therapy with manualized "Bridging" sessions for transfer and practice of problem-solving strategies for real-world stressors, including those that trigger suicidal thoughts. This 10-week (20 session) Neuropsychological Educational Approach to Cognitive Remediation CR+Bridging telehealth intervention will be administered virtually via HIPPA-compliant services to 36 Veterans with major depressive disorder and a history of suicide attempt(s). Pre-, post-treatment, and follow-up assessments of neurocognitive, clinical, social, and real-world functioning also will be conducted. This study has potential for high public health impact and promise to help improve quality of life for Veterans at high risk for suicide.

COMPLETED
Global Impact of the COVID 19 Pandemic on Stroke Care, Cerebral Venous Thrombosis, and Subarachnoid Hemorrhage
Description

A 1-year analysis of global selected stroke metric data will be conducted comparing the results during the Covid-19 pandemic to the pre-pandemic period. In most countries, this will correspond to March 1, 2020 to February 28, 2021. In some countries, the pandemic period would be adjusted for onset of case surge (i.e. China pandemic start date would begin earlier, i.e. January 2020). The specific metrics that will be analyzed include: 1. ischemic stroke or transient ischemic attacks (TIA) hospitalizations 2. intracranial hemorrhage hospitalizations 3. cerebral venous thrombosis (CVT) hospitalizations (with or without thrombocytopenia) 4. CVT in-hospital mortality 4) aneurysmal subarachnoid hemorrhage hospitalizations 5) mechanical thrombectomy 6) intravenous thrombolysis 7) ruptured aneurysm endovascular coiling 8) ruptured aneurysm clipping. 9) aneurysmal subarachnoid hemorrhage admissions 10) SAH in-hospital mortality 11) SAH presentation by Hunt Hess Grade

Conditions
COMPLETED
Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic
Description

The overall goal of this overall goal is to pilot an adaptation of an established Social-Emotional Learning Program with novel wellness and COVID-19 safety components that are trauma-informed and culturally-specific in a resettled refugee community. In this pilot, "EMPOWER" (Emotions Program Outside the clinic and Wellness Education for Refugees), the study team will assess implementation outcomes (adoption, acceptability, and feasibility) of EMPOWER with refugee children and families during the COVID-19 pandemic through longitudinal evaluations and measurements of feasibility, acceptability, and attrition. The study team will also evaluate the impact of EMPOWER by assessing (a) children's social-emotional learning competence and (b) children's and family's COVID-19 knowledge.

COMPLETED
The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change
Description

Background: The indirect effects of the COVID-19 pandemic on mental health are of increasing concern. Perceived stress can lead to binge eating and weight gain. Researchers want to learn more about the relationship between eating behavior and the pandemic. Objective: To study how the stress of the COVID-19 pandemic is affecting eating behaviors and weight. Eligibility: English-speaking adults ages 18 and older who have access to a computer or smartphone connected to the internet. Design: This is an online study. Participants will answer surveys through the study website. Participants will complete a one-time survey. It will ask about their experiences throughout the COVID-19 pandemic, their socioeconomic standing, their mental and physical health, and their eating habits. They will have the option to repeat the survey once a month for the next 12 months. This will show changes in their thoughts and behaviors over time. They will provide their email address to get survey links. Participants will also have the option to complete a 2-minute survey on their smartphone. They will complete the survey daily for 7 days in a row. It will ask about their stress and eating behavior in real time, in their home environment. They will provide their phone number to get survey links via text message. If a participant has taken part in a previous NIH study on the Phoenix AZ campus, they will be asked to share their first and last name, date of birth, and email address. This information will be used to connect data from this study to their past data. Participation is typically 25 minutes but may last up to 1 year. \*\*\*To participate in this study go to the REDCap study link: https://redcap.link/nihcovidstudy.\*\*\*...

Conditions
COMPLETED
Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic
Description

Background: COVID-19 has caused a high rate of deaths. The steps taken to control its spread have caused social isolation, changes in lifestyle, economic turmoil, and increased work-related stress. As a result, there has been a rise in mental and physical health problems. These burdens are particularly severe for people with a history of mental illness. Researchers want to learn more about the relationship between stressors related to COVID-19 and self-rated measures of anxiety and other variables. Objective: To better understand the impact of this stressful time on people s lives and families. Also, to learn the strategies people have been using to deal with the COVID-19 pandemic. Eligibility: Adults ages 18 and older. Design: This is an online study. Participants will fill out surveys online. The surveys will ask about their mood, anxiety, medical history, substance use, and COVID-19 stressors. Participants will complete an online task. For the task, they will stare at the center of a computer screen. When they see certain images, they will indicate the location of that image as quickly as possible. It will take about 1.5 hours for participants to complete the surveys and tasks. They may be contacted again if additional data is needed. Some participants may have taken part in other NIH studies. If so, their new data may be linked to their previously collected data.

UNKNOWN
Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic
Description

This is a pilot study to determine how to identify and characterize effective approaches to assist Hispanic families who face food insecurity worsened by the Covid-19 pandemic. The investigators will enroll 50 children with food insecurity who are patients of the largest Federally Qualified Health Center in Austin, Texas. The investigators will follow them for 6 months, providing their caretakers with community resources, food literacy education and assisting them with web sites and applications that they can use to learn about and contact community assistance programs. The investigators will review food insecurity screening, qualitative interviews, dietary assessments, the child's anthropometrics, and standard of care laboratory results. The investigators will schedule follow up phone visits throughout the study to discuss with the families their needs and perceived assistance from the resources provided.

UNKNOWN
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Description

A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.

COMPLETED
Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic
Description

TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center (TELECAST-CSC) during the COVID-19 pandemic is a pre-post study evaluating guideline-based acute ischemic stroke care following the implementation of inpatient telestroke at a comprehensive stroke center during the COVID-19 global pandemic. TELECAST-CSC compares two cohorts: the "in-person phase" (December 1, 2019-March 15, 2020), when all inpatient stroke team care was delivered conventionally in-person and the "telestroke phase" (March 16, 2020-June 29, 2020) when all inpatient stroke team care was delivered exclusively via telestroke as part of our healthcare system's pandemic response. We studied the following primarily clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, mortality, and stroke recurrence and readmission rates.

Conditions
COMPLETED
Stories for Change: Digital Storytelling Intervention for Diabetes Self-Management in the COVID-19 Pandemic
Description

Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities. Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP) Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs. RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change. The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults during a pandemic.

Conditions
UNKNOWN
Parkinson's Disease and Experiences Throughout the COVID-19 Pandemic
Description

The purpose of this research study is to examine the relationship between personal characteristics and satisfaction with care in those diagnosed with Parkinson's disease during the COVID-19 pandemic. Participants will take 4 different surveys regarding their satisfaction with care throughout the duration of the COVID-19 pandemic. The surveys in total should not take more than 30 minutes to complete

COMPLETED
Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic
Description

The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.

COMPLETED
Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
Description

People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future.