318 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing. The main questions it aims to answer are: Does the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients? Does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)? Researchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles. Participants will: Take the assigned supplement daily for 3 months (ViTAL SCAN or placebo) Attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring Complete quality of life and health behavior questionnaires Undergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein) Record supplement intake This study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.
The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Post Acute Covid Syndrome (PACS). The main questions it aims to answer are: Can the current HOBSCOTCH program be adapted for people with PACS? Will people with PACS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program? Participants will be asked to: * attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PACS sessions with a one-on-one certified HOBSCOTCH-PACS coach * complete a brief clinical questionnaire about their diagnosis of PACS * complete seven questionnaires before and after the HOBSCOTCH-PACS sessions about their quality of life, memory and thinking processes (objective and subjective cognition), about their physical and mental health and about autonomic symptoms associated with their diagnosis of PACS * keep a short daily diary (using a smart phone app or on paper) about their PACS symptoms and use of the self-management strategies taught in the HOBSCOTCH-PACS program * complete two brief surveys to assess satisfaction with their experience after the entire HOBSCOTCH-PACS program
The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older. The main research questions this study aims to answer are: 1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS? 2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS? At the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well. This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS.
Post-Acute COVID-19 Syndrome (PACS), colloquially known as Long COVID, is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from Long COVID not only experience lingering physical symptoms following COVID-19 infection, but have increased mental health problems including sleep disorders, anxiety disorders, trauma and stress-related disorders as well as increased use of opioid and non-opioid pain medications, antidepressants, and sedatives to treat these conditions. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority, however available Long COVID treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. Long COVID Coping and Recovery (LCCR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to Long COVID symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to Long COVID Coping and Recovery (LCCR). Findings will be used to make a final adaptation of the treatment materials and to develop a research protocol for a large scale RCT of LCCR for Veterans with Long COVID. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with Long COVID. The results of the proposed study will provide data to 1) identify adaptations needed to optimize LCCR for Veterans with Long COVID; 2) identify possible benefits of LCCR; 3) inform development of a large scale RCT of LCCR for Veterans with Long COVID.
This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.
To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.
Use the Intermountain real-world MAb-treatment registry and control group to prospectively evaluate PACS symptoms at least 60 days after initial COVID-19 diagnosis.
This study aims to find out the efficacy of Xlear nasal spray as an adjunct medication against COVID-19. This encompasses reduction in the number of days to negativization via nasal swab PCR from the average 14 days and early improvement of symptoms.
This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".
This study is being conducted in two parts, A and B. Part A is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension (OLE) study for patients who complete Part A.
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. An anticipated total of 132 participants will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and laboratory outcomes of all the participants enrolled in the study will be evaluated at the end of the study to explore if there is any difference in the outcomes between 2 groups.
The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.
The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID. The main questions it aims to answer are: 1. Do probiotics reduce the number and severity of symptoms in those with Long COVID? 2. Do probiotics improve physical and mental health quality of life in those with Long COVID? 3. Do probiotics improve return to work and daily activities in those with Long COVID? Researchers will compare probiotics to a placebo (a look-alike substance that contains no probiotics) to see if probiotics works to treat Long COVID. Participants will take the study medication (placebo or probiotic) for 4 months. They will then cross-over (take the other medication) for an additional 4 months. Participants will complete a survey at baseline, 4 months, and 8 months.
Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) of Severe Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed at Columbia found that plasma levels of the short chain fatty acid (SCFA), butyric acid, remained lower in people with Neuropsychiatric PASC (NP-PASC) than in people with PASC after SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in the general population but have not been studied among people with PASC in the United States. The purpose of this pilot study is to characterize changes in plasma SCFA levels and gut microbiome after treatment with synbiotics and placebo in people with NP-PASC. The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will be Maltodextrin.
The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.
About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARSCoV-2 infection (referred here as PASC). While treatments offered at emerging outpatient COVID recovery clinics are being informed by previous similar diseases, the need is great for a better understanding of the unique needs of this growing population and for tested, efficacious rehabilitation programs to address them. We provide both here.The targeted six-week program will be comprised of a core set of therapies, including individually titrated stretching and flexibility, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation tailored to patients' needs.
Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability following COVID-19 negatively impact Veterans' community functioning and quality of life, contribute to significant human suffering, and are costly to VHA. Rehabilitation is a critical priority for Veterans with long COVID. One promising treatment to improve functioning in Veterans with post-COVID-19 cognitive symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. This randomized controlled trial aims to address important RR\&D priorities by examining feasibility, acceptability, and preliminary efficacy of a COVID-19-specific rehabilitation intervention, CCT for long COVID (CCT-C) compared to a robust control condition. The proposed study has the potential to improve cognitive function, functional independence, and quality of life for Veterans with late or delayed effects of secondary conditions related to COVID-19 infections.
The goal of this observational study is to determine the feasibility of conducting a large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat patients with post-COVID-19 symptoms. The main questions it aims to answer are: 1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with post-COVID-19 symptoms (based on how many patients agree to participate and how many complete the study)? 2. How much change in patients' post-COVID-19 symptom severity, quality of life, and ability to return to work can we expect to see following OMT? Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session. 1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of life, ability to return to work, and adverse events they experienced 3 days after every other OMT session. 2. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first. 3. Additionally, participants will complete a follow-up questionnaire 2 months after they stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the study, whichever comes first.
Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations
REVERSE-LC is a phase 3 trial of baricitinib versus placebo in adults with neurocognitive impairment (a form of Alzheimer's Disease and Related Dementias or ADRD) or cardiopulmonary symptoms due to Long COVID.
The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, \& disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm.
This research is being done to collect preliminary data on the potential of computerized "brain-training" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID.
This study is testing a new brief mindfulness practice for people suffering from long COVID-19 symptoms. People suffering from long COVID are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. The goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long COVID.
The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.
This is a multi-site study that will try to determine the effects of Immulina ™, a natural dietary supplement, on blood chemicals associated with inflammation that are often increased in patients with long COVID (also called PASC).
This is a double-blind, randomized, placebo-controlled single-center clinical trial to explore the safety and efficacy of a full cannabis flower formulation, rich in cannabinoids and terpenes formulation, Xltran Plus™ and Xltran™, both compared to placebo for the treatment of Long COVID patients with prolonged symptoms caused by COVID-19.
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (\~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID
The purpose of the study is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Long Haul COVID (LHC).