10,679 Clinical Trials for Various Conditions
When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3 I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.
The focus of this study is to determine whether adding Whole Health Coaching (WHC) improves pain care among adults with chronic pain and who are currently working with a pain management team (PMT) at the VA.
Purpose of the Study: This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal. Who Is in the Study: Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with. Main Questions the Study Wants to Answer: Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital? What Will Happen: Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
Cluster-randomized trial assessing the impact of interventions on guideline-concordant prescribing in Emergency Departments (ED). The study compares the effectiveness of feedback messages about potentially inappropriate medications (PIMs) delivered by peer clinician prescribers or anonymous systems, compared to standard of care. The goal is to reduce PIM prescribing for older adults discharged from emergency departments.
A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only.
Justice-involved individuals face disproportionately high rates of stimulant use disorder and HIV, along with disrupted access to HIV treatment and prevention services like ART and PrEP. Contingency management (CM) is the most effective intervention for stimulant use, but its use in justice-involved populations has been limited by logistical and structural barriers. DynamiCare is an FDA-approved mobile app that delivers behavioral CM and has shown promise in reducing stimulant use, but its impact on HIV-related outcomes remains unknown. The RESTORE study (Recovery and Engagement for Stimulant Users on Re-entry) will evaluate whether combining DynamiCare with patient navigation (DynamiCare-plus) improves PrEP/ART initiation and reduces stimulant use among individuals recently released from justice settings. The R61 phase will assess feasibility, acceptability, and preliminary effectiveness among 40 participants. If milestones are met, the R33 phase will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost. This scalable, mobile approach has the potential to address a critical gap in care for a highly vulnerable population.
The goal of this single-site, single-arm pilot study is to examine the impact of breathwork training for posttraumatic stress symptoms in an adult veteran population. Participants will complete a single, in-person breathwork session (2 hours) led by a certified breathwork facilitator and engage in an integration session (30 minute) with a licensed psychologist. Participants will be invited to engage in two, optional, virtual follow up breathwork sessions (40 minute practice each) during weeks 2 and 3 following the in-person breathwork session.
This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-AT compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
The purpose of this study is to understand whether psilocybin therapy is safe and well tolerated in improving chronic pain and increasing motivation to quit smoking for people who have chronic pain and smoke cigarettes. Psilocybin is a psychedelic drug and the active ingredient in "magic mushrooms." Psilocybin is currently being studied in clinical trials but has no current medical use in the United States. Some studies have shown that a dose of psilocybin can help people quit smoking. Other studies have shown that a dose of psilocybin may improve certain chronic pain conditions, such as migraine headaches. We believe that it may also be helpful for people who smoke and have chronic pain, but this has not been tested yet.
Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.
The goal of this clinical trial is to learn if a tailored amino acid supplement works to help adults living with Parkinson's disease to improve nutrition, metabolic function, body composition, and physical and mental function. The main questions it aims to answer are: Does the tailored amino acid supplement increase essential amino acids (nutritional status)? Does the tailored amino acid supplement increase an antioxidant (complex amino acid) and decrease an amino acid associated with oxidative stress? Does the tailored amino acid supplement improve physical and mental health compared to a placebo supplement? Researchers will compare the tailored amino acid supplement to a placebo (a look-alike substance that contains no active ingredients) to see if the tailored amino acid supplements work to support health for people with Parkinson's disease. Participants will: Take the tailored amino acid supplement or a placebo every day for 6 months, visit the lab at baseline, after 3 months, and after 6 months for fasting blood draws, body composition assessment, and physical and mental health testing and keep a diary of their food intake and supplement intake.
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
This is a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.
The purpose of this study is to examine the acute effects of exercise on cognitive flexibility and symptom reactivity. The main questions it aims to answer are: Does moderate intensity physical activity reduce subjective distress, compulsive urges, and intrusions- and increase cognitive flexibility- in adults with obsessive-compulsive disorder compared to low-intensity physical activity? Researchers will compare low- to moderate-intensity exercise to see if moderate physical activity increases cognitive flexibility and reduces symptom reactivity in adults with obsessive-compulsive disorder (OCD). Participants will: Complete self-report surveys, psychiatric interviews, and cognitive tasks. Be assigned to either a low- or moderate-intensity exercise condition and complete physical activity. Repeat cognitive and symptom measures following the exercise intervention.
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in SF3B1 wild type, lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
This is a cross-sectional, clinical research study comparing postmenopausal women of African Descent (AD) with different hemoglobin genotypes: normal and sickle cell trait (SCT). This research study has two purposes. The first purpose is to determine whether having SCT is a risk factor for the development of bone thinning in older women. The second purpose is to investigate whether women with SCT have reduced muscle function and increased frailty compared to women without SCT. The investigators estimate enrolling 50 female volunteers who are at least 50 years old and have not had a menstrual period for at least 12 consecutive months. Volunteers need not know whether they have SCT as this will be evaluated as part of the study.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.
The purpose of this study is to investigate the effects of consuming grape powder on immune profiles in healthy middle- and older-aged individuals. Specifically, the investigators are interested in evaluating the potential effects of grapes in influencing markers of immune function, inflammation, and metabolism that are known to change with aging. Grapes contain several nutrients and antioxidant polyphenols such as resveratrol, quercetin, vitamin K and fiber, which are known to promote heart and immune health. However, the effects of grapes on altering immune profiles within the context of aging is not well understood. Therefore, this study will explore how daily grape consumption impacts certain markers of immunity in healthy middle- and older-aged adults. The main study procedures include consumption of a freeze-dried grape powder and control powder (which tastes the same but has none of the grape compounds that are being studied) mixed with water as a beverage on a daily basis for 4 weeks each. The investigators will additionally ask that participants avoid eating grapes and certain other antioxidant/grape-related foods and beverages throughout the 13-week study. Participants will additionally be asked to complete surveys about their diet, physical activity, and medical history, as well as provide blood samples and body weight measures throughout the course of the study. Participation in the study is expected to last about 6.25 hours over the course of 13 weeks and will include 7 visits.
The primary objective of this study is to determine the effect of a 6-month pilot randomized controlled trial of medically tailored grocery delivery plus nutrition counseling vs. medically tailored grocery delivery alone vs. standard of care (with delayed grocery delivery alone) among 100 individuals with any stage and type cancer who reside in Maine on change in diet quality from baseline to 6-months. The secondary objective is to assess the benefits of the intervention on change from baseline to 6-months on self-reported healthcare utilization (e.g., hospitalizations, emergency room visits), malnutrition, cancer-treatment related symptoms, food insecurity, quality of life, and financial toxicity. We will also evaluate feasibility and acceptability of the intervention in the target population.
This is a survey-based study using an online panel. The goal of the study is to understand whether information about overdiagnosis influences breast cancer screening intention among older women. Participants are first asked a series of questions about breast cancer screening including their intention to continue screening, knowledge of screening, and beliefs about screening. They are then shown one of three videos about breast cancer screening that contain information about overdiagnosis or a fourth control video that is identical but contains no information about overdiagnosis. Participants are then again asked about screening intention, along with knowledge of screening, overdiagnosis, and questions around trust.
This study aims to improve a short motivational conversation to better help young adults who were injured in assaults and also use alcohol or cannabis. Researchers will gather both interview and survey data from young adults who came to the emergency department after an assault and currently use alcohol or cannabis. Guided by a theory about risky behaviors, the study will focus on how confident young people feel about making changes to their alcohol and cannabis use, and how their friends and family influence their alcohol and cannabis use and involvement in injuries from assault. The team will follow a step-by-step process used by the NIH to adapt and test the improved motivational conversation in the emergency department.
The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
The purpose of this research study is to test a mindfulness app called Calm Health among young adults with type 1 diabetes or other absolute insulin deficiency diabetes. Mindfulness is the practice of being aware of your thoughts and feelings in the moment without judgment or negative reaction. All participants will receive mindfulness guidance and personalized feedback about the relationship among your mindfulness, blood sugar, stress, and sleep.
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE).
This research is being done to determine if producing sperm after an ultrashort period of abstinence (1 hour of abstinence) will be effective in improving the rates of embryos with normal chromosomes (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that a shorter period of abstinence is effective at improving rates of normal chromosomes among embryos.
Parallel-arm randomized controlled trial with a wait list control arm. Participants will be randomized 1:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.