Background: Each year, the number of cases of tick-borne diseases increases. The deer tick (Ixodes scapularis) is the vector of at least 7 pathogens that cause human diseases, including Lyme disease. Researchers want to learn more to help them develop vaccines against ticks in the future. Objective: To learn how people s bodies, particularly the skin, respond to tick bites. Eligibility: Healthy adults aged 18 years and older who have no known history of a tick-borne disease or tick bite exposure. Design: Participants will be screened with a medical history, physical exam, and blood tests. Participants will have 2 skin punch biopsies of healthy skin. For this, a sharp instrument will be used to remove a round plug of skin about the size of a pencil eraser. Participants will then have 10 clean laboratory-bred ticks placed at 2 different sites on their skin (20 ticks total). The ticks will be removed from the first site 1 day after placement and from the second site 2-4 days after placement. Participants will complete symptom diary cards. They will answer questions about itching at the tick feeding sites. They will give blood samples. Photos will be taken of the tick feeding sites. Skin punch biopsies will be collected at the sites of the tick bites. Participants will repeat the tick feeding procedures 2 times, each 2-8 weeks apart. For the 2nd and 3rd procedures, 10 clean laboratory-bred ticks will be placed at 1 site. The ticks will be removed 2-3 days after tick placement. They will have telephone follow-up visits after each procedure. After the final tick removal, participants will have follow-up visits in 4-6 weeks and again in 3 months. They will give blood samples and discuss how they are feeling. Participation will last about 5-7 months.

Type: Interventional

Start Date: Feb 2022

open study

The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).

Type: Interventional

Start Date: Jan 2026

open study

Smoking is the leading preventable cause of death in the United States, and quitting is especially difficult for couples who both smoke. When both partners smoke, they are less likely to quit successfully and more likely to relapse compared to people whose partner does not smoke. Research suggests that the way romantic partners interact and support each other during a quit attempt can make a real difference - but researchers do not yet know enough about what kinds of support actually help. This study examines a concept called "communal coping," which refers to when partners treat a shared health challenge - like quitting smoking - as something they are facing together as a team rather than as separate individuals. Researchers believe that couples who approach quitting this way may have better outcomes. To study this, researchers will ask both members of dual-smoking couples to complete brief daily surveys over two weeks while making a quit attempt. These surveys will track how partners support (or discourage) each other's quitting efforts on a day-to-day basis, along with cigarette use, cravings, and stress. This will help researchers understand which relationship patterns are most helpful for quitting, and identify specific targets for future couples-based smoking cessation programs.

Type: Observational

Start Date: Mar 2025

open study

This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment. It will enroll 192 women within 12 months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.

Type: Interventional

Start Date: Nov 2025

open study

This clinical trial aims to evaluate the nature and duration of effects of three FDA-approved medications (propranolol and hydrocortisone) on military-relevant cognitive, emotional, and motor performance following an exposure to a stressful situation (i.e., exposure to a tarantula) in physically healthy adult volunteers (aged 18 - 40) with fear of spiders to help the future development of medications for treating Acute Stress Reactions. The main questions this study aims to answer are: Will placebo treatment (oral placebo) result in significant decrements in Psychomotor Vigilance Task (PVT) performance compared to propranolol treatment? Will placebo treatment [intramuscular (IM) placebo] result in significant decrements in PVT performance compared to hydrocortisone treatment? Participants will receive one of five study medications (oral propranolol, oral placebo, IM hydrocortisone, or IM placebo) after a brief exposure to a tarantula. Participants will complete cognitive and simple motor tasks and psychological assessments before and after the study medication administration.

Type: Interventional

Start Date: May 2025

open study

The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo. The hypotheses for this study include: - Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. - Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.

Type: Interventional

Start Date: Aug 2024

open study

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. Participants will: - undergo tests of breathing, cough, and swallow function - complete questionnaires about the treatment, their swallow function - complete breathing exercises daily

Type: Interventional

Start Date: May 2024

open study

Duchenne muscular dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD-CM, now the leading cause of death in patients with DMD. Despite risk factors for hyperglycemia, including the use of glucocorticoids (GCs), sarcopenia, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. The goal of this remote study is to evaluate rates of hyperglycemia in individuals with DMD compared to control participants using continuous glucose monitors, and to determine the relationship between hyperglycemia and heart rate variability. Participants will utilize continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep.

Type: Observational

Start Date: Mar 2024

open study

This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) in vulnerable and underserved youth aged 11-14.

Type: Interventional

Start Date: Oct 2025

open study

The goal of this clinical trial is to test the feasibility & acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD). The aims are as follows: K99 Aim: Test feasibility & acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews. R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months. R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning & analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.

Type: Interventional

Start Date: Jul 2023

open study

Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.

Type: Interventional

Start Date: Apr 2021

open study

The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.

Type: Interventional

Start Date: Feb 2016

open study

The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.

Type: Interventional

Start Date: Mar 2026

open study

The goal of this observational study is to learn more about how genes impact the risk of kidney disease. Anyone 18 or older living in the US is eligible, and a diagnosis of kidney disease is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.

Type: Observational

Start Date: Apr 2026

open study

This study is being done to test the effects of doxycycline on inflammation and the bacteria in the body in people with HIV and in people on HIV pre-exposure prophylaxis. This drug is approved by the Food and Drug Administration (FDA) for the treatment of bacterial infections. The study team will investigate whether the drug has additional effects on inflammation or on the bacteria that live in the body.

Type: Interventional

Start Date: Oct 2025

open study

The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are: - Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms? - Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control? - Is the intervention acceptable, appropriate, and feasible as delivered in a community setting? Participants will: - Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation. - Complete surveys online - Have their blood pressure measured with a non-invasive blood pressure cuff - Attend 1 focus group (optional)

Type: Interventional

Start Date: Sep 2025

open study

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines [≥150 min/week of MVPA]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

Type: Interventional

Start Date: Jan 2025

open study

This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.

Type: Interventional

Start Date: Oct 2024

open study

The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).

Type: Interventional

Start Date: Mar 2025

open study

The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil.

Type: Interventional

Start Date: Apr 2025

open study

Advance care planning is important for all adults, but perhaps even more so for the 5.7 million persons with Alzheimer's disease or related dementia (ADRD), due to the progressive and protracted cognitive deterioration associated with the disease process. In the context of ADRD, medical decision-making at the end of life is typically left to one's care partner, who often does not have the knowledge or confidence in their ability to make such decisions. This study will refine and evaluate a web-based platform, called the LEAD Intervention (Life-Planning in Early Alzheimer's and other Dementias), which is designed to help persons in the preclinical or early stage of ADRD engage in conversations about, document, and share their end-of-life values and preferences with a care partner, extended family members, and health care providers.

Type: Interventional

Start Date: Aug 2024

open study

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Type: Interventional

Start Date: Jun 2024

open study

In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.

Type: Interventional

Start Date: Apr 2024

open study

More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial. The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses. The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).

Type: Interventional

Start Date: Feb 2023

open study

While many have strongly suggested that transcranial direct current stimulation (tDCS) may represent a beneficial intervention for patients with primary progressive aphasia (PPA), this promising technology has not yet been applied widely in clinical settings. This treatment gap is underscored by the absence of any neurally-focused standard-of-care treatments to mitigate the devastating impact of aphasia on patients' family, work, and social lives. Given that tDCS is inexpensive, easy to use (it is potentially amenable to home use by patients and caregivers), minimally invasive, and safe there is great promise to advance this intervention toward clinical use. The principal reason that tDCS has not found wide clinical application yet is that its efficacy has not been tested in large, multi-center, clinical trials. In this study, scientists in the three sites that have conducted tDCS clinical trials in North America-Johns Hopkins University and the University of Pennsylvania in the US, and the University of Toronto in Canada, will collaborate to conduct a multi-site, Phase II clinical trial of tDCS a population in dire need of better treatments.

Type: Interventional

Start Date: Feb 2024

open study