Clinical trials

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Polymyalgia Rheumatica (PMR) is treated with corticosteroids; however, long-term treatment is not feasible due to side effects. Withdrawal of corticosteroids causes a subset of patients to relapse, and there is no current way to understand what underlies this. Our research team has preliminary data from a small clinical study that indicates that different immune effector dynamics during the tapering of steroids correlate with relapse. This was achieved using the DNA methylation-specific immune cell profiling methods that Dr. Christensen has pioneered. What is proposed is a larger prospective study of 50 PMR patients to validate differences in CD4 and CD8 memory cells as a predictor of relapse. Finally, we also focus on the Glucocorticoid Methylation Index (GCMI), which is a collection of 28 CpG islands that are methylated in response to corticosteroids. This will allow our team to determine the predictive power of the GCMI for PMR.

Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. If this method is successful, researchers could develop a smartphone application to help healthcare providers better monitor patient's depression and intervene earlier if symptoms return.

The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.

The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.

The goal of this observational study is to determine whether implementing a culturally sensitive, tablet-based safety planning program called Plan \& Protect (P\&P) within rural emergency departments can improve home safety and reduce suicide risk in adolescents presenting with suicidality. The main questions it aims to answer are: * Will implementing P\&P increase caregiver-reported home safety (reduce access to firearms and unsafe medication storage) for adolescents 12-17 years old presenting to rural EDs with suicidal ideation, self-harm, or mental health crisis? * Will implementing P\&P decrease adolescent-reported perceived suicide risk and related outcomes (e.g., suicide events, and attendance at follow-up mental healthcare)? Researchers will compare outcomes for adolescents and caregivers receiving P\&P (implemented as the new standard of care at sites during the intervention periods) to those receiving usual care (prior to P\&P implementation at those hospitals) to see if P\&P increases home safety and decreases suicide risk and related healthcare utilization. Participants will, if clinically appropriate: * Complete the tablet-based P\&P modules during their ED visit * Complete self-report measures at baseline, \~30 days, and \~3 months post-discharge * A subset will also participate in semi-structured interviews

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD. All eligible consenting patients will undergo daily stoma management per standard of care. Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes. Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes. Follow-up: Study participants will be followed at 1 week and 2 weeks.

The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis; 1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength, 2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and 3. Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique. It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by either ligament reconstruction (I) or suture suspension (II), provides greater improvement in grip and pinch strength, and better hand function, than might be achieved following provision of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space will correlate positively, and MCPJ hyperextension will correlate negatively, with improved thumb function and lateral pinch strength. Primary Aims (within 3 procedure cohorts): 1. Compare pre-operative pinch and grip strength as well as patient-reported outcomes (PROs) for pain in patients before and after lidocaine injection of the trapeziometacarpal joint, prior to thumb basal joint arthroplasty; 2. Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6 months after thumb basal joint arthroplasty with pre-operative values before and after lidocaine injection; 3. Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph with postoperative improvement in pinch and grip strength, and PROs for pain and function; 4. Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position. Secondary Aims (between 3 procedure cohorts): 1. Compare change in pre- and post-operative pinch and grip strength and PROs for pain and function between patients having basal joint arthroplasty with and without specific metacarpal stabilization; 2. Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and 3. Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups. 4. Compare postoperative neuritis and complications between surgical groups.

The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy. It will also learn if a modification of the program for youth with epilepsy, ages 13 - 17, improves thinking and memory and quality of life and reduces stress for their parents. Researchers will enroll 260 young adults with epilepsy and 40 youth with epilepsy and their parent or guardian. Researchers will compare responses to questionnaires and surveys before and after participation in the HOBSCOTCH program to see if thinking, memory and quality of life have improved for young adults and youth with epilepsy and to see if parents have improved quality of life as well. Participants will: * Attend 9 weekly one-hour sessions of the HOBSCOTH program in their homes with a one-on-one coach using their computer or their phone; youth with epilepsy (ages 13 - 17) will attend alongside a parent or legal guardian. * Keep a short daily diary about their seizures and activity in the program using a smart phone app(lication) * Complete surveys and questionnaires before HOBSCOTCH and 3 months and 6 months later. There are no study visits to a medical center. HOBSCOTCH is a virtual or telehealth intervention.

The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are: • Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum? Participants will undergo: * Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection * Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy

Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. This randomized control study seeks to answer whether the addition of an implementation intention guide impacts behaviors when completing FIT screening. The primary objective includes determining if the implementation intention guide increases completion rate of screening FIT. The secondary objectives is whether this intervention decreases the lab sample rejection rate and reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.

The investigators have developed interactive, multimedia-intensive, computer-based treatment programs that include depression (Problem-Solving Therapy), stress management, and conflict management. Together the three modules are called PATH. The problem-solving module is based on an evidence-based psychotherapy called Problem-Solving Therapy in which depressed patients identify problems in their lives and work through a structured format for solving these problems. We have subjected the problem-solving module to Phase 1-3 feasibility, acceptability and efficacy trials which have been positive and without adverse events. The conflict program uses a cognitive-behavioral-therapy-based approach. The program includes a conflict briefing, an interactive conflict simulation, a conflict assessment tool, an interactive training exercise in interest-based negotiation, and a cognitive restructuring exercise. The stress program also uses a cognitive behavioral therapy (CBT) approach. In the program, the mentor introduces the "stress pyramid", which demonstrates how stress triggers can lead to different feelings, actions and thoughts, which are analogs to the CBT realms of dysfunctional emotions, maladaptive behaviors, and faulty cognitive processes. The stress management content is delivered over 6 sessions, with each session including exercises in the 3 domains of thoughts, feelings, and actions. The program includes briefings, cognitive restructuring exercises, interactive scenarios, and self-assessments. This program has been evaluated with law and business students and was shown effective in reducing stress levels. The purpose of the current study is to make the problem-solving, stress, and the conflict modules available through the internet for any adult 18 or older in order to assess their feasibility, acceptability and effectiveness under naturalistic conditions.

The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial. The main questions the researchers aim to answer are: * Do the steps for identifying eligible participants work? * Do the steps for administering CKD Topics work? * Do the steps to administer survey questions work?

The goal of this open pilot is to co-design and test a clinical agenda-setting intervention in the inpatient pediatric environment. We pilot a co-designed structured agenda-setting intervention (SAS) for multi-family meetings about children with medical complexity. Our open pilot will evaluate the feasibility and acceptability of using the SAS during routine multidisciplinary family meetings (MFM) at Dartmouth Hitchcock Medical Center. By doing an open pilot, researchers will learn if the agenda-setting instrument and implementation process are feasible and acceptable to patients, their care partner and their clinicians.

The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are: * Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model? * Does using a clinical decision support system improve patient and clinician satisfaction with care? Researchers will compare the enhanced collaborative care with traditional collaborative care. Patient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and/or patient in a visual dashboard inside the electronic health record.

Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.

The purpose of this study is to determine whether people with MCI (Mild Cognitive Impairment) and healthy comparison subjects differ with respect to their ability to hear soft sounds and how their brain understands and processes sound. The investigators are also evaluating, within those with MCI, whether the hearing tests are associated with neurocognitive functioning. The investigators are interested in learning whether changes in cognition in those with MCI can be detected using tests of how the brain processes sound. The investigators hypothesize that participants with MCI will score worse on both hearing tests and neurocognitive tests than participants without MCI. Participants are asked to complete multiple types of hearing tests, take a series of neurocognitive tests, and complete a few questionnaires.

This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.

The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform \<150 minutes of MVPA at the 6-week data collection burst. Participants who performed \<150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are: 1. What percentage of participants who are eligible for the intervention phase enroll in the intervention phase? 2. Will participants assigned to the "step-up" intervention pathway demonstrate equal or greater rates of study retention and intervention engagement relative to those assigned to the standard intervention arm? 3. What percentage of the sample is performing \>150 minutes accelerometer measured MVPA/week at the intervention mid-point (week 6-data collection burst) and end-of-study (week 12-data collection burst)? 4. Do at least 50% of participants assigned to the "step-up" intervention pathway achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up? All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in three meetings with the interventionist (an exercise specialist) meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 consecutive days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks. Some participants (those performing \<150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.

The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.

There is no study to date that has evaluated the impact or effect of a Mediterranean diet in children with CF. The goal of this study would be to help provide better guidance around questions the investigators, as CF care providers continue to receive from patients and families about how to best promote overall health in pediatric cystic fibrosis from a dietary perspective. Currently, the updated nutritional recommendations are variable and broad. Parents continue to search for more concrete guidance about how best to promote long-term health given the ever-increasing life expectancy of cystic fibrosis patients in this new area of advanced therapeutics. Given the changing landscape of the CF care in general, children are less likely to struggle with early life malnutrition, and it is becoming increasingly clear that high fat, high calorie diets are not beneficial nor are necessary for all children with CF.

The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.

The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are: 1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.

Depression is a significant problem in care partners of people living with dementia; despite the expansion of options for accessing evidence-based treatments, most care partners of people living with dementia are not screened for depression and do not receive treatment. The objective of this project is to identify a screening method for depression that is feasible and acceptable to care partners and to adapt an innovative pathway to online evidence-based treatment for depression (iPath\*D) as a means of increasing mental health literacy, screening rates and treatment access for care partners of people living with dementia. The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to evidence based treatment with the potential for reaching an unprecedented number of care partners who have unmet mental health needs.