Clinical trials

Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward. The purpose of this study is to better understand the biological changes in the airway tissue before and after these standard medical procedures. During the procedure, small samples of tissue that would already be collected as part of normal care will be analyzed in the laboratory. The results may help doctors learn more about airway healing and could guide better treatments in the future.

The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care. Studies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer. Patients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment. For patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A). For patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor. Information such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility. The ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B). Overall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.

Withdrawal management strategies are currently the most utilized and ubiquitous intervention for opioid use disorder in the US, yet existing measures of opioid withdrawal lack Food and Drug Administration (FDA) qualification. This project will develop and validate a clinical outcome assessment (COA) for opioid withdrawal,essential for standardizing withdrawal mitigation strategies and establishing best practices. In line with the FDA's drug development tool qualification guidelines, our methodological process will involve conducting focus groups with persons with lived experience of opioid withdrawal for concept elicitation, refining these concepts through cognitive interviews, and conducting construct and longitudinal validations of the new assessment in laboratory settings and across diverse treatment contexts.

The purpose of this study is to test photobiomodulation (PBM) with a non-invasive light device for reducing discomfort during dental treatments in children. We plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. The first study aims to test if PBM works for tooth and soft tissue by assessing response to cold testing and probing of gums. The second study aims to test if use of PBM on soft tissues before injection reduces discomfort. The third study aims to test if PBM can be used to do simple dental fillings in baby teeth without numbing injection.

The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.

This pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using Brillouin microscopy, a non-contact imaging technique. The study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in corneal biomechanics following intraocular pressure (IOP)-lowering treatment. The goal is to determine whether Brillouin-derived biomechanical measurements can serve as biomarkers for glaucoma risk and progression.

This research study is being done to find out if a drug called cemiplimab is safe in adult patients who have non-small cell lung cancer (NSCLC) that can be surgically removed (resectable Stage II, IIIA, or select IIIB NSCLC). The purpose of this study is also to look at how well the study drug works and whether certain patients can skip chemotherapy before their surgery. The goal is to see if they can safely avoid the harsh side effects of chemo and still have a successful outcome. The investigators are doing this study because the investigators want to find out if this treatment approach is better or worse than the usual approach for early-stage NSCLC that can be surgically removed. The usual approach for the participants type of cancer is treatment with a combination of platinum-doublet chemotherapy and an immune checkpoint inhibitor (ICI) such as cemiplimab (LIBTAYO®) given before the tumor is surgically removed. (Immune checkpoint is a normal part of the immune system used to prevent an immune response from becoming so strong that it inadvertently destroys healthy cells in the body). Cemiplimab is given via infusion and will be administered at the study center. Everyone on the study will get the active study drug, cemiplimab. No one will get placebo. Placebos look like the study drug but don't have medicine in them. Infusion of cemiplimab will be given for 2 cycles followed by an evaluation. An evaluation means that participants will have imaging studies ("scans") done to see if the tumor has changed. After the scans, participants may receive one final cycle of cemiplimab followed by resection (surgery to remove the tumor) or combination chemotherapy plus cemiplimab for 2 cycles followed by resection.

Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery. Surgical guides with integrated irrigation channels have been developed to deliver coolant more directly to the osteotomy site, but clinical evidence regarding their effectiveness remains limited. This study will evaluate whether an internal irrigation surgical guide system reduces heat generation during osteotomy compared with a conventional guided implant surgery approach. The study will also assess clinical outcomes associated with implant placement. The findings may help inform safer and more effective protocols for guided dental implant surgery.

This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).

This is a research study to test two different interventions to decrease apathy in assisted living residents with some memory issues. Apathy makes older adults not feel like doing much activity. This study is completely voluntary and will not affect the care you receive at your assisted living community. The two possible interventions are 1) participation in a volunteering opportunity within the assisted living community OR 2) participation in a guided current events group within the assisted living community. These activities would be in addition to any other regular activities you participate in within the assisted living community. Both activities would take place three days per week for approximately 30 minutes. You would be randomly assigned (like a coin flip) to which intervention you would do. You do not get to choose. You would participate in the activity for a total of 6 months. In addition to participating in the intervention (either volunteering or current events), you will be asked to answer some questions about your memory, level of activity, mood, confidence in your ability to do a volunteer job, and feelings of usefulness. You will answer these questions at baseline (before the activity begins, at 3 months after doing the intervention activity, and aging at 6 months after starting the interventions activity. You will also be asked to wear a MotionWatch for 5 days at each time point (baseline, 3months and 6 months). A motion watch measures your level of activity. It feels like wearing a regular watch. You will be in the study for 6 months total. Risks to participating in this study are minimal and include privacy (other people may find out you are in the study), confidentiality of the data collected if someone other than study staff accesses your records, fatigue with answering the questionnaires, and some mild discomfort with wearing the MotionWatch. This is also a minor risk that you could fall or otherwise harm yourself getting to or participating in your intervention activity. The benefit of participating in this study include possible enjoyment of participating in the intervention activity.

The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.

The purpose of this research study is to test a new process for diagnosing pancreatic cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

Although the primary knee motion occurs in flexion/extension, the frontal and transverse (off-axis) knee motions are smaller but crucial for maintaining joint stability and normal knee loading. Altered kinematics and neuromuscular control in off-axis knee motions have been reported in patients with knee osteoarthritis (OA), which are associated with excessive knee loading and the progression of knee OA. However, traditional rehabilitative treatments for people with knee OA and existing exercise equipment often focus on sagittal plane movement. Probably due to the technical limitations, there is a lack of convenient and effective equipment/method to train patients with knee OA in off-axis (frontal and transverse) planes. The purpose of this study is to use a robot-aided elliptical training device to measure knee neuromechanical properties and to improve neuromuscular control in off-axis knee motions, aiming for joint de-loading and pain reduction for individuals with knee OA.

The purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.

The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm. Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark. The secondary objectives are: 1. To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews. 2. To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments. 3. To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial. 4. To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.

This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement. Throughout the approximately 6-month study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material and barrier placement, and dental implant placement. Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug). Genotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Long-Term Care Medicine. There are, however, many challenges to translating the use of Clinical Practice Guidelines into clinical settings. To overcome these challenges we developed and previously tested a theoretically based approach and merged this approach with the Pain Management CPG, which is referred to as the PAIN-CLINICAL PRACTICE GUIDELINE-USING THE EVIDENCE INTEGRATION TRIANGLE (PAIN-CPG-EIT). The PAIN-CPG-EIT involves a research nurse facilitator working with an identified community champion(s) and stakeholder team for 12 months to provide the following four components: Component I: Establishing and meeting monthly with a Stakeholder Team; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain; Component IV: Ongoing evaluation of resident pain outcomes. Twelve communities will be included with 25 residents living with dementia and pain recruited from each community. Six communities will be randomized to treatment (PAIN-CPG-EIT) and six randomized to education only (EO) which involves providing the same education to staff as is done in Component II of PAIN-CPG-EIT. The primary aim of this study is to test the effectiveness of use of the PAIN-CPG-EIT to improve the assessment, diagnosis and management of pain and decrease pain intensity among nursing home residents living with dementia between baseline, 4 and 12 months and evaluate treatment fidelity. A secondary aim of the study is to consider differences in measurement, treatment and response to treatment between male and female and Black versus White residents living with dementia. Findings from this study will help build on the currently limited information about pain presentation and management among older adults living with dementia in nursing homes and improve health equity of aging populations experiencing pain.

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.