Milwaukee, WI Paid Clinical Trials

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Read Less

Salt sensitive hypertension is a significant health problem worldwide and a primary modifiable risk factor for renal, cardiovascular, and cerebrovascular diseases. Yet, the underlying mechanisms remain poorly understood. The proposed study determines how renal oxygenation and substrate metabolism differs between individuals with and without salt sensitivity, with the ultimate goal of identifying mechanisms, diagnostic criteria, and treatment strategies for salt sensitive hypertension. Read Less

Mutual goal setting and action planning in patients with long-term conditions in outpatient settings is associated with favorable effects on measures of physical health, psychological health, subjective health status, self-management self-efficacy levels, activation levels, and perceived empowerment. The purpose of this study is to examine the impact of an educational intervention delivered to the staff nurses of two surgical units on how to engage patients in mutual goal-setting in the acute care setting. Staff nurses from two 32-bed surgical units will be scheduled to attend an hour-long educational intervention. A total of 630 chart audits will be conducted one month prior and one and three months following the intervention per unit, to examine the number of patients with a daily goal recorded in the prior 24 hours and the quality of the recorded goal using the SMART-GEM. The self-efficacy of engaging in mutual goal-setting with patients will be examined by asking nurses to complete the Appraisal Inventory Tool (AIT) prior to and immediately following the intervention. The patient experience of engaging in mutual goal-setting will be examined by having a total of 165 patients complete the Patient Experience of Mutual Goal-Setting Tool (PEMGST) one month prior to the intervention and one and three months following the intervention on each of the two units. Read Less

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period. Read Less

This study seeks to determine the effectiveness of a specific treatment protocol using dry needling with perineural electrical stimulation in comparison to standard treatment in physical therapy for patients with migraine headaches. This will be a randomized cross-over study in which participants will be in the first arm of the study, have a washout period, then cross over to the other arm of the study. Read Less

The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. Read Less

This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide. Read Less

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments. Read Less

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. Read Less

Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of taxanes and platinum derivative based chemotherapeutic agents, common in breast cancer treatment regimens. It can have a significant effect on both quality of life and treatment outcomes, often resulting in dose modifications and early treatment discontinuation. The use of IncobotulinumtoxinA (INA) ((Xeomin®, Merz) has recently been shown to be effective in the treatment of neuropathic pain via inhibiting the release of several neurotransmitters involved in pain signaling pathway. The purpose of this study is to examine the efficacy and safety of intradermal INA injections for treatment of CIPN in breast cancer patients. The study will recruit a total of 40 participants, randomly assigned to receive either INA (Experimental group, n=20) or saline placebo injections (Control group n=20). Potential participants who have received chemotherapy for breast cancer will be screened for the diagnosis of peripheral neuropathy. After obtaining informed consent, participants will be further screened with the DN4 questionnaire, a clinician administered questionnaire that has a high level of sensitivity and specificity in discriminating neuropathic pain. Those study participants who score ≥4 on this tool will undergo nerve conduction studies to confirm the presence of peripheral neuropathy. Recruited study participants will then be randomized to treatment or control groups; the treatment group will undergo intradermal injections of INA (100 Units INA, total volume 5ml), and the control groups will undergo placebo injection with preservative-free normal saline (equal volume, 5mL). Total injection volume will be divided evenly and injected intradermally into a total of 50 sites on either the feet or hands (25 sites per limb). The primary outcome will be the assessment of pain using the neuropathic pain scale (NPS) prior to intervention and at eight weeks post intervention. Secondary outcomes will include the change in NPS for each domain at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months, the change in the Neuropathic Pain Impact on Quality of Life (NePIQoL) score at time points: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and the incidence of treatment related adverse events within each cohort. Statistical analysis will be utilized to determine whether the injection of intradermal INA is effective in improving pain as measured by the NPS scales vs placebo. We hypothesize that the study participants treated with INA will have lower NPS scores as compared to placebo. Read Less

This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols. Read Less

The purpose of this pilot trial is to examine the preliminary efficacy of online-delivered Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E). In the study, 30 children with persistent tic disorders (PTDs) will be recruited via information provided to patients of the Marquette University (MU) Tic Disorders Specialty Clinic (TDSC) and information conveyed via local medical health professionals, with the goal of randomizing 10 participants to each group. For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, but there will be two modifications. CBIT typically consists of the implementation of strategies to help manage the environment related to tics and the implementation of an exercise to engage in when an individual feels the urge to tic. CBIT-E will include these same techniques, plus additional in-session and out of session practice of the exercises, called competing responses, that individuals use when they feel the urge to tic. Treatment will be delivered over Microsoft Teams, which is a secure video conferencing system. The therapist will administer treatment from a private room in the Marquette University Tic Disorder Specialty Clinic, while the parent and child will be at their home. Treatment will include a screening visit, baseline assessment, 11 weeks (9 sessions) of CBIT-E, a post treatment assessment, and a three-month follow up assessment. Further, starting after session 3, there will be four 15-minute practice periods scheduled each week between sessions. During these practice periods, the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task. Children randomized to the waitlist control (WLC) will not receive treatment during the 11-week period. Instead, they will be placed on a waitlist to receive standard CBIT following the end of the study period. Participants in this group will complete a screening visit, baseline assessment, and a final assessment, which will occur approximately 11 weeks after baseline. Read Less