Current care patterns for patients with acute chest pain fail to provide optimal quality and value. To avoid missing acute
coronary syndrome (ACS), emergency physicians hospitalize >50% of patients who present to the Emergency Department with
chest pain. However, <10% are ultimately diagnosed with ACS, and this pervasive overtriage
costs $1013
billion annually.
The HEART Pathway, which was developed at Wake Forest Baptist Health (WFBH), is designed to improve care for patients with
chest pain. It uses a validated clinical decision aid and serial troponin measures to provide realtime
decision support to providers.
In our prior studies, the HEART Pathway decreased hospitalizations, stress testing, and hospital length of stay, without
increasing adverse events. These studies led to a learning health system project in collaboration with insurers, in which the
HEART Pathway was fully integrated into the WFBH EHR. Preliminary results demonstrate further reductions in hospitalizations
and stress testing. Given WFBH's success with the HEART Pathway, the next logical step is regional dissemination.
This project will leverage Carolinas Collaborative infrastructure to collect data specific to the HEART Pathway from all 4 health
systems, establishing rates of healthcare utilization and ACS outcomes for Emergency Department patients with chest pain in
the Carolinas. In addition, we will engage key stakeholders at each health system to develop an implementation strategy. This
proposal builds on our prior work and will provide pilot data essential for a larger grant application that will support rigorous
testing and implementation of the HEART Pathway across Carolinas Collaborative health systems.

The study will include 9 key informant interviews discussing how patients developed their impression of the benefit of an implant and how patients prefer expectation data be relayed. No video recordings will be performed during interviews. Interview notes or audio recordings will be taken and uploaded into a password protected network server. The results of interviews will mainly be descriptive. To test the plasticity of preoperative patient expectations and the impact of the CI evaluation the CIQOL expectations form will be administered prior to CI evaluation, directly after the CI evaluation, and prior to surgery for all patients who are undergoing cochlear implantation and meet inclusion/exclusion criteria and agree to participate. The decisional conflict scale will also be administered directly after the CI evaluation and prior to surgery for the above patient group. The 9 patients who undergo key informant interviews will also be part of the larger study group of 200 patients and have the same surveys administered and be subject to the same inclusion/exclusion criteria. The group of patients will also be asked about how they prefer expectation and QOL data to be relayed. All survey data will be collected in a secure RedCap database. Patients expectations at the three preoperative timepoints will be compared using paired T-tests. Data regarding how patients develop expectations and how they prefer expectation data to be presented to them will be mainly qualitative and discussed in terms of the most common themes from patient surveys and interviews. When exploring how patients prefer expectations and QOL data to be relayed we intend to include numbered clinical vignettes relaying differing levels of hearing capability. We will compare relaying information through vignettes to more conventional outcome measures such as speech recognition and QOL scores to determine which is the more effective means of communication.

This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
The total duration of participation for each participant is expected to be about 3 years (up to 35 months). Women will be enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Over the course of the study, CF clinical data, patient-reported outcomes, questionnaires, obstetrical outcomes, infant growth, child development outcomes, baseline CF-related therapies and co-morbidities will be collected to enable evaluation of changes from before pregnancy to during pregnancy and post-delivery.
MAYFLOWERS participants will be provided an opportunity to participate in an optional continuous glucose monitoring (CGM) sub-study to evaluate glucose control in pregnancy. Participants will undergo CGM sensor placement and data collection as part of the MAYFLOWERS study.

For patients with head and neck cancer, delays starting adjuvant radiation therapy are common, disproportionately burden racial minorities, and contribute to poor survival and racial disparities in mortality. However, effective therapies to improve the delivery of timely, equitable, guideline-adherent adjuvant radiation therapy are lacking. We have developed a navigation-based multilevel intervention to enhance care coordination, communication, and key cancer care delivery processes that could provide the first effective treatment in this population, thereby improving survival, decreasing racial disparities in outcomes, and developing new standards of clinical care.

5-aminosalicylic acid (5-ASA) medications are first line treatment for mild to moderate Ulcerative Colitis (UC), comprise 81% of all UC prescriptions, and have a market share of 1.5 billion. However, despite 5-ASA frequency and optimization, 35% of patients fail induction therapy and 52% of patients fail to maintain remission at 12 months, requiring step up therapy to immunomodulators or biologics which have increased side effects and cost. This highlights a key challenge in UC which is to address the large inter- and intrapatient variabilities in both disease progression and variability in response to treatment. Chronotherapy is the timing of medical interventions according to the host circadian rhythms in order to optimize drug response and minimize toxicity, and is one explanation for the large variability in response to medications. The long-term objective of our research is to establish the hypothesis that is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels. To test this hypothesis, In
response to the small R01 for pilot and feasibility clinical trials (PAS-20-160) and to test our hypothesis, we propose to conduct a six month, single center, randomized crossover pilot trial involving 60 subjects with inactive UC [Mayo score ≤2, endoscopic score 0-1] but subclinical inflammation [stool calprotectin > 50 mcg/g] on a stable dose of once daily 5-ASA medication. All subjects will be randomized to once daily 5-ASA medications two different times of the day: either between 06:00 – 10:00 h or 18:00 – 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 3, at the completion of first arm (condition 1), and 3) month 6, after completion of the second arm (condition 2). We will assess time impact of our chronotherapy protocol on: 1) subclinical inflammation (Aim 1): a) stool calprotectin; b) intestinal barrier integrity; and c) endoscopic/histology scores; 2) Microbiota: mucosal and stool microbiota structure and function (Aim 2); and 3) 5-ASA metabolism: a) increase mucosal levels of 5-ASA and b) mucosal NAT activity (Aim 3). In addition, optimal 5-ASA treatment (i.e., Aims 1-3) will depend upon host chronotype which will be monitored by validated questionnaires, rest-wake actigraphy, and urinary melatonin. The results of this innovative proposal will establish a key role for chronotherapy in the treatment of UC and provide pilot data for the future larger multicenter clinical trials. Chronotherapy will allow for a personalized medicine approach that incorporates circadian biology to improve efficacy and minimize intolerance in treatment of UC.

The present study is a first-in-human, non-randomized, open-label, multi-center, Phase 1 trial with NM32-2668 in selected advanced solid tumors that represent a group of indications most likely to overexpress ROR1. The key purpose of the trial is to determine the maximum tolerated dose (MTD) sequence and/or therecommended Phase 2 dose (RP2D) sequence of NM32-2668 monotherapy. Up to 15 sites in the United States, Canada, and Spain (Part I and Part II, Dose
Escalation) Up to 40 sites in the United States, Canada, and EU (Part III, Dose Expansion) Part I and Part II (Dose Escalation): approximately 36 months Part III (Dose Expansion): approximately 18 months.

This is a prospective, longitudinal, multicenter, nonrandomized observational study to obtain research quality data across key outcome measures in people with Cystic Fibrosis who are ineligible and/or not taking a approved CFTR modulator and who are not receiving an investigational therapy.

Participants will be seen at study sites for research visits to include spirometry, patient reported outcomes (PROs), and blood collections on Day 0, Day 90 (3 months), Day 180 (6 months), and Day 360 (12 months). Participants will complete home spirometry as well during this period.