North Carolina Paid Clinical Trials

This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor. The two goals are: To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training. Read Less

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation. Read Less

Purpose: To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints in healthy young individuals. Participants: 20 healthy males and females aged 18-35 years. Procedures (methods): Subjects will be randomly exposed to three consecutive days of filtered air (4 hr/day) and three consecutive days of PM2.5 (approximately 35 µg/m3; 4 hr/day) in an exposure chamber. Blood collection for inflammatory factors such as C-reactive protein (CRP), clotting factors; heart rate variability (HRV); spirometry; and a symptom questionnaire will be conducted before and after each exposure. Read Less

The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding. Read Less

The Connect® Lymphoma Disease Registry is a US-based, multicenter, prospective observational (non-interventional) cohort study designed to collect real-world, participant-level data longitudinally in participants diagnosed with various subtypes of non-Hodgkin lymphoma (NHL). Read Less

Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor decision-making. These impairments on critical active duty tasks could have a significant impact on task readiness and military performance. Therefore, CM presents a challenge for the "return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic treatment for CM; however, this treatment requires refrigeration, to which there is little access for the forward-deployed members who have limited access to adequate storage for this treatment. Therefore, it is imperative to identify a CM treatment that does not require refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting international shortages in critical medication production and delivery, it is imperative to identify more than one treatment option for the management of CM. In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a conversion ratio of 1:1. Read Less

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. Read Less

The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))[D/C/F/TAF] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))[B/F/TAF] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain. Read Less

This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor. Read Less

This is an adaptive platform. This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged. This information will be used to create a computer tool that will help predict a patient's risk of being readmitted into the hospital after being discharged. Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message. Participants will receive the text messages twice a day. When the participant receives the text message, they will click on the link and follow the instructions. Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature. Additional questions will also be asked. After 30 days, the text messages will stop, and participation will be complete. Read Less

Purpose: Investigate the safe wearability and basic functionality - epidermal melanin concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood Oxygen Sensor (MABOS) Participants: Healthy adults 18-65 years of age Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the study. The investigators aim to enroll 4 participants with skin tones associated with those of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent (Group C). Additionally, the investigators aim to ensure half of group is male, and the other half female. For the duration of the study, two wearable devices will be placed on the participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on each patient's inner wrist. Following this, the two devices will be placed on the patient, set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410, 660, and 940 nm). After the calibration period, all participants will be asked to perform the following procedure 5 times as part of the testing period: a deep inhalation lasting no longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds. Between each trial, a five-minute break will be required. For the entire testing period, all two devices will be continuously acquiring data. After this testing period, all two devices will continue taking measurements until 90 minutes have elapsed. Skin integrity will be examined before spectrometer use, after spectrometer use, after the calibration period, every 30 minutes after the start of the testing period, and after the testing period. During the study, if the participants report any uncomfortable feeling and/or pain or if a change to the skin at the site of device placement occurs, the measurements will be discontinued, and all the devices placed on the participants will be removed. Questionnaires will be provided after the study period and during follow-up visits approximately 48 hours and 96 hours post the device testing visit for a proof-of-concept evaluation of the safe wearability. Read Less

This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month. Read Less