Charleston, SC Paid Clinical Trials

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure [PROM] of HNC-related body image distress [BID]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators). Read Less

The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19. Read Less

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Read Less

This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer. Read Less

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF). Read Less

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each. All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys. Read Less

The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. Read Less

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost. Read Less

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s). Read Less

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy Read Less

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence. This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). Read Less

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care [SOC]) [dose optimization] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in on two different dosing schedules. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Read Less