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Clinical Trials in North Carolina

654 actively recruiting studies with sites in North Carolina. Filter by condition or check your eligibility in under a minute.

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Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Breast Cancer · Metastatic Breast Cancer · Triple Negative Breast Cancer

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

Chapel Hill, NC18+ yrsAll genders
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Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Myelofibrosis · Post-PV MF · Post-ET Myelofibrosis

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Charleston, Charlotte +more, NC18+ yrsAll genders
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Multimedia Aid for Genetic Testing in Gynecologic Oncology

Ovary Cancer · Endometrial Cancer

This pilot study aims to estimate rates of genetic testing in patients with ovarian and endometrial cancer before and after the implementation of educational videos about genetic testing. Subjects will be asked to view one of three videos relevant to their cancer diagnosis and genetic testing, and have the option to complete a brief satisfaction survey. A chart review to evaluate rates of genetic testing ordered and referrals placed to Genetics before and after the implementation of the videos will be conducted. Up to 15-20% of ovarian cancer and 3-5% of endometrial cancer is due to inherited genetic mutation. Given this association, the National Comprehensive Cancer Network (NCCN) recommends genetic counseling and testing for all individuals with a diagnosis of ovarian cancer and endometrial cancer. Some challenges to obtaining genetic counseling and testing include missed identification and referral of eligible patients by providers, lack of provider knowledge, and busy clinic visits limiting time for informed consent and maintaining patient autonomy for genetic testing. Although heterogeneous, the literature supports multimedia use in cancer genetics. However, there is a paucity of data in the field of gynecologic oncology for the role of integrating a multimedia approach to genetic counseling.

Chapel Hill, NC18+ yrsWomen
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Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Schizophrenia · Schizoaffective Disorder

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings

Chapel Hill, NC18–65 yrsAll genders
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Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Multiple Myeloma

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Charlotte, Durham +more, NC18+ yrsAll genders
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Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Chapel Hill, NC18+ yrsAll genders
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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Eosinophilic Gastrointestinal Disorders (EGIDs) · Eosinophilic Esophagitis · Eosinophilic Gastritis

The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Chapel Hill, NC3+ yrsAll genders
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COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

Ulcerative Colitis, Pediatric · Inflammatory Bowel Diseases · Crohn Disease

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is: Are the newer medications used to treat IBD just as safe and effective for treating IBD in children. Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.

Chapel Hill, Charlotte +more, NC1–18 yrsAll genders
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A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Narcolepsy Type 1 · Narcolepsy Type 2 · Idiopathic Hypersomnia

This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

Denver, Huntersville, NC18–65 yrsAll genders
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Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Hearing Loss, Unilateral · Deafness, Unilateral

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

Chapel Hill, NC5+ yrsAll genders
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Paroxysmal AF

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Durham, Winston-Salem, NC18–80 yrsAll genders
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Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Sarcoma · Gastrointestinal Cancer

This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy. Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.

Chapel Hill, NC18+ yrsAll genders
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Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage II Breast Cancer AJCC v8 · Anatomic Stage IIIA Breast Cancer AJCC v8

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Asheboro, Asheville +more, NC18+ yrsAll genders
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