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438 Study Matches

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

This study looks at how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC082
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• planning to receive Immune Checkpoint Therapy (ICI) for a solid tumor cancer
• if received prior ICI-based therapy must have completed it at least 180 days before starting the study
• must be able to complete Patient-Reported Outcome (PRO) forms in English, Spanish, or French
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: cancer, ICI, Immune Checkpoint Therapy, solid tumor
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A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma (PRISM-1)

The purpose of this study is to compare treatment with quemliclustat, nab-paclitaxel and gemcitabine to treatment with placebo (inactive drug), nab-paclitaxel and gemcitabine for people who have metastatic pancreatic cancer.

Principal Investigator: Sunn Sunn Thaw
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC090
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
• have not been treated for PDAC
• prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months ago
• may not be able to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work -see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of brain metastases or leptomeningeal metastases
• prior treatment with a CD73 antagonist or inhibitor
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Metastatic Pancreatic Ductal Adenocarcinoma, pancreatic cancer, PDAC
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Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for missing doses of medication. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC098
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• fluent in written and spoken English or Spanish
• diagnosis of new or established hormone receptor (HR)+ HER2- metastatic breast cancer
• started taking any of the CKD4/6 inhibitor drugs (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) in the last 30 days before consenting or have received a prescription and plan to start taking within the 30 days after consent
• must have an email address
• at least able to do limited selfcare; confined to bed or chair more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
• previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio
Conditions: Cancer
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Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma.

Principal Investigator: Chaithanya Bhaskar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC089
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
• completed therapy and had with a complete response
• last date of prior systemic therapy was no more than one year ago
• must be English speaking
• have internet access through computer, tablet, or smartphone and an email address
• at least able to do limited selfcare, may be confined to bed or chair more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (CAMBRIA-2)

This is study to determine if a new drug, camizestrant, improves outcomes compared to usual adjuvant endocrine therapy for people who have ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence. People who have completed initial therapy (with or without chemotherapy) are eligible for the trial. Treatment is planned to continue for 7 years.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC080
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years to 130 years old
• confirmed ER+/HER2- early-stage resected invasive breast cancer
• may have received up to 12 weeks of endocrine therapy
• start the study within 12 months of definitive breast surgery
• strenuous activity may be restricted but able to walk and do light or sedentary work e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• inoperable locally advanced or metastatic breast cancer
• history of any other cancer in the past 5 years that required treatment
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Breast Cancer
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A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

The goal of this study is to evaluate nemtabrutinib compared with either ibrutinib or acalabrutinib for treatment of people with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy.

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC093
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of CLL/SLL and with active disease requires therapy
• able to swallow and retain oral medication
• at least capable of all selfcare but may unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active hepatitis B virus/ hepatitis C virus
• history of severe bleeding disorder
• clinically significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: chronic lymphocytic leukemia, CLL, SLL, small lymphocytic lymphoma
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S2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

This trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning.

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC086
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer
• stage II or III breast cancer
• have not received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy
• must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Breast cancer, HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer
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NRG-GY028: A PHASE IB AND RANDOMIZED PHASE II TRIAL OF MEGESTROL ACETATE WITH OR WITHOUT IPATASERTIB IN RECURRENT OR METASTATIC ENDOMETRIOID ENDOMETRIAL CANCER

This trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in women who have endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC078
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer
• may have received unlimited prior lines of therapy
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of medications
• must agree to use adequate contraception during study therapy and for 28 days following the last dose of study therapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• diabetes either requiring insulin therapy or with a baseline fasting glucose > 160 mg/dL and/or high glycosylated hemoglobin A1c (HbA1c) (> 8)
• require chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease
• history of known or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
• clinically significant history of liver disease
• women who are pregnant or breast feeding
Conditions: Cancer
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

This trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who had a complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC077
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Triple Negative Breast Cancer (TNBC) without any remaining disease after neoadjuvant chemotherapy with pembrolizumab for at least 6 cycles
• no more than 12 weeks between surgery and starting the trial
• see link to clinicaltrails.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• women who are pregnant or breast feeding
• history of any prior invasive breast cancer in either breast
• active liver disease
• medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer
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HM2024-28: A Pilot Study to Investigate the Clinical Utility of Tremoflo Airway Oscillometry in the Pediatric and Adolescent Population with Pulmonary Pathology or at Risk of Lung Injury

The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.

Principal Investigator: Samuel Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023347
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
Exclusion Criteria:

• unlikely to complete required study components
Conditions: Cancer, Respiratory System
Keywords: child cancer, lungs, oxygen level, asthma, BPD, Cystic Fibrosis, interstitial lung disease
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A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

This study is testing the study drug BDTX-4933 in people with locally advanced (unresectable) or metastatic solid tumors that are characterized by a KRAS, BRAF, or NRAS mutation/alteration(s). The primary objective of the study is to assess how well participants tolerate the drug and if it is effective.

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021016
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• recurrent or advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations
• exhausted all available standard-of-care therapies
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• cancer that has a known MEK1/2 mutation
• ongoing anticancer or radiation therapy
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastatic cancer, RAS or BRAF mutations, Recurrent cancer
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MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis

The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025182
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases, Immune Diseases
Keywords: Clinics and Surgery Center (CSC), Scleroderma
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A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

The purpose of this study is to find out if a study drug called nerandomilast can help slow down or reduce worsening lung scarring in people with a family history of pulmonary fibrosis. This study compares nerandomilast with a placebo to see if there is a difference in lung changes seen on scans and lung function over time. The placebo looks like nerandomilast but does not contain any active drug.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026805
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 40 years old
• have at least 1 close biological family member (parent, sibling, or child) diagnosed with pulmonary fibrosis or a related lung scarring condition
• imaging scan showing early signs of lung scarring or interstitial lung disease (ILD)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• known or more advanced pulmonary fibrosis that may require treatment with approved therapies
• medical conditions known to increase the risk of pulmonary fibrosis, such as some connective tissue diseases
• prior or current use of certain pulmonary fibrosis medications including nerandomilast, nintedanib, or pirfenidone
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Respiratory System
Keywords: Clinics and Surgery Center (CSC), Pulmonary Fibrosis
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MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)

The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.

Principal Investigator: Binoy Yohannan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027728
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), amyloid light chain (AL) amyloidosis
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PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) (PRECIDENTD)

People with type 2 diabetes have a higher risk for heart disease than people without diabetes. We are doing this research to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease for people with type 2 diabetes. People who are in the study will be randomly (by chance) assigned to take one of two types of diabetes medications that have been approved by the FDA. Your usual care provider will continue to manage your diabetes care.

Principal Investigator: Elizabeth Rogers
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024423
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 40 to 80 years old with -diagnosis of Type 2 diabetes, HbA1c ≥6% measured in the past 12 months,
• AND one of the following:
• diagnosis of coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
• OR: -60-80 years old and at least 1 additional high-risk feature:
• active smoking, HbA1c ≥ 8% measured within past 12 months or chronic kidney disease
• willing to be randomly (by chance) assigned to a class of medication and fill the prescription with personal pharmacy insurance plan
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• any other type of diabetes
• history of diabetic ketoacidosis
• active diabetic foot ulcer
• history of pancreatitis
• active treatment for cancer
• history of solid organ or bone marrow transplant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: ASCVD, Atherosclerotic Cardiovascular Disease, Diabetes, Type2Diabetes
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A Phase 3, multicenter, clinical study to evaluate the efficacy and safety of safusidenib erbumine in participants with isocitrate dehydrogenase 1 (IDH1)-mutant glioma (SIGMA) (SIGMA)

This study is evaluating safusidenib, an investigational oral medication, for people with certain types of IDH1-mutant glioma. The study has three parts and will examine how well safusidenib works, how safe it is, and how the body processes the medication. Depending on the type and stage of glioma, participants may receive safusidenib after standard treatment, safusidenib or placebo, or safusidenib following surgery.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00028677
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• have a confirmed IDH1-mutant glioma that has returned, progressed, or meets the study-specific criteria for treatment
• have received the required prior treatment for their type of glioma, which may include surgery, radiation therapy, chemotherapy, or other standard treatments
• have measurable tumor remaining or recurring that can be seen on imaging
• see link to ClinicalTrials.gov for complete Inclusion criteria
Exclusion Criteria:

• prior treatment with certain medications targeting IDH1/IDH2 or other investigational treatments for glioma
• tumor involves the brainstem or spinal cord, or there is evidence of cancer spread along the lining of the brain or spinal cord
• significant medical, neurological, or heart conditions that could interfere with participation in the study
• see link to ClinicalTrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), glioma, IDH1
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University of Minnesota Registry for Epilepsy and Seizure Disorder Research

The University of Minnesota Registry for Epilepsy and Seizure Disorder Research (UM-REaSD) connects people interested in epilepsy and seizure disorder research with University of Minnesota researchers. By joining the registry, you can share your contact information and basic health information so researchers can contact you about future studies you may be eligible to participate in.

Principal Investigator: Sandipan Pati
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00029205
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• interested in participating in epilepsy and seizure disorder research at the University of Minnesota
Conditions: Brain & Nervous System
Keywords: Epilepsy, seizure
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MT2023-01:Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to evaluate the safety of a new NK cell therapy for people with relapsed or treatment-resistant acute myeloid leukemia (AML). Participants will receive chemotherapy followed by an infusion of specially selected donor immune cells designed to help the body recognize and fight leukemia cells. Researchers will study the safety of this treatment, determine the most appropriate dose, and learn more about how the therapy works in the body.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027586
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of acute myeloid leukemia (AML)
• adequate heart, lung, liver, and kidney function
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• diagnosed with leukemia involving the brain or spinal fluid
• active HIV, Hepatitis B, Hepatitis C, other serious infection, recent heart attack, or another active cancer requiring recent chemotherapy
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), acute myeloid leukemia, AML
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MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.

Principal Investigator: Ashish Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023330
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
Exclusion Criteria:

• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), SCD, Sickle cell disease
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)

The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022419
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Exclusion Criteria:

• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
Conditions: Rare Diseases, Infectious Diseases
Keywords: C. Diff Infection, CDI, Clostridium Difficile, Clostridium Difficile Infections, Diarrhea
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)

The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026133
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer
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A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024172
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025612
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
Exclusion Criteria:

• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: Acute Lymphoblastic Leukemia, ALL
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MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy

This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027558
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
Exclusion Criteria:

• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), solid tumor cancer
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Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This study is looking at whether rezpegaldesleukin can help preserve insulin-producing cells in people who were recently diagnosed with type 1 diabetes. Participants will receive treatment every 2 weeks for 26 weeks, followed by a 6-month follow-up period.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027051
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 8 to 45 years
• recently diagnosed with type 1 diabetes (T1D) within the past 100 days
• have at least one blood test showing an immune response associated with T1D and some remaining insulin production
• see link to ClinicalTrials.gov for complete Inclusion criteria
Exclusion Criteria:

• current or recent serious infection, including tuberculosis, HIV, or hepatitis B or C
• currently taking medications that suppress the immune system or have recently received certain immune-modulating treatments
• history of certain serious heart conditions, cancer, or organ transplant
• currently pregnant or breastfeeding, or planning to become pregnant during the study
• see link to ClinicalTrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, type 1 diabetes
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Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)

Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.

Principal Investigator: Beth Thielen
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019522
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
Exclusion Criteria:

• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Conditions: Community Health, Infectious Diseases, Respiratory System
Keywords: germs, infection, respiratory illness, RSV, virus, cough
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HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination with CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML).

This study is meant for participants who have been diagnosed with acute myeloid leukemia (AML) and have a specific mutation in a gene called TP53. The study will give these participants an investigational drug called bortezomib in combination with an approved drug for AML, CPX-351 (brand name: Vyxeos). The researchers are studying this combination to find out if it is safe to give to people, as well as to find out how well it works for people who have AML with the TP53 mutation.

Principal Investigator: Joseph Norton
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024980
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have not received any systemic chemotherapy for the treatment of AML
• able to care for self but may be unable to carry on normal activity or to do active work
• sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active central nervous system malignancy or symptoms of CNS involvement
• cardiac disease including congestive heart failure with symptoms, heart attack (myocardial infarction) in the past 6 months, serious arrhythmia, unstable angina
• women who are pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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MT2022-49: Early identification of cognitive side-effects of immunotherapy

This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019811
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
Exclusion Criteria:

• presence of speech or hearing problem
• diagnosis of cognitive impairment
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), CAR-T, Chimeric Antigen Receptor T-Cell Therapy
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MT2021-30: Severe Combined Immune Deficiency: Prospective and Longitudinal Study of Genotypes, Management and Outcomes

This study follows people with severe combined immunodeficiency (SCID) over time. We want to learn how people do before and after treatment, including potential factors that may affect their long-term health. By taking part, participants may be able to help us better understand SCID and the effects of treatment.

Principal Investigator: Meera Srikanthan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001475
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have suspected or confirmed severe combined immunodeficiency (SCID)
• some participants with confirmed SCID may have already received treatment for the condition
Exclusion Criteria:

• have another primary immune deficiency that does not meet the study's SCID criteria
• have an immune deficiency caused by another condition, including HIV infection
Conditions: Rare Diseases, Immune Diseases
Keywords: Immune System, Immunodeficiency, Rare Disease, SCID
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Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients

The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.

Principal Investigator: Susan Kline, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019575
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
Exclusion Criteria:

• surgery scheduled less than 10 days after the baseline cultures
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