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A Study to Assess Growth in Children With Idiopathic Short Stature
Alison Lunsford - alison.lunsford@prismahealth.org
ALL
2 years to 16 years old
NCT06309979
Inclusion Criteria:
• Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
• A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).
• Participants who have either never received hGH, or who are currently receiving hGH treatment.
• Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
• Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
Exclusion Criteria:
• Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
• Known presence of one or more pituitary hormone deficiencies
• Bone age advanced over chronological age by more than 3 years.
• For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
• For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
• Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .
Idiopathic Short Stature
ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
18 years and over
PHASE3
NCT06876714
Inclusion Criteria:
* Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)
* Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible
* HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer
* Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR
* If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts (including the requirement that at least one biopsied site on each side must have been HER2+)
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively
* Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)
* Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped \> 12 months prior to registration on this protocol
* No use of investigational anti-cancer agents at time of registration
* Patient must register within 14 weeks of final surgery
* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
* Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed
* Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon
* Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible
* Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion
* Targeting of the regional nodal basins will be at treating investigator discretion
* Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice
* Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility
* No stage IV (metastatic) breast cancer
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* No history of any prior (ipsilateral \[ipsi-\] or contralateral) invasive breast cancer. Prior DCIS is allowed
* No evidence of recurrent disease following preoperative therapy and surgery
* Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.
* Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF \< 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)
* No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab
* No contraindication to receipt of further HER2-directed therapy
* No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.
Exclusion Criteria:
\- BIOLOGICAL: Trastuzumab (Herceptin), BIOLOGICAL: Pertuzumab, PROCEDURE: Echocardiography, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mammography, PROCEDURE: Ultrasound, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage Breast Carcinoma
Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
18 years and over
PHASE2
NCT05642572
Inclusion Criteria:
* Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
* Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol
* Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed
* Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA \[ctDNA\]) next generation sequencing (NGS) assay. MET amplifications may have been determined based on tissue submitted for testing by Foundation Medicine Inc (FMI) through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib (alone or in combination with another agent\[s\]). The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/Independent Ethics Committee (IEC), College of American Pathologists (CAP), or similar certification
* Note: Participants previously tested for and determined to have MET amplified NSCLC, at the time of progression on osimertinib, outside of LUNGMAP, must also submit tissue for central FMI testing on the LUNGMAP screening protocol, if available
* Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable
* Participants must have a CT with contrast or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
* Participants with symptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be neurologically stable and have a stable or decreasing corticosteroid requirement for at least 5 days before sub-study randomization
* Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia and vitiligo
* Participants must be able to swallow tablets whole
* Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to sub-study randomization)
* Hemoglobin \< 9.0 g/dL (within 28 days prior to sub-study randomization)
* Platelets \>= 100 x 10\^3/uL (within 28 days prior to sub-study randomization)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to sub-study randomization). Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional ULN. Participants with history of liver metastasis must have AST =\< 5 x ULN (within 28 days prior to sub-study randomization)
* Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
* Participants must have an electrocardiogram (ECG) performed, with a Fridericia's Correction Formula (QTcF) =\< 470 msec, within 28 days prior to sub-study randomization. It is suggested that a local cardiologist review the QTcF intervals
* Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization
* Participants must have a urinalysis performed 28 days prior to sub-study randomization. Participant must have a urinary protein =\< 1+ on dipstick or routine urinalysis (UA). Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria \>= 2+, then a 24-hour urine is to be collected and demonstrate \< 2000 mg of protein in 24 hours to allow participation in the study
* Participants must have an International Normalized Ratio (INR) =\< 1.5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days to sub-study randomization. Participants must have a partial thromboplastin time (PTT) =\< 5 seconds above the 'institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days prior to sub-study randomization
* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load within 6 months prior to sub-study randomization
* Participants must have asymptomatic serum amylase =\< 2 x ULN and serum lipase =\< ULN obtained within 28 days prior to sub-study randomization. Asymptomatic is defined as having no signs and/ or symptoms suggesting pancreatitis or pancreatic injury (e.g. elevated P. amylase, abnormal imaging findings of pancreas, etc.)
* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* Participants with impaired decision-making capacity must not have a neurological or psychological condition that precludes their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator). For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria:
* Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor
* Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization
* Note: osimertinib may continue up to the day prior to study treatment initiation
* Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
* Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
* Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. John's Wort); CYP3A4 inhibitors; CYP1A2 substrates; P-gp and BCRP substrates; sensitive substrates of MATE1 and MATE2K; or drugs that are known to prolong QT interval within 7 days prior to sub-study registration and must not be planning to use any of these throughout protocol treatment
* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen PROCEDURE: Biospecimen Collection, DRUG: Capmatinib, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Osimertinib, BIOLOGICAL: Ramucirumab
Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
12 years and over
PHASE2
NCT06900595
Inclusion Criteria:
* STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma
* STEP 1: Locally advanced unresectable or recurrent/metastatic disease
* STEP 1: Evaluable disease as defined by RECIST v 1.1
* STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.
* Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be \< 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll
* STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy
* STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant
* STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment
* STEP 1: Age 12 years and above; and BSA ≥ 1.2m\^2
* STEP 1:
* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
* Patients 12 to \<16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
* Patients ≥ 16 to \<18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50
* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Platelet count ≥ 100,000/mcL
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Hemoglobin ≥ 8 g/dL
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL
* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN)
* STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg
* STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min
* STEP 1: Mitotane level \< 2 mg/L\*
* Only applicable for patients who have received mitotane ≤ 6 months prior to registration
* STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production
* Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is \< 20 pg/mL plus random serum cortisol is \> 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy
* STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required
* STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional within 28 days of registration. To be eligible for this trial, patients should be class II or better
* STEP 1: No known history of congenital long QT syndrome
* STEP 1: No known history of myocarditis
* STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration
* STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation
* STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration
* STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration
* STEP 1: No current radiologic or clinical evidence of pancreatitis
* STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration
* STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)
* STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration
* STEP 1: No history of pneumonitis
* STEP 1: No known tumor invading or encasing any major blood vessels
* STEP 1: No history of fracture within 28 days of registration
* STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
* STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible
* STEP 1: Verbalizes the ability to swallow oral tablet formulation
* STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib
* STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be eligible
* STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:
* immune related neurologic disease,
* multiple sclerosis,
* autoimmune (demyelinating) neuropathy,
* Guillain-Barre syndrome (GBS), myasthenia gravis,
* systemic autoimmune disease such as systemic lupus erythematosus (SLE),
* connective tissue diseases,
* scleroderma, inflammatory bowel disease (IBD),
* Crohn's, ulcerative colitis,
* patients with a history of toxic epidermal necrolysis (TEN),
* Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
* Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* STEP 1: No steroid use \> 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy
* STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* STEP 1: Herbal supplements and traditional Chinese medicines are not allowed
* STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
* STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria
* Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement
* STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.
* Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)
* STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done ≤ 14 days prior to re-registration is required PROCEDURE: Biospecimen Collection, DRUG: Cabozantinib, BIOLOGICAL: Cemiplimab, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma, Recurrent Adrenal Cortical Carcinoma, Stage III Adrenal Cortical Carcinoma AJCC v8, Stage IV Adrenal Cortical Carcinoma AJCC v8, Unresectable Adrenal Cortical Carcinoma
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
Amgen Call Center - medinfo@amgen.com
ALL
50 years to 105 years old
PHASE3
NCT07136012
Inclusion Criteria:
* Age ≥50 years
* Lp(a)≥ 200 nmol/L during screening
* Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Exclusion Criteria:
* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
* Prior or planned arterial revascularization
* History of major bleeding disorder DRUG: Olpasiran, DRUG: Placebo
Cardiovascular Disease
Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
Carolyn Borme - clinical@fire1foundry.com
ALL
18 years and over
NA
NCT05763407
Main Inclusion Criteria
* Adults 18 years of age or older.
* Patients meeting diagnostic criteria for heart failure diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC/HFSA guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidenced by meeting either 2a, 2b, OR 2c criterion below:
• NYHA functional class III: with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF and NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL). For patients presenting with atrial fibrillation NT-proBNP ≥900 pg/mL (or BNP ≥300 pg/mL). OR
• NYHA functional class III: NT-proBNP ≥1000 pg/mL (or BNP ≥300pg/mL). For patients presenting with atrial fibrillation NT-proBNP≥1,600 pg/mL (or BNP ≥500 pg/mL). OR
• NYHA functional class II: with documented HF decompensation within the previous 12 months resulting in a primary HFhospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL (or BNP ≥300 pg/mL). For those patients presenting with atrial fibrillation NT-proBNP ≥1,600 pg/mL (or BNP ≥500 pg/mL). * Patients must also be on a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the 2 weeks prior to screening. * IVC diameter within the landing zone of between 14mm and 28mm. * Minimum IVC landing zone length of 60mm. * Patient has sufficient Cellular and/ or Wi-Fi Internet coverage at home. * Provide informed consent for participation in the clinical investigation and be willing and able to comply with the required daily system readings, care plan instructions, and clinical follow-up visits according to the specified schedule. Main
• NYHA functional class III: with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF and NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL). For patients presenting with atrial fibrillation NT-proBNP ≥900 pg/mL (or BNP ≥300 pg/mL). OR
• NYHA functional class III: NT-proBNP ≥1000 pg/mL (or BNP ≥300pg/mL). For patients presenting with atrial fibrillation NT-proBNP≥1,600 pg/mL (or BNP ≥500 pg/mL). OR
• NYHA functional class II: with documented HF decompensation within the previous 12 months resulting in a primary HFhospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL (or BNP ≥300 pg/mL). For those patients presenting with atrial fibrillation NT-proBNP ≥1,600 pg/mL (or BNP ≥500 pg/mL). * Patients must also be on a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the 2 weeks prior to screening. * IVC diameter within the landing zone of between 14mm and 28mm. * Minimum IVC landing zone length of 60mm. * Patient has sufficient Cellular and/ or Wi-Fi Internet coverage at home. * Provide informed consent for participation in the clinical investigation and be willing and able to comply with the required daily system readings, care plan instructions, and clinical follow-up visits according to the specified schedule. Main
Exclusion Criteria:
* Significant comorbidity that, in the investigator's opinion, would results in the patient being unable to safely undergo the procedure or participate in the clinical investigation.
* Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 ml/min/1.73m2
* Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC.
* Patients who have severe right sided valvular disease or a right sided mechanical valve.
* Patients with a cardiac resynchronization therapy device implanted ≤ 3 months to prior to screening.
* Patients who have undergone invasive cardiac surgery in the 3 months prior to screening.
* Patients who have undergone percutaneous valve / structural heart intervention in in the 3 months prior to screening.
* Patients who have received heart transplant or a ventricular assist device or planned for advanced therapies within the next year.
* Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins. DEVICE: NORM™ System
Heart Failure
Cardiovascular Disease
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Maggie Salle, RN- Research Coordinator - margaret.salle@prismahealth.org
ALL
18 years to 90 years old
NA
NCT04671771
Inclusion Criteria:
Pre-Operative Inclusion Criteria:
Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:
• Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
• Age 18 to 90 years old, inclusive;
• Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
• Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);
• Able and willing to give informed consent;
• Anticipated life expectancy of at least 1 year. Intra-Operative
Inclusion Criteria:
Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).
Pre-Operative Exclusion Criteria:
Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:
• History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;
• Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
• For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \< 18 cm;
• History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
• Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
• Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;
• Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
• Baseline hemoglobin \<7 g/dL;
• Baseline platelet count \<50,000 or \>500,000 cells/mm3;
• Documented history of stroke within 6 months prior to enrollment;
• Treatment with any investigational drug or device within 30 days prior to enrollment;
• Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);
• History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
• Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;
• Documented or suspected hypercoagulable condition;
• Bleeding diathesis, other than that associated with ESRD;
• Documented history of heparin-induced thrombocytopenia (HIT);
• Active local or systemic infection as documented from the medical history or bloodwork/blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
• Scheduled renal transplant within 6 months;
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;
• Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.
DEVICE: InnAVasc Arteriovenous Graft (IG) surgical implant
End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy (DINE-GLP1)
John D Scott, MD - john.scott@prismahealth.org
ALL
18 years and over
NCT07313384
Inclusion Criteria:
* Adults aged 18 and older
* Recently has been prescribed GLP-1 therapy for the treatment of obesity or T2DM but have not yet initiated the medication
* Has regular access to a smartphone and internet to complete short surveys and food recalls online
* Willing to sign informed consent.
Exclusion Criteria:
* Already began the GLP-1 medication
* Have medical concerns making participation unsafe DRUG: GLP-1 Therapy
Obesity Type 2 Diabetes Mellitus, Obesity (Disorder)
GLP-1 Therapy, Nutrition Support, Obesity, Weight loss therapy
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)
Site Public Contact - Kim.Williams3@prismahealth.org
FEMALE
18 years to 60 years old
PHASE3
NCT05879926
Inclusion Criteria:
* A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
* The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.
* Female patients must be greater than or equal to 18 years of age.
* Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:
* Age 50 years or under with spontaneous menses within 12 months; or
* Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or
* Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or
* Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.
* The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).
* Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
* Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
* Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
* For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)
* For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)
* Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).
* The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
* By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)
* By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).
* Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.
* Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.
* Oncotype DX RS (recurrence score) requirements\*:
* If node-negative:
* Oncotype DX RS must be RS 21-25, or
* Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.
* If 1-3 nodes involved:
* Oncotype DX RS must be less than 26.
\* Patients with a "Low Risk" or "MP1" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.
* The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.
* The tumor must be HER2-negative by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines based on local testing results.
* The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.
* Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.
* Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.
Exclusion Criteria:
* • Definitive clinical or radiologic evidence of metastatic disease.
* pT4 (pathological state) tumors, including inflammatory breast cancer.
* History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.)
* If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.
* Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.
Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:
* ANC (absolute neutrophil count) less than 1200/mm3;
* Platelet count less than 100,000/mm3;
* Hemoglobin less than 10 g/dL;
* Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;
* AST(aspartate aminotransferase)(SGOT)/ALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;
* Renal function of GFR (glomular filtration rate) less than 30 mL/min/1.73m2.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Non-epithelial breast malignancies such as sarcoma or lymphoma.
* Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.
* Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs).
* Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.
* Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)
* Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. DRUG: Ovarian Function Suppression + Aromatase Inhibitor, DRUG: Adjuvant Chemotherapy + Ovarian Function Suppression
Breast Cancer
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study (STOP-VTE)
Kim.Williams3@prismahealth.org
ALL
18 years and over
NCT07215624
Inclusion Criteria:
SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
\* Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study
SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
\* APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study
SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
\* Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)
SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
\* Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)
SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:
\* Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP
Exclusion Criteria:
* N/A OTHER: Non-Interventional Study, OTHER: Non-Interventional Study, OTHER: Non-Interventional Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone (AMBITION BTK)
Anna Quillin - anna.quillin@angiodynamics.com
ALL
PHASE4
NCT06777901
Inclusion Criteria:
* Age of subject is ≥ 18.
* Estimated life expectancy ≥1 year.
* Subject is able and willing to comply with all assessments in the study.
* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
* Rutherford Category classification of 4 or 5 of the target limb.
* Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.
Angiographic Inclusion Criteria
* Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).
* Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
* Only a single lesion is included in the study per subject.
* The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
* Lesion length ≥50mm and ≤300mm.
* Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.
* Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.
Exclusion Criteria:
* Target lesion is in a vessel graft or synthetic graft.
* Treatment of target lesion with radial access.
* Planned target limb major amputation (above-the-ankle).
* Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
* History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
* Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
* Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
* Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
* Myocardial infarction within 60 days prior to enrollment.
* History of stroke/CVA/TIA within 60 days prior to enrollment.
* History of thrombolytic therapy within 14 days of enrollment.
* Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or is on dialysis.
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
* Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.
* Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
* Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
Angiographic Exclusion Criteria
* Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with \<50% residual stenosis with no serious angiographic complications (e.g., embolism or dissection) prior to treatment of the target lesion.
* Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
* The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and/or PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomy devices (with the exception of bailout stents for Class C/D dissections).
Subjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.
Observational Study Inclusion Criteria:
* Subjects intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.
* Subjects presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.
* Age of subject is ≥ 18.
* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
Observational Study Exclusion Criteria:
* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints. DEVICE: Auryon Atherectomy System, DEVICE: Balloon Angioplasty
Peripheral Arterial Diseases
4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
Amy Hayes - Amy.Hayes@prismahealth.org
ALL
6 years to 11 years old
PHASE2
NCT06553547
Inclusion Criteria:
• ≥6 and \<12 years old at the Screening visit (Visit 1)
• Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential.
• Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C
• Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
• Meet the entry criteria assessed during the 2-week Screening period
• Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
• Patient must provide verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
Exclusion Criteria:
• Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
• IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
• History of non-retentive fecal incontinence;
• Required manual disimpaction any time prior to randomization (after consent)
• Currently has both unexplained and clinically significant alarm symptoms (lower gastrointestinal \[GI\] bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
• Patient has any of the following conditions:
• Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
• Cystic fibrosis;
• Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
• Down's syndrome or any other chromosomal disorder;
• Active anal fissure (Note: History of anal fissure is not an exclusion);
• Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
• Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
• Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
• Lead toxicity, hypercalcemia;
• Neurodevelopmental disabilities
• Inflammatory bowel disease
• Childhood functional abdominal pain syndrome
• Childhood functional abdominal pain
• Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
• Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
• History of cancer other than treated basal cell carcinoma of the skin;
• History of diabetic neuropathy.
• Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator.
• Patient has had surgery that meets any of the following criteria:
• Surgery to remove a segment of the GI tract at any time before the Screening Visit;
• Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
• An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
• Other major surgery during the 30 days before the Screening Visit
• History of alcohol or substance abuse
• Participation in other clinical trials within 1 month prior to Screening
• Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial
• If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable
DRUG: Tenapanor, DRUG: Placebo
Irritable Bowel Syndrome With Constipation (IBS-C)
IBS-C
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
Toll Free Number - Trialsites@msd.com
ALL
18 years and over
PHASE3
NCT06717347
Inclusion Criteria:
* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
* Has received no prior treatment for their DLBCL
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
* Has a history of transformation of indolent disease to DLBCL
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
* Has Ann Arbor Stage I DLBCL
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
* Has clinically significant pericardial or pleural effusion
* Has ongoing Grade \>1 peripheral neuropathy
* Has a demyelinating form of Charcot-Marie-Tooth disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has ongoing corticosteroid therapy
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) lymphoma
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has active infection requiring systemic therapy
* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant BIOLOGICAL: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, BIOLOGICAL: Rituximab Biosimilar, DRUG: Prednisone, DRUG: Prednisolone, DRUG: Vincristine, DRUG: Rescue medication, BIOLOGICAL: Zilovertamab vedotin
Diffuse Large B-Cell Lymphoma
Lymphoma, Large B-Cell, Diffuse