SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor (ACSPIRE)
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
- Adults able to provide informed consent.
- Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non-malignant.
- Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either untreated or on stable standard of care treatment, based on at least one of:
- HbA1c ≥ 5.7% but not > 9.5%;
- 2-hour glucose level ≥ 7.8 mmol (140 mg/dL) on a 75 g OGTT.
- At least one additional documented cortisol-related morbidities, either untreated or on stable standard of care treatment:
- Hypercholesterolemia with total cholesterol > 3.9 mM (150 mg/dL);
- Hypertriglyceridemia with triglycerides > 2.3 mM (200 mg/dL);
- Osteopenia with bone densitometry Z-score < -2.0 or T-score < -1.0;
- History or evidence of minimally traumatic or osteoporotic fracture; or;
- Hypertension with resting supine blood pressure > 130 but < 180 mmHg systolic or > 85 but < 120 mmHg diastolic.
- Poorly suppressible hypercortisolemia:
- Morning serum cortisol > 50 nM (1.8 mcg/dL) after a 1 mg ONDST;
- Subjects with dexamethasone < 3.3 nmol/L (130 ng/dL) will undergo a high-dose (8 mg) ONDST;
- Subjects who take estrogen-containing medicines will be evaluated based on free cortisol > 2.2 nM (80 ng/dL);
- For subjects with morning serum cortisol > 138 nM (5.0 mcg/dL) after ONDST, the Investigator will assess for adrenal Cushing's syndrome.
- Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosterinoma, adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy associated hypercortisolism including history of adrenal carcinoma.
- History of adrenalectomy or planned adrenalectomy within 4 months after randomization.
- Exogenous hypercortisolism.
- Uncontrolled, clinically significant hypo- or hyperthyroidism.
- History of idiopathic thrombocytopenia.
- Moderately impaired renal function (estimated glomerular filtration rate < 60 mL/min/1.73m^2 ).
- History of cancer (other than non-melanoma skin, thyroid, or early-stage prostate cancer) within 3 years.
- Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
- Pregnant or lactating.
- Positive test for severe acute respiratory syndrome coronovirus 2 infection within 4 weeks, or hospitalization for Coronovirus disease 2019 within 6 months, prior to randomization.
- Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.
Evaluation of a Wearable Physiologic Monitor to Detect Sleep Quality
Evaluate Sleep Quality from Wearable Physiologic Monitor
- Adults > 18 years of age.
- Body-Mass Index (BMI) < 35.
- Normal sleep routine (typically awake during day and asleep at night).
- Prior diagnosis of, or positive STOP-BANG screen (> 3) for sleep apnea.
- Excessive daytime sleepiness (the recorded Epworth Sleepiness Scale (ESS) must be ≤ 9).
- History of heart failure, atrial fibrillation, pulmonary, neurological, or psychiatric disease.
- Currently being treated pharmacologically for depression or other significant medical condition (broadly speaking).
- Subject is receiving hypnotics or stimulant medication.
- Habitual use of 3 or more cups of coffee/caffeinated tea per day.
DART 2.0 ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy (GMROR2271) (GMROR2271)
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
- Age ≥ 18 years.
- Histological confirmation of p16+ OPSCC or HPV(+) OPSCC.
- Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy.
- Absence of distant metastases on standard diagnostic work-up ≤ 16 weeks prior to registration. (Chest CT or PET/CT).
- ECOG Performance Status (PS) ≤ 1 (Appendix I).
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Willing to provide tissue and blood samples for correlative research purposes, including anonymous shipment of samples to for NavDx Testing.
Exclusion Criteria
- Any of the following:
-
- Pregnant women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be HIV+.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- Other active malignancy ≤ 5 years prior to registration.
- EXCEPTIONS: Nonmelanotic skin cancer or carcinoma-in-situ of the cervix, or prostate or localized endometrioid endometrial cancer.
- NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
- Prior history of radiation therapy to the affected site.
- Prior systemic chemotherapy in the last 5 years.
- History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease.
- History of allergic reaction to docetaxel.
- Receiving any medications or substances which in the opinion of the investigators would interfere with treatment. Examples could include strong inhibitors of CYP3A4 at oncologist discretion.
- Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated with Osteoarthritis
Osteoarthritis Injectable Treatment with SL-1002 to Assess the Safety and Efficacy
1. Male or female patients 35 years of age or older, with a Body Mass Index (BMI) of 18.0
to 40.0 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
2. Patients with chronic knee pain resulting from osteoarthritis for greater than 6
months prior to study Screening Visit 1 that interferes with functional activities
(e.g., ambulation, prolonged standing, etc.).
3. Patients currently experiencing continued pain despite receiving at least 3 months of
conservative treatments, inclusive of activity modification, home exercise, protective
weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
4. Patients with a baseline average pain score of ≥ 6 on an 11-point NRS scale as "usual
level of pain over the past 24 hours during weight-bearing activities" for the index
knee at Screening. The baseline average pain score is computed by finding the mean of
the daily NRS pain intensity scores reported during the 7-day run in period.
5. Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically
confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit
1.
6. Patients with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain
subscale score ≥ 19 and ≤ 67 in the index knee.
7. Patients taking analgesics, inclusive of membrane stabilizers (e.g.,
Neurontin/gabapentin) and/or antidepressants (e.g., Cymbalta/duloxetine), for
osteoarthritis associated knee pain must be on a stable dose for at least 6 weeks
prior to study Screening Visit 1. Patients must agree to not alter the dose of
analgesics for the duration of the study without prior approval from the Investigator.
8. Female patients of childbearing potential who are sexually active with a male partner
must be willing to use one of the following acceptable contraceptive methods
throughout the study and for 30 days after the last study drug administration:
1. Intra-uterine contraceptive device placed at least 4 weeks prior to study drug
administration;
2. Male condom with intravaginally applied spermicide starting at least 21 days
prior to study drug administration;
3. Hormonal contraceptives starting at least 4 weeks prior to study drug
administration must agree to use the same hormonal contraceptive throughout the
study;
4. Sterile male partner (vasectomized since at least 6 months).
9. Female patients of non-childbearing potential as defined below:
1. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable
cases a blood sample with simultaneous follicle stimulating hormone (FSH) and
estradiol levels consistent with menopause).
2. Pre-menopausal females with one of the following:
- Documented tubal ligation
- Documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion
- Hysterectomy
- Documented bilateral oophorectomy.
10. Patients must agree to see one treating physician (study Investigator) for knee pain
treatment for study duration.
11. Patients who have a positive response to a single genicular nerve block of the index
knee using 1.5
•3mL of lidocaine 2% solution administration to the genicular nerves
planned for treatment in each cohort (0.5mL per nerve). A positive response to the
qualifying lidocaine prognostic block is defined as ≥ 80% pain reduction within 60
minutes of receiving the lidocaine injections and ≥ 80% pain relief for a duration of
at least 60 minutes as documented on a standardized 6-hour pain log.
12. Patients must be able to understand and be able to complete all assessments associated
with the study outcome measures.
13. Patients must be able to understand the informed consent and be willing to provide
written informed consent. Patients must be able to comply with the requirements of the
protocol for the entire duration of the study.
1. Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any
other systemic inflammatory condition (e.g., gout, pseudogout). 2. Current diagnosis of
fibromyalgia. 3. Patients with evidence of neuropathic pain affecting the index knee. 4.
Patients with prior or planned lower limb amputation. 5. Patients who have received an
intra-articular steroid injection into the index knee within 90 days of study Screening
Visit 1. 6. Patients who have received hyaluronic acid injection, Platelet Rich Plasma
(PRP), stem cell or arthroscopic debridement/lavage injection into the index knee within
180 days of study Screening Visit
- Patients who have received prior radiofrequency ablation or any other neurolytic
procedure of the genicular nerves of the index knee within 1 year of study Screening
Visit 1.
- Patients who have received prior partial, resurfacing, or total knee arthroplasty of
the index knee (residual hardware).
- Patients with clinically significant ligamentous laxity of the index knee as per
Investigator discretion.
- Patients with clinically significant valgus/varus deformities or evidence of pathology
(other than osteoarthritis of the knee) that materially affects gait or function of
the index knee or is the underlying cause of the knee pain and/or functional
limitations.
- Patients who are extremely thin and those with minimal subcutaneous tissue thickness
that could place the patient at risk of a chemical skin burn, at the discretion of the
Investigator.
- Patients with a pending or active compensation claim, litigation or disability
remuneration (possibility of secondary gain).
- Patients with chronic pain associated with significant psychosocial dysfunction.
- Patients with a Patient Health Questionnaire
•9 (PHQ-9) score of >10 (indicative of a
state of moderate depression).
- Patients with a systemic infection, active joint infection, or localized infection at
the planned needle entry sites (patient may be considered for inclusion once infection
is resolved).
- Patients with history of uncontrolled coagulopathy or unexplained or uncontrollable
bleeding that cannot be corrected, and patients with coagulopathy or who are being
treated with anticoagulants.
- Patients with moderate to severe hepatic impairment or moderate to severe renal
impairment.
- Identifiable anatomical variability that would materially alter the procedure as
described in the protocol.
- Patients currently prescribed opioid medications at a dose of >50 daily morphine
equivalents.
- Patients with uncontrolled immunosuppression (e.g., AIDs, cancer, diabetes) as per
Investigator discretion.
- Female patients who are pregnant or planning to become pregnant during the duration of
the study.
- Female patients who are breast-feeding.
- Patients who are unable or unwilling to comply with the requirements of the protocol.
- Patients taking any of the following concurrent medications/over-the counter products
(refer to Appendix 8 in full protocol for a list of applicable medications): c.
Probenecid or other organic anion transporter (OAT3) inhibitors. d. Inhibitors of
CYP2E1, such as disulfiram.
- Patients with known allergies or hypersensitivity to iodinated contrast medium and
gadolinium-based contrast medium. Known allergies or hypersensitivity to phenol and/or
lidocaine and/or their excipients.
- Patients with a documented history or evidence of alcohol or drug abuse within 1 year
of study screening visit 1.
- Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days of study Screening Visit 1,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.
- Patients with clinically significant ECG abnormalities or vital sign abnormalities at
during study Screening Visit 1. Patients with ECG or vital sign abnormalities deemed
nonclinically significant or unlikely to result in clinical compromise by the
Principal Investigator may be considered for study inclusion.
- Patients with clinically significant laboratory results (as judged by the Principal
Investigator).
- Any condition, in the opinion of the Principal Investigator, that may pose a
significant risk to the patient, confound the results of the study or interfere
significantly with the patient's participation in the study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.
Patient Reported Quality of Life with Neurogenic Bladder and Urologic Reconstruction
Neurogenic Bladder and Urologic Reconstruction Quality of Life as Reported by Patient
- Neurogenic bladder diagnosis.
- ≥ 18 years old.
- Non-neurogenic bladder patients undergoing key surgical procedures (urinary diversion, bladder augmentation, creation of catheterizable channel, urethral reconstruction, ureteric reconstruction).
- < 18 years old.
- No Neurogenic bladder diagnosis or non-neurogenic bladder patients not undergoing key surgical procedures (urinary diversion, bladder augmentation, creation of a catheterizabel channel, urethral reconstruction, ureteric reconstruction).
Eligibility last updated 4/29/22. Questions regarding updates should be directed to the study team contact.
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients with Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP trial
Study of Gastric Cancer and Limited Peritoneal Metastasis Using Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy
- Restricted to 18 to 80 years of age.
- ECOG performance status ≤ 2.
- Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type III GE junction adenocarcinomas
- Adequate renal, and bone marrow function:
- Leukocytes ≥ 3,000/uL;
- Absolute neutrophil count ≥ 1,500/uL;
- Platelets ≥ 50,000/Ul d. Serum creatinine ≤ 1.5 mg/dL.
- Metastasis confined to the peritoneum:
- Positive peritoneal cytology;
- Peritoneal metastasis on diagnostic laparoscopy;
- Peritoneal metastasis on imaging.
- Response to systemic chemotherapy defined as at least one of the following:
- Reduction (≥ 30%) in SUV max;
- Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (≥ 30% decrease in the longest diameter of target lesion) or laparoscopy (reduction in PCI or conversion of peritoneal cytology);
- Reduction (≥ 30%) in serum tumor markers CEA or CA 19-9.
- Peritoneal Carcinomatosis Index (PCI) ≤ 7 and surgeon deems high likelihood for a complete cytoreduction.
- BMI ≤ 35 kg/m^2.
- Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc).
- Malignant ascites at time of study enrollment.
- Comorbidities that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
- Subjects deemed unable to comply with study and/or follow-up procedures.
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was lifethreatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
Hip RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Hip Cartilage Defects
REcycled CartiLage Auto/Allo IMplantation
- Male or female ages 18-50 years.
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years following treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit.
- Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions ranging in size from 2 to 8 cm^2. Patients with episodes of contralateral knee pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, as outlined in the primary study endpoints, patients with previous episodes of contralateral knee pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
- Radiographic knee OA of Kellgren-Lawrence Grade 1 or less, consisting of normal knee radiographs (Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping (Grade 1).
- Previous 6 week or longer trial of one of the following conservative treatments:
- activity modification;
- weight loss;
- physical therapy;
- anti-inflammatory medications; or
- injection therapy (e.g., cortisone).
- If applicable, at least 3 months will have passed since the last target knee intraarticular injection prior to undergoing RECLAIM therapy and at least 6 months will have passed between any prior arthroscopic or open knee procedures.
- Able to routinely walk without assistance (e.g., cane, walker).
- Clinically stable target knee. Patients undergoing primary anterior crucial ligament (ACL) reconstruction will be eligible for inclusion if their target knee is otherwise stable and well-aligned.
- No additional surgery planned in the target knee for at least 12 months following RECLAIM therapy.
- Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment.
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.
- Pregnant or nursing, or planning on becoming pregnant during the study period.
- Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results.
- Significant knee malalignment that is not corrected at the time of RECLAIM surgery.
- Injections of any kind into the target knee within 3 months prior to study enrollment.
- Greater than 50% preoperative loss in native meniscus volume (i.e., meniscectomy, degenerative loss) in the surgical knee compartment. Patients undergoing repair of meniscus tears without > 50% meniscus volume loss will remain eligible for inclusion.
- History of intra-articular infection in the target knee.
- History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee.
- History of falls requiring medical attention, or gait instability.
- Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results.
- Body mass index (BMI) > 35 kg/m^2.
- Taking anticoagulant medications (e.g., warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to surgical RECLAIM therapy.
- Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the RECLAIM treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin).
- Taking non-steroidal anti-inflammatory medications (e.g., COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle.
- Use of electrotherapy or acupuncture for knee pain, unless there is a stable regimen for at least 4 weeks before baseline assessment.
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
- Current tobacco product use, including nicotine patch or other nicotine products.
- Clinically significant systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome.
- Clinically significant rheumatological or inflammatory disease of the knee or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropath.
Eligibility last updated 8/2/22. Questions regarding updates should be directed to the study team contact.
Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis
- Adult patients, ≥ 18 years old.
- Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
- Ability to communicate in English.
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
- Cognitive impairment or inability to understand and follow instructions.
- Traditional PR completed within 3 months of study recruitment.
- Hospice or end-of-life care at the time of screening.
- Acute exacerbation at the time of screening.
Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.
Preliminary Evaluation of At-Home Self-Collection for Pre-Transplant Patients
At-Home Self-Collection for Pre-Transplant Patients
- Adult (≥ 18 years) pre-transplant kidney patient.
- Individuals < 18 years.
- Not pre-transplant kidney patient.
Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.
GRASP-IBD (GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease) (GRASP-IBD)
GI and Rheumatology Assessment of Spondyloarthritis in Inflammatory Bowel Disease
- Adult patients, ages 18-70 years.
- Patients with Irritable Bowel Disease (IBD).
- Patients < 18 and over 70 years of age.
Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.
A Review of Midgut Malrotation in the Adult Population: Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure
Diagnosis, Techniques and Outcomes of the Laparoscopic Ladd’s Procedure: A Review of Midgut Malrotation
- Patients who underwent Ladd’s procedure.
- < 18 years of age.
Metabolomic Analysis of Nasal Swab Mucus
A Study of Nasal Swab Mucus with Metabolomic Analysis
- Age 18 years and older.
- Scheduled to undergo nasal endoscopy
- Cystic fibrosis.
- Cigarette smoking in the last 6 months.
- Common Variable Immunodeficiency Disease.
- EGPA or small vessel vasculitis.
- Primary ciliary dyskinesia.
- Primary immune deficiency disorder.
- Treatment with antibiotics within the past 4 weeks before visit.
- Oral corticosteroids in the past 2 weeks before visit.
- Intramuscular corticosteroids in the past 6 weeks before visit.
- Current cancer treatment with immunotherapy and chemotherapy.
- Treatment with biologics or zileuton.
Transform the Practice – Pilot Study: Radio Signal Characterization of Seizures. Phase 3 Remote Home-Based Monitoring
Remote Home-Based Monitoring Using Radio Signal Characterization of Seizures
- Adult (18+) male and female subjects.
- Carry a diagnosis of epilepsy.
- Able to provide consent.
- Have a reliable home wifi service provider.
- Have a smartphone.
- Able to independently (or with help from a family member) complete the directions to self-install the device and ship it back at time of study completion.
- Subjects who are pregnant or may be pregnant.
- Pediatric patients (< 18 years of age).
- Subjects unable or unwilling to undergo remote monitoring using the Emerald device.
- Lack capacity to consent for self.
- Subjects who plan to have more than one additional person in the room with them during nocturnal hours (10 pm – 6 am).
Eligibility last updated 5/6/22. Questions regarding updates should be directed to the study team contact.
Gait Analysis in Aging and Neurological Disease
Analyzing Patient Gait in Aging and Neurological Disease
- Any consenting adult over the age of 18 presenting to the Mayo Clinic Study of Aging will be included.
- Any consenting adult presenting to the department of Neurology with a gait disorder will be included.
- Individuals under the age of 18.
- Individuals who are immobile (defined as unable to walk with or without a gait aid) will be excluded.
- Individuals with severe cognitive or neuropsychiatric impairment which may affect their gait or makes them unable to provide informed consent will be excluded.
Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)
68GaFAPI-46 PET/CT for Pancreatic Ductal Adenocarcinoma
- Adults > 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings
diagnostic for PDA on baseline imaging (CT, MRI, or PET)
- Localized disease expected to undergo surgical resection following neoadjuvant therapy
(NAT)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Ability to provide informed consent
- Hypersensitivity to any excipients in 68Ga-FAPI-46
- Require emergency surgery
- Non-PDA histology on biopsy
- Histopathologically proven metastatic PDA
- Pregnant women
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/30/22. Questions regarding updates should be directed to the study team contact.
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Brightline-1: A Study to Compare Bi 907828 With Doxorubicin In People With a Type of Cancer Called Dedifferentiated Liposarcoma
- Provision of signed and dated, written informed consent form (ICF) in accordance with
ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or
analyses.
- Male or female patients ≥18 years old at the time of signature of the informed consent
form (ICF). Women of childbearing potential (WOCBP) and men able to father a child
must be ready and able to use 2 medically acceptable methods of birth control per ICH
M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly beginning at screening, during trial participation, and
until 6 months and 12 days after last dose for women and 102 days after last dose for
men. A list of contraception methods meeting these criteria is provided in the patient
information.
- Histologically proven locally advanced or metastatic, unresectable (surgery morbidity
would outweigh potential benefits), progressive or recurrent dedifferentiated
liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted
for entry into this trial but will be confirmed by independent pathological review
while the patients receive treatment in this trial.
- Written pathology report indicating the diagnosis of DDLPS with positive mouse double
minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by
fluorescence in situ hybridization or next generation sequencing (NGS) must be
available.
- Formalin fixed paraffin embedded tumor blocks or slides must be available for
retrospective histopathological central review.
- Presence of at least one measurable target lesion according to Response Evaluation
Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target
lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of
the target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Patient must be willing to donate blood samples for the pharmacokinetics,
pharmacodynamics, and tumor mutation analysis.
- Patient willing to undergo a mandatory tumor biopsy at the time point specified in the
flowchart unless exempt.
- Adequate organ function
- Known mutation in the TP53 gene (screening for TP53 status is not required).
- Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to randomization or planned within 6 months after screening.
- Prior systemic therapy for liposarcoma in any setting (including adjuvant,
neoadjuvant, maintenance, palliative).
- Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the
previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in
situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered
cured by local treatment.
- Previous treatment with anthracyclines in any setting (systemic treatment with other
anticancer agents is allowed if completed at least 5 years prior to study entry with
the exception of hormone therapy).
- Patients who must or intend to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial.
- Currently enrolled in another investigational device or drug trial, or less than 30
days since ending another investigational device or drug trial(s) or receiving other
investigational treatment(s).
- Patients not expected to comply with the protocol requirements or not expected to
complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
condition that, in the investigator's opinion, makes the patient an unreliable trial
participant).
- Further exclusion criteria apply
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/6/23. Questions regarding updates should be directed to the study team contact
A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients with Endogenous Cushing’s Syndrome
Assess the Long-term Safety and Effecticeness of Osilodrostat in Patients with Endogenous Cushing’s Syndrome
Two cohorts of patients are planned to be enrolled in the study:
- “New user”: patients starting osilodrostat at study entry;
- “Prior user”: patients that have started osilodrostat any time prior to study entry.
InclusIon Criteria:
- Written informed consent obtained prior to registration of any patient data.
- Male or female patients, aged 18 years or older
- Diagnosed with endogenous Cushing's Syndrome (CS).
- Treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.
- Patients with exogenous CS.
- Patients with Pseudo CS.
- Patients participating in an interventional clinical trial with an investigational drug.
Eligibility last updated 5/9/22. Questions regarding updates should be directed to the study team contact.
Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
Inhaled Treprostinil in Pulmonary Hypertension for O2 Transfer From the Lung to Mitochondria
- ≥ 18 Years of Age
- Patients with suspected Pulmonary Arterial Hypertension related to Interstitial Lung Disease (ILD-PAH) undergoing right heart catheterization.
- Undergoing cardiac catheterization for clinical indications at Mayo Clinic Rochester over a 12-month period.
- < 18 years old.
Long-Term Follow-Up Study of Patients With Spinal Muscular Atrophy Receiving Risdiplam Treatment
Long-Term Follow-Up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
- Confirmed diagnosis of 5q-autosomal recessive SMA
- Prescribed or continued risdiplam based on clinical judgment of prescriber, as per the
Evrysdi® USPI, after U.S. FDA approval (07 August 2020)
- Hypersensitivity to risdiplam
- Participated in a registrational trial for risdiplam (i.e., Firefish [NCT02913482],
Sunfish [NCT02908685], Jewelfish [NCT03032172], and Rainbowfish [NCT03779334])
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.
Perceptions of Patients who Have Navigated Long-Haul COVID-19
Patients Perceptions of Long-Haul COVID-19
- ≥ 18 years of age and older.
- Previous laboratory confirmed positive COVID-19 test.
- Patient of the Public Health, Occupational Medicine, and Infectious Disease Clinic.
- Patient of the Nurse Practitioner.
- Patients < 18 years of age.
- Patients who are unable to return to work without restrictions and those who have not to return to work.
- Patients who are not currently employed.
Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.
A Phase 1b/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-0974 in Participants With Myelofibrosis and Anemia
Study of DISC-0974 in Participants With Myelofibrosis and Anemia
1. Age 18 years or older at the time of signing the informed consent (ICF).
2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4
(intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as
confirmed in the most recent local bone marrow biopsy report, according to World
Health Organization (WHO) 2016 criteria.
3. Washout of at least 28 days prior to Screening of the following treatments: androgens,
erythropoietin, cladribine, immunomodulators (lenalidomide, thalidomide), interferon
alpha-2a or any other MF-directed therapy. Systemic corticosteroids are permitted for
non-hematological conditions if stable or decreasing dose for ≥ 28 days prior to
Screening and receiving an equivalent to ≤ 10 mg prednisone for the 28 days
immediately prior to Screening.
4. Anemia: For Phase 1b: Hemoglobin (Hgb) < 10 g/dL on ≥ 3 assessments over 84 days prior
to Screening, without RBC transfusion, or Hgb < 10 g/dL and receiving RBC transfusions
periodically but not meeting criteria for TD participant as defined for the TD cohort.
The baseline Hgb value for these participants is the lowest Hgb level during the 84
days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units packed RBCs (PRBC) over the 84 days immediately prior to
Screening. There must not be any consecutive 42-day period without an RBC transfusion
in the 84-day period, and the last transfusion must be within 28 days prior to
Screening. For Phase 2a: RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units PRBC over the 84 days immediately prior to Screening. There
must not be any consecutive 42-day period without an RBC transfusion in the 84-day
period, and the last transfusion must be within 28 days prior to Screening.
5. Stable dose of JAK inhibitor and/or hydroxyurea, or, if taking any other treatment for
MF, stable for at least 4 months prior to Screening.
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after
Screening.
8. Liver iron concentration by MRI < 7 mg/g dry weight.
9. Serum ferritin ≥ 30 ?g/L at Screening.
10. Platelet count ≥ 25,000/?L and < 1,000,000/?L; neutrophils ≥ 1,000/?L; and total white
blood cell (WBC) count < 50,000/?L at Screening.
11. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 by the Chronic Kidney
Disease-Epidemiology Collaboration (CKD-EPI) formula.
12. Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0 x upper limit of
normal (ULN) at Screening.
13. Direct bilirubin < 2x ULN at Screening. Higher levels are acceptable if these can be
attributed by the Investigator to ineffective erythropoiesis.
Medical History:
1. Hereditary hemochromatosis
2. Hemoglobinopathy or intrinsic RBC defect associated with anemia
3. Splenectomy
4. Hematopoietic cell transplant
5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or
bleeding
6. Active immune-mediated hemolytic anemia
7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or
bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units
of RBCs in the 6 months prior to Screening
8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any
previous surgery
9. Malignancy within the past 3 years, other than primary MF, post-ET, or post-PV MF. The
following history or concurrent conditions are allowed:
1. basal or squamous cell carcinoma
2. carcinoma in situ of the cervix or the breast
3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
metastasis [TNM] clinical staging system)
10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior
to Screening
11. Known allergic reaction to any study drug excipient, or anaphylaxis to any food or
drug
12. A history of anti-drug antibody formation
13. Inadequately controlled heart disease (New York Heart Association Classification 3 or
4) and/or known to have left ventricular ejection fraction < 35%
14. Active Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral
load
15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to
the infection, without improvement despite appropriate treatment)
Treatment History:
16. Concurrent or planned treatment with momelotinib during the study period
17. Iron chelation therapy in the 3 months prior to Screening
18. Change in anticoagulant therapy regimen within 8 weeks prior to Screening
Laboratory Exclusions:
19. Peripheral blood myeloblasts ≥ 10% of WBC differential at most recent evaluation prior
to Screening
20. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at
Screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.
Vitamin D-Sulfates in Breastmilk
Study of Breastmilk With Vitamin D-Sulfates
- Lactating women.
- ≥ 2 weeks after delivery.
- No intentions of weaning during the study.
- History of sarcoidosis.
- History of renal disease.
- Premature birth.
- Taking daily supplement with ≥ 600 IU vitamin D in the past 30 days (accounting for washout period).
Determining How Indoor Lighting Affects the Brain Health of Older Adults
Indoor Lighting's Affects on the Brain Health of Older Adults From
- At least age 60.
- Able to wear wearable devices throughout the study.
- Willing to have their lighting in their kitchen and dining areas changed and controlled for the study.
- Willing to have environmental sensors placed in their residence.
- Able to provide informed consent.
- Have severe sleep disturbance (as diagnosed by a clinician or based on a sleep assessment such as the Berlin Questionnaire) unless partner is eligible and participating in this study.
- Legally blind.
- History of diagnosed moderate to severe cognitive impairment (as diagnosed by a physician or based on a cognitive assessment such as the Kokmen Short Test of Mental Status) unless partner is eligible and participating in this study.
- Renovated their living units and no longer have the standard lighting installation offered by the Senior Living Facility.
- Spend or plan to spend > 5 hours per day outside of their residence during the study.
- Plan to travel to a different time zone during the study.
- Plan to be away from their residence for more than a week during the study.
Eligibility last updated 5/20/22. Questions regarding updates should be directed to the study team contact.
Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System (rēST)
remedē System Therapy Study
Eligibility Criteria:
- Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.
- Age 18 years or older.
- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent.
- In the opinion of the investigator, subject is willing and able to comply with the protocol.
- Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- In the opinion of the Investigator, life expectancy exceeds one year.
- The subject is not pregnant or planning to become pregnant.
Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op)
Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology
Inclusion Criteria:
- Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester.
- Age ≥ 18.
- Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC.
- Patient has given permission to give blood sample for research testing.
Exclusion Criteria:
- HPV() OPSCC.
- Unable to provide informed consent.
- Unwilling to attend screening visit at Mayo Clinic site, if indicated.
- Non-English speaking.
- Unwilling/unable to complete surveys electronically.
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Oral Epalrestat Therapy in Pediatric Subjects With Phosphomannomutase 2-congenital Disorder of Glycosylation (PMM2-CDG)
Oral Epalrestat Therapy in Pediatric Subjects With PMM2-CDG
1. Age ≥ 2 and < 18 years.
2. Diagnosis of PMM2-CDG, based on molecularly confirmed biallelic PMM2 pathogenic variants (can be historical diagnosis with lab report on file).
3. Informed consent (and assent, as applicable) document personally signed by the legally authorized representative of the patient, indicating that the patient's parent/guardian has been informed and agreed to all aspects of the study.
4. Be willing and able to adhere to the study assessments and schedule described in the protocol and consent/assent documents.
5. Negative urine pregnancy test (only for female subjects of child-bearing potential)
6. For subjects of child-bearing potential-only, subject has been counseled on and agrees to the requirement either for double barrier contraceptive methods and/or for total
abstinence from prior to randomization through 3-months after the cessation of treatment.
1. Known or suspected other known CDG.
2. Known allergy to aldose reductase inhibitors.
3. Hypersensitivity to epalrestat.
4. Hepatic impairment defined as any one of the following:
1. AST/ALT > 5 x ULN in the 6 months prior to screening;
2. Bilirubin > 2 x ULN in the last 6 months prior to screening;
3. Synthetic liver dysfunction (albumin deficiency < 2.8 mmol/L) at screening; or
4. Diagnosis of liver fibrosis (Fibroscan > 7 kPa) confirmed by liver elastogram at screening;
5. Renal impairment defined as serum creatinine: > 0.5 mg/dL (≤ 6 years); > 0.7 mg/dL (7-10 years); > 1.24 mg/dL (≥ 11 years);
6. Low platelet count (< 125x10^9 /L);
7. Any other clinically significant lab abnormality which, in the opinion of the investigator, should be exclusionary;
8. Anemia (Hgb < 10 g/dL);
9. Use of an investigational drug, including acetazolamide, in the past 28 days; use of an investigational biologic in the past 12 months;
10. Concurrent or planned participation in interventional protocol or use of any other unapproved therapeutics; and
11. Any other medical condition, which, in the opinion of the investigator, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
Assessing the Utility of Disc Space Aspirate Cell Count and Differential in the Diagnosis of Native Vertebral Osteomyelitis
Diagnosis of Native Vertebral Osteomyelitis by Assessing the Utility of Disc Space Aspirate Cell Count and Differential
- Patients 18 years of age or older.
- Referred to the neuroradiology department for diagnostic image guided biopsy.
- The reason for image-guided biopsy would either be due to suspicion for NVO or for other reasons such as ruling out malignancy.
- Patients less than 18 years of age.
- Patients with spinal hardware / instrumentation.
- Post operative patients.
- Patients unable to provide consent.
Eligibility last updated 6/1/22. Questions regarding updates should be directed to the study team contact.
Exploratory Phase 2A, Double-blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, PD, and PK of HU6 for the Treatment of Subjects With Obese Heart Failure With Preserved Ejection Fraction (HFpEF) (HFpEF)
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
- Adult male or female, ≥ 40 years of age.
- Competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and must sign the form prior to the initiation of any study procedures.
- Body mass index (BMI) ≥ 30 kg/m^2;
- Signs and symptoms of HF in the judgement of the Investigator, and meets the following disease severity criteria:
- KCCQ OSS ≤ 80;
- NYHA Classification Class II-III;
- Baseline peak VO2 ≤ 18 mL/kg/min for females or ≤ 20 mL/kg/min for males;
- Respiratory exchange ratio (respiratory quotient) (RER [RQ]) at baseline of > 1.0;
- Left ventricular ejection fraction (EF) ≥ 50%;
- At least 1 of the following objective criteria for HF:
- Documented hospitalization with HF as primary cause within in last year, or if greater than the past year, then with addition of structural heart disease on echocardiography (increased left atrial volume size or left ventricular hypertrophy, with sex-specific cut-points as per Lang, 2015) as follows:
- Left ventricular hypertrophy (LVH):
- Men: Either septal wall thickness (cm) either ≥ 1.1 or posterior wall thickness ≥ 1.1;
- Women: Either septal wall thickness (cm) either ≥ 1.0 or posterior wall thickness ≥ 1.0;
- Left atrial dilation (LAD): AP dimension (cm): ≥ 4.0 in men; > 3.8 in women;
- Pulmonary capillary wedge pressure (PCWP) at rest > 15 mmHg (or left ventricular end-diastolic pressure [LVEDP] ≥18 mmHg) or > 25 mmHg (or 2.0 mmHg/L/min) with exercise in the last year;
- E/e' ratio ≥ 14 at septal annulus at rest on Doppler and tissue Doppler imaging in the last year; or iv. Currently elevated NT-proBNP defined as > 125 pg/mL without atrial fibrillation and > 350 pg/mL for subjects with chronic controlled atrial fibrillation.
- Participants should maintain their stable level of physical activity throughout the duration of the study and must agree to not enroll in an exercise training program during the study.
- Participants should maintain their stable diet and no plan to enter into a weight loss program prior to or during the course of the study.
- Euthyroid as assessed by a thyroid profile utilizing thyroid stimulating hormone (TSH) and free thyroxine (T4) testing at screening. Subjects with a stable history of thyroid disease and who have been on stable doses of thyroid medications for a minimum of 4 months can be enrolled.
- Ambulatory (not wheelchair- or scooter-dependent) and able to perform upright exercise testing including a 6 MWT.
- Stable doses of medications (defined as no new medication or change in existing dose of medication ≥ 50%) for 30 days prior to screening, with additional specific criteria for the diuretics:
- If treated with a loop or thiazide diuretic, must be on stable regimen, which dose permits a flexible diuretic dosing schedule.
- Life expectancy < 1 year due to non-cardiovascular reasons, in the judgement of the Investigator.
- History of malignancy within 5 years (except non-high-grade skin cancers, carcinoma-in-situ, or low-grade prostate cancer).
- Weight change (gain or loss) of ≥ 10 pounds either by self-reporting or documented weight loss within the past 90 days.
- Bariatric surgery prior to screening or planned bariatric surgery during the course of the study.
- Treatment with GLP-1 receptor antagonist begun within 1 year of screening.
- Treatment with SGLT2 inhibitors begun within 6 months of screening.
- Intolerance to MRI or with conditions contraindicated for MRI procedures including but not limited to:
- Having surgical clips/metallic implants/shrapnel/internal electric implants; or
- Inability to fit into MRI scanner due to subject habitus or exceeding weight tolerance limit of the scanner (generally, 350 or 400 lbs, dependent on manufacturer); or
- Claustrophobia: history of severe claustrophobia that would lead to inability to conduct MRI.
- Current acute decompensated HF requiring intravenous (IV) diuretics or recent (< 1 month before screening) hospitalization for HF.
- Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic [congenital], congenital, or any other primary cardiomyopathy, in the judgement of the Investigator.
- Active myocarditis (COVID-induced or otherwise).
- Active collagen vascular disease.
- Current greater than moderate left- or right sided valve disease, in the opinion of the Investigator.
- Planned cardiac surgery or catheter intervention during the time of trial participation.
- Prior documented EF < 40% within the last 3 years.
- Tachycardia (> 110 beats/minute) at screening.
- Atrial fibrillation or atrial flutter with an uncontrolled heart rate response or with a resting heart rate greater than 110 bpm by ECG at screening. Subjects may rescreen after appropriate adjustment of medication to manage the atrial fibrillation. A maximum of 16 subjects with this condition can be enrolled in this study.
- Untreated, life-threatening dysrhythmia.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.
Examining the Sociocultural Influences on Menstrual Health and Uterine Fibroids among Latinas and Black Women
Cultural Experiences of Black and Hispanic/Latina Women with Uterine Fibroids
- Over the age of 18 years of age.
- Biologically female.
- Self-reported diagnosis of symptomatic uterine fibroids.
- Self-identify as Black/African American and/or Hispanic/Latina.
- Under the age of 18.
- Biologically male.
- Not diagnosed with symptomatic uterine fibroids.
- Does not self-identify as Black/African American and/or Hispanic/Latina.
Eligibility last updated 5/26/22. Questions regarding updates should be directed to the study team contact.
Hepatocellular Carcinoma Recognition by Metabolomic Analysis of Serum (HERMES)
Recognition by Metabolomic Analysis of Serum of Hepatocellular Carcinoma
- Liver cirrhosis of any etiology. Diagnosis of cirrhosis based on at least one of the following criteria:
- Histology;
- Imaging showing cirrhotic liver;
- Elastography indicating cirrhosis
- FibroTest result of F4;
- Varices AND chronic liver disease;
- Ascites AND chronic liver disease.
- Patient is scheduled for HCC surveillance according to standard of care (SOC) using abdominal ultrasound (US) and blood-based liver function tests (LFT).
- Age ≥ 18 years.
- Patient information received, read, understood, and signed.
- History of liver cancer.
- History of any other cancer.
- History of liver resection.
- History of solid organ transplant.
- Liver fibrosis < F4.
- Life expectancy is < 12 months.
Eligibility last updated 6/6/22. Questions regarding updates should be directed to the study team contact.