Genes in Diabetic Retinopathy Project (Genes)
A Study to Analyze Genes in Diabetic Retinopathy
- To be eligible for this project, a patient must currently be enrolled in an applicable DRCR.net study or previously been enrolled in an applicable DRCR.net study.
- The DRCR.net procedures manual will indicate which DRCR.net protocols are applicable for study enrollment.
Interrater Reliability of the Modified Prone Instability Test for Lumbar Instability in Patients with Mechanical Low Back Pain (DC/EL mPIT)
Interrater Reliability of the Modified Prone Instability Test in Patients with Mechanical Low Back Pain
- Adult (age >18).
- Current symptoms of LBP (acute, acute on chronic, subacute, or episodic).
- Able to lie prone, seeking “standard” medical or rehabilitative care (in other words, recruited at time of physiatry, spine, or physical therapy evaluation).
- "Current" will be defined a positive response to asking the subject on day of testing if they still have- any one (or more) of their previously described low back pain symptoms present.
- Radiating symptoms (pain or paresthesia) below the knee.
- Red-flags (sudden, progressive lower-extremity weakness or loss of reflexes, saddle anesthesia, bowel/bladder changes).
- Known history of spinal surgery or fracture, spinal deformity, systemic inflammatory condition, neurologic disease, or other serious medical conditions that indicate non-musculoskeletal cause of LBP.
- Individuals with work-related LBP or who are unable to read/speak English.
- Individuals with LBP who report current pregnancy or current breastfeeding will be excluded.
AbatacepT foR ImmUne checkpoint inhibitor associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Compared to Placebo in Hospitalized Participants with Immune Checkpoint Inhibitor Associated Myocarditis (ATRIUM)
Abatacept in Immune Checkpoint Inhibitor Myocarditis (ATRIUM)
- Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his/her medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures.
- Aged greater than or equal to 18 years at the time of informed consent.
- Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e., chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may caue myocarditis.
- A diagnosis of myocarditis.
- Hospitalized at the time of randomization.
- On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug.
- Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥ 5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥ 5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥ 5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible.
- The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care:
- Total white blood cell (WBC) count > 2,500/µl;
- Absolute neutrophil count (ANC) > 1,500/µL;
- Platelet count > 75 × 10^9/L (> 75,000 per µl);
- Absolute lymphocyte count > 800/µL;
- Hemoglobin > 8 g/dL;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 20 times the upper limit of the institutional normal ranges.
- Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug.
- Must be willing and able to abide by all study requirements and restrictions.
- Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization:
- A sudden cardiac arrest;
- Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended);
- A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (> 30 seconds, > 120 beats per minute) or a ventricular tachyarrhythmia requiring intervention.
- Recent (≤ 2 month) exposure to abatacept or belatacept.
- Concurrent or recent (≤ 2 month) use of the following non-corticosteroid immunosuppressive therapies: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, intravenous immunoglobulin, infliximab, and plasma exchange.
- Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities.
- Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.
- Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.
- Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications.
- Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections.
- Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug.
- Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.
- Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
* Participants are included in ATRIUM RESCUE if their initial presentation with myocarditis was with one of the following:
- Resuscitated sudden cardiac arrest;
- Cardiogenic shock;
- A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended);
- A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (> 30 seconds, > 120 beats per minute); or a ventricular tachyarrhythmia requiring intervention.
Eligibility last updated 8/10/23 Questions regarding updates should be directed to the study team contact.
Understanding Arabic interpreters’ experiences working with pediatric physical therapists, patients, and families during outpatient physical therapy sessions: A qualitative study
Arabic Interpreters’ Work Experiences With Pediatric Physical Therapists, Patients, and Families During Outpatient Physical Therapy Sessions
- Have provided interpreter services in the outpatient pediatric physical therapy setting at Mayo Clinic within the last 8 years (5 years for recent recall, plus 3 years to account for decreased patient population of interest during Covid-19 pandemic);
- Have worked with at least 1 pediatric physical therapy session in person; report ability to discuss experience with this appointment type.
- < 22 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.
Popliteal Artery Entrapment Syndrome (PAES) Prospective Registry (PAES)
A Study to Create a Registry for Popliteal Artery Entrapment Syndrome
- Patients diagnosed with popliteal artery entrapment syndrome (PAES) and undergo surgical management.
-
Medically managed PAES.
A Randomized Phase 2 Trial With a Safety Lead-In to Evaluate Palbociclib Versus Palbociclib and Cemiplimab for the Treatment of Advanced Dedifferentiated Liposarcoma
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
- ELIGIBILITY CRITERIA (STEP 1): Patients must have histologically documented
dedifferentiated liposarcoma (DDLPS). Patients with mixed
well-differentiated/ dedifferentiated liposarcoma (WD/DD LPS) tumors are eligible
provided there is a histologically confirmed DDLPS component at some point during the
treatment course
- Disease must be metastatic or locally advanced and surgically unresectable, in
the opinion of the treating investigator
- Note: Intact retinoblastoma protein (RB) can be assumed in DDLPS. In a query of
project Genomics Evidence Neoplasia Information Exchange (GENIE) (American
Association for Cancer Research [AACR]), including 286 DDLPS tumors, the rate of
RB1 mutation in DDLPS was 1.37%. Therefore, molecular testing to determine intact
Rb is not required
- ELIGIBILITY CRITERIA (STEP 1): Patients must have at least one lesion that is
measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
criteria to be eligible for this study. Previously radiated lesions should not be used
as target lesions unless there is documented evidence of disease progression of that
lesion after radiation
- ELIGIBILITY CRITERIA (STEP 1): Patients may have received any number of prior systemic
treatment lines for DDLPS, including none
- ELIGIBILITY CRITERIA (STEP 1): Patients must have recovered to baseline or =< grade 1
per CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse
events are clinically nonsignificant and/or stable on supportive therapy, and with the
exceptions of fatigue (which must be =< grade 2), alopecia and/or endocrinopathies
related to prior immunotherapy which are controlled with hormone replacement
- ELIGIBILITY CRITERIA (STEP 1): Patients must have completed all prior anti-cancer
treatment, including radiation, >= 14 days prior to registration
- ELIGIBILITY CRITERIA (STEP 1): Age >= 18 years
- ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) Performance
Status 0-2
- ELIGIBILITY CRITERIA (STEP 1): Absolute neutrophil count (ANC) >= 1000/mm^3
- ELIGIBILITY CRITERIA (STEP 1): Platelet count >= 100,000/mm^3
- ELIGIBILITY CRITERIA (STEP 1): Hemoglobin >= 9 g/dL
- ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance (CrCl) >= 30 mL/min
- ELIGIBILITY CRITERIA (STEP 1): Total bilirubin =< 1.5 x upper limit of normal (ULN)
- ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST)/alanine
aminotransferase (ALT) =< 3.0 x ULN
- ELIGIBILITY CRITERIA (STEP 1): Patients with known history or current symptoms of
cardiac disease, or history of treatment with cardiotoxic agents, should have a
clinical assessment of cardiac function using the New York Heart Association
Functional Classification. To be eligible, patients should be class IIB or better.
Furthermore, patients may not have an uncontrolled ventricular arrhythmia or recent
(within 3 months) myocardial infarction
- ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B (HBV)
infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated
- ELIGIBILITY CRITERIA (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 receiving treatment, they are eligible if they have an undetectable HCV
viral load
- ELIGIBILITY CRITERIA (STEP 1): Human immunodeficiency virus (HIV)-infected patients on
effective anti-retroviral therapy with undetectable viral load within 6 months are
eligible for this trial
- ELIGIBILITY CRITERIA (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 are eligible for this trial.
Patients participating on this trial may not be receiving other anti-neoplastic
therapies and there should be no anticipated need for such therapy
- ELIGIBILITY CRITERIA (STEP 1): Patients with treated brain metastases that are
non-progressing are eligible if follow-up brain imaging performed at least 4 weeks
after central nervous system (CNS)-directed therapy shows no evidence of progression.
Patients with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are not eligible
- ELIGIBILITY CRITERIA (STEP 1): Patients must be able to swallow oral medications
- RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): In
order to cross over to Arm 2, patients must meet the same eligibility criteria as
described above
- RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2):
Patients must have demonstrated progression of disease on palbociclib monotherapy (Arm
1) per RECIST version 1.1 criteria
- ELIGIBILITY CRITERIA (STEP 1): Patients may not have received prior treatment with
CDK4/6 inhibitors (including, but not limited to: palbociclib, ribociclib or
abemaciclib) or anti-PD-1/anti-PD-L1 antibodies
- ELIGIBILITY CRITERIA (STEP 1): 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 pregnancy test
done =< 7 days prior to registration is required
- ELIGIBILITY CRITERIA (STEP 1): Patients must not have an active autoimmune disease
with the exception of vitiligo, well-controlled asthma or allergic rhinitis, type 1
diabetes, psoriasis or hypothyroidism. Patients with a history of adrenal
insufficiency are eligible if on a stable dose of prednisone =< 10 mg or equivalent
- ELIGIBILITY CRITERIA (STEP 1): Patients must not have an uncontrolled intercurrent
illness including, but not limited to, ongoing or active infection, uncontrolled major
seizure disorder, unstable spinal cord compression, superior vena cava syndrome,
extensive interstitial bilateral lung disease on high resolution computed tomography
(HRCT) scan or any other condition that would limit compliance with study requirements
- ELIGIBILITY CRITERIA (STEP 1): Patients may not require the use of chronic steroids in
excess of 10 mg prednisone daily or equivalent
- ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known
strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease
inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir,
boceprevir, telaprevir). The required washout period prior to re-registration 2 weeks
- ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known
strong CYP3A inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin,
rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort). The required
washout period prior to re-registration is 5 weeks for enzalutamide or phenobarbital
and 3 weeks for other agents
- RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2):
Patients may not have experienced a grade 3 or higher non-hematologic adverse event
deemed clinically significant in the opinion of the treating investigator, or have
discontinued palbociclib due to toxicity, while participating on Arm 1
- Patients must also have recovered to baseline or =< grade 1 per CTCAE version 5.0
from toxicity related to Arm 1 treatment, unless adverse events are clinically
nonsignificant and/or stable on supportive therapy, and with the exceptions of
fatigue (which must be =< grade 2), alopecia and/or endocrinopathies related to
prior immunotherapy which are controlled with hormone replacement
- Note: Patients who underwent dose reduction of palbociclib during treatment on
Arm 1 will begin treatment on Arm 2 at the same dose (i.e. dose re-escalation is
not allowed)
- RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2):
Patients may not have received prior treatment with anti-PD-1/anti-PD-L1 antibodies
- RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): 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 pregnancy test done =< 7 days prior to
re-registration is required
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.
Physical Activity Levels and Physiologic Response in People with Non-Traumatic Brain Injury During Inpatient Rehabilitation
Non-Traumatic Brain Injury During Inpatient Rehabilitation Study of Physical Activity Levels and Physiologic Response
- 18 years of age or older.
- NTBI diagnosis and allocation to the NTBI CMG.
- Participant, family member or legally appointed representative (LOR) will provide informed consent.
- History of pacemaker.
- History of Parkinson’s disease or multiple sclerosis.
- Concurrent orthopedic fracture or injury to the lower extremity.
- Stroke without neoplasm.
- Patients with Heart transplant or LVAD placement.
- Participant has allergy to wrist bands of the monitor.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/16/23. Questions regarding updates should be directed to the study team contact.
The Assessment of Carotid Blood Velocity Using Continuous Wave Doppler During Hemodynamic Changes Following Blood Loss and Fluid Replacement
Assessing Alterations in Carotid Blood Velocity Using Continuous Wave Doppler During Fluid Loss and Following Fluid Replacement
- Hemoglobin (Hgb) level > 13.0g/dl for men and > 12.0g/dl for women.
- Body weight > 110lbs.
- Blood pressure (BP) > 90/50 mmHg (systolic/diastolic).
- Blood pressure (BP) < 180 mmHg (systolic) and 100mmHg (diastolic).
- Adults over the age of 18-50 years and who are willing and able to give informed consent.
- No known diseases (i.e., cardiovascular, pulmonary, diabetes, kidney).
- Non-smokers.
- Subjects underwent blood donation within 112 days.
- Hgb level < 13.0g/dl for men and < 12.0g/dl.
- Under the age of 18 or over 50 years.
- Subjects who have severe hypotension (SBP < 90mmHg).
- Subjects who have severe hypertension (SBP > 180mmHg) and/or (DBP > 100mmHg).
- Current smokers.
- Obesity (BMI > 38kg/m^2).
- Women who are known to be pregnant or plan to become pregnant within the course of this study.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/17/23. Questions regarding updates should be directed to the study team contact.
Evaluation of blood-based Alzheimer's Disease biomarkers in patients undergoing Lecanemab treatment
Blood-based Alzheimer's Disease Biomarkers in Patients Undergoing Lecanemab Treatment
-
Patients that are enrolling on Lecanumab infusion treatment.
- Patient not enrolled in Lecanumab infusion treatment.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 7/12/23. Questions regarding updates should be directed to the study team contact.
Noninvasive assessment of portal hypertension and hepatic interstitial pressure with advanced magnetic resonance elastography (MRE)
Noninvasive Study of Portal Hypertension and Hepatic Interstitial Pressure With Advanced MRE
- Age ≥ 18 years.
- Diagnosis of primary liver diseases.
- Diagnosis of suspected portal hypertension.
- Patients undergoing endoscopy (EGD) exam; OR
- Patients undergoing follow-up EGD exams in compliance with the practice guideline and clinical indication; OR
- Patients undergoing transjugular hepatic venogram with hepatic venous pressure gradient (HVPG) measurement.
- Age < 18 years.
- History of liver transplantation or hepatic resection
- History of splenectomy.
- Absolute contraindications to MRI, including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, a deep brain stimulator, and severe claustrophobia.
- Women who are pregnant or breastfeeding.
- Any severe medical condition that, in the opinion of the Principal Investigator, would serve as exclusion criteria for study enrollment.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.
Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study (LCN RESCU)
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
1. Age 18-75 years
2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or
chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus), or cryptogenic cirrhosis
3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the
following:
1. At least one liver biopsy within 5 years prior to consent showing either: Metavir
stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
2. At least 2 of the following:
i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized
umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled
transient elastography within 48 weeks prior to consent or during Screening ≥ 12.5
kilopascal or magnetic resonance elastography within 48 weeks prior to consent or
during Screening ≥ 5 kilopascal iii. Evidence of varices demonstrated on imaging or
endoscopy within 3 years prior to consent or during Screening iv. Either:
Fibrosis-4>2.67 or platelets <150/mL within 6 months prior to consent or during
Screening
4. Two measures of vibration-controlled transient elastography: one at screening and one
at the randomization study visit, meeting the following criteria:
1. The first measure must be ≥ 12.5 kilopascal.
2. The two measures must be at least 1 day apart and no more than 60 days apart from
one another.
3. The mean of two measurements must be ≥ 12.5 kilopascal.
5. Compensated defined by:
1. Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
currently or in the last 48 weeks, as determined clinically by investigator.
2. If prior history of decompensation, must be without current symptoms of
decompensation and no longer requiring treatment of complications for the last 48
weeks, including the use of diuretics for the treatment of ascites, and/or
rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of
non-selective beta blockers will be allowed.
3. Child-Pugh score < 8
6. Provision of written informed consent.
1. Currently on a statin or any statin exposure within 48 weeks prior to consent.
2. Known indication for statin therapy, defined as:
1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which
statins are indicated for secondary prevention, OR
2. Documented familial hypercholesterolemia, heterozygous familial
hypercholesterolemia, OR
3. Fasting LDL-C ≥ 190 mg/dL
4. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24
weeks of screening.
3. Alcohol Use Disorder Identification Test (AUDIT) score of ≥8. 4. Patients with
limitations in attending study visits. 5. Prisoners. 6. Known prior or current
hepatocellular carcinoma (HCC) or cholangiocarcinoma. 7. Known transjugular intrahepatic
portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or
porto-systemic shunt surgery regardless of time of occurrence.
8. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic
fibrogenesis or confound endpoint assessment, defined as:
1. amiodarone
2. methotrexate
3. warfarin 9. Current (in past 24 weeks prior to consenting) use of medications which
may increase risk for rosuvastatin-related myositis or drug-induced liver injury,
defined as:
a. fenofibrate b. erythromycin c. gemfibrozil d. niacin (500 mg or more) e. HIV protease
inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
f. colchicine g. cyclosporin 10. Presence of portal or hepatic vein thrombosis 11.
Receiving an elemental diet or parenteral nutrition 12. Chronic pancreatitis or pancreatic
insufficiency 13. Etiology of cirrhosis other than alcohol-associated liver disease, NAFLD,
viral hepatitis or cryptogenic (including immune-mediated such as autoimmune hepatitis,
primary sclerosing cholangitis and primary biliary cholangitis, cardiac cirrhosis or
Fontan-associated liver disease, alpha-1-anti-trypsin, Wilson's disease, etc) 14.
Conditions which may confound study outcome:
a. Unstable or active inflammatory bowel disease b. Active infection c. Any malignant
disease (other than squamous or basal cell carcinoma of the skin) within previous 5 years
d. Prior solid organ or hematopoietic cell transplant e. Bariatric surgery in the last 24
weeks prior to consent or planned bariatric surgery within the next 96 weeks f. Current
liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage
3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on
home oxygen.
15. Known current medical or psychiatric conditions which, in the opinion of the
investigator, would make the participant unsuitable for the study for safety reasons or
interfere with or prevent adherence to the protocol.
16. The following laboratory abnormalities within 90 days of screening:
1. Absolute neutrophil count <1.0 x 109 / L
2. Hemoglobin <10 g/dL
3. Albumin <3.0 g/dL
4. Prolonged international normalized ratio (INR) >1.5
5. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted
by normal direct bilirubin fraction)
6. Uncontrolled diabetes (HbA1c ≥ 9.0%) within past 24 weeks 17. Kidney function
abnormalities including:
a. Dialysis b. Baseline epidermal growth factor receptor < 30 cc/min with chronic kidney
disease-Epi equation c. Known nephrotic proteinuria, defined as 3g or greater of protein in
24-hour urine collection 18. Recent (within 48 weeks) or present hepatic decompensation
with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding 19. Untreated chronic
hepatitis B or C infection
1. Hepatitis C virus eligible for enrollment if hepatitis C virus RNA negative and after
sustained virologic response at 24 weeks
2. Hepatitis B virus eligible if Hepatitis B virus DNA <100 IU/mL and on treatment 20.
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L
within the past 24 weeks 21. Documented history of intolerance to statins 22. Serious
co-morbid medical disease which in the investigator's opinion renders a
life-expectancy less than 96 weeks 23. Active illicit substance abuse, including
inhaled or injected drugs, in the 48 weeks prior to screening 24. Pregnancy, planned
pregnancy or breast-feeding 25. Current participation in active medication treatment
trials (within 24 weeks prior to randomization) or planned participation in active
medication treatment trials simultaneous to participation in present trial.
26. Significant existing muscle pain or tenderness as determined by a site physician.
27. Failure or inability to provide informed consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/19/23. Questions regarding updates should be directed to the study team contact.
GLYcemic Control Evaluation by continuous glucose Monitor compared with a1C in Left Ventricular Assist Device-supported patients (GLYCEM1C-LVAD)
Left Ventricular Assist Device Glycemic Control Evaluation by Continuous Glucose Monitor Compared With a1c
- At least 18 years of age.
- Previous diagnosis of type II diabetes mellitus on antihyperglycemics.
- Cell phone capable of uploading glycemic data through the Libre 3 app.
- Willing to give informed consent.
- Type I diabetes mellitus.
- Unable to return at 3 month evaluation.
- Unwillingness to provide informed consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/14/22. Questions regarding updates should be directed to the study team contact.
A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve (MOMENTIS)
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
- 18 years or older at the time of informed consent
- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- Provides written informed consent
- Willingness to follow protocol requirements
- Active endocarditis 3 months prior to the procedure
- Stage 4 renal disease or requiring dialysis
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- High predicted risk of mortality prior to procedure
- Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or
- Surgeon estimated risk of mortality of > 8
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/22/23. Questions regarding updates should be directed to the study team contact.
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
- PRIOR TO STEP 1 REGISTRATION INCLUSION:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell
carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth
(FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge,
retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration
- Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC]
8th edition [ed.]) based on the following diagnostic workup:
- History/physical examination within 42 days prior to registration
- Imaging of head and neck within 42 days prior to registration
- PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic
resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic
quality CT is preferred and highly recommended for the PET/CT when possible.
- Imaging of chest within 42 days prior to registration; chest x-ray, CT chest
scan (with or without contrast) or PET/CT (with or without contrast)
- Surgical assessment within 42 days prior to registration. Patient must be a candidate
for surgical intervention with sentinel lymph node (SLN) biopsy and potential
completion neck dissection (CND) or elective neck dissection (END)
- Surgical resection of the primary tumor will occur through a transoral approach
with anticipation of resection free margins
- Zubrod performance status 0-2 within 42 days prior to registration
- For women of child-bearing potential, negative serum or urine pregnancy test within 42
days prior to registration
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry
- Only patients who are able to read and understand English are eligible to participate
as the mandatory patient reported NDII tool is only available in this language
- PRIOR TO STEP 2 RANDOMIZATION:
- FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be
submitted for central review.
- PET/CT node negative patients, determined by central read, will proceed to
randomization.
- PET/CT node positive patients will go off study, but will be entered in a
registry and data will be collected to record the pathological outcome of neck
nodes for diagnostic imaging assessment and future clinical trial development
- NOTE: All FDG PET/CT scans must be performed on an American College of
Radiology (ACR) accredited scanner (or similar accrediting organization)
- The patient must complete NDII prior to step 2 registration
- PRIOR TO STEP 1 REGISTRATION EXCLUSION:
- Definitive clinical or radiologic evidence of regional (cervical) and/or distant
metastatic disease
- Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer,
including effectively treated basal cell or squamous cell skin cancer, or carcinoma in
situ of the breast or cervix) unless disease free for ≥ 2 years
- Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx,
nasopharynx, hypopharynx, and larynx
- Unable or unwilling to complete NDII (baseline only)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Patient with severe, active co-morbidity that would preclude an elective or completion
neck dissection
- Pregnancy and breast-feeding mothers
- Incomplete resection of oral cavity lesion with a positive margin; however, an
excisional biopsy is permitted
- Prior surgery involving the lateral neck, including neck dissection or gross injury to
the neck that would preclude surgical dissection for this trial. Prior thyroid and
central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious
nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be
biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy
- Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic
leukemia [CLL]) or other active disease capable of causing lymphadenopathy
(sarcoidosis or untreated mycobacterial infection)
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte
or immunomodulatory therapy
- Currently participating in another investigational therapeutic trial
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/8/23. Questions regarding updates should be directed to the study team contact.
A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial (EASE SBS 3)
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
- Informed consent obtained before any trial-related activity
- Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)
- Any condition, disease, or circumstance that in the Investigator's opinion would put
the patient at any undue risk, prevent completion of the trial, or confound the
planned assessments of the trial
- Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with
remnant colon). Note. The results of the colonoscopy must not give rise to any safety
concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving
rise to any safety concerns is accepted. For patients with a remnant colon, which is
not connected to the passage of foods and is thereby dormant, a computerized
tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the
discretion of the Investigator
- Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4)
inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of
glepaglutide trial drug is allowed
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become
pregnant, or are not using highly effective contraceptive methods
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/9/23. Questions regarding updates should be directed to the study team contact.
DelIVery for Pulmonary Arterial Hypertension (PAH) Continued Support Study
Ongoing Support for Pump Refills in the DelIVery for Pulmonary Arterial Hypertension Study
- Patient is currently enrolled in the DelIVery for PAH Study (G100017).
- The physician and patient determine that continued use of the PIVoT system is medically advisable.
- Patient is willing to sign and date the Patient Informed Consent Form.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.
Exposure of mucocutaneous separation of fecal and urinary stomas into the opening of the solid skin barrier (wafer).
Cutting the Solid Skin Barrier to Expose the Mucocutaneous Separation Into the Opening of the Solid Skin Barrier
- Adults aged 18 to 90.
- Living in the United States.
- Having had ostomy creation surgery within the past 30 days.
- Having a diagnosis of mucocutaneous separation.
- Patients with diagnosed or suspected pyoderma gangrenosum, current malignancy at the stoma site by medical record review.
- Participants with documented dementia or evident cognitive impairment on screening interview.
- Participants currently intubated as these conditions change the ability of participants to participate in their ostomy self-care.
- Those who do not read or write English.
- Patients younger than 18 years of age and older than 90 years of age.
- Any mucocutaneous separation that includes tunneling.
- Any patient having a skin sensitivity or allergy to an ostomy product that would necessitate use of a nonadhesive pouching system for treatment.
- Patients with a silver allergy.
- A separation with measurements too small to quantify on the study measuring guide (< 0.5 sq. cm).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/14/23. Questions regarding updates should be directed to the study team contact.
First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (AMPLIFY-7P)
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
- KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor.
- Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery
and chemotherapy/radiation therapy where applicable.
- Screening CT is negative for recurrent disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Presence of tumor mutations where specific therapy is approved.
- Known brain metastases.
- Use of immunosuppressive drugs.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/19/23. Questions regarding updates should be directed to the study team contact.
Effect of breathing pattern on resting limb hemodynamics
Breathing Pattern Effect on Resting Limb Hemodynamics
- 18 years of age and older.
- Without current, confounding cardiorespiratory, metabolic, or musculoskeletal conditions.
- < 18 years of age.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.
Assessing the longitudinal changes in islet function during pregnancy
Longitudinal Changes in Islet Function During Pregnancy
- Subjects will be recruited 1 year from their most recent live birth.
- 30 with GDM in the preceding pregnancy.
- 30 with no history of GDM.
- Individuals < 20 or > 40 years at the preceding pregnancy.
- Active systemic illness.
- Preceding multiple gestation pregnancy.
- Taking medication that affects glucose metabolism.
- Upper GI surgery that alters gastric emptying.
- Current BMI < 25kg/m^2.
- For the GDM group, those with GDM in any pregnancy prior to the most recent pregnancy will be excluded (to reduce within group heterogeneity)
- Currently pregnant or breastfeeding.
Eligibility last updated 4/13/23. Questions regarding updates should be directed to the study team contact.
Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial
Ultrahigh Dose Diuretics Compared to Standard Dose Over 24 Hours in Decompensated Heart Failure
- Age ≥ 18 years.
- Diagnosis of decompensated heart failure receiving intravenous diuretics.
- Ability to provide informed consent.
- Patients on home inotrope medications.
- Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis.
- Patients lacking the capacity to consent for themselves.
- Known pregnancy or breastfeeding mothers.
- Complex congenital heart disease.
- Allergy to furosemide or bumetanide.
- Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support.
- Hypotension with systolic blood pressure < 90 mm Hg.
- Acute coronary syndrome.
- Ventricular tachycardia in the last 48 hours.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.
Coronary Artery Calcium in PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults
- Enrolled in PREVENTABLE.
- Agree to have a historical non-contrast chest CT scan submitted and analyzed.
- None.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/14/23. Questions regarding updates should be directed to the study team contact.
A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock (TIGRIS)
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
1. Age ≥18 years of age.
2. Hypotension requiring vasopressor support: Requirement for at least one of the
vasopressors listed below, at the dose shown below, for at least 2 continuous hours
and no more than 30 hours:
- Norepinephrine > 0.05mcg/kg/min.;
- Dopamine > 10 mcg/kg/min.;
- Phenylephrine > 0.4 mcg/kg/min.;
- Epinephrine > 0.05 mcg/kg/min.;
- Vasopressin > 0.03 units/min.;
- Vasopressin (any dose) in combination with another vasopressor listed above.
3. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg
administered within 24 hours of eligibility.
4. Documented or suspected infection defined as definitive or empiric intravenous
antibiotic administration.
5. The subject must have a screening multi-organ dysfunction score (MODS) > 9 OR a
sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be
obtained due to missing measurements.
6. Endotoxin Activity Assay between ≥ 0.60 to <0.90 EA units.
7. Evidence of at least 1 of the following criteria for new onset organ dysfunction that
is considered to be due to the acute illness:
- Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube;
- Thrombocytopenia defined as acute onset of platelet count < 150,000µ/L or a reduction of 50% from prior known levels;
- Acute oliguria defined as urine output < 0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation.
1. Inability to obtain an informed consent from the subject, family member or an
authorized surrogate.
2. Lack of commitment for full medical support.
3. Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg
despite vasopressor therapy and fluid resuscitation.
4. Subject has end-stage renal disease and requires chronic dialysis.
5. There is clinical support for non-septic shock such as:
- Acute pulmonary embolus;
- Transfusion reaction;
- Severe congestive heart failure (e.g., NYHA Class IV, ejection fraction < 35%).
6. Subject has had chest compressions as part of CPR during this hospitalization without
immediate return to communicative state.
7. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks.
8. Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24
hours).
9. Major trauma within 36 hours of screening.
10. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or
severe thrombocytopenia (platelet count less than 30,000 cells/mm^3).
11. HIV infection in association with a last known or suspected CD4 count of < 50/mm^3.
12. Subject's baseline state is non-communicative.
13. Subject has sustained extensive third-degree burns within the past 7 days.
14. Body weight < 35 kg (77 pounds).
15. Known hypersensitivity to Polymyxin B.
16. Subject has known sensitivity or allergy to heparin or has a history of heparin
associated thrombocytopenia (H.I.T.).
17. Subject is currently enrolled in an investigational drug or device trial.
18. Subject has been previously enrolled in the current trial.
19. Any other condition, that in the opinion of the investigator, would preclude the
subject from being a suitable candidate for enrollment, such as end-stage chronic
illness (e.g., lack of source control and bowel necrosis) with no reasonable expectation
of survival to hospital discharge.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/3/22. Questions regarding updates should be directed to the study team contact.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) (POETYK SLE-2)
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
- Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the
screening visit
- Meet the European Alliance of Associations for Rheumatology (EULAR)/American College
of Rheumatology (ACR) 2019 classification criteria for SLE
- One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR
positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central
laboratory at screening
- Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6
points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or
cutaneous vasculitis, and/or rash
- Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry
- At least one SLE background therapy(immunosuppressant and/or antimalarial) is required
for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks
before the screening visit, and must remain stable until randomization and throughout
study participation
- Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted
but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks
before the screening visit, cannot exceed 30 mg/day at screening, and must remain
stable until the Week 4 visit. Participants can be on an OCS as well as an
antimalarial and/or an immunosuppressant
- Diagnosis of drug-induced SLE rather than idiopathic SLE
- Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel
disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus,
thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not
excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis,
scleroderma, and mixed connective tissue disease are excluded
- Active or unstable lupus neuropsychiatric manifestations, including, but not limited
to, any condition defined by BILAG A criteria
- Active, severe Class III, and IV, lupus nephritis that requires or may require
treatment with cytotoxic agents or high-dose CS
- History of congenital or acquired immunodeficiency
- Known active infection, or any major episode of infection requiring hospitalization or
treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics
antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or
treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on
any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus,
invasive bacterial or fungal infections, or atypical mycobacteria)
- Taking more than 1 immunosuppressant at screening
- In Japan only: Participants with positive result of ?
•D-glucan assay
Other protocol-defined inclusion/exclusion criteria apply
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/20/23. Questions regarding updates should be directed to the study team contact.
Evaluation of a new point-of-care ultrasound system for the non-invasive assessment of liver steatosis and fibrosis.
Non-invasive Assessment of Liver Steatosis and Fibrosis New Point-Of-Care Ultrasound System Evaluation
- Patients from 18 to 80 years of age.
- Patients at risk of NAFLD-NASH referred to hepatology specialists by their referring physician for further investigation, with or without a liver biopsy.
- Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials.
- Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation.
- Patients under 18 years of age or over 80 years of age.
- Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients’ skin.
- Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures.
- Pregnant and breastfeeding women.
- People deprived of their freedom rights.
- People who have been hospitalized without giving informed consent or under emergency situation.
- People admitted in a social or sanitary institution for other reasons than the Clinical Investigation.
- Patients included in another research study that could interfere with the present Clinical Investigation.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/20/23. Questions regarding updates should be directed to the study team contact.
Impact of aromatase inhibitor therapy on glucose homeostasis and diabetes risk
Aromatase Inhibitor Therapy Impact on Glucose Homeostasis and Diabetes Risk
- Women aged 18-85.
- Women with non-metastatic breast cancer.
- Further stratification will be done based on aromatase inhibitor therapy use.
- Established diagnosis of diabetes,
- Therapy with anti-hyperglycemic medications that could affect glucose metabolism.
- Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%.
- History of bariatric or similar malabsorptive surgery.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/30/23. Questions regarding updates should be directed to the study team contact.
Artificial Intelligence enhanced detection of dyskalemia in the hospital setting
Artificial Intelligence Enhanced Detection of Hospitalized Dyskalemia
- Age ≥ 18 years and able to provide consent (for prospective portion).
- Patients under age 18 and patients unable to provide consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/8/23. Questions regarding updates should be directed to the study team contact.
The Effect of Synaquell™ on Objective Measures of Brain Health in Male and Female Youth Contact Sport Athletes.
The Effects of Synaquell™ on Brain Function in Youth Contact Sport Athletes
- 13 to 19 years of age.
- Fluent English speakers.
- Medically cleared to play contact sport.
- An allergy to the ingredients of Synaquell™ or the placebo (ingredients listed on page 3).
- Clinically documented hearing issues.
- In-ear hearing aid or cochlear implant.
- Metal or plastic implants in skull.
- Lack of verbal fluency in the English language.
- History of seizures.
- Allergy to rubbing alcohol or EEG gel.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.
Evaluation of Temperature Elevation during Total Knee Arthroplasty: A Pilot Study
Temperature Elevation During Total Knee Arthroplasty
- Adults aged ≥ 18 years undergoing primary, robotic, total knee arthroplasty for a primary underlying diagnosis of osteoarthritis.
- Age < 18 years.
- Revision or partial total knee arthroplasty.
- Manual total knee arthroplasty.
- Primary TKA requiring hardware removal.
Eligibility last updated 6/30/23. Questions regarding updates should be directed to the study team contact.
Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
Accelerated Resolution Therapy for Early Maladaptive Grief
- Primary caregiver of immediate family member who has a life expectancy of less than 12 months.
- Score of 60 or higher on the Marwit-Meuser Caregiver Grief Inventory, indicating clinically significant pre-loss grief.
- Symptoms of significant psychological trauma (DSM-5 PTSD checklist (PCL-5) score > 33).
- Denial of suicidal ideation or intent, with no evidence of psychotic behavior.
- Since becoming a family caregiver (FCG), they have engaged in another trauma based psychotherapeutic regimen (EMDR, prolonged exposure therapy, trauma focused cognitive behavioral therapy) that could influence response to accelerated resolution therapy (ART).
- Self-reported or clinically assessed major psychiatric disorder (e.g., bipolar disorder, schizophrenia).
- Score of > 2 on the adapted CAGE questionnaire indicating alcohol /drug dependence.
- Cognitive impairment (SPMSQ > 4 errors).
Eligibility last updated 3/7/23. Questions regarding updates should be directed to the study team contact.