Testing for Monoclonal Proteins by Blood Spot and Saliva
Monoclonal Proteins by Blood Spot and Saliva
- Adult patients ≥ 18 years old.
- Diagnosed with plasma cell disorders.
- Children < 18 years old.
- Pregnant females.
Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.
The Effect of Synaquell on Objective Brain Function Measures in Youth Ice Hockey Players
The Effects of Synaquell on Brain Function of Ice Hockey Players
- 18 years of age or greater.
- Fluent English speakers.
- Medically cleared to play ice hockey.
- An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine,
- Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside,
- Docosahexanoic Acid).
- Clinically documented hearing issues.
- In-ear hearing aid or cochlear implant.
- Implanted pacemaker or defibrillator.
- Metal or plastic implants in skull.
- Lack of verbal fluency in the English language.
- History of seizures.
- Allergy to rubbing alcohol or EEG gel.
- Unhealthy scalp.
Eligibility last updated 4/11/22. Questions regarding updates should be directed to the study team contact.
STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon
STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
- Age 14-25.
- An ACL-deficient knee.
- Skeletal maturity (i.e., closed epiphyseal growth plates on standard knee radiographs).
- At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score
of ≥ 4) and/or genu recurvatum > 10 degrees.
- Previous ACLR on either knee.
- Partial ACL injury (defined as one bundle ACL tear requiring
reconstruction/augmentation of the torn bundle with no surgery required for the intact
- Multiple ligament injury (two or more ligaments requiring surgery).
- Symptomatic articular cartilage defect requiring treatment other than debridement.
- > 3 degrees of asymmetric varus.
- Inflammatory arthropathy.
- Inability to provide consent.
- Pregnancy at baseline.
Eligibility last updated 9/23/22. Questions regarding updates should be directed to the study team contact.
Early Naturalistic Hands-on Autism Caregiver Training (ENHAnCE) Study (ENHANCE)
Early Naturalistic Hands-on Autism Caregiver Training
- Children diagnosed with autism spectrum disorder (ASD).
- Between 2 years, 0 months to 4 years, 11 months of age.
- With less than phrased speech.
- Child must have at least one caregiver willing to participate in the study.
Children and parents if they do not meet the above inclusion criteria.
Ph.1, Open-Label, Dose Escalation & Expansion for Safety, Tolerability, PK, & Anti-Tumor Activity of STP707 Administered IV in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy.
Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors
1. Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy.
2. Measurable disease per RECIST v 1.1 (primary or metastatic disease).
3. ECOG performance status 0
4. Life expectancy of at least 3 months.
5. Age ≥ 18 years.
6. Signed, written Institutional Review Board (IRB) approved informed consent
7. A negative serum pregnancy test (for nonsterile women of child-bearing potential).
8. Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal;
- AST (SGOT), ALT (SGPT) ≤ 5 times upper limit of normal because of cancer or metastases to the liver.
9. Acceptable renal function, defined as:
o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 50 mL/minute.
10. Acceptable hematologic status:
- Hemoglobin ≥ 9 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter);
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3;
- Platelet count ≥ 100,000 plt/mm^3 x 10^9/ L.
11. Urinalysis with no clinically significant abnormalities.
12. Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤ 1.5 times upper limit of normal unless patient is on anti-coagulants and has stable PTT and PT that are within normal therapeutic range for disease under management.
13. Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL. If subjects are below this threshold, they may receive
vitamin D supplementation se per clinic dosing guidelines and may still be enrolled provided they are started on vitamin D supplementation.
14. Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening.
15. For men and women of child-producing potential, the use of effective contraceptive methods during the study.
1. Baseline Q-T corrected interval (QTc) interval of > 470 msec for all subjects calculated using Fridericia's formula.
2. New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/ peripheral artery bypass graft, congestive heart failure within the past 6 months.
3. Known active, uncontrolled infection with HIV or hepatitis B; subjects with hepatitis B allowed if on anti-viral therapy and have a viral load ≤ 500 IU; patients with a history of HIV must be on antiretroviral therapy for at least four weeks and have an HIV viral load ≤ 400 copies/mL, have CD4+ T cell counts ≥ 350 cells/uL and no history of AIDS-defining opportunistic infections within 3 months prior to treatment.
4. Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure, during the course of the study.
Note: Placement of a central venous access catheter(s) (e.g., port or similar) is not
considered a major surgical procedure.
5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
6. Pregnant or nursing women.
Note: Women of child-bearing potential and men must agree- to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
7. Participation in a clinical study involving administration of an investigational compound within the past 30 days prior to study entry.
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Known allergy or hypersensitivity to the study drug(s) or one of the ingredients in the formulation (e.g., Trehalose dihydrate).
10. Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism
or excretion of the drug.
Eligibility last updated 4/11/22. Questions regarding updates should be directed to the study team contact.
RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study (NAUTILUS)
RNS® System NAUTILUS Study
- Participant is age 12 and older.
- Participant is male or is a female of childbearing potential who is surgically
sterile, 2 years postmenopausal, or practices a reliable method of contraception
(hormonal, barrier method or abstention).
- Participant failed treatment with a minimum of two antiseizure medications (used in
appropriate doses) with adequate monitoring of compliance and the effects of
treatment, as determined by the investigator.
- Participant is able to maintain an electronic diary alone or with the assistance of a
- Participant is able to attend clinic appointments in accordance with the study
- Participant or parent(s) or legal representative have signed an IRB approved written
informed consent/assent. The informed consent form or specific assent form, where
required, will be signed and dated by minors.
- Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
- In the investigator's opinion, participant is able to tolerate a neurosurgical
- Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing
primary generalized tonic-clonic seizures, with or without myoclonic or absence
seizures, consistent with the International League against Epilepsy Revised
Classification of Seizures (2017).
- Participant has had 2 or more generalized tonic-clonic seizures during the two month
- Participant has had a routine electroencephalogram (EEG) within 2 years prior to
enrollment with electroencephalographic features consistent with idiopathic
generalized epilepsy; other concomitant anomalies must be explained by adequate past
- Participant has been on a stable antiseizure medication (ASM) regimen during the two
month retrospective baseline and is willing to remain on a stable ASM regimen during
the prospective Baseline and throughout the Effectiveness Evaluation Period, if
medically possible; rescue benzodiazepine medications for acute seizure clusters are
- Participant has undergone computed tomography (CT) or magnetic resonance imaging (MRI)
within 10 years prior to enrollment that ruled out a progressive cause of epilepsy or
an abnormality likely to be associated with focal-onset seizures.
- Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant's
VNS is OFF during the two month retrospective baseline and participant is willing to
keep the VNS off during the study.
- Participant is pregnant.
- Participant is participating in a therapeutic investigational drug or other device
- Participant is implanted with an electronic medical device that delivers electrical
energy to the brain.
- Participant requires procedures that are contraindicated based on current RNS System
- Participant has been diagnosed with active psychosis, major depression or suicidal
ideation in the preceding year. Participants with post-ictal psychiatric symptoms need
not be excluded.
- In the opinion of the investigator, the participant has a clinically significant or
unstable medical condition (including alcohol and/or drug abuse) or a progressive
central nervous system disease.
- Participant has a history of partial-onset seizures or EEG findings within the past 2
years indicative of partial-onset or symptomatic generalized abnormalities.
- Participant has been diagnosed with psychogenic or non-epileptic seizures in the
- Participant has experienced unprovoked status epilepticus in the preceding year.
- Participant is taking any anticoagulants.
Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose-Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed With Cirrhosis With Ascites Who Have Developed Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI)
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
- Signed informed consent form (ICF) by participant or their legal/authorized representatives.
- Diagnosed with decompensated cirrhosis with ascites.
- Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days prior to randomization into the study.
- Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.
- No sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin.
- Female participants must have a negative pregnancy test prior to randomization and agree to avoid becoming pregnant during the study and for 30 days after the end of
treatment. Male participants must agree to use 2 effective contraceptive methods during the study and up to 30 days after the end of treatment.
- Serum Creatinine > 3.8 mg/dL.
- Large volume paracentesis (LVP ≥ 6L) within 4 days of randomization.
- Pulse oximeter reading of < 90% on 2L or less.
- Sepsis and/or uncontrolled bacterial infection.
- Experienced shock within 72 hrs prior to screening.
- Model for End-Stage Liver Disease (MELD) score > 35.
- Hypertension with a Systolic BP > 140 mmHg and/ or a Diastolic BP >100 mmHg.
- Treated with or exposed to nephrotoxic agents or has had exposure to radiographic contrast agents within 72 hrs prior to screening.
- Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic hepatitis.
- Proteinuria greater than 500 mg/dL.
- Impaired cardiac function as evidenced by symptoms consistent with New York Heart Association Classification Class 2 or worse.
- Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.
- Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).
- Pregnant or breastfeeding.
- Diagnosed with a malignancy within the past 5 years.
- History or current evidence of any condition (COVID-19 positive with respiratory/cardiac complications), therapy or laboratory abnormality that might confound the results of the study, interfere with the participation for the full duration of the study, or is not in the best interest to participate in the opinion of the investigator.
- Participated in a study of an investigational medical product or device within the last 8 weeks preceding screening.
- Experienced a major blood loss (≥ 500 mL) within the last 4 weeks prior to screening.
- Is stuporous or comatose at screening (West Haven scores III and IV) exhibiting bradycardia.
Eligibility last updated 3/8/23 to match clinicaltrials.gov. Questions regarding updates should be directed to the study team contact.
A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
- Clinical or mutational diagnosis of TSC consistent with (Northrup and Krueger, 2013):
- Molecular confirmation of a pathogenic mutation in TSC1 or TSC2. A pathogenic mutation is defined as a mutation that clearly prevents protein synthesis and/or inactivates the function of the TSC1 or TSC2 proteins (e.g., nonsense mutation or frameshift mutations, large genomic deletions) or is a missense mutation whose effect on protein function has been established by functional assessment. The PI or designee must review the results of the genetic analysis and confirm that the causal relationship to the epilepsy syndrome is likely; OR
- Clinical diagnosis of definite TSC which includes 2 major features or 1 major feature with ≥ 2 minor features.
- Major features:
- Hypomelanotic macules (≥ 3, at least 5-mm diameter);
- Angiofibroma (≥ 3) or fibrous cephalic plaque;
- Ungual fibromas (≥ 2);
- Shagreen patch;
- Multiple retinal hamartomas;
- Cortical dysplasiasa;
- Subependymal nodules;
- Subependymal giant cell astrocytomas;
- Cardiac rhabdomyoma;
- Lymphangioleiomyomatosis (LAM)**;
- Angiomyolipomas (≥ 2)**.
- Minor features:
- “Confetti” skin lesions;
- Dental enamel pits (≥ 3;
- Intraoral fibromas (≥ 2) Retinal achromic patch Multiple renal cysts Nonrenal hamartomas.
* Includes tubers and cerebral white matter radial migration lines.
** A combination of the 2 major clinical features (LAM and angiomyolipomas) without other features does not meet criteria for a definite diagnosis.
- The investigator must document which of the features (major or minor) fulfill the clinical diagnostic criteria. 2. Male or female participants aged 1 through 65 years, inclusive. 3. Participant/parent or LAR willing to give written informed consent/assent, after being properly informed of the nature and risks of the study and prior to engaging in any studyrelated procedures. 4. Assent for participants over 7 years of age should be obtained if appropriate. 5. Failure to control seizures despite appropriate trial of 2 or more AEDs at therapeutic doses and for adequate duration of treatment per PI judgment. 6. Participants should be on a stable regimen of AEDs (including moderate or strong inducer or inhibitor anti-seizure medications eg, carbamazepine, phenytoin, etc.) at therapeutic doses for ≥ 28 days prior to the screening visit, and without a foreseeable change in dosing for the duration of the study. (Note: Minor dose adjustment to address tolerability and safety events may be allowed on case-by-case basis and it should be discussed with the study medical monitor.) 7. A history of at least 8 countable seizures per month in the 2 months prior to screening with no more than 1 seizure free week in each month. 8. Have an average of at least 2 primary endpoint seizures per week in the 28 days following the screening visit. The primary endpoint seizure types are defined as the following:
- Focal motor seizures without impairment of consciousness or awareness;
- Focal seizures with impairment of consciousness or awareness with motor features;
- Focal seizures evolving to bilateral, tonic-clonic seizures.
- Generalized motor seizures including tonic-clonic, bilateral tonic, bilateral clonic, or atonic/drop seizures. Seizures that do not count towards the primary endpoint include:
- Focal aware seizures without motor features;
- Focal and generalized nonmotor seizures (e.g., absence or focal nonmotor seizures with or without impairment of awareness);
- Infantile or epileptic spasms;
- Myoclonic seizures.
- Participants with surgically implanted VNS will be allowed to enter the study provided that all of the following conditions are met:
- The VNS has been in place for ≥ 1 year prior to the screening visit;
- The settings must have remained constant for 3 months prior to the screening visit and are expected to remain constant throughout the study;
- The battery is expected to last for the duration of the study.
- Parent/caregiver or the participant, as appropriate, is able and willing to maintain an accurate and complete daily seizure eDiary for the duration of the study.
- Able and willing to take IP (suspension) as directed with food TID.
- Sexually active WOCBP must be using a medically acceptable method of birth control and have a negative quantitative serum β-HCG test collected at the initial screening visit. Childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for 1 month prior to the screening visit, surgical sterilization, or adequate double barrier methods (e.g., diaphragm or condom and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable method of birth control.
- Male participants must agree to take all necessary measures to avoid causing pregnancy in their sexual partners during the study and for 30 days after the last dose of IP. Medically acceptable contraceptives include surgical sterilization (such as a vasectomy) and a condom used with a spermicidal gel or foam.
- Note: The Epilepsy Study Consortium will review and classify all seizure types reported by the investigator, incorporating the medical history, genetic testing, seizure description, and historical records (including EEG, when available). This review and classification does not need to be completed prior to study entry but should be completed in parallel, and may complete after the participant has been enrolled in the study
- Previous exposure to GNX.
- Pregnant or breastfeeding.
- Participants who have been taking felbamate for less than 1 year prior to screening.
- Participants taking CBD preparations other than Epidiolex.
- A positive result on plasma drug screen for CBD or THC at Visit 1 (screening), with the exception of results that are fully explained by Epidiolex, which is being prescribed and managed by the investigator.
- Concurrent use of ACTH, prednisone or other glucocorticoid is not permitted, nor use of the strong inducers of CYP3A4, rifampin and St John’s Wort. Participants on ACTH, prednisone, or other systemically (non-inhaled or topical) administered steroids should be off the product > 28 days prior to screening. Rifampin and St John’s Wort must be discontinued at least 28 days before Visit 2, study drug initiation.
- Note: Use of concomitant intranasal or PRN topical steroids for dermatologic reactions and allergic rhinitis are allowed during the study;
- This exclusion criterion does not prohibit the use of approved AEDs.
- Changes in any chronic medications within the 4 weeks prior to the screening visit. All chronic concomitant medications must be relatively stable in dose for at least 4 weeks prior to the screening visit unless otherwise noted. Small dose adjustment to manage tolerability and safety events is permitted and should be discussed with the study medical monitor.
- Participants who have epilepsy surgery planned during the study or who have undergone surgery for epilepsy within the 6 months prior to screening.
- An active CNS infection, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive as evaluated by brain imaging (MRI). This includes tumor growth which in the opinion of the investigator could affect primary endpoint seizure control.
- Any disease or condition (medical or surgical; other than TSC) at the screening visit that might compromise the hematologic, cardiovascular (including any cardiac conduction defect), pulmonary, renal, gastrointestinal, or hepatic systems; or other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the IP, or would place the participant at increased risk or interfere with the assessment of safety/efficacy. This may include any illness in the past 4 weeks which in the opinion of the investigator may affect seizure frequency.
- Hepatic impairment sufficient to affect patient safety, or an AST/SGOT or ALT/SGPT > 3 × the ULN at screening or baseline visits and confirmed by a repeat test.
- Biliary impairment sufficient to affect patient safety, or total bilirubin levels > 1.5 × ULN at screening or baseline visit and confirmed by a repeat test. In cases of Gilbert’s Syndrome, resulting in stable levels of total bilirubin greater than ULN, the medical monitor can determine if a protocol exception can be made.
- Renal impairment sufficient to affect patient safety, or eGFR < 30 mL/min (calculated using the Cockcroft-Gault formula or Pediatric GFR calculator or Bedside Schwartz), will be excluded from study entry or will be discontinued if the criterion is met post baseline (Levey et al, 2006). Cases of temporary renal insufficiency should be discussed with the medical monitor to determine the participant’s study continuation.
- Exposed to any other investigational drug or investigational device within 30 days or fewer than 5 half-lives prior to the screening visit. For therapies in which half-life cannot be readily established, the Sponsor’s Medical Monitor should be consulted.
- Unwillingness to avoid excessive alcohol use throughout the study.
- Have active suicidal plan/intent, active suicidal thoughts or a suicide attempt in the past 6 months.
- Known sensitivity or allergy to any component in the IP(s), progesterone, or other related steroid compounds.
GUt Microbiome In Early and Established Scleroderma Study (The GUMIES study) (GUMMIES)
GUt Microbiome In Early and Established Scleroderma Study
- Age (years) ≥ 18.
- Able to provide Written Informed consent.
- Systemic sclerosis as defined by VEDOSS or ACR/EULAR 2013 Classification criteria.
- Individuals < 18 years.
- History of IBD (Crohn’s disease or ulcerative colitis), microscopic colitis, or celiac disease.
- Prior abdominal surgery (except hernia, fundoplication, C-section, hysterectomy, appendectomy, and cholecystectomy).
- Prior antibiotic use or new probiotic use in the last 2 weeks.
Pilot study to estimate a reduction of TAVR associated Conduction Disturbance through notification of Cara Monitor during TAVR procedure (CARA 2.0)
Cara CDRM (Conduction Disturbance Risk Monitor) 2.0
- Subject must be ≥ 18 years of age.
- Subject meets indications for TAVR using approved devices.
- The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Subject is willing to comply with specified follow-up evaluations.
- Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
- Patient with any implanted or have an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
- Any contraindication to the TAVR procedure according to the instructions for use.
- Subject is less than the legal age of consent, legally incompetent, or otherwise vulnerable.
- Patients who have a planned treatment with any other investigational device, drug or procedure (excluding registries) during the study period.
Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.
Bedside Confirmation of Intrauterine Contraception Using Point-of-Care Ultrasound
Using Point-of-Care Ultrasound for Bedside Confirmation of Intrauterine Contraception
Eligibility last updated [date of initial abstraction or last Mod]. Questions regarding updates should be directed to the study team contact.
68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy
Diagnostic 68Ga-PSMA-11 PET/CT
- An adult male patient who:
- Is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a Nuclear Medicine Physician or Radiologist in the Nuclear Medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB).
- Is acceptable to be potentially eligible for therapy but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future.
- Is acceptable to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer.
- Is eligible to be documented in the medical record by the clinical practice.
- Has not received a 68Ga-PSMA-11 PET/CT or PET/MR, or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility.
- Does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan.
- An adult above the age of 18.
- A patient who is:
- Under the age of 18.
- Unable to consent per Mayo guidelines.
- Unable to lay still, or otherwise successfully complete the imaging exam.
Eligibility last updated 4/15/22. Questions regarding updates should be directed to the study team contact.
A Phase 2, Randomized, Open-label Study of Encorafenib and Cetuximab Plus Pembrolizumab Versus Pembrolizumab Alone in Participants with Previously Untreated BRAF V600E-Mutant, MSI H/DMMR Metastatic Colorectal Cancer (SEAMARK)
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
- Locally confirmed microsatellite instability-high/ deficient mismatch repair
(MSI-H/dMMR) stage IV colorectal carcinoma
- Locally confirmed BRAF V600E mutation in tumor tissue or blood
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have not received prior systemic regimens for metastatic disease.
- Measurable disease per RECIST 1.1
- Adequate organ function
- Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is
- Known active central nervous system metastases and/or carcinomatous meningitis;
- Immunodeficiency or active autoimmune disease requiring systemic treatment in the past
- Presence of acute or chronic pancreatitis
- Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular
accident events ≤ 12 wks prior)
- Received a live or live-attenuated vaccine within 30 days of planned start of study
- Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib,
vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR)
inhibitor (eg, cetuximab, panitumumab).
- Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death
[PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Tracking Real-time Lung Physiology in Fighter Pilots
Real-time Lung Physiology in Fighter Pilots
- Healthy adults with no history of cardiac or respiratory related disease (no asthma).
- Similar demographics with USAF pilots – age ranges (20 to 50 years).
- BMI < 32 kg/m^2 – generally ovoid significant obesity although some variation in body habitus is good.
- Regularly active – no exercise limitations – orthopedic or other.
- Age under 20 or over 50 years.
Community Engagement to Address Disparities in Complex Care for Spanish-Speaking Patients with Limited English Proficiency
Disparities in Complex Care for Spanish-Speaking Patients with Limited English Proficiency
Either a community leader with insights and opinions about complex care among Spanish speaking populations or a patient, family member, caregiver with recent experience of complex care in hospital -greater than 10 day stay, within last 2-3 years, used an interpreter.
- Non-Spanish speaking.
- No leadership role or experience with complex care.
- < 18 years.
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® insulin lispro-aabc
Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc
- Age 2-80 years at time of screening.
- Has a clinical diagnosis of type 1 diabetes:
- 14–80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis;
- 7–13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis;
- 2-6 years of age: A clinical diagnosis of type 1 diabetes for 6 months or more, as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
- Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
- Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
- Subject and/or legally authorized representative is willing to provide informed consent for participation.
- Is willing to perform fingerstick blood glucose measurements as needed.
- Is willing to wear the system continuously throughout the study.
- Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
- Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
- Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
- Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range, the Free T3 is below or within the lab’s reference range and Free T4 is within the normal reference range.
- Uses pump therapy prior to screening:
- 7-80 years of age: greater than 6 months prior to screening (with or without CGM experience);
- 2-6 years of age: greater than 3 months prior to screening (with or without CGM experience).
- Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
- Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations as required during the run-in period: a. Humalog (insulin lispro injection) b. NovoLog (insulin aspart injection).
- Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).
- Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®.
- Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization);
- Seizures. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
- Has had DKA in the last 6 months prior to screening visit.
- Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Is female of child-bearing potential and result of pregnancy test is positive at screening.
- Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
- Is female and plans to become pregnant during the course of the study.
- Is being treated for hyperthyroidism at time of screening.
- Has diagnosis of adrenal insufficiency.
- Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoid during the course of the study.
- Is using hydroxyurea at time of screening or plans to use it during the study.
- Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
- Is currently abusing illicit drugs.
- Is currently abusing marijuana.
- Is currently abusing prescription drugs.
- Is currently abusing alcohol.
- Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
- Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
- Has elective surgery planned that requires general anesthesia during the course of the study.
- Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
- Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
- Is diagnosed with current eating disorder such as anorexia or bulimia.
- Has been diagnosed with chronic kidney disease that results in chronic anemia.
- Has a hematocrit that is below the normal reference range of lab used.
- Is on dialysis.
- Has serum creatinine of > 2 mg/dL.
- Has celiac disease that is not adequately treated as determined by the investigator.
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
- Has had history of cardiovascular event 1 year or more from the time of screening without:
- a normal EKG and stress test within 6 months prior to screening or during screening; or
- clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
- Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:
- Age > 35 years;
- Type 1 diabetes of > 15 years’ duration;
- Presence of any additional risk factor for coronary artery disease;
- Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria);
- Presence of peripheral vascular disease;
- Presence of autonomic neuropathy.
- Is a member of the research staff involved with the study.
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients With Treatment-refractory Mycobacterium Avium Complex Lung Disease (MACrO2)
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
1. Male or female patients who are 18 years of age or older.
2. Willing and able to provide written informed consent.
3. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all
of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria:
1. Microbiological criteria:
- One Pre-Study MAC-positive respiratory specimen. Documentation of a MAC
positive specimen collected per standard of care within 6 months of
- One Screening MAC-positive expectorated or induced sputum sample.
2. Clinical criteria: At least 2 of the following patient-reported clinical
- Cough with sputum production
- Cough without sputum
- Chest congestion
- Night sweats or unusual sweating
3. Radiographic criteria: Chest CT scan within 8 weeks prior to randomization with
abnormalities consistent with MAC lung disease.
4. Patients who are willing to comply with all the study activities and procedures
throughout the duration of the study and comply with all planned study visits and
study procedures from Screening through the LFU Visit.
5. All patients must agree to use an effective method of birth control.
6. Patients expected to survive with continued antimycobacterial therapy and appropriate
supportive care from Screening through the LFU Visit, in the judgment of the
1. Patients with a presence of any suspected or confirmed disease or condition at
Screening or the time of randomization that, in the opinion of the Investigator, may
confound the assessment of symptom-based clinical response.
2. Patients with active pulmonary malignancy or any malignancy that required or would
require chemotherapy or radiation therapy within 1 year prior to randomization through
the LFU Visit.
3. Patients with creatinine clearance (CrCl) of ≤50 mL/min, as estimated by the Cockcroft
Gault formula, at Screening or at the time of randomization.
4. Patients with hemoglobin <10.0 g/dL or <6.2 mmol/L at Screening; donation of blood or
plasma within 28 days prior to randomization; or symptomatic loss of blood or
hemorrhage within 28 days prior to randomization.
5. Patients with severe hemoptysis within 28 days prior to randomization, defined as >100
mL over any 24-hour period or severe or extremely severe hemoptysis.
6. Patients with severe hepatic impairment, as evidenced by alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN) or total
bilirubin >2 × ULN, or clinical signs of cirrhosis or end-stage hepatic disease.
7. Patients who are pregnant or breastfeeding.
8. Patients with a mean QT interval corrected using Fridericia's formula (QTcF) >480 msec
based on triplicate 12-lead ECGs at Screening.
9. Patients with an immunodeficiency or an immunocompromised condition and risk for an
opportunistic pulmonary infection.
10. Patients with an anticipated start of new non-study antimycobacterial therapy to be
administered at any time between Screening and Month 6.
11. Patients who have received any investigational medication during the 30 days or 5 half
lives, whichever is longer, prior to randomization.
12. Patients with any prior exposure to epetraborole.
13. Patients with any condition that, in the opinion of the Investigator, interferes with
the ability to safely complete the study or adhere to study requirements, including
the patient's inability or unwillingness to comply with all study assessments and
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/13/23. Questions regarding updates should be directed to the study team contact.
Cardio-Oncology Clinic Registry
Cardio-Oncology Clinic Registry
- Patients referred to the Mayo Clinic cardio-oncology clinic.
- Adults ≥ 18 years old.
- Individuals < 18 years old.
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
- Have advanced breast cancer or another solid tumor with the presence of a PIK3CA
H1047R mutation (or other Sponsor and SRC-approved, activating PIK3CA mutations other
than H1047R mutation).
- Have adequate archival tumor tissue sample available or be approved by the Sponsor for
enrollment if no tumor sample is available.
- Have stopped all cancer treatment and have recovered from the major side effects.
- Have adequate organ function, as measured by blood tests.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Patients must have:
- Measurable disease
- Patients with non-breast tumor types must have at least 1 measurable lesion.
- Non-measurable bone-only disease (breast cancer patients only).
For patients with an ER+ breast cancer diagnosis:
- If female, must be postmenopausal.
- If male, must agree to use hormone suppression.
- Dose escalation and backfill patients:
- Advanced solid tumor.
- Patients may have had up to 5 prior regimens.
- ER+/HER2- advanced breast cancer.
- Patients may have had up to 2 prior regimens for advanced disease.
- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy require
- ER+/HER2- advanced breast cancer.
- Patients may have had up to 2 prior regimens for advanced disease.
- ER+/HER2- advanced breast cancer.
- Patients may have had up to 5 prior regimens for advanced disease.
- Prior CDK4/6 inhibitor therapy required.
- Have a diagnosis of diabetes mellitus Type 2.
- Advanced breast cancer.
- Patients may have had up to 5 prior regimens for advanced disease.
- Advanced solid tumor.
- Patients may have had up to 3 prior regimens for advanced disease.
- Colorectal cancer.
- Endometrial cancers with specific concurrent oncogenic alterations.
- A history of known active or suspected.
- Diabetes mellitus Type 1 or
- Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all
parts of Phase 1b except Part C).
- Serious concomitant systemic disorder.
- Known or suspected history of untreated or uncontrolled central nervous system (CNS)
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or
other clinically significant active disease process.
- Prior exposure to PI3K/AKT/mTOR inhibitor(s), except in certain circumstances.
First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Laboratory values meeting the criteria outlined in the protocol.
- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma
Working Group (IMWG) criteria.
- Has measurable disease at screening as defined in the protocol.
- Known or centrally determined t(11;14) positive status and/or centrally determined
BCL2 high status.
- Refractory to or intolerant of all established MM therapies that are known to provide
clinical benefit and received all standard of care (SOC) agents in previous line(s) of
therapy, including a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and
an anti-CD38 monoclonal antibody.
- Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy.
- Life expectancy ≥ 12 weeks.
- Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined
in the protocol.
Correlation Between Ovarian Axis Hormones and Adrenal Androgens and Measurements of Satiation, Postprandial Satiety, and Hunger in Pre- and Post-menopausal Women
Ovarian Axis Hormones and Adrenal Androgens and Measurements of Satiation, Postprandial Satiety, and Hunger in Pre- and Post-menopausal Women
- Age 40-48 at the time of original study recruitment.
- Regular menstrual periods for at least 1 year on no hormonal contraception at the time of their participation in the original study.
- Age 52-60 at the time of original study recruitment.
- Confirmed menopausal status at the time of their participation in the original study: no menstrual periods for at least 1 year (but no more than 2 years).
- History of hysterectomy.
- History of surgical, chemical, or radiation-induced menopause (i.e., oophorectomy, aromatase inhibitors, chemotherapy for cancer treatment, or radiation therapy).
- Use of any drug that can affect estrogen production or signaling (e.g., GnRH agonists and antagonists, estrogen receptor modulators, etc.).
- Use of systemic estrogen and/or progesterone (oral contraceptives, contraceptive implants, hormone replacement therapy).
- Use of non-hormonal contraceptive methods that can affect the regularity of menstrual cycles (e.g., intrauterine devices).
- History of hypothalamic or pituitary disease (e.g., pituitary adenomas, empty sella, pituitary surgery, hypothalamic masses).
- Patients who denied future use of biological samples or further contact from the previous listed IRBs.
Eligibility last updated 4/18/22. Questions regarding updates should be directed to the study team contact.
ROA2233: Pilot Study of PROS Monitoring
Pilot Study of PROS Monitoring
- Female, 18 years of age or older.
- Women treated for breast cancer with radiation with a curative intent
- Non breast cancer.
- Children under 18-years of age.
- Non curative intent.
Eligibility last updated 4/19/22. Questions regarding updates should be directed to the study team contact.
Disrupted Sleep in Somali Americans – Implications for Hypertension Risk (Somali OSA)
Study of Disrupted Sleep in Somali Americans
- Self-identify as Somali.
- Adult males and females who are older than 18 years of age.
- Anyone under 18 years or over 70 years.
- Positive pregnancy.
Eligibility last updated 3/8/23. Questions regarding updates should be directed to the study team contact.
Initial Evaluation of the Pulmonary Hypertension Functional Class Self Report
A Study of Functional Class Self Report in Pulmonary Hypertension
- ≥ 18 years of age.
- Subject must have a clinician-recorded diagnosis of Pulmonary Hypertension (PH).
- Subject must have either PAH (WHO Group 1), PH due to left heart disease (WHO Group 2), PH due to lung disease (WHO Group 3), PH due to blood clots in the lungs (WHO Group 4), or PH with unclear and/or multifactorial mechanisms (WHO Group 5) based on a clinician-reported diagnosis.
- Subject is able to read and complete an English-language electronic survey.
- Subject has access to a computer or tablet to complete the electronic survey.
- Subject is willing and able to provide electronic informed consent.
≤ 18 years of age.
Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: Multiple Independent Sub-studies of Setmelanotide in Patients with POMC/PCSK1, LEPR, NCOA1 (SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway (EMANATE)
Phase 3 Study of Setmelanotide in Patients With POMC, PCSK1, LEPR, SRC1, SH2B1, or PCSK1 N221D Genetic Variants
- Patients must have a pre-identified:
- Heterozygous genetic variant in the POMC gene or PCSK1 gene;
- Heterozygous genetic variant in the LEPR gene;
- Homozygous, heterozygous, or compound heterozygous variant in the SRC1;
- Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, or chromosomal 16p11.2 deletion encompassing the SH2B1 gene;
- Heterozygous N221D variant in the PCSK1 gene; OR
- Be an N221D variant of the PCSK1 gene If a patient has composite heterozygous variants eligible for the study she/he will be accounted for the higher category based on ACMG classification;
- Example: If a patient is a composite heterozygous for POMC pathogenic variant, and LEPR VOUS, the patient will be categorized as POMC pathogenic.
- If the 2 variants have the same ACMG classification, adjudication will be assigned to the less prevalent gene sub-study;
- If a patient is a composite heterozygous for LEPR VOUS and SRC1 VOUS, the patient will be categorized as SRC1(sub-study 35c);
- If a patient is a composite heterozygous for SH2B1 VOUS and SRC1 VOUS, the patient will be assigned to SRC1 (sub-study 35c).
- If the investigator has genetics results on a patient who may be eligible for the study, but the genetics have not yet been categorized by a CLIA/CAP/ISO15189 certified laboratory, then Rhythm may provide testing and/or categorization through a third-party laboratory.
- Between 6 and 65 years of age at the time of provision of informed consent/assent.
- Obesity, defined as BMI ≥ 30 kg/m^2 for patients ≥ 18 years of age or BMI ≥ 95th percentile for age and gender for patients 6 up to 17 years of age, based on the United States (US) Centers for Disease Control and Prevention criteria.
- Patient and/or parent or guardian is able to communicate well with the Investigator, understand and comply with the requirements of the study (including once daily [QD] injection regimen and all other study procedures), and is able to understand and sign the written informed consent/assent. Patients who are unable to comply with all study procedures due to cognitive limitations or any other reason should not be enrolled into the study.
- Patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood.
- For women of child-bearing potential (WOCBP), agrees to use a highly effective form of contraception throughout the study and for 30 days following the study:
- Highly effective forms of contraception include:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
- Intrauterine device (IUD);
- Sexual abstinence only if it is the preferred and usual lifestyle of the patient.
- Highly effective forms of contraception include:
- Reported history of lifestyle intervention of diet and exercise.
- Reported history of hyperphagia.
- Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that has resulted in > 2% weight loss.
- Use of any medication that is approved to treat obesity within 3 months of first dose of study drug (e.g., orlistat, phentermine-topiramate, naltrexone-bupropion) if >2% weight loss in the last 3 months.
- History of Bariatric surgery with evidence of weight loss of > 2% in the last 3 months.
- Documented diagnosis of any psychiatric disorder(s) that the Investigator believes will interfere significantly with study compliance.
- Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS) during Screening, any suicide attempt in the past 5 years, or any suicidal behavior in the last month.
- Current, clinically significant pulmonary, cardiac or oncologic disease considered severe enough to interfere with the study and/or confound the results. Any patient with a potentially clinically significant disease should be reviewed with Rhythm to determine eligibility.
- HbA1C > 10% at Screening.
- History of significant liver disease other than non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
- Glomerular filtration rate (GFR) < 30 mL/min at Screening.
- History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism.
- Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion), determined as part of a comprehensive skin evaluation performed by the Investigator during Screening. Any concerning lesions identified during Screening will be biopsied and results known to be benign prior to enrollment. If the pre-treatment biopsy results are of concern, the patient may need to be excluded from the study.
- Patient is, in the opinion of the Study Investigator, not suitable to participate in the study.
- Participation in any clinical study with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first day of dosing.
- Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
- Significant hypersensitivity to any excipient in the study drug.
- If female, pregnant or breastfeeding.
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (MODULAR ATP)
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
- Patient who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has
an existing TV-ICD[iii] or S-ICD[iv]
- Patient who is deemed to be at risk for MVT based on at least ONE of the following:
- History of Non-Sustained MVT with LVEF ≤ 50%
- History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant
- History of syncope deemed to be arrhythmic in origin
- History of ischemic cardiomyopathy with LVEF ≤ 35%
- History of non-ischemic cardiomyopathy with LVEF ≤ 35% and significant scar*
- Patient who is willing and capable of providing informed consent (which is not to
include the use of a legally authorized representative (LAR) for documentation of
informed consent) and participating in all testing associated with this investigation
at an approved study site and at the intervals defined by this protocol
- Patient who is age 18 years or above, or of legal age to give informed consent
specific to state and national law
- Patient with an ongoing complication due to Cardiac Implantable Electronic Device
(CIED) infection or CIED explant
- Transvenous lead remnants within the heart from a previously implanted CIED (Note:
transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
- Patient with a known LA thrombus
- Patient with a ventricular arrhythmia due to a reversible cause
- Patient indicated for implantation of a dual chamber pacemaker or cardiac
resynchronization therapy (CRT)
- Patient with another implanted medical device that could interfere with implant of the
leadless pacemaker, such as an implanted inferior vena cava filter or mechanical
tricuspid heart valve
- Patient requires rate-responsive pacing therapy
- Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)
- Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable
Angina) within 40 days
- Inability to access femoral vein with a 21-French (inner diameter)/ 23.5-French outer
diameter) introducer sheath due to known anatomy condition, recent surgery, and/ or
other relevant condition
- Patient who has an active implanted electronic medical device intended for chronic use
concomitantly with the study system, such as a left ventricular assist device (LVAD).
Note that a temporary pacing wire is allowed.
- Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Patient with a known cardiovascular anatomy that precludes implant in the right
- Patient with a known allergy to any system components
- Patient with a known or suspected intolerance to S-ICD conversion testing, based on
- Patient is not likely to have meaningful survival** for at least 12 months (documented
or per investigator's discretion)
- Patient is enrolled in any other concurrent study. Co-enrollment into other studies
such as observational studies/ registries needs prior written approval by BSC. Local
mandatory governmental registries are accepted for co-enrollment without approval by
- Patient who is a woman of childbearing potential who is known to be pregnant at the
time of study enrollment (method of assessment upon investigator's discretion)
[i]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with
Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the
American College of Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.
[ii] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and
the prevention of sudden cardiac death: The Task Force for the Management of Patients with
Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society
of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.
[iii] TV-ICD system is expected to be fully explanted during or prior to full Coordinated
[iv] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for
MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse
Generator; Patients with an existing S-ICD PG subject to the electrical overstress field
action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219,
or future BSC S-ICD Pulse Generator
*Significant cardiac scar is defined as a scar involving at least one ventricular
myocardial segment (i.e., basal infero-septum) as identified in the official findings of a
cMRI, or nuclear viability study, or echo report by the interpreting radiologist/
cardiologist who is not affiliated with the study
**meaningful survival means that a patient has a reasonable quality of life and functional
Mixed Reality Technology Integration Into Clinical Care
Integration of Mixed Reality Technology Into Clinical Care
- Age 18 to 100 years old.
- Able to consent.
- Pregnant women, fetuses or neonaters.
- Adults lacking capacity to consent.
Eligibility last updated 4/22/22. Questions regarding updates should be directed to the study team contact.
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
COMPASSION S3 Post-Approval Study
- Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve.
- RVOT/PV (Pulmonic Valve) with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg.
- Inability to tolerate an anticoagulation/antiplatelet regimen.
- Active bacterial endocarditis or other active infections.
Eligibility last updated 5/13/22. Questions regarding updates should be directed to the study team contact.
Obesity-Induced Dysfunction of Human MSC in Peripheral Microvascular Repair
Dysfunction of Mesenchymal Stem/Stromal Cells Induced by Obesity
- Group 1:
- Age 18-80 years;
- BMI ≥ 35 kg/m^2;
- Eligible for bariatric surgery;
- Ability to provide consent.
- Group 2:
- Age 18-80 years;
- BMI ≤ 30 kg/m^2;
- Undergoing live donor nephrectomy;
- Ability to provide consent.
- Chronic Inflammatory Disease (e.g., rheumatoid arthritis).
- Active malignancy.
- Recent stroke or myocardial infarction.
- Solid organ transplant recipients.
- Therapeutic doses of immunosuppressive drugs (including calcineurin inhibitors and prednisone (> 10 mg/day).
- Senolytic supplements.
- Subjects on therapeutic doses of anticoagulants [including Warfarin (Coumadin), Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa)].
- Subjects deemed ineligible to comply with study protocol.
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over 52 Weeks in Patients With IPF
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the study (and prior to any study procedure including shipment of high-resolution
computed tomography (HRCT) to reviewer).
2. Patients (male/female) with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF), aged ≥
40 years when signing the informed consent. IPF diagnosis based on 2018
ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan
taken within 12 months of Visit 1 and if available surgical lung biopsy; AND Usual
interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical
diagnosis of IPF, as confirmed by central review prior to Visit 2.
3. Patients need to be either:
-- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to
Visit 1 and during screening and planning to stay on this background treatment after
randomization. Combination of nintedanib plus pirfenidone is not allowed;
[*stable therapy is defined as the individually and general tolerated regimen of
either nintedanib or pirfenidone (no dose changes) for at least 12 weeks]; OR
-- not on a therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit
1 or during the screening period. (e.g. either antifibrotic (AF)-treatment naïve or
previously discontinued) and start or re-start of an antifibrotic is not planned.
4. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.
5. Diffusing capacity for carbon monoxide (DLCO) corrected for Haemoglobin (Hb) [visit 1]
≥ 25% and <90% predicted of normal at Visit 1.
6. Female and male patients: Women of childbearing potential (WOCBP) and men able to
father a child must be ready and able to use highly effective 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. A list of contraception methods meeting these criteria and
instructions on the duration of their use is provided in the patient information.
1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume (FEV)1/FVC <
0.7) at Visit 1.
2. In the opinion of the Investigator, other clinically significant pulmonary
3. Acute IPF or Interstitial Lung Disease (ILD) exacerbation within 3 months prior to
screening and/or during the screening period (investigator-determined).
4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit
1 and/or during the screening period.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and
viral hepatitis and a confirmed infection with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) within the 4 weeks prior to Visit 1 or during the screening
A patient can be re-screened if the patient was treated and/or cured from the acute
6. Any documented active or suspected malignancy or history of malignancy within 5 years
prior to Visit 1, except appropriately treated basal cell carcinoma of the skin,
"under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
7. Major surgery (major according to the investigator's assessment) performed within 3
months prior to Visit 1 or planned during the course of the trial. Being on a
transplant list is allowed.
8. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) > 2.5 x upper
limit of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.
Additional Exclusion Criteria may apply.
Eligibility last updated 7/7/22. Questions regarding updates should be directed to the study team contact.