T-cell Clonality in Rheumatoid Arthritis (SMRA)
Somatic Mutation in Rheumatoid Arthritis
- Diagnosis of seropositive rheumatoid arthritis (either Rheumatoid factor or anti-CCP positive).
- Age-matched Healthy Controls.
- Chronic active viral infection.
- History of chemo/radiotherapy.
- History of cancer.
- Other autoimmune disease.
- Pregnancy.
Eligibility last updated 3/23/22. Questions regarding updates should be directed to the study team contact.
An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
- According to the Investigator's opinion, will benefit from continuing treatment with relacorilant.
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Has poorly controlled hypertension.
- Has Stage ≥ 4 renal failure.
Eligibility last updated 2/8/22. Questions regarding updates should be directed to the study team contact.
Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
- Age 19 or over at time of informed consent.
- Diagnosis of metastatic renal cell cancer (mRCC) with no prior systemic therapy for
mRCC.
1. Prior surgery and radiation therapy are permitted.
2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma
are permitted.
3. Patients currently not on therapy and being observed are permitted.
- Evidence of signed and dated informed consent document indicating that the patient has
been informed of all pertinent aspects of the study.
- Ability to comply with completion of PROs
- Patients being treated for active malignancies other than mRCC are excluded, unless
all systemic therapy was completed at least 3 months prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 4/12/23. Questions regarding updates should be directed to the study team contact.
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II) (ADI 3)
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
- Adults over the age of 18 and who are willing and able to give informed consent.
- Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
- Volunteers of any race, any gender.
- Range of physiques.
- Injury or skin disturbance in the area of the test device.
- Pregnant.
- Currently smokes cigarettes.
- Has known respiratory conditions such as:
- Flu;
- Pneumonia/bronchitis;
- Shortness of breath/respiratory distress;
- Respiratory or lung surgery;
- Emphysema, COPD, lung disease.
- Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function.
- Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask).
Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE) (C2LOE)
Long-Term Observational Extension of Participants in CREST-2Trial (C2LOE)
- Currently active or graduated participants in the CREST-2 randomized trial at a site located in the United States.
- Able to provide written informed consent by self.
- Fluent in English.
- Unable to provide written informed consent.
- Inability to follow study procedures.
Eligibility last updated 2/20/23. Questions regarding updates should be directed to the study team contact.
A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared with Mepolizumab in Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy (OCEAN)
OCEAN (depemOkimab effiCacy Eosinophilic grAnulomatosis with polyaNgiitis)
- Participant (male or female) must be 18 years of age or older at the time of signing
the informed consent.
- Participants who are >=40 kilogram at Screening Visit 1.
- Participants with a documented diagnosis of EGPA for at least 6 months based on the
history or presence of: asthma plus eosinophilia defined as >1.0*10^9/Liter (L) and/or
>10 percentage (%) of leucocytes plus at least 2 of the following additional features
of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or
perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation,
neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary
infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by
echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red
cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable
purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase
3.
- History of relapsing OR refractory disease.
- Participants must be on a stable dose of oral prednisolone or prednisone of >=7.5
mg/day (but not >50 mg/day) for at least 4 weeks prior to Baseline (Visit 2).
- If participants receiving immunosuppressive therapy (excluding cyclophosphamide) the
dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the
study.
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies: Is a woman of
non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP)
and using a contraceptive method that is highly effective, with a failure rate of <1%.
- Capable of giving signed informed consent
- Participants diagnosed with granulomatosis with polyangiitis; previously known as
Wegener's granulomatosis or microscopic polyangiitis.
- Participants with organ-threatening EGPA as per EULAR criteria,
- Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1).
- A current malignancy or previous history of cancer in remission for less than 12
months prior to Screening.
- Participants with alanine aminotransferase >2*upper limit of normal (ULN) or if
participant is on background methotrexate or azathioprine >3*ULN, aspartate
aminotransferase >2*ULN or if participant is on background methotrexate or
azathioprine >3*ULN, alkaline phosphatase >=2.0*ULN, total bilirubin >1.5*ULN
(isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct
bilirubin <35%), Cirrhosis or current unstable liver or biliary disease per
investigator assessment.
- Participants who have severe or clinically significant cardiovascular disease
uncontrolled with standard treatment.
- Participants who have known, pre-existing, clinically significant system abnormalities
that are not associated with EGPA and are uncontrolled with standard treatment.
- Clinically significant abnormality in the hematological, biochemical or urinalysis
screen at Visit 1.
- Chronic or ongoing active infectious disease requiring systemic treatment.
- Participants with a known, pre-existing parasitic infestation within 6 months prior to
Screening Visit 1.
- A known immunodeficiency (e.g. human immunodeficiency virus [HIV]).
- Participants that, according to the investigator's medical judgment, are likely to
have active coronavirus disease 2019 (COVID-19) infection. Participants with known
COVID-19 positive contacts within the past 14 days must be excluded for at least 14
days following the exposure during which the participant must remain symptom-free.
- Participants with a known allergy or intolerance to a monoclonal antibody or biologic
therapy or any of the excipients of the investigational products.
- Participants who have a previous documented failure with anti-Interleukin-5
/Interleukin-5 receptor therapy. Participants who have received monoclonal antibodies
(mAb) and who have not undergone the required washout periods, prior to Visit 1.
- Participants receiving any of the following: Oral corticosteroids: Participant
requires an oral corticosteroid dose of >50 mg/day prednisolone/prednisone in the
4-week period prior to Baseline (Visit 2), Intravenous (IV), intramuscular or
subcutaneous (SC) corticosteroids in the 4-week period prior to Baseline (Visit 2),
Omalizumab within 130 days prior to Screening (Visit 1), Cyclophosphamide (CYC): oral
CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to
Baseline (Visit 2), if their total white blood cells is >=4*10^9/L (measured using the
local laboratory if necessary), Rituximab within 12 months prior to Screening (Visit
1); in addition, the Participant must have shown recovery of peripheral B-cell count
to within the normal range, Tezepelumab and Dupilumab with a washout period of 5
half-lives prior to Screening Visit 1, IV or SC immunoglobulin within 6 months prior
to Screening (Visit 1); For China and Japan only within 12 weeks prior to Screening
(Visit 1), Interferon-alpha within 6 months prior to Screening Visit 1, Anti-tumor
necrosis factor therapy within 12 weeks prior to Screening Visit 1, Anti-CD52
(alemtuzumab) within 6 months prior to Screening Visit 1.
- Participants with QT interval corrected for heart rate according to Fridericia's
formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with
Bundle Branch Block in the 12-lead ECG central over-read from at Screening Visit 1.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/29/23. Questions regarding updates should be directed to the study team contact.
Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (OLE for EECSWS)
Extension Study to Evaluate NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (Steamboat 2)
Key
- Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.
Key Exclusuion Criteria:
- Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.
- Body weight <10 kg at randomization Day 1.
- Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
- Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study.
Eligibility last updated 8/10/23. Questions regarding updates should be directed to the study team contact.
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study) (MAGNETIC Study)
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
- Male or female and ≥ 18 years-of-age at the time of informed consent.
- ECOG Performance status 0 or 1.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
- Measurable disease as per RECIST v1.1.
- Ability to swallow and retain oral medications.
- Acceptable hematologic and organ function at screening.
- Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
- Resolution of all toxicities of prior therapy or surgical procedures.
- Life expectancy ≥ 12 weeks after the start of the treatment.
- Chemotherapy or small molecule antineoplastic agent given within 21 days or < 5 half- lives, whichever is shorter, prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
- Patients who are pregnant or breastfeeding.
- Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.
- Uncontrolled, symptomatic brain metastases.
- Uncontrolled hypertension.
- Moderate or severe hepatic impairment.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.
Quantitative Contrast-free Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors (qHDMI)
Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors
- Male and female, age 18 and older.
- Suspected of having eye tumor.
AIM 1 - SUBSET OF LARGE CHOROIDAL NEVI:
- Lesions with thickness > 1.5 mm and minimum documented stability interval of 2 years.
- Lesions with thickness < 1.5 mm or fewer than 2 years of documented stability.
SUBSET LARGE MELANOMA:
- Choroidal, ciliary body, or ciliochoroidal melanoma in a patient who elected to have enucleation for primary tumor treatment.
- Iris melanoma or melanoma that has undergone prior treatment before enucleation.
PRESUMED CHOROIDAL MELANOMA:
- Choroidal, ciliary body, or ciliochoroidal melanoma with thickness > 1.5 mm treated by radiation. These lesions may sometimes have biopsy for cytogenetic testing at the time of radiation treatment.
- Iris melanoma, lesions with thickness < 1.5 mm, non-melanoma tumors.
AIM 2
- Orbital mass with completed neuroimaging (typically with MRI) and clinical/MRI suspicion for lymphoma.
- Recent orbital biopsy (within the past 3 months) prior to qHDMI, clinical impression clearly compatible with a non-lymphoma tumor type.
Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.
Per Oral Endoscopic Myotomy - A Minimally Invasive Treatment Modality for Achalasia (POEM Prospective)
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)
- Patients ≥ 18 years old
- Patients undergoing POEM for:
- Achalasia (types I, II, and III);
- Non-achalasia esophageal motility disorders (e.g., diffuse esophageal spasm).
- POEM performed at Mayo Clinic by providers in the Division of Gastroenterology or the Division of Thoracic Surgery.
- Patients < 18 years old.
- Patients with prior POEM performed outside of Mayo Clinic.
- Prior upper gastrointestinal surgery.
- No authorization for research participation at Mayo Clinic.
- Inability to communicate/provide history of symptoms.
Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure (ACCLAIM)
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
1. Patient must be at least 18 years old.
2. Patient has signed a written informed consent for the MWA and participation in the
study.
3. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging
(e.g., CT or MRI).
4. Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
5. Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any
lymph node ≤2.0 cm in the largest diameter
6. Ability to safely create an ablation zone (AZ) that completely covers the tumor with
minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule)
or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be
included. For these tumors, the calculation of the margin will not apply to the area
abutting the capsule or the vessel.
7. The target tumor(s) is/are visible by US and/or CT in a location where MWA is
technically achievable and safe based on the proximity to adjacent structures.
Protective maneuvers such as hydrodissection for organ mobilization are allowed and
will be recorded.
8. ECOG performance status of 0-1.
9. Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study
treatment.
1. Patient is unable to lie flat or has respiratory distress at rest.
2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
3. Patient has a history of an allergic reaction to intravenous iodine that cannot be
pre-medicated or prevents performance of a CT with IV contrast.
4. Patient has evidence of active systemic infection.
5. Patient has a debilitating medical or psychiatric illness that would preclude giving
informed consent or receiving optimal treatment or follow up.
6. Patient is currently participating in other experimental studies that could affect the
primary endpoint.
7. Patient unable to receive general anesthesia or adequate analgesia and sedation.
8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central
ducts).
9. Patient is currently pregnant or intends to become pregnant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.
Impact of General Anesthesia vs. Moderate Sedation on Cognitive Function After LAOO: An Observational Study
Impact Of General Anesthesia Vs Moderate Sedation On Cognitive Function After LAAO
- Men and women ≥ 50 years of age.
- The patient has met eligibility criteria and is planned to undergo LAAO with the WATCHMAN FLX device as part of clinical care.
- The patient is able and willing to undergo non-invasive cognitive testing using the Viewmind headset by a trained personal.
- The patient is able to give informed consent for the procedure.
- The patient unwilling or unable to complete cognitive testing using the specialized virtual reality googles.
- Primary language is not English.
Eligibility last updated 3/11/22. Questions regarding updates should be directed to the study team contact.
Artificial Intelligence Enhanced Assessment of Speech Disorders: Prospective Data (NAIP-Speech)
Artificial Intelligence Enhanced Assessment of Speech Disorders
- Adult (18 years or older).
- Able to provide informed consent
- Able to provide samples in English.
- U.S. based patient.
- Age < 18 years of age.
- Unable to provide samples in English (i.e., need for interpreter flag in Epic).
- Nonverbal / No speech.
- HPP (High Profile Patient) status.
- International patient.
Eligibility last updated 3/3/22. Questions regarding updates should be directed to the study team contact.
A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
- Provide written informed consent prior to initiation of any study-specific procedures
- Advanced stage solid tumor
- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of
tumor tissue or ctDNA
- Measurable or evaluable disease according to RECIST v1.1
- ECOG performance status 0 or 1
- Adequate organ function, as measured by laboratory values (criteria listed in
protocol)
- Able to swallow, retain, and absorb oral medications
- Known clinically-active or clinically-progressive brain metastases from non-brain
tumors
- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic
mineralization or calcification, or corneal or retinal disorder/keratopathy
- GI tract disease causing an inability to take oral medication, malabsorption syndrome,
requirement for intravenous alimentation, or uncontrolled inflammatory GI disease
- Active, uncontrolled bacterial, fungal, or viral infection
- Women who are lactating or breastfeeding, or pregnant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 7/5//23. Questions regarding updates should be directed to the study team contact.
A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in adults with Child Pugh A and B Cirrhosis (PharmaIN)
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
1. Body mass index within the range 18 to 40 kg/m^2 (inclusive) at screening.
2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.
3. Cirrhosis based on histology or a combination of clinical, radiological, or biochemical and classified as Child-Pugh A or B.
1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.
2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
3. Significant kidney disease.
4. Estimated glomerular filtration rate (eGFR by CKD-Epi) < 60 ml/min/1.73 m^2 or Cr > 2.0 mg/dL.
5. Hepatic encephalopathy > grade 2 in the previous 3 months. Stable drug treatment for HE is not exclusionary.
6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).
7. Known positive HIV serology confirmed by HIV viral load.
8. Subjects with acute infections, including acute viral hepatitis are to be excluded. Subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3
months prior to study inclusion.
Eligibility last updated 8/23/23. Questions regarding updates should be directed to the study team contact.
A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) (HER2CLIMB-05)
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
- Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.
- Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
- Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression.
- Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-]).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -CNS Inclusion.
- Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following:
- No evidence of brain metastases;
- Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane;
- Previously treated brain metastases which are asymptomatic;
- Brain metastases previously treated with local therapy must not have progressed since treatment.
- Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug).
- Unable to undergo contrast MRI of the brain -
CNS Exclusion:
- Based on screening brain MRI and clinical assessment.
- Symptomatic brain metastasis.
- Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane.
- Ongoing use of systemic corticosteroids at a total daily dose of > 2 mg of dexamethasone (or equivalent).
- Any untreated brain lesion in an anatomic site which may pose risk to participant.
- Known or suspected leptomeningeal disease (LMD).
- Poorly controlled (> 1/week) seizures, or other persistent neurologic symptoms.
Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.
A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma (CLN-PRO-V005)
Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma
- Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction.
- Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
- Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g., because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization.
- Aged 18 to 85 years old, inclusive.
- Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures.
- Patient or relative is able, willing and competent to give informed consent.
- Life expectancy of at least 1 year.
- Mangled Extremity Severity Score (MESS) of ≥ 7.
- Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury).
- Catastrophic injuries that make survival unlikely (e.g., Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) > 60).
- HAV may not be used for coronary artery repair.
- Known pregnant women.
- Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries.
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV.
- Previous exposure to HAV.
- Known participation in any investigational study within the last 30 days.
- Employees of the sponsor or patients who are employees or relatives of the investigator.
Eligibility last updated 3/22/22. Questions regarding updates should be directed to the study team contact.
A Phase 0/Ia Study of BI 907828 Concentrations in Brain Tissue and a Non-randomized Open-label, Dose- escalation Study of BI 907828 in Combination with Radiotherapy in Patients with Newly-diagnosed Glioblastoma (BI 1403-0007)
A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma
Inclusion Criteria
•Main Phase 0:
- Histologically (if prior biopsy) or radiologically diagnosed glioblastoma.
- Eligible for neurosurgical tumor resection.
- Patients must be at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate organ function.
- Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
Inclusion Criteria
•Main Phase Ia:
- Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated MGMT promoters (Glioblastoma definition according to 2021 WHO Classification of CNS tumors; i.e., IDH-wild type only).
- Patient has undergone neurosurgical tumor resection and is eligible for standard radiotherapy.
- Formalin-fixed paraffin-embedded tumor blocks or representative H/E (haematoxylin/eosin) slides (preferably both) must be available for retrospective histopathological central review.
- Locally performed histopathological diagnosis will be accepted for entry into this trial.
- Patients must be at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate organ function.
- Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
Exclusion Criteria
•Main Phase 0:
- Known TP53 mutant glioblastoma.
- Note: testing is not mandatory for inclusion.
- Known IDH mutant grade IV astrocytoma.
- Note: testing is not mandatory for inclusion.
- Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
- Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).
Exclusion Criteria
•Main Phase Ia:
- Patients who have received previous systemic therapy (with the exception of patients who participated in Phase 0) or radiotherapy for glioblastoma.
- Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
- Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).
Eligibility last updated 3/1/22. Questions regarding updates should be directed to the study team contact.
A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors (CGT9486-21-301)
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Key
1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report
is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
2. Documented disease progression on or intolerance to imatinib.
3. Subjects must have received the following treatment:
- Part 1a: Treatment with ≥1 prior lines of therapy for GIST;
- Part 1b: Treatment with ≥ 2 prior TKI for GISTs;
- Part 2: Prior treatment with imatinib only.
4. Have at least 1 measurable lesion according to mRECIST v1.1.
5. ECOG
•0 to 2.
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
Key
1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency.
2. Clinically significant cardiac disease.
3. Major surgeries (e.g., abdominal laparotomy) within 4 weeks of the first dose of study drug.
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
5. Any active bleeding excluding hemorrhoidal or gum bleeding.
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening.
8. Received strong CYP3A4 inhibitors or inducers.
9. Received sunitinib within 3 weeks (Part 1a, Part 1b).
Eligibility last updated 8/8/23. Questions regarding updates should be directed to the study team contact.
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II) (COSIRA-II)
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
1. Subject is older than 18 years of age
2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of
persistent refractory angina pectoris classified as CCS Grade III or IV despite
maximally tolerated guideline directed medical therapy as determined by the local
heart team and confirmed by a Central Screening Eligibility Committee.
Note: subjects may also have exertional dyspnea, but the symptoms that limit activity
must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with
or without radiation to the neck, jaw, shoulders, arms, or other location) and not
dyspnea
3. Must have attempted treatment with the maximally tolerated dose of at least three of
the four (preferably all four) approved classes of anti-anginal agents: long-acting
nitrates, calcium channel blockers (either a dihydropyridine or a
non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at
least 60 days prior to enrollment, must remain stable from enrollment to
randomization, and there must be no intent to change the medical regimen for at least
12 months after randomization Note: If the dose of a medication was increased or
decreased for a temporary period and then returned to the original dose, which will
then be continued for at least 12 months after randomization, the subject may be
immediately enrolled without needing to otherwise requalify.
4. Subject has either no treatment options for revascularization by coronary artery
bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable
or high risk for revascularization as determined by the local heart team, and
confirmed by a Central Screening Eligibility Committee
5. Evidence of either exercise or pharmacologically induced reversible ischemia severity
by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR, iFR, or
other non-hyperemic FDA approved tests in the distribution of the left coronary artery
(LCA), performed within 12 months prior to enrollment and while the patient is
maintained on their stable regimen of maximally tolerated doses of anti-anginal
medications.
Note: If the subject has evidence of ischemia in both the LCA and RCA distributions,
the extent of ischemia must be greater in the LCA distribution.
Note: The qualifying assessment must be performed after any myocardial infarction,
CABG, or successful PCI within the prior 12 months. If the anti-anginal medication
regimen is permanently changed after the assessment of ischemia, the test must be
repeated. For subjects with multiple assessments, the one performed closest to
enrollment will serve as the qualifying study.
6. Functional limitation due to refractory angina as defined by a modified Bruce exercise
tolerance test duration of greater than or equal to 2 minutes but less than or equal
to 8 minutes, performed while the subject is maintained on their stable regimen of
maximally tolerated doses of anti-anginal medications.
Note: The ETT variability must be less than 20% between last two ETTs performed.
7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the
12-months prior to enrollment Note: The LVEF must be reassessed after any intervening
myocardial infarction. For subjects with multiple assessments, the most recent LVEF
assessment is used as the qualifying test.
8. Subject is willing and able to sign informed consent
9. Subject is willing to comply with the specified follow-up evaluations
Angiographic
1) Three-vessel coronary angiography performed within 12 months prior to enrollment
demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50%
•<70%
with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared
non-hyperemic physiological assessment of ≤0.89 in one or more lesions) in the left
coronary artery (main epicardial vessels or branches) that is not suitable for and will not
be treated with PCI or CABG as determined by the local heart team.
Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction
or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel
angiograms, the one performed closest to enrollment will serve as the qualifying study.
1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary
syndrome (NSTEMI or STEMI).
Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may
still be enrolled
2. Recent successful revascularization by either CABG or PCI within six months prior to
enrollment Note: Successful revascularization is defined as any CABG procedure, or any
PCI procedure with a reduction of one or more lesions to <50% diameter stenosis
3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion)
within 30 days prior to enrollment
4. The predominant manifestation of angina is dyspnea. Note: some dyspnea may be present
with exertion, but the predominant symptom that limits activity must be angina (i.e.,
chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation
to the neck, jaw, shoulders, arms, or other location)
5. Has extra-coronary contributory causes of angina
•e.g., untreated hyperthyroidism,
anemia (hgb <10 g/dL), uncontrolled hypertension (systolic blood pressure >160 mmHg or
diastolic blood pressure >100 mmHg despite medications), atrial fibrillation with
rapid ventricular response (consistently >100 bpm despite medications) or other
tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left
ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric
left ventricular hypertrophy is not an exclusion criterion).
6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF
during the 90 days prior to enrollment
7. Life threatening rhythm disorders or any rhythm disorders that would require future
placement of an internal defibrillator and/or pacemaker
8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced
expiratory volume in one second (FEV1) that is less than 55% of the predicted value,
or need for home daytime oxygen or oral steroids
9. Severe valvular heart disease (any valve)
10. Moderate or severe RV dysfunction by echocardiography
11. Pacemaker electrode/lead is present in the coronary sinus
12. A Class I indication is present for an implantable defibrillator or cardiac
resynchronization therapy according to ACCF/AHA/HRS guidelines
13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the
right atrium within 90 days of enrollment
14. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD
formula) or subjects on chronic dialysis
15. Known allergy to stainless steel or nickel
16. Any clinical condition that might interfere with the trial protocol or the subject's
ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse,
dementia, magnetic resonances imaging (MRI) planned within 8 weeks of randomization.)
17. Currently enrolled in another investigational device or drug trial that has not
reached its primary endpoint or that might clinically interfere with the current trial
endpoints or procedures
18. Pregnant or planning pregnancy within the next 12 months (women of reproductive
potential must have a negative pregnancy test within 7 days of the randomization
procedure)
19. Subject is part of a vulnerable population who, in the judgment of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include individuals with mental
disability, persons in nursing homes, children, impoverished persons, persons in
emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.
20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral
anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on
a chronic oral anticoagulant
21. Comorbidities limiting life expectancy to less than one year
22. Subject is currently hospitalized for definite or suspected COVID-19
23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been
asymptomatic for <8 weeks prior to enrollment or has not returned to his or her prior
baseline (pre-COVID-19) clinical condition
24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within
the past 4 weeks prior to enrollment
Angiographic/Hemodynamic
1) Coronary anatomy amenable to revascularization of ischemic myocardial territory by
either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or
angina equivalent symptoms, as per the assessment of the local heart team.
Note: If a pathway to coronary revascularization is present which, in the opinion of the
local heart team, is reasonably low risk and reasonably likely to provide long-term symptom
relief and the subject refuses the revascularization procedure, the patient is ineligible
for randomization
Procedural Angiographic/Hemodynamic Randomization
1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening
procedure for eligibility assessment and potential randomization
2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left
superior vena cava [SVC]) as demonstrated by angiogram
3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal
to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm
Single Arm Registry
The subject must meet all inclusion and exclusion criteria for the main randomized trial,
except for three possible specific conditions as follows:
1. Subjects with evidence of either exercise or pharmacologically induced reversible
ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR,
iFR, or other non-hyperemic FDA approved or cleared tests in the predominate (RCA >
LCA ischemia) or sole distribution of the right coronary artery
2. Subjects with evidence of either exercise or pharmacologically induced reversible
ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, CFR, or IMR
without documented obstructive coronary disease (i.e. estimated diameter stenosis in
all coronary lesions is <50%)
3. Subjects who are unable to complete the required COSIRA-II exercise tolerance test due
to lower limb amputation (above the ankle).
Single-Arm Registry Angiographic Inclusion Criteria
1. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months
prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis
of ≥70%) in the RCA if it is single vessel disease, or the ischemia in the territory
of the RCA is greater than the ischemia in the territory of the LCA when it is >2
vessel coronary disease, or a fractional flow reserve (FFR) value of ≤0.80 or an iFR
(or other FDA-approved/cleared non-hyperemic physiologic assessment) of ≤0.89 in an
RCA lesion with a visually assessed diameter stenosis of ≥50% in single RCA coronary
disease, that is not suitable for and will not be treated with PCI or CABG as
determined by the local heart team.
2. Non-obstructive CAD: Patients with non-obstructive CAD (coronary narrowing of <50%,
and/or FFR ≥0.81) Note: The qualifying 3-vessel angiogram must be performed after any
myocardial infarction or CABG within the 12 months prior to enrollment. For patients
with multiple 3-vessel angiograms, the one performed closest to enrollment will serve
as the qualifying study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 4/18/23. Questions regarding updates should be directed to the study team contact.
Mayo Clinic Digital Menopause Management Study
Testing of a Menopause Management Digital Health Application
- Adult postmenopausal women, aged 45-60 years.
- Menopause symptoms (hot flashes/night sweats) rated moderate or greater or total MRS score ≥ 14.
- Current use of hormone therapy.
Eligibility last updated 3/10/22. Questions regarding updates should be directed to the study team contact.
A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies
A Study to Investigate LYL797 in Adults With Solid Tumors
- ≥ 18 years of age at time of informed consent
- Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or
locally advanced and unresectable that is ROR1+ by central laboratory
immunohistochemistry (IHC)
- Measurable disease including a target lesion and an additional lesion for biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and marrow function
- Women of childbearing potential must have a negative pregnancy test at screening
- All participants must agree to practice highly effective methods of contraception
- Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy
- Prior solid organ transplantation
- Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain
involvement by disease is allowed
- Untreated or active infection at the time of screening or leukapheresis
- HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active
tuberculosis
- Impaired cardiac function or clinically significant cardiac disease
- Uncontrolled pleural or pericardial effusion
- Systemic corticosteroids or other immunosuppressive medications within 14 days of
leukapheresis
- Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or
Factor Xa inhibitors
- Pregnant or lactating/nursing women
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.
Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers (Trans-Pacific)
Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
- Able to speak and read English or Spanish (for patients enrolled at MD Anderson and Mayo Clinic), English or Korean (for patients enrolled at Yonsei), and English or Japanese (for patients enrolled at Keio).
- Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention.
- Age ≥ 18.
- Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract.
- Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent.
- Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion.
- Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG).
Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.
Tiered Inpatient Telemetry - Validation
Tiered Inpatient Telemetry
- Age 18+.
- Capable of consenting.
- Actively being monitored on Philips inpatient telemetry.
- Under the age of 18.
- Unable to consent.
- Pregnant patients.
Eligibility last updated 4/21/22. Questions regarding updates should be directed to the study team contact.
A Phase 1, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies
Inclusion Criteria :
1. Provision of signed and dated written informed consent prior to any study-specific
procedures, sampling, or data collection
2. Age ≥ 18 years
3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise
noted) of one of the following: MZL (Part 1a and 1b only), FL (Part 1a only), MCL,
CLL/SLL, WM (Part 1a and 1b only), DLBCL (Part 1a only), or >2 treatments per the
Richter's transformation to DLBCL (Part 1a only).
4. Patients who have previously received a covalently-binding BTK inhibitor in any line
of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless
reason for discontinuation is intolerance).
5. For dose-finding and dose-expansion, patients who had previously received a
covalently-binding BTK inhibitor as monotherapy or in combination with other
anticancer agents are eligible for the study if they meet any of the following
criteria: discontinued the previous BTK inhibitor due to disease progression,
experienced disease progression after completing treatment with a BTK inhibitor or
discontinued the BTK inhibitor due to toxicity or intolerance.
6. Measurable disease by radiographic assessment or serum IgM level (WM only)
7. ECOG Performance Status of 0 to 2
8. Patients enrolling in the dose finding phase of the study may be previously treated
with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of
enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2)
must have been treated with a BTKi in a prior line of therapy.
1. Prior malignancy (other than the disease under study) within the past 2 years, except
for curatively treated basal or squamous skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate
cancer
2. Requires ongoing systemic treatment for any other malignancy
3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)
corticosteroid treatment.
4. Current or history of central nervous system involvement including the brain, spinal
cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
biopsy) by B-cell malignancy, regardless of whether patient had received treatment for
central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt
lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman
disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB
DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary
cutaneous DLBCL
•leg type, DLBCL associated with chronic inflammation, primary
mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+
large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC
and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma
•NOS, B-cell lymphoma
unclassifiable with features intermediate between DLBCL and classical Hodgkin
lymphoma, or history of or currently suspected Richter's transformation of an indolent
lymphoma to an aggressive histology (only patients with Richter Transformation to
DLBCL are eligible for Part 1a).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/19/23. Questions regarding updates should be directed to the study team contact.
REstrictive versus LIberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury ( RELIEVE-AKI)
REstrictive versus LIberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (RELIEVE-AKI)
- Age ≥ 18 years.
- Stage 3 acute kidney injury according to the KDIGO criteria.
- Started or intending to start CKRT for volume management.
- Attending intensivist or nephrologist intending to remove fluid using CKRT for at least 48 hours.
- Respiratory distress due to pulmonary edema or fluid overload.
- Massive volume infusion (i.e., > 200 mL/h for > 6 hours of continuous infusion).
- No intention to remove fluid as determined by attending intensivist or nephrologist.
- Attending intensivist or nephrologist believes that the protocol will not be followed.
- Continuous fluid removal for > 24 hours prior to study enrollment.
- Actual or estimated premorbid body weight > 120 kilograms.
- Patients treated with intermittent hemodialysis during the current admission.
- Patients on chronic outpatient hemodialysis.
- Patients with history of, or current admission for kidney transplantation.
- Do not resuscitate, intubate, or comfort measures only orders (i.e., DNR/DNI/CMO).
- Moribund not expected to survive > 24 hours.
- Confirmed pregnancy.
- Patients treated with extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or intra-aortic balloon pump (IABP).
- Organ donors with neurological determination of death (i.e., brain dead donors).
- Drug overdose requiring CKRT.
- Enrollment in a concurrent interventional clinical trial with direct impact on fluid balance (e.g., > 500 mL study drug administration).
Eligibility last updated 3/9/22. Questions regarding updates should be directed to the study team contact.
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
1. Subjects 45-75 years old
2. Able to provide a signed informed consent.
3. Willing and able to comply with the specified study requirements and can be contacted
by telephone.
4. Scheduled for colonoscopy procedure no later than 60 days after C-Scan ingestion
5. Maximal abdominal circumference < 125 cm.
1. Subject who is not a suitable candidate for a colonoscopy
2. Known history of dysphagia or other swallowing disorders.
3. History of the following:
1. Colorectal polyps
2. A personal history of CRC
3. A family history of CRC or adenomatous polyps diagnosed in a relative before 60
years of age
4. A history of inflammatory bowel disease of significant duration
5. One of two (2) hereditary syndromes
4. Known motility disorders:
1. Chronic Constipation: less than three (3) bowel movements/week, without the use
of laxatives within the last 3 months.
2. Ongoing diarrhea defined as passage of loose or watery stools at least three
times within 24-hour
3. Delayed gastric emptying.
5. Known IBD (Crohn's, Ulcerative Colitis)
6. Prior history of gastrointestinal tract surgery.
7. Prior history of abdominal surgery that might cause bowel strictures leading to
capsule retention, as determined by a physician
8. Any condition believed to have an increased risk for capsule retention, known
strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such
as esophageal diverticulosis, intestinal tumors, radiation enteritis) or incomplete
colonoscopies as determined by a physician.
9. Significant change in diameter and frequency of stool within the last 3 months.
10. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or
melena.
11. Implanted cardiac device or any other implanted active device
12. Known sensitivity to iodine
13. Acute kidney failure
14. Known condition which precludes compliance or is contraindicated with study and/or
device instructions.
15. Any procedure requiring contrast agent, or which may introduce electronic interference
(such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled
within 14 days of C-Scan ingestion
16. Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
17. Known condition of opioid use disorder and/or alcoholism.
18. Women who are either pregnant or nursing at the time of screening (to be verified by
urine or serum pregnancy test for woman of child- bearing potential who are not
post-menopausal or undergone surgical sterilization).
19. Concurrent participation in another clinical trail using any investigational drug or
device.
20. Previous colonoscopy performed five (5) years or less before date of enrolment
21. Subjec
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.
ts who tend to hyperhidrosis in the back area
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
1. Is willing and able to provide written informed consent/assent and to comply with all
protocol procedures and assessments required for the study.
2. Is age ≥ 12 years and > 40kg at informed consent/assent.
3. Has had an initial allogeneic HSCT for any indication using any graft source, donor
source, conditioning regimen intensity or prophylaxis.
4. Has evidence of myeloid engraftment
5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based
on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of
study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day
1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy,
with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the
breast.
2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after
HSCT.
3. Evidence of persistent molecular disease requiring treatment that was not specified
prior to HSCT.
4. Evidence of cGVHD or overlap syndrome
5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
6. Use of any systemic corticosteroids of > 0.5 mg/kg/day methylprednisolone or equivalent
for any indication other than aGVHD within 7 days before the onset of aGVHD.
Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.
A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
1. Subjects or their legally authorized representative must provide a signed and dated
informed consent form to participate in the study.
2. Subjects must be able (in the judgment of the Investigator) to understand the nature
of the study and all risks involved with participation in the study.
3. Subjects must be willing to cooperate and comply with all protocol restrictions and
requirements.
4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been
compliant with study drug.
1. Subjects of childbearing potential unwilling to use an acceptable method of
contraception from the Day 1/screening visit until 3 months after the last dose of
study medication. Subjects who are sexually active who do not agree to use
contraception during the study period.
2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy
test) or lactating at the Day 1/screening visit.
3. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior
or suicidal ideation of type 4 (active suicidal ideation with some intent to act,
without a specific plan) or type 5 (active suicidal ideation with specific plan and
intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of
Study MT-1186-A02.
4. Subjects who are not eligible to continue in the study, as judged by the Investigator
in conjunction with the MTDA medical monitor.
5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.
Furthering Our Understanding of Neurovascular Function in Women with Uterine Fibroids
Neurovascular Function in Women with Uterine Fibroids
- Premenopausal women, ages 18-50 years old.
- Uterine fibroid group (n≈20): These participants will have had a previous or current diagnosis of UF determined by ultrasound, hysteroscopy, or MRI, confirmed with medical documentation within one year of recruitment.
- Control (non-fibroid) group (n≈20): These participants will not have evidence of UF (confirmed by imaging) at the time of study participation.
- History or evidence of:
- hepatic, renal, or hematological disease;
- peripheral vascular disease;
- stroke/neurovascular disease;
- diabetes;
- dyslipoproteinemia;
- hypertension (> 130/80 mmHg brachial cuff pressure);
- lung disease;
- arthritis affecting ability to exercise; or
- a body mass index > 30 kg/m^2.
- Participants also will be excluded if taking antihypertensive medication or medication that alters autonomic or vascular function (e.g., tricyclic antidepressants, alpha-blockers, beta-blockers, etc.).
- Participants will be non-smokers.
- Subjects must have a negative pregnancy test in order to participate in the study.
- Participants who are breastfeeding will be excluded.
- Women who have undergone hysterectomy will be excluded.
Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.