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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

3159 Study Matches

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A Phase 3, Multicenter, Randomized, Controlled, Open-Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)

Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)

Nathan Smischney
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307016-P01-RST
22-001084
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Inclusion Criteria:


- Adults ≥18 years of age;

- Patients who are anticipated to require >12 hours of invasive mechanical ventilation
and continuous sedation in the ICU; and

- Receipt of continuous sedation due to clinical need for sedation to RASS <0.


Exclusion Criteria:


- Need for RASS -5;

- Sedation for invasive mechanical ventilation immediately prior to Baseline for >72
hours;

- Severe neurological condition before ICU admission that causes the patient to lack
ability to participate in the study (ie, unable to be assessed for RASS and CPOT);

- Ventilator tidal volume <200 or >1000 mL at Baseline;

- Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal
(ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive
ventilation (HFPV) at Screening;

- Comfort care only (end of life care);

- Contraindication to propofol or isoflurane;

- Known or family history of MH;

- Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min
(or equivalent vasopressor dose) to maintain blood pressure within acceptable range,
assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;

- Allergy to isoflurane or propofol, or have propofol infusion syndrome.

- History of ventricular tachycardia/Long QT Syndrome;

- Requirement of IV benzodiazepine or barbiturate administration for seizures or
dependencies, including alcohol withdrawal

- Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal
cord injury, amyotrophic lateral sclerosis, etc);

- Concurrent enrollment in another study that, in the Investigator's opinion, would
impact the patient's safety or assessments of this study;

- Participation in other study involving investigational drug(s) or devices(s) within 30
days prior to Randomization;

- Anticipated requirement of treatment with continuous infusion of a neuromuscular
blocking agent for >4 hours;

- Female patients who are pregnant or breast-feeding;

- Imperative need for continuous active humidification through mechanical ventilation
circuit;

- Attending physician's refusal to include the patient; or

- Inability to obtain informed consent.

Device, Drug
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The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer (NSCLC)

Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer

Konstantinos Leventakos
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307019-P01-RST
21-013359
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Patient

Inclusion Criteria:

  • Adults ≥ 18 years with biopsy proven resected NSCLC.
  • Appointment to discuss adjuvant treatment of resected NSCLC.

Patient


Exclusion Criteria:

  • Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment).

Clinician

Inclusion Criteria:

  • Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC.

Clinician


Exclusion Criteria:

  • None.

PAG Member

Inclusion Criteria:

  • Adults ≥ 18 years.
  • Member of the KER Unit PAG.

PAG Member


Exclusion Criteria:

  • None.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

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Outcomes of Treatment with Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study (VNS-PoCoS)

Vagal Nerve Stimulation for Post-COVID Fatigue

Ravindra Ganesh
All
18 years and over
Not Applicable, Post Market
This study is NOT accepting healthy volunteers
2022-307072-H01-RST
22-000925
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Presence of fatigue and post exertional malaise.
  • Presence of headache
  • Clinical diagnosis of post COVID syndrome.
  • They have consented to participate in the study
  • They have the ability to participate in all aspects of the study.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Pregnant.
  • Prior adverse reaction to 14FDG.
  • Active implantable medical device e.g. pacemaker, hearing aid implant
  • Metallic device e.g. stent, orthopedic hardware in neck
  • Using another electronic device at the same time e.g. TENS, mobile phone. 
  • Any other condition deemed exclusionary by the study principal investigator

Eligibility last updated 1/26/22. Questions regarding updates should be directed to the study team contact.

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A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Spinal Cord Stimulation to Treat Chemotherapy-Induced Peripheral Neuropathy

Ryan D'Souza
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307074-P01-RST
22-001218
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Inclusion Criteria:


- Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater
than six months after stopping chemotherapy

- Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower
extremities at enrollment

- Failed conventional medication management with at least two neuropathic pain
medications

- Have electrophysiological evidence of length-dependent peripheral neuropathy

- Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and
reported a successful trial of at least 75% reduction in pain intensity

- Have stable neurological status

- Be on a stable analgesic regimen

- Be an appropriate candidate for surgical procedures required in this study

- Be able to read and understand English-written questionnaires and sign an informed
consent form in English

- Be willing and capable of giving informed consent

- Be willing and able to complete study-related requirements, procedures, and visits


Exclusion Criteria:


- Patient refusal to be included in study

- Presence of lower limb mononeuropathy

- History of lower limb amputation or ulceration

- Presence of another painful condition that is unrelated to CIPN and that is not
intended to be treated in this study

- Body mass index (BMI) >= 40

- Omeprazole (OME) > 120 mg

- Progressive neurological disease (multiple sclerosis, chronic inflammatory
demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord
tumor, central deafferentation syndrome, complex regional pain syndrome, acute
herniating disc, severe spinal stenosis)

- Certain comorbidities: coagulation/bleeding disorders, diminished capacity from
cardiac/pulmonary disease

- Obtaining another interventional procedure unrelated to SCS to treat limb pain

- Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm.
Included patients must be deemed as in remission per discretion of treating oncologist

- Have a life expectancy of less than one year

- Have untreated addiction or dependency to medications, alcohol, or illicit drugs

- Have active, disruptive, and/or unstable psychological or psychiatric disorder

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

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Normative Biomechanical Measures of Reaching in Able-Bodied Adults

Reach Normal Controls

Kristin Zhao
All
20 years to 59 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307103-H01-RST
22-000958
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Inclusion Criteria:


- 20-59 years of age at time of enrollment


Exclusion Criteria:


- Failure to give consent or follow simple commands

- Score of 7 or above on the QuickDASH Outcome Measure

- Score of 5 or above on the Oswestry Low Back Disability Questionnaire

- Score of 76 or below on the Lower Extremity Functional Scale

- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis,
fibromyalgia)

- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional
vertigo)

- Insufficient active range of motion of bilateral shoulders or hips that results in
inability to perform forward or lateral reaching tasks

- Any illness or condition which, based on the research team's assessment, will
compromise the patient's ability to comply with the protocol, patient safety, or the
validity of the data collected during this study

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

Other, Functional reach test
Finding related to ability to reach
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Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)

Cell Saver During Tumor Resection

Matthew Houdek
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307110-H01-RST
22-000975
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Inclusion Criteria:

  • Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.


Exclusion Criteria:

  • Patients undergoing surgery with an expected blood loss of less than 135cc.
  • Provisions for inclusion of minorities: 
    • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

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Heart Failure (HF) Clinic Biobank

Heart Failure (HF) Clinic Biobank

Horng Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307126-H01-RST
22-000991
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Inclusion Criteria:

  • Patients referred to the Mayo Clinic HF Clinic with a diagnosis of heart failure who have a clinical blood draw scheduled.
  • Adults ≥ 18 years old.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Any history of Hemoglobin less than 9 mg/dL during the past 3 months.
  • Active cancer.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

 

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Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence with Natera (cfDNA with Natera)

cfDNA with Natera

Shanda Blackmon
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307127-P01-RST
22-001607
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Inclusion Criteria:

  • Esophageal cancer any stage.
  • Age ≥ 18 years old.
  • Willing and able to provide consent.
  • No prior history of neoadjuvant therapy for the esophageal cancer.


Exclusion Criteria:
 

  • Age < 18 years old.
  • Unable to provide consent.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Cadman Leggett
All
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307142-P01-RST
22-001278
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Inclusion Criteria:
 

  • Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
  • Between the ages of 45 and 80 years, inclusive.
  • Able and willing to provide written informed consent.


Exclusion Criteria:

  • Self-reported pregnancy.
  • Known diagnosis of Colorectal Cancer.
  • History of, or referral for, Inflammatory Bowel Disease.
  • Previous surgery involving the colon or rectum.
  • Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
  • High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
  • Referral for overt, symptomatic gastrointestinal bleeding.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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Intracardiac Flow Assessment in Cardiac Amyloidosis

Intracardiac Flow Assessment in Cardiac Amyloidosis

Ian Chang
All
40 years and over
This study is NOT accepting healthy volunteers
2022-307150-H01-RST
22-001098
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Inclusion Criteria:


- Subject is clinically stable without cardio-vascular-related hospitalizations within 6
weeks prior to enrollment as assessed by the investigators.

- Subject is able to provide written informed consent and is willing and able to
complete study procedures.

- Currently in sinus rhythm by clinical assessment or documented electrocardiographic
studies.

- Subject and disease characteristics noted by medical record review:

- Healthy control volunteers must also meet the following criteria: Karnofsky
performance scale > 80%; ECOG status 0 or 1.

- ATTRwt cardiac amyloidosis based on meeting all the following criteria: Diagnosis
of amyloidosis within two years prior to study screening; Documentation of
absence of pathogenic TTR mutation; Documentation of absence of plasma cell
dyscrasia, including monoclonal gammopathy of undetermined significance (MGUS) by
laboratory studies including serum free light chain assay and serum or urine
immunofixation; Amyloid deposits in cardiac tissue with TTR protein
identification by mass spectrometry or immuno-histochemistry, OR technetium
(99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake; Evidence of
cardiac involvement by echocardiography with an end-diastolic mean wall thickness
> 12 mm, OR CMR diagnostic of amyloidosis;

- AL with cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; Documented clinical signs and symptoms
consistent with heart failure in the absence of an alternative explanation;
Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR
Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence
of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence of renal failure
or atrial fibrillation OR CMR diagnostic of amyloidosis;

- AL without cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; No documented clinical signs and symptoms
consistent with heart failure from AL; Absence of cardiac involvement as defined
by: Echocardiography with an end-diastolic mean wall thickness < 13 mm if the
subject does not have other causes for increased wall thickness AND NT-proBNP
<333 ng/L if the subject does not have renal failure or atrial fibrillation AND
No CMR diagnostic of amyloidosis if CMR is available prior to screening.


Exclusion Criteria:


- Unable to consent or unable to complete all study procedures.

- Unable to ambulate for 6 minutes (confirmed at study coordinator visit).

- Unable to maintain in supine position for 30 minutes.

- Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator
visit).

- Contraindications for safe CMR scanning (e.g., claustrophobia, cochlear implant,
implanted neural stimulator).

- Presence of implantable cardiac pacemaker, defibrillator or recorder.

- History of intracardiac prosthesis, congenital heart disease, intracardiac shunt,
prior intrathoracic surgery, or procedures to the thoracic aorta or pulmonary
arteries.

- Significant artifact from prior MRI studies.

- Pregnant or breast-feeding women.

- Weight equal to or greater than 155 kg.

- Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70
cm.

- Documented non-sinus rhythm within 6 months prior to screening.

- For healthy controls, the following exclusion criteria apply, confirmed per chart
review and/or patient report:

- History of cardiomyopathy or structural heart disease;

- History of valvular disease of greater than mild severity;

- History of coronary artery disease or coronary heart disease;

- History of cardiac or thoracic surgery.

- History of atrial tachyarrhythmia, ventricular tachyarrhythmia, or symptomatic
bradyarrhythmia;

- Left ventricular hypertrophy or abnormally increased myocardial thickness by
prior echocardiography, cardiac computed tomography, or CMR;

- Acute kidney injury, OR chronic renal disease with glomerular filtration rate <
60 mL/min/1.73m^2 as per medical record review.

- Uncontrolled hypertension of systolic blood pressure > 140 mmHg or diastolic
blood pressure > 90 mmHg as per medical record review;

- Taking two or more anti-hypertensive medications;

- Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c
greater than 7, as per medical record review;

- Taking two or more diabetic medications;

- History of stroke or transient ischemic attack;

- Current cigarette smoker;

- History of peripheral artery disease of aortopathy;

- History of plasma cell dyscrasia or chronic hematologic diagnosis;

- BMI > 35 kg/m^2.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact

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CBYL719C2202, EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participants With HR+, HER2-, Advanced Breast Cancer With a PIK3CA Mutation Following Progression on/After Endocrine-based Therapy (EPIK-B4)

Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

Karthik Giridhar
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307161-P01-RST
22-001322
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Inclusion Criteria:

  • Participant has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer by local laboratory.
  • Participant has a PIK3CA mutation(s) present in tumor prior to enrollment.
  • Participant has prior treatment with an endocrine-based treatment (i.e. letrozole, anastrozole, exemestane, fulvestrant or oral SERD) and may be:
    • relapsed with documented evidence of progression while on (neo) adjuvant endocrine- based therapy or within 12 months from completion of (neo)adjuvant endocrine-based therapy with no treatment for metastatic disease -relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine-based therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine-based therapy for metastatic disease;
    • newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine-based therapy.
      • Note: Participants with newly diagnosed endocrine-based treatment naïve advanced breast cancer will NOT be included in the study.
  • Participants may or may not have received prior CDK4/6i therapy. If prior CDK4/6i therapy was administered, it may have been in the adjuvant or metastatic setting.
  • If female, then the participant is postmenopausal.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participant has adequate bone marrow and organ function


Exclusion Criteria:

  • Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.
  • Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator’s assessment.
  • Participant had more than 1 line of prior treatment in the metastatic setting.
  • Participant has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), any PI3K, mTOR or Akt inhibitor.
  • Participant has a known hypersensitivity to alpelisib, fulvestrant, dapagliflozin and metformin XR alone or in combination or to any of their excipients.
  • Participant has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), any PI3K, Mammalian Target of Rapamycin (mTOR) or Protein Kinase B (Akt) inhibitor.
  • Participant has inflammatory breast cancer at screening.
  • Participant is concurrently receiving other anti-cancer therapy.
  • Participant has had major surgery within 14 days prior to study treatment start and/or has not recovered from major side effects.
  • Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤ 1. Exception to this criterion: participant with any grade of alopecia are allowed to enter in the study.
  • Participant with Child Pugh score B or C.
  • Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
  • Participant has a concurrent malignancy or malignancy within 3 years prior to randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Participants with previously untreated central nervous system (CNS) involvement are ineligible for this study, unless they fulfill the following 3 criteria:
    • completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study entry; and
    • CNS tumor is clinically stable at the time of screening; and
    • participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
  • Participants with an established diagnosis of diabetes mellitus type I or participants with uncontrolled type II diabetes mellitus (FPG > 160 mg/dL and/or HbA1c > 8%) or type II diabetes mellitus requiring antihyperglycemic therapy.
  • Moderate to severe renal impairment (e.g., estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2 ).
  • Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on Investigator discretion.
  • Participant has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.
  • Participant has uncontrolled hypertension, defined as a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm/Hg, with or without antihypertensive medication. Initiation or adjustment of anti-hypertensive medication(s) is allowed prior to screening.
  • Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, contraindicate participant participation in the clinical study (e.g., chronic active hepatitis [testing not mandatory unless required by local regulations or requirements], severe hepatic impairment, etc.).
  • Participant has currently documented pneumonitis/interstitial lung disease (the chest Computerized Tomography (CT) scan performed before start of study treatment for the purpose of tumor assessment should be reviewed to confirm that there are no relevant pulmonary complications present).
  • Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
    • History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;
    • History of documented congestive heart failure (New York Heart Association functional classification III-IV);
    • Left Ventricular Ejection Fraction (LVEF) < 50% at screening as determined by MUGA or ECHO;
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high grade atrioventricular (AV) block (e.g., bifascicular, Mobitz type II and third degree AV block without pacemaker in place);
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or Fridericia QT correction formula (QTcF) > 470 msec at screening.
  • Participant has a history of severe cutaneous reaction, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS.
  • Participant has unresolved osteonecrosis of the jaw (ONJ).
  • Participant is currently receiving any of the following medications and cannot be discontinued at least 7 days prior to the start of study treatment:
    • Strong CYP3A4 inducers;
    • Inhibitors of BCRP.
  • Participant is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
    • Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Participant is a sexually active male not sterilized (at least 6 months prior to screening) or unwilling to use a condom during intercourse while taking study treatment, and for at least 1 year after stopping fulvestrant or for at least 1 week after stopping alpelisib. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during the study and up to the time period specific above.
  • Participant participated in a prior investigational study within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
  • Participant is not able to understand and to comply with study instructions and requirements, including oral administration of study treatment

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

Focal Prostate Ablation Utilizing TULSA Profound System

David Woodrum
Male
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307169-P01-RST
22-001336
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Inclusion Criteria:

  • Male patients.
  • Age 45-80 years, with > 10 years life expectancy.
  • Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
  • Stage ≤ T2c, N0, M0.
  • ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
  • PSA ≤ 20 ng/mL reported within 3 months of baseline.
  • Treatment naïve.
  • Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.  


Exclusion Criteria:

  • Inability to undergo MRI or general anaesthesia.
  • Suspected tumour > 30 mm from the prostatic urethra.
  • Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:                
    • Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
  • Unresolved urinary tract infection or prostatitis.
  • History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
  • Artificial urinary sphincter, penile implant or intraprostatic implant.
  • Less than 10 years life expectancy.
  • Patients who are otherwise not deemed candidates for RP.
  • Inability or unwillingness to provide informed consent.
  • History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

 

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A Placebo-Controlled Efficacy in iNPH Shunting (PENS) Trial (PENS)

Efficacy in iNPH Shunting (PENS) Trial

Benjamin Elder
All
60 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307196-P01-RST
22-001615
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Inclusion Criteria:


1. Age ≥ 60 years; and

2. Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator's
clinical judgement based on criteria and testing as described in the iNPH Guidelines;

3. Evans Ratio ≥ 0.30; and

4. One positive supplementary test to include either large volume Lumbar Puncture or
extended CSF drainage per institutional standards; and

5. History or evidence of gait impairment (such as decreased step height or length,
decreased speed, retropulsion as described in the iNPH Guidelines) duration ≥ 6
months; and

6. Participant has the sensory motor skills, communication skills and understanding to
comply with the testing and reporting required in the PENS trial; and

7. Participant is able to give written informed consent.


Exclusion Criteria:


1. Unable to walk 10 meters with or without an assistive device; or

2. Baseline fastest gait velocity (out of three gait trials) >1 m/sec prior to drainage
trial and fastest gait velocity improvement is < 30% with or without an assistive
device; or

3. Unable to return to the study center for follow up evaluation and shunt programming;
or

4. Participant is not medically cleared for shunt surgery per local standards; or

5. Secondary NPH. (Prior encephalitis, meningitis, subarachnoid hemorrhage, traumatic
brain injury (including concussion) within two years or with brain injury or skull
fracture on baseline imaging, brain abscess, brain tumor, obstructive hydrocephalus
(including acquired aqueductal stenosis and carcinomatous meningitis); or

6. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical
intervention for hydrocephalus; or

7. Previous intracranial neurosurgical procedure; or

8. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening
(asymptomatic lacunar infarctions are permitted); or

9. Diagnosis of Parkinsonian syndrome that, in the investigator's judgment, will
complicate the outcome evaluation; or

10. Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that,
in the investigator's judgment, will complicate the outcome evaluation (such as
neuroleptic treatment for schizophrenia); or

11. Diagnosis of dementia disorder where the investigator considers cognition deficit
limits participation in the study; or

12. Conditions impairing gait that are considered to be unrelated to hydrocephalus, such
as hemiparesis, spasticity, cerebellar ataxia or musculoskeletal and joint disease,
which will interfere with gait assessment or the potential for gait improvement.

13. Individuals with contraindication to MRI (e.g., implanted electric and electronic
devices, aneurysm clip(s), any metallic fragment or foreign body, coronary and
peripheral artery stents, cardiac pacemaker, known claustrophobia, or known/possible
pregnancy or breast-feeding) will be excluded according to institutional guidelines.

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Placental inflammation and function – in vitro analysis

Placenta Study

Sylvie Girard
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
2022-307202-H01-RST
22-000892
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Inclusion Criteria:

  • Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.


Exclusion Criteria:

  • Multiple pregnancy.
  • Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
  • Intrauterine growth retardation or fetal macrosomia.
  • Maternal age under 18 or over 50.
  • Maternal body mass index (BMI) of less than 18 and more than 40.
  • Pregnancy less than 37 weeks of completed gestation.

Eligibility last updated 2/2/22. Questions regarding updates should be directed to the study team contact.

 

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A Post-market Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon (PAS-S)

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Barham Abu Dayyeh
All
22 years to 65 years old
Post Market
This study is NOT accepting healthy volunteers
2022-307203-P01-RST
22-001232
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Inclusion Criteria:

  • Age 22
    •65 years.
  • BMI ≥ 35 and < 40 kg/m^2 or BMI of 30 to 34.9 kg/m^2 with one or more major obesity-related comorbid conditions.
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of obesity (BMI ≥ 30) for at least 2 years.
  • History of failure with non-surgical weight loss methods.
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling.
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow-up visits.
  • Ability to give informed consent.
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.  Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence.  Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester
    •the timing of which will be determined via consultation with the subject’s obstetrician.


Exclusion Criteria:

  • Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
  • Prior open or laparoscopic bariatric surgery.
  • Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
  • Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  • A gastric mass.
  • A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
  • Acid reflux symptoms to any degree that require more than one medication for symptom control.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device.
  • Severe coagulopathy.
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
  • Chronic abdominal pain.
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
  • Hepatic insufficiency or cirrhosis.
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
  • Alcoholism or drug addiction.
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  • Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  • Patients who have BOTH:
    • A previous history of a serotonin syndrome; AND
    • currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
  • Patients who are pregnant or breast-feeding.
  • Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
  • Subjects who have tested positive for H. Pylori, and who have not yet been treated.

Eligibility last updated 2/3/22. Questions regarding updates should be directed to the study team contact.

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T-cell Clonality in Rheumatoid Arthritis (SMRA)

Somatic Mutation in Rheumatoid Arthritis

Jorg Goronzy
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307251-H01-RST
22-001428
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Inclusion Criteria:

  • Diagnosis of seropositive rheumatoid arthritis (either Rheumatoid factor or anti-CCP positive).
  • Age-matched Healthy Controls.


Exclusion Criteria:

  • 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.

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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

Irina Bancos
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307253-P01-RST
22-001433
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Inclusion Criteria:
 

  • 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.


Exclusion Criteria:

  • 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.

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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II) (ADI 3)

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Bruce Johnson
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2022-307263-P01-RST
22-001477
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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).
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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)

Ulrich Specks
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307298-P01-RST
22-001822
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Inclusion Criteria:

  • Participant (male or female) must be 18 years or older at the time of signing the informed consent.
  • Participants who are ≥ 40 kg at Screening Visit 1.
  • EGPA diagnosis: Participants who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia [Jennette, 2013] defined in this study as > 1.0x10^9/L and/or > 10% 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 [MRI]);
    • glomerulonephritis (haematuria, red cell casts, proteinuria);
    • alveolar haemorrhage (by bronchoalveolar lavage);
    • palpable purpura;
    • ANCA positive Myeloperoxidase (MPO) or Proteinase 3 (PR3).
  • History of relapsing OR refractory disease defined as:
    • Relapsing disease: Participants must have a history of at least one confirmed EGPA relapse (i.e., requiring increase in OCS dose, initiation/increased dose of immunosuppressive therapy or inpatient hospitalisation due to EGPA) within the past 2 years. EGPA relapse should have occurred at least 12 weeks or more prior to Screening (Visit 1) whilst receiving a dose of prednisolone (or equivalent of) ≥ 7.5 mg/day;
    • Refractory disease: Defined as either failure to attain remission (BVAS=0 and OCS dose ≤ 7.5 mg/day prednisolone or equivalent) within the last 6 months prior to Screening Visit 1 and following induction treatment with a standard OCS regimen, administered for at least 3 months OR participants with recurrence of EGPA symptoms within 6 months prior to Screening (Visit 1) whilst tapering OCS and occurring at any dose level ≥7.5 mg/day prednisolone or equivalent.
      • NOTE: Recurrent symptoms of EGPA do not necessarily need to meet the protocol definition of relapse.
  • Corticosteroid therapy: 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).
  • Immunosuppressive therapy: If 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 nonchildbearing 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%, from at least 14 days prior to the first dose of study intervention until the following durations (whichever is greater)
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.


Exclusion Criteria:

  • GPA or MPA: Diagnosed with granulomatosis with polyangiitis (GPA; previously known as Wegener’s granulomatosis) or microscopic polyangiitis (MPA).
  • EULAR defined organ-threatening EGPA: Organ-threatening EGPA as per EULAR criteria, i.e., organ failure due to active vasculitis, creatinine > 5.8 g/dL (> 513 µmol/L) within 3 months prior to Screening (Visit 1).
  • Life-threatening EGPA: Imminently life-threatening EGPA disease defined as any of the following within 3 months prior to Screening (Visit 1).
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. Participants that had localised carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded).
  • Liver Disease: Alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine > 3 x ULN, AST > 2 x ULN or if participant is on background methotrexate or azathioprine > 3 x ULN, Alkaline Phosphatase ≥ 2.0 x ULN , Total bilirubin > 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%), Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
  • Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment including but not limited to: Known ejection fraction of < 20%, OR Severe heart failure that meets New York Heart Association Class IV, OR Hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III OR Myocardial infarction or angina diagnosed less than 3 months prior to or at Screening Visit 1 ORUncontrolled life threatening arrythmia within 3 months prior to or at Screening Visit 1).
  • Other Concurrent Medical Conditions: Participants who have known, pre‑existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory or any other system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment.
  • Laboratory abnormality: Evidence of clinically significant abnormality in the haematological, biochemical or urinalysis screen at Visit 1, as judged by the investigator.
  • Infectious disease: Chronic or ongoing active infectious disease requiring systemic treatment.
  • Parasitic infection: Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
  • Immunodeficiency: A known immunodeficiency (e.g., human immunodeficiency virus – HIV), other than that explained by the use of OCS or other immunosuppressants taken as therapy for EGPA.
  • COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active 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.
  • Hypersensitivity: Participants with a known allergy or intolerance to a monoclonal antibody or biologic therapy or any of the excipients of the investigational products.
  • Monoclonal antibodies targeting IL-5/5R: Participants who have a previous documented failure with anti-IL-5/5R therapy.
  • Participants who have received treatment with investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).  Participants who are currently participating in any other interventional clinical study.
  • Other prohibited medications: 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, intramuscular or SC corticosteroids in the 4-week period prior to Baseline (Visit 2);
    • Omalizumab within 130 days prior to Screening (Visit 1);
    • Cyclophosphamide:  oral CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to Baseline (Visit 2), if their total WBC is ≥ 4 x10^9/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;
    • 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-α within 6 months prior to Screening Visit 1;
    • Anti-TNF therapy within 12 weeks prior to Screening Visit 1;
    • Anti-CD52 (alemtuzumab) within 6 months prior to Screening Visit 1.
  • Previous participation: Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 6 months prior to Screening Visit 1.
  • ECG Assessment: QTcF ≥ 450 msec or QTcF ≥ 480 msec for participants with Bundle Branch Block at Screening Visit 1.
  • Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
  • Pregnancy: Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
  • Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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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)

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Anthony Fine
All
4 years to 16 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-307311-P01-RST
22-001706
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Inclusion Criteria:

  • Written or oral pediatric assent from the subject deemed capable of providing assent and written informed consent from the subject’s parent(s) or legal guardian(s) in accordance with the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and according to local laws and regulations. Informed consent/assent may be done remotely, if allowed per site and remote consenting procedures are in place.
  • Completed 12 weeks of treatment (3 weeks titration and 9 weeks maintenance) in Study NBI-827104-CSWS2010.
  • Subjects of childbearing potential must agree to use highly effective birth control methods consistently while participating in the study until 90 days after the last dose of the study treatment.
  • A female subject of childbearing potential is defined as a subject who has had her first menstrual cycle (ie, menarche). A male subject of childbearing potential is defined as a subject who has reached spermarche.
  • Highly effective methods of birth control for female subjects of childbearing potential are:
    • Combined (estrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception used with an effective nonhormonal method of contraception (eg, barrier contraception used with spermicide);
    • Intrauterine hormone-releasing system used with an effective nonhormonal method of contraception (eg, barrier contraception used with spermicide);
    • Intrauterine device;
    • Bilateral tubal occlusion;
    • Vasectomized partner;
    • True abstinence from sexual intercourse as the preferred lifestyle;
    • Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) is not acceptable.     
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Day 1.
  • The acceptable methods of contraception for male subjects of childbearing potential are:
    • Condom with spermicide (cream, spray, foam, gel, suppository, or polymer film);
    • Vasectomy at least 3 months prior to screening with medically confirmed successful procedure;
    • True abstinence from sexual intercourse as the preferred lifestyle. Note that periodic abstinence is not acceptable.
  • A subject who becomes of childbearing potential during the study will be required to use contraception as described.
  • Willing to comply with all study procedures and restrictions.


Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
  • 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 Day 1 or plans to use such an investigational drug (other than NBI-827104) during the study.
  • It is anticipated that the subject will require treatment with at least 1 of the prohibited concomitant medications or other restrictions during the specified study time frame.
  • 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.
  • The subject or the subject’s parent(s)/caregiver(s) are, in the investigator’s opinion, unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

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Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration (BISII)

Effect of Timing of Commencement of BIS Monitoring in Relation to Muscle Relaxant Administration

Matthew Ritter
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307319-H01-RST
22-001485
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Inclusion Criteria:
  

  • Adult patient ≥ 18 years old.
  • Undergoing elective cardiac surgery. 
  • Muscle relaxation administration by rocuronium. 


Exclusion Criteria:
   

  • Patient refusal. 
  • Pediatric patients. 
  • Patients less than 18 years old. 
  • Emergency procedure. 
  • Patients with known or suspected carotid or cerebrovascular disease. 
  • Patients with prior stroke. 
  • Skin condition or anatomy preventing proper sensor placement. 
  • Patients who receive ketamine during the study timeframe. 

Eligibility last updated 2/15/22. Questions regarding updates should be directed to the study team contact.

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EAQ202: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Zhaohui Jin
All
18 years to 39 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307328-P01-RST
22-001776
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Inclusion Criteria:

  • Patient must be ≥ 18 years and ≤ 39 years of age at registration.
  • Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
  • Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
  • Patient must have an ECOG performance status 0-3.
  • Patient must have a life expectancy > 24 months.
  • Patient must be able to complete questionnaires in English.
  • Patient must have internet access through computer, tablet, or smartphone.
  • Patient must have an email address.
  • Patient must have a mobile phone able with text messaging capabilities.
  • Patient must be able to accurately provide self-report data (e.g., per clinical judgment, cognitive function is intact). Patient must be able to provide informed consent.


Exclusion Criteria:

  • Patient must not have a recurrence or second primary cancer.
  • Patient must not have basal cell skin carcinoma.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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Per Oral Endoscopic Myotomy - A Minimally Invasive Treatment Modality for Achalasia (POEM Prospective)

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

Karthik Ravi
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307348-H01-RST
22-001899
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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.

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(ECTx) A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations (JSI-1187-01)

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Robert McWilliams
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307388-P01-RST
22-002123
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Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy.
  • Part A (JSI-1187 Monotherapy Dose Escalation):
    • Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions; e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit.
    • Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation):
      • Histologically or cytologically confirmed BRAF V600-mutated locally advanced or metastatic solid tumor, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit.
  • Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
    • Cohort 1: BRAF V600-mutated metastatic melanoma after two prior therapies for metastatic disease, including anti-PD1 therapy, with or without ipilimumab, and BRAF/MEK inhibitor treatment;
    • Cohort 2: BRAF V600-mutated metastatic melanoma after adjuvant therapy for Stage 3 disease followed by one prior therapy for metastatic disease, including anti-PD-1 therapy, with or without ipilimumab or BRAF/MEK inhibitor treatment;
    • Cohort 3: Either BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), or BRAF V600-mutated metastatic solid tumor, after 1 or 2 prior therapies.
  • MAPK mutation tumor status will be established prior to entry based on previous MAPK pathway mutation reports from a CLIA qualified laboratory, or, if a report is not available, the mutation analysis will be performed at Screening on archival tissue or newly biopsied tumor tissue.
  • Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤ 1.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Life expectancy of ≥ 3 months -Subjects with asymptomatic stable, prior or currently treated brain metastases are allowed -Adequate hematologic parameters without ongoing transfusional support:
    • Hemoglobin (Hb) ≥ 9 g/dL -Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L;
    • Platelets ≥ 75 x 10^9 cells/L -Adequate renal and hepatic function;
    • Creatinine ≤ 1.5 times the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula;
    • Total bilirubin ≤ 2 times the (ULN) unless due to Gilbert's disease;
    • ALT/AST ≤ 2.5 times the ULN, or < 5 times the ULN for subjects with liver metastases.
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
  • Ability to provide written informed consent.


Exclusion Criteria:

  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV.
  • QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inhibitors of BCRP are prohibited during study and for 14 days prior to the first dose of study drugs(s).
  • Subjects on dabrafenib (Parts B and C) also are advised to avoid concurrent administration of strong inhibitors of CYP2C8 as these medications may increase the concentration of dabrafenib -History of or current evidence/risk of retinal vein occlusion or central serous retinopathy, or has medically relevant abnormalities identified on screening ophthalmologic examination -Symptomatic central nervous system malignancy or metastasis -Gastrointestinal conditions that could impair absorption of study drug(s).
  • Current hematologic malignancies -Second, active primary solid tumor malignancy that, in the judgement of the investigator or Sponsor medical monitor, may affect the interpretation of results.
  • Prior malignancies, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, Gleason 3+3 prostate cancer and prior malignancies in remission whose likelihood of recurrence is very low, as judged by the Sponsor medical monitor.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment.
  • Other active infection requiring IV antibiotic usage within the last week prior to study treatment.
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Participation within the last 28 days in a clinical trial, or currently enrolled in a clinical trial, involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
  • If female, pregnant, breast-feeding, or planning to become pregnant.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

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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

Mohamad Adnan Alkhouli
All
50 years and over
This study is NOT accepting healthy volunteers
2022-307407-H01-RST
22-002761
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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.

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Artificial Intelligence Enhanced Assessment of Speech Disorders: Prospective Data (NAIP-Speech)

Artificial Intelligence Enhanced Assessment of Speech Disorders

Hugo Botha
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307409-H01-RST
22-002430
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Inclusion Criteria:

  • Adult (18 years or older).
  • Able to provide informed consent (patient or power of attorney).
  • Able to provide samples in English.
  • U.S. based patient.


Exclusion Criteria:

  • 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.

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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

Zhaohui Jin
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307410-P01-RST
22-002140
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Inclusion Criteria:


- 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


Exclusion Criteria:


- 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 10/5/22. Questions regarding updates should be directed to the study team contact

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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

Ciara O'Sullivan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307417-P01-RST
22-002198
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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.

 

Biologic/Vaccine, Drug, Other
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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

Todd Rasmussen
All
18 years to 85 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-307421-P01-RST
22-001156
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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.

Drug, Procedure/Surgery
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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

Jann Sarkaria
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307429-P01-RST
22-002233
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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.

Drug, Radiation
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