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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.

3290 Study Matches

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Pushing the Envelope in Reduction of Hysterectomy Surgical Site Infection (SSI): Studying the role of an Anal Occlusive Dressing (AOD) (AOD and SSI)

Anal Occlusion and SSI Reduction

Tarek Khalife
Female
18 years to 65 years old
This study is NOT accepting healthy volunteers
2022-307005-H01-MAIJ
22-000637
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Inclusion Criteria:

  • Patients subject to a laparoscopic hysterectomy procedure necessitating uterine manipulator use,
  • Age 18-65.


Exclusion Criteria:

  • Patient known to have a vesicovaginal or rectovaginal fistula.
  • Patients who have a documented tape allergy.
  • Patients know to have an active pelvic infection.
  • Patient diagnosed or known to have fecal incontinence.
  • Patients diagnosed or known to have severe external hemorrhoids.
  • Patients with a very short perineal body with < 2cm.
  • Patients who were found to have a disruption in the occlusive dressing seal at the end of the case (blood soilage).
  • Patients necessitating a rectal exam or manipulation as part of the procedure.
  • Patient with visible skin irritation or inflammation around the anal orifice.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Assessing the Experiences of LGBTQ patients in the ICU (LGBT in ICU)

Assessing the Experiences of LGBTQ Patients in the ICU

Erin DeMartino
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307009-H01-RST
22-000846
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Inclusion Criteria:

  • Is 18 years old or older.
  • Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
  • Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.


Exclusion Criteria:
 

  • Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.

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

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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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Mayo Clinic — Rochester, MN

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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Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial (HAPCET)

Comparing ESG to ESG with APC

Barham Abu Dayyeh
All
21 years to 65 years old
Early Phase 1
This study is NOT accepting healthy volunteers
2022-307124-H01-RST
22-001202
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Inclusion Criteria:

  • Age 21-65.
  • BMI ≥ 30 and ≤ 40 kg/m² .
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • 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, and 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. 


Exclusion Criteria:
 

  • History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
  • Prior gastrointestinal surgery with sequelae; i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions.  
  • Prior open or laparoscopic bariatric surgery.  
  • Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery. 
  • Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) 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. 
  • Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.  
  • A gastric mass or gastric polyps > 1 cm in size.  
  • A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.  
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.  
  • Achalasia or any other severe esophageal motility disorder.
  • Severe coagulopathy. 
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ 9. 
  • 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.
  • Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.  
  • Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
  • 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 high dose aspirin (> 80 mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.  
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
  • Patients who are pregnant or breast-feeding.  
  • Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. 
  • 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 taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
  • Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
  • Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.  
  • Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia or cancer.  
  • Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.  
  • Specific diagnosed genetic disorder such as Prader Willi syndrome. 
  • Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 
  • Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism. 
  • If deemed medically inappropriate or ineligible by investigator. 

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
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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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SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome (SPI-62-CL-2001)

SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome

Irina Bancos
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307148-P01-RST
22-002075
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Inclusion Criteria:

Subjects must satisfy all following criteria at the Screening visit unless otherwise stated:

  • Male or female aged 18 years or older.
  • Able to provide written informed consent.
  • Active and consistent cortisol excess:
    • Active and consistent cortisol excess: This is defined as UFC > upper limit of normal (ULN) based on at least 2 valid (i.e., complete) 24-hour urine samples collected during Screening. The subjects will be provided collection devices for three 24-hour collections to ensure 2 complete collections are received, particularly if a subject requires washout of other cortisol-suppressing agents. If more than 2 valid collections are received; the mean of all valid completed collections collected after completion of the washout period (if applicable), and available at Day 1 must be >ULN, as confirmed by the central laboratory. Should an additional, otherwise disqualifying, UFC value become available only after Day 1 randomization, the subject will be allowed to continue planned treatment and a sensitivity, per-protocol analysis will be conducted.
  • Documented diagnosis of ACTH-dependent Cushing’s syndrome:
  • This includes Cushing’s disease, ectopic ACTH secretion, and ectopic CRH secretion. Subjects may include newly diagnosed patients who have declined or are not considered candidates for surgery or patients with residual or recurrent disease after surgery in whom surgery or radiation are not planned within the next 6 months. Previous medical records will be used to support the diagnosis.
  • At least 1 of the following will be considered satisfactory to establish the diagnosis:
  • History of positive ACTH-staining pathology.
  • History of documented, transient, AI after tumor removal requiring glucocorticoid replacement.
  • ACTH level > 20 pg/mL with positive ACTH or cortisol response to CRH or desmopressin (DDAVP) stimulation in the presence of hypercortisolemia.
  • Inferior petrosal sinus sampling with ACTH central:plasma gradient ≥ 2 before CRH or DDAVP or ≥ 3 after CRH or DDAVP.
  • Presumptive Cushing’s disease based on presence of a pituitary tumor ≥ 6 mm along with positive ACTH or cortisol response to CRH or DDAVP stimulation or an overnight or high-dose (8 mg) dexamethasone suppression of cortisol, performed and interpreted according to locally recognized standards of diagnosis.
  • In the absence of any of the above, an individual might be eligible if ectopic ACTH-dependent Cushing’s syndrome was otherwise confirmed via adequate testing consistent with the local standards of care. Such cases must be discussed with and explicitly approved by the Medical Monitor and Sponsor, and the specific diagnostic criteria used to establish the diagnosis of ACTH-dependent Cushing’s syndrome must be documented.
  • Willing to comply with reproductive precautions.
  • Current evidence of Cushing’s morbidities of hyperglycemia, dyslipidemia, hypertension, or osteopenia:
    • Defined by having at least 1 of the below criteria, ideally including both or either of “a” and “b”, but including any of “a”, “b”, “c”, or “d”.
      • Diagnosis of insulin-resistance/pre-diabetes or type 2 diabetes: Including subjects on stable diabetic treatment, but excluding those ethically requiring further or frequent therapy adjustments. Type 2 diabetes is defined as a current HbA1c ≥ 6.5% but ≤ 9.5% (otherwise excluded), fasting blood glucose (FBG) > 126 mg/dL, or 2 hr OGTT ≥ 200 mg/dL. Pre-diabetes is defined as current HbA1c < 6.5 but > 5.7%, FBG > 100 to 125 mg/dL, or 2-hour OGTT 140 to 199 mg/dL. Insulin-resistance may also be defined by abnormal HOMA-IR > 2.5 or by CGM data (e.g., mean glucose, glycemic variability, time in range, estimated HbA1c)28;
      • Diagnosis of dyslipidemia: This is evidenced by history of total cholesterol level of ≥ 6.2 mmol/L (240 mg/dL) or triglycerides of ≥ 5.2 mmol/L (200 mg/dL) Current total cholesterol may be < 6.2 mmol/L, and current triglycerides may be < 5.2 mmol/L, if controlled with allowed lipid-lowering therapy;
      • Diagnosis of hypertension: Incident hypertension should be brought under control and stabilized prior to randomization at Day 1. Subjects with hypertension which is reasonably, but sub-optimally managed by standard therapy at baseline (systolic blood pressure [SBP] >140 but < 180 or DBP > 90 but < 120 mmHg) qualify;
      • Diagnosis of osteoporosis or osteopenia: Osteopenia (T-score ≤ -1.0 or Z-score ≤ -2.0) or osteoporosis as determined previously, during by the site’s local Baseline DEXA reading, or history or evidence of minimal-traumatic or osteoporotic fracture treated with lifestyle modification with mineral or vitamin supplementation or stable approved osteoporosis therapies.

Exclusion Criteria

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

  • Recent or planned Cushing’s surgery: Surgery for Cushing’s within the past 6 weeks or planned within 24 weeks after randomization.
  • Use of medications for Cushing’s syndrome within the washout periods prior to randomization.
  • Recent Cushing’s radiotherapy: Any fractionated radiation therapy for Cushing’s within the past 2 years, or conventional radiation therapy within 4 years.
  • History of bilateral adrenalectomy.
  • History of pseudo-Cushing’s syndrome.
  • History of cyclic Cushing’s syndrome.
  • Exogenous hypercortisolism or factitious Cushing’s syndrome.
  • History of non-ACTH-dependent hypercortisolism:
  • This includes that caused by a known inherited syndrome (e.g., McCune Albright syndrome, Carney complex) but not including multiple endocrine neoplasia type 1 where diagnostic testing has led to a diagnosis of Cushing’s disease (79%) while excluding autonomous adrenal Cushing’s syndrome (21%).
  • High risk of Nelson’s syndrome: Current evidence of macroadenoma with, or at risk of, optic nerve or vital structure compression, e.g., tumor showing aggressive growth within 2 mm of optic chiasm or with evidence of blood-vessel encroachment.
  • Uncontrolled Cushing’s morbidities of hyperglycemia, dyslipidemia, hypertension, or osteopenia:
  • Including evidence of chronic, poor glycemic control (HbA1c > 9.5%), symptomatic dyslipidemia (e.g., hypercholesterolemia with recent (< 1 year) cerebro- or cardiovascular events, hypertriglyceridemia with pancreatitis), persistent uncontrolled hypertension (systolic blood pressure > 180 mmHg or DBP > 120 mmHg), or recent (< 1 year) osteoporotic fracture ethically requiring additional medical intervention.
  • Use of drugs likely to interfere with study assessments:
  • These include chronic systemic corticosteroids, thiazolidinediones, 5-alpha-reductase inhibitors, certain drugs that affect cognitive testing (e.g., oxybutynin or opioids) within 12 weeks prior to the first dose of study drug. See concomitant medications section for recommendations regarding use of certain other allowed medications.
  • Uncontrolled hypothyroidism or hyperthyroidism: Free thyroxine should be in normal range and stable, whether endogenous or on levothyroxine replacement [> 8 weeks] and without elevated thyroid-stimulating hormone.
  • Moderate or severe renal impairment: Defined by an estimated glomerular filtration rate (GFR) repeatedly < 60 mL/min or confirmed by measured GFR < 60 mL/min.
  • Medically significant liver disease.
  • Including cirrhosis, chronic active hepatitis, chronic persistent hepatitis, or subjects with serum total bilirubin > 1.5 × ULN (unless previously diagnosed with benign Gilbert’s disease) or serum ALT or AST >3 × ULN.
  • Medically significant cardiovascular or ECG abnormalities:
  • This includes patients with recent (< 1 year) myocardial infarction or stroke, orthostatic or vasovagal syncope, QT interval corrected (QTc) intervals > 500 ms, or evidence of significant, life-threatening arrhythmia or bradycardia (HR < 45 bpm).
  • History of idiopathic thrombocytopenic purpura.
  • History of adrenal carcinoma.
  • Recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: Positive test for infection within the past 4 weeks or hospitalization for coronavirus disease 2019 (COVID-19) within the past 6 months.
  • History of cancer within 3 years other than ectopic ACTH from an unidentified source, non-melanoma skin cancer, thyroid cancer, or early-stage prostate cancer.
  • If stable and requiring hormone-suppressive therapy, patients with prostate cancer may be included at Medical Monitor discretion, however their data may be excluded in assessment of SPI-62 effects on HPA and HPG axes).
  • Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
  • Pregnant, lactating, or planning fertility in the next 6 months and unwilling to adhere to approved contraceptive use or abstinence.
  • Participation in any clinical trial within 1 month prior to informed consent (or longer for biologic and long-lasting experimental therapies).
  • Receipt of blood products within 2 months prior to Screening.
  • Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening. Subjects are not to donate blood, plasma, or platelets during the study.
  • Poor peripheral venous access.
  • Any other current or prior medical condition expected to interfere with the conduct of the study or the evaluation of its results.

Eligibility last updated 10/5/22. 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.

- ATTR cardiac amyloidosis based on meeting all the following criteria: Diagnosis
of amyloidosis within two years prior to study screening; Documentation of
absence of AL, heavy chain disease, multiple myeloma or malignant
lymphoproliferative disorders; Transthyretin amyloid deposits in cardiac tissue
OR technetium (99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake
OR Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic
evidence of cardiac involvement or an end-diastolic mean wall thickness >12mm OR
Transthyretin amyloid deposits in non-cardiac tissue with 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 or symptoms
consistent with heart failure; 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 12/21/22]. 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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Genomic Testing for Well-treated Patients with Partial OTC Deficiency Who Experienced Sudden, Unexpected Death

OTC Deficiency Study

Amy White
All
Not specified
This study is NOT accepting healthy volunteers
2022-307225-H01-RST
22-001296
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Inclusion Criteria:

  • Deceased children with partial ornithine transcarbamylase (OTC) deficiency who were under strict treatment and died unexpectedly, and their parents.


Exclusion Criteria:
 

  • Lack of quality or significant volume of DNA from all submitted specimens.

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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Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Wen Wee Ma
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307312-P01-RST
22-001698
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Inclusion Criteria:

  • 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.


Exclusion Criteria:

  • 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.

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A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia (DIUR-014)

Chronocort Versus Standard Hydrocortisone Replacement Therapy to Treat Congenital Adrenal Hyperplasia in Participants Aged 16 Years and Over

Irina Bancos
All
16 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307325-P01-RST
22-001875
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Inclusion Criteria:


- Male or female participants must be aged 16 years or older at the time of signing the
informed consent/assent.

- In participants aged <18 years, height velocity must be less than 2 cm/year in the
last year and puberty must be completed (Tanner stage V).

- Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in
childhood with documented (at any time) elevated 17-OHP and with or without elevated
A4 and currently treated with hydrocortisone, prednisone, prednisolone or
dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable
glucocorticoid therapy for a minimum of 3 months.

- Participants who are receiving fludrocortisone must be on a documented stable dose for
a minimum of 3 months prior to enrollment and must have stable renin levels at
screening.

- Female participants of childbearing potential and all male participants must agree to
the use of an accepted method of contraception during the study.

- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has
a negative pregnancy test at entry into the study. Note: females presenting with
oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially
fertile and therefore should undergo pregnancy testing like all other female
participants.

- Capable of giving signed informed consent/assent which includes compliance with
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.


Exclusion Criteria:


- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times
the upper limit of normal (ULN) or elevated liver function tests (alanine
aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).

- History of bilateral adrenalectomy.

- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks
prior to entry into the study).

- Participants who have type 1 diabetes or receive regular insulin, have uncontrolled
diabetes, or have a screening HbA1c greater than 8%..

- Persistent signs of adrenal insufficiency or the participant does not tolerate
treatment at the end of the 4-week run-in period.

- Participants with any other significant medical or psychiatric conditions that in the
opinion of the Investigator would preclude participation in the study.

- Participants on regular daily inhaled, topical, nasal or oral steroids for any
indication other than CAH.

- Co-morbid condition requiring daily administration of a medication or consumption of
any material that interferes with the metabolism of glucocorticoids.

- Participants who are receiving <10 mg hydrocortisone dose at screening or the
hydrocortisone dose equivalent.

- Participants anticipating regular prophylactic use of additional steroids e.g. for
strenuous exercise.

- Participation in another clinical study of an investigational or licensed drug or
device within the 12 weeks prior to screening.

- Inclusion in any natural history or translational research study that would require
evaluation of androgen levels during the study period outside of this protocol's
assessments.

- Participants who have previously been exposed to Chronocort in any Diurnal study.

- Participants who routinely work night shifts and so do not sleep during the usual
night-time hours.

- Participants, who in the opinion of the Investigator, will be unable to comply with
the requirements of the protocol.

- Participants with a known hypersensitivity to any of the components of the Chronocort
capsules, the Cortef tablets, or the placebo capsules.

- Participants with congenital galactosemia, malabsorption of glucose and galactose, or
who are lactase deficient.

- Participants with a body weight of 45 kg or less.

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

Eligibility last updated 1/18/23. 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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Quantitative Contrast-free Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors (qHDMI)

Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors

Azra Alizad
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307344-P01-RST
22-001824
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Inclusion Criteria:

  • Male and female, age 18 and older.
  • Suspected of having eye tumor.

AIM 1 - SUBSET OF LARGE CHOROIDAL NEVI:

Inclusion Criteria:

  • Lesions with thickness > 1.5 mm and minimum documented stability interval of 2 years.


Exclusion Criteria:

  • Lesions with thickness < 1.5 mm or fewer than 2 years of documented stability.

SUBSET LARGE MELANOMA:

Inclusion Criteria:

  • Choroidal, ciliary body, or ciliochoroidal melanoma in a patient who elected to have enucleation for primary tumor treatment.


Exclusion Criteria:

  • Iris melanoma or melanoma that has undergone prior treatment before enucleation.

PRESUMED CHOROIDAL MELANOMA:

Inclusion Criteria:

  •  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.


Exclusion Criteria:

  • Iris melanoma, lesions with thickness < 1.5 mm, non-melanoma tumors.

AIM 2

Inclusion Criteria:

  • Orbital mass with completed neuroimaging (typically with MRI) and clinical/MRI suspicion for lymphoma.


Exclusion Criteria:

  • 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.

 

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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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