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3289 Study Matches

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Understanding the Baseball Swing Through Motion Capture (MoCap)

A Study of the Baseball Swing Through Motion Capture

Christopher Camp
Male
14 years to 30 years old
This study is NOT accepting healthy volunteers
2021-306490-H01-RST
21-012145
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Inclusion Criteria:

  • Age 15-30 years, inclusive.
  • Male gender.
  • Active participation in collegiate level baseball as a batter. 
  • No current musculoskeletal complaints for which the subject is being treated.
  • Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
  • Willingness to participate in the study
  • The testing will be completed at the Mayo Clinic Motion Analysis Laboratory utilizing currently available equipment and standardized techniques for motion capture.


Exclusion Criteria:
 

  • Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
  • History of fracture, dislocation, subluxation, or separation affecting the cervical spine, thoracic spine, rib cage, elbow, or either shoulder girdle.
  • History of rotator cuff injury, elbow injury, or shoulder instability for which the subject has been evaluated and/or treated in the past 12 months.
  • History of dominant side shoulder or elbow surgery.
  • Known neurological, visual, or vestibular disease affecting balance or coordination
  • Congenital deformity of the neck, upper extremity, or lower extremity.
  • Congenital or acquired scoliosis or significant thoracic kyphosis (> 30 degrees).
  • History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

Eligibility last updated 11/18/21. Questions regarding updates should be directed to the study team contact.

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A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups

A Study of Educational Materials for Hiccups

Aminah Jatoi
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306492-H01-RST
21-012057
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Inclusion Criteria:

  • Age ≥ 18 years of age.
  • Hiccups in the 4 weeks prior to phone contact (patient must confirm).
  • Able to speak and read English.
  • Has an e-mail address.


Exclusion Criteria:
 

  • Individuals < 18 years of age.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

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Autosomal Dominant Hypocalcemia Types 1 and 2 (ADH1/2) Disease Monitoring Study (DMS) (CLARIFY)

CLARIFY: ADH1 and ADH2 Disease Monitoring Study (DMS)

Peter Tebben
All
up to 90 years old
This study is NOT accepting healthy volunteers
2021-306497-P01-RST
21-012116
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Inclusion Criteria:

  • Participants from birth to age 90 years must meet all the following criteria for inclusion during screening:
    • Have a documented activating variant of the CASR gene for ADH1 or documented activating variant of the GNA11 gene for ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment
      • Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
    • Be willing and able to provide informed consent or assent after the nature of the study has been explained, and prior to any research-related procedures.
    • Be willing to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available.
    • Be willing and able to comply with the study visit schedule and study procedures.


Exclusion Criteria:

  • Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures.
  • Enrollment in an ADH1/2 interventional clinical study at the time of DMS Screening visit or at any point during the DMS.

Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.

Autosomal dominant hypocalcemia
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Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum (DBS)

Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum

Elitza Theel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306510-H01-RST
21-012151
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Inclusion Criteria:

  • Subjects who are ≥ 18 years of age.
  • Subjects who are known to be positive for syphilis antibodies using routine, standard of care serologic assays.


Exclusion Criteria:
 

  • Subjects who are < 18 years of age.
  • Subjects who are unable to give informed consent.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

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A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) (VGN-TED-301)

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Marius Stan
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-306514-P01-RST
21-012535
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Inclusion Criteria:

  • Subjects must be ≥ 18 years of age at Screening.
  • Clinical diagnosis of Graves’ Disease and/or autoimmune Hashimoto’s thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
  • Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
  • Subjects must be euthyroid (defined as normal TSH) or, have subclinical hyperthyroidism (defined as normal FT4 and FT3 with TSH below the normal range). Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial.
  • Does not require immediate surgery, radiotherapy or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
  • Diabetic subjects must have HbA1c < 9.0%. Type 2 diabetic subjects who are not on insulin, must not be prescribed insulin within 60 days prior to screening. If Type 1 or Type 2 diabetic subjects are on insulin, the prescribed total daily insulin dose must not have changed by more than 20% or more than 10 units (whichever is greater) in the 60 days prior to Screening. Subjects must not have severe hypoglycemic events (requiring medical care by health care professional) in the 60 days before screening.
  • Women of childbearing potential are required to have a negative serum pregnancy test at time of Screening and a negative urine pregnancy test at each timepoint that is specified in protocol. The definition of childbearing potential also includes women with the onset of menopause < 2 years prior to Screening, women with non-therapy-induced amenorrhea for < 12 months prior to Screening, and women who are considered infertile (sterile) from non-surgical conditions [absence of ovaries and/or uterus]). These women are also required to have a negative serum pregnancy test at time of Screening and a negative urine pregnancy test at each timepoint that is specified in protocol. Women who are sexually active with non-vasectomized male partners must agree to use 2 reliable forms of contraception during the trial. It is recommended that hormonal (ie: oral contraceptive) contraception be one of these contraceptive methods used. Hormonal contraception must be initiated ≥ 21 days prior to Baseline visit and continue for 7 days following the last dose of study drug. When used correctly and consistently, highly effective contraceptive methods including combined oral contraceptives, some intrauterine devices (IUDs), injectables, implants, sexual abstinence or sex with a vasectomized partners have a failure rate < 1% per year.
  • Male subjects who are sexually active with a female partner of childbearing potential (as defined above), must agree to use barrier contraceptive method from Screening through 7 days after the last dose of study drug. Otherwise, sexually active male subjects must be surgically sterile.
  • Subject is willing and able to sign written informed consent and comply with the protocol for the duration of the study.


Exclusion Criteria:

  • Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
  • Corneal decompensation unresponsive to medical management.
  • Decrease in CAS of ≥ 2 points in the primary study eye between Screening and Baseline.
  • Decrease in proptosis of ≥ 2 mm in the primary study eye between Screening and Baseline.
  • Previous orbital irradiation or surgery.
  • Prior IGF-1R inhibitor therapy for any condition.
  • Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to > 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening. NOTE: previous use of steroid eye drops is allowed if discontinued at least 4 weeks prior to Screening).
  • Corticosteroid use (including topical) for conditions other than TED within 4 weeks prior to Screening (inhaled steroids are allowed)
  • Use of any other non-steroid immunosuppressive agent within 4 weeks prior to Screening.
  • Any previous treatment with anti-IL6 receptor, anti- CD20, (MS4A1) antibodies or monoclonal antibody for immunomodulation within the past 9 months prior to Screening.
  • Selenium and/or biotin use as a treatment for TED within 3 weeks prior to screening is disqualifying, not allowed, and must not be restarted during the clinical trial or Follow-up period. In addition, a multivitamin containing selenium and/or biotin must be discontinued at screening and not restarted during the trial.
  • Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
  • Under no circumstances are subjects who have enrolled in this study permitted to be re-randomized to this study. Note: Prior to enrollment subjects who have failed screening may be allowed to rescreen after consultation with the Medial Monitor.
  • Identified pre-existing ophthalmic or other disease that in the judgement of the Investigator, would preclude study participation or complicate interpretation of study results (e.g. including, but not limited to: previous eyelid surgery, corneal disease [other than keratopathy caused by TED that does not meet any other exclusion], uveitis, diabetic macular edema, diabetic retinopathy, retinal vein occlusion, macular degeneration, other retinopathy, retinal detachment, glaucoma, or optic nerve disease or optic nerve injury).
  • Ocular surgery other than routine cataract surgery or subsequent YAG laser capsulotomy. (Cataract surgery and YAG laser capsulotomy are allowed if the surgical procedure(s) were performed more than 3 months prior to randomization).
  • Biopsy-proven or clinically suspected inflammatory bowel disease (e.g., diarrhea with or without blood or rectal bleeding associated with abdominal pain or cramping/colic, urgency, tenesmus, or incontinence for more than 4 weeks without a confirmed alternative diagnosis OR endoscopic or radiologic evidence of enteritis/colitis without a confirmed alternative diagnosis).
  • History of QTcF prolongation; or QTcF prolongation at Screening; mean QTcF interval > 450 msec (males); and > 470 msec (females).
  • Use of drugs causing QT interval prolongation within 14 days prior to Day 1 dosing (See Section 12.2 List of QT Prolonging Drugs).
  • Bleeding diathesis that in the judgment of the Investigator would preclude inclusion in the clinical trial.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) according to age at Screening.
  • Serum creatinine > 2 x ULN for the reference range laboratory according to age at Screening.
  • Malignant conditions being actively treated or treated in the past 12 months (with the exception of successfully treated basal cell of the skin). Recent (within 3 months of Screening) basal cell of the eyelid skin is excluded.
  • Pregnant or lactating women.
  • Current drug, marijuana or alcohol abuse, or history of either within the past 1 year, in the opinion of the Investigator, or as reported by the subject.
  • In the opinion of the Investigator, any conditions which may pose increased risk of participation for the subject or may interfere with interpretation of study results.
  • Positive Human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.

Eligibility last updated 12/2/21. Questions regarding updates should be directed to the study team contact.

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CAAA617C12301, PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PSMAddition)

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

Brian Costello
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306540-P01-RST
22-000515
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Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Patients must be adults ≥ 18 years of age.
  • Patients must have an ECOG performance status of 0 to 2.
  • Patients must have a life expectancy > 9 months as determined by the study investigator.
  • Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site).
  • Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader.
  • Patients must have documented metastatic disease to bone and/or soft tissue/visceral sites documented in one of the following manners within 28 days prior randomization:
    • Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans; OR
    • Lymph node metastases of any size or distribution. If lymph nodes are the only site of metastasis, then at least one must be at least 1.5 cm in short axis AND outside of the pelvis; OR
    • Visceral metastases of any size or distribution. If a subject has a history of visceral metastases at any time prior to registration, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes).
  • Patients must have adequate organ function:
    • Bone marrow reserve ANC ≥ 1.5 x 10^9/L;
    • Platelets ≥100 x 10^9/L;
    • Hemoglobin ≥ 9 g/dL;
    • Hepatic Total bilirubin ≤ 2 x the institutional upper limit of normal (ULN);
    • For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases;
    • Renal eGFR ≥ 50 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation.
  • Albumin ≥ 2.5 g/dL.
  • Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial.
  • Patients must be:
    • Treatment naïve OR minimally treated with:
    • Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of therapy.
    • If received, prior LHRH agonist/antagonist use in the adjuvant/neo-adjuvant setting must have been discontinued > 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy;
    • Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No exposure for earlier stages of prostate cancer is allowed.


Exclusion Criteria:

  • Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy.
  • Any systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria 11), including chemotherapy, PARP inhibitors, immunotherapy or biological therapy (including monoclonal antibodies).
  • Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  • Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  • Ongoing participation in any other clinical trial.
  • Use of other investigational drugs within 30 days prior to day of randomization.
  • Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
  • Transfusion for the sole purpose of making a subject eligible for study inclusion.
  • Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (magnetic resonance imaging (MRI) preferred or CT with contrast).
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.
    • Note: Patients with a history of CNS metastases that have received prior therapy and are neurologically stable, asymptomatic and not receiving corticosteroids are allowed.
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance) and had no symptoms for at least 28 days before the first dose of study medication.
  • No active clinically significant cardiac disease defined as any of the following:
    • NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45% with improvement in symptoms to class < 3;
    • History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as:
    • Concomitant clinically significant cardiac arrhythmias; e.g., sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block);
    • History of familial long QT syndrome or known family history of Torsades de Pointes;
    • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature .
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Any condition that precludes raised arms position.
  • Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 6 months after stopping study treatment. 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 for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

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Intestinal Permeability in Patients with Active Inflammatory Bowel Disease: Towards Development of a Non-invasive, Inexpensive Test to Detect Intestinal Inflammation

Developing a Non-invasive Test to Detect Intestinal Inflammation in Active Inflammatory Bowel Disease

Michael Camilleri
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306555-H01-RST
21-012369
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Inclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

  • Active disease as defined by SES-CD (PMID: 15472670) > 6 (> 4 if ileal only), AND active symptoms of CD (CDAI score > 220) or full Mayo score for UC ≥ 2 with an endoscopy score of ≥2 (PMID: 31272578) within the past 4-6 weeks. 9,10,11,12,13
  • Remission as defined by SES-CD 0-2 and CDAI score ≤150, or full Mayo score for UC 0-2 with endoscopy score < 2.9,10,11,12,13.
  • Ability to give informed consent.

Healthy Adults

  • ≥ 18 years age.
  • No underlying medical illnesses that could serve as confounders with the objectives of the study.  


Exclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

  • Less than 18 years of age.
  • Prior history gastrointestinal surgeries including IPAA, ileostomy and colostomy.
  • Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test.
  • Use of osmotic laxatives and unable to unwilling to stop taking one week prior to permeability test.
  • Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous two weeks and for the duration of the study.
  • Multiple dietary restrictions or unable or unwilling to alter dietary protein or dietary fiber for the permeability testing.
  • Unwilling or unable to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
  • Bowel preparation for colonoscopy must be completed more than 48 hours prior to completion of permeability test. If intestinal biopsies were performed, 7 days must pass prior to permeability testing.
  • Pregnancy or plan to become pregnant during the study time frame.
  • Vulnerable adult.

Healthy Adults 

  • Less than 18 years of age.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

 

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Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR) (AMSCAR)

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Timucin Taner
All
18 years to 70 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-306557-H01-RST
21-012522
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Inclusion Criteria:


- Able to understand and provide informed consent.

- Have received a renal transplant (first or repeat), and the most recent protocol
biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.

Clinical
Inclusion Criteria:


- Stable renal function:

- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the
serum creatine prior to the biopsy (must be within 3 months of the biopsy);

- Estimated eGFR > 30 ml/min by MDRD.

Histologic Criteria for Eligibility:

- ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular
capillaritis (ptc) (g:1 or 2; ptc:1 or 2).

- Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2);
intimal arteritis (v) (v: 1 or 2).

- Mixed ABMR and cellular rejection.


Exclusion Criteria:


- Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year
preceding screening.

- History of post-transplant intervention for obstructive uropathy

- One or more of the following laboratory values:

o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT)
≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0,
Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase
their platelet count will not be excluded).

- One or more of the following parameters:

o Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤
90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or >
140/min

- Patients with the following grades/classes of vascular diseases:

- NYHA Class 3-4 CHF

- Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular
response, supraventricular tachycardia, Wolff-Parkinson-White syndrome,
ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled
chronic atrial fibrillation will be allowed to participate.

- Cerebrovascular accident (CVA) within 90 days of screening

- Peripheral Arterial Disease (PAD), patients who have had prior vascular
interventions for PAD in the index lower extremity.

- Acute illness within 30 days of screening.

- History of allergy or intolerance to iodinated contrast agents

- Women of childbearing potential or male subjects with female partners of childbearing
potential unwilling to use an effective method of contraception during and for 12
months post-treatment.

- History of or current evidence of alcohol abuse, illicit drug use or dependence

- Active COVID 19 or positive test for the SARS-CoV-2 virus

- History of malignancy within 5 years of enrollment. History of adequately treated
in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous
cell) will be permitted

- Serologic evidence of human immunodeficiency virus 1 or 2 infection

- Epstein Barr Virus (EBV) sero-negativity (EBV naïve)

- Cytomegalovirus (CMV) sero-negativity

- Active post-transplant opportunistic infections at the time of screening (CMV, BK
virus, polyoma virus, EBV)

- Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core
antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV
IgG positive), or those with HBV surface antibody positive but HBV core antibody
negative subjects will not be excluded from the study.

- Have received a kidney transplant from a Hepatitis C positive donor and plan to
receive anti-viral treatment after transplant

- Any chronic condition for which anti-coagulation cannot be safely interrupted for
kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall
into either the high or the moderate thrombotic risk, they will be deemed to be not
safe to interrupt anticoagulation:

- High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any
caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months)
stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6,
CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic
attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within
3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or
antithrombin; antiphospholipid antibodies; multiple abnormalities)

- Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve
prosthesis and 1 or more of the of following risk factors: atrial fibrillation,
prior stroke or transient ischemic attack, hypertension, diabetes, congestive
heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6;
Venous thromboembolism: VTE within the past 3 to 12 months, non-severe
thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation),
recurrent VTE

- For all other subjects, anticoagulation can be safely interrupted for 3 days
prior to infusion and resumed a day after the infusion.

- Positive pregnancy test

- Participation in any other studies that involved investigational drugs or regimens in
the preceding year

- Any other condition, in the investigator's judgment, that increases the risk of A-MSC
infusion or prevents safe trial participation

- Unwilling or unable to adhere to study requirements and procedures

- Per Banff criteria category 6: the presence of other changes not considered to be
caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant
Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury,
Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or
Drug-Induced Interstitial Nephritis

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

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

Tradipitant for Functional Dyspepsia

Xiao Jing Wang
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306560-H01-RST
21-012527
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Inclusion Criteria:

  • Patients with functional dyspepsia.
  • Age 18-70 years.
  • Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) will be selected based on gastric emptying of solids which is NOT delayed.
  • Ability to provide informed consent.
  • Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
  • Body mass index of 18-35 kg/m^2.
  • Females must not be pregnant or lactating due to administration of study medications and radiation exposure.
  • Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are permissible.

Standard Functional Dyspepsia (FD) Criteria:

Symptoms fulfilled for the last 3 months with onset > 6 months before diagnosis: 

  • > One symptom being bothersome: postprandial fullness, early satiation, epigastric pain or burning;
  • No evidence of organic, systemic, or metabolic disease (e.g., diabetes mellitus) to explain the symptoms on routine investigations.
  • Medications that need to be avoided 24 hours prior and during baseline and treatment testing are medications that alter GI transit, including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin; Acetaminophen (Tylenol); and alcohol.


Exclusion Criteria:

  • Patients with current H. pylori infection.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

 

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Developing a Cancer Distress Management Program for Liver and Biliary Cancer within a Specialized Program of Research Excellence (SPORE) (SPORE)

Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE

Shawna Ehlers
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306566-H01-RST
21-012404
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Inclusion Criteria:

  • Patients who have received care for hepatobiliary cancer at Mayo Clinic in the past 5 years.
  • Caregiver of above patient.
  • Clinician providing care for hepatobiliary cancer patients at Mayo Clinic.
  • Member of SPORE Patient Advocacy Board.


Exclusion Criteria:
 

  • Inability to complete an English language electronic survey for any reason. Non-English speaking patients will be offered translation services when available.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

 

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Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS Registry)

Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

Abhishek Deshmukh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306583-P01-RST
21-012967
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Inclusion Criteria:

  • Adults age 18 years and older.
  • Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician.
  • IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy.
  • Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures .


Exclusion Criteria:

  • Study materials not available in the subject’s preferred language.
  • Patients undergoing treatment for active concomitant ventricular arrhythmias.
  • Standard exclusions for elective sotalol use (at the time of initiation):
    • Heart rate < 40 bpm or 2nd/3rd degree AV block without pacemaker;
    • QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block);
    • Severe left ventricular hypertrophy (thickness > 1.5 cm).
  • Patients who were previously intolerant to antiarrhythmic class III therapy.
  • Patients missing key data elements in their electronic health record (for retrospective subjects only).

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

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IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients by Using a 20 Hz Filter to Better Assess Electrocardiogram Abnormalities (IQ-ECG)

IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306589-H01-RST
21-013016
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Inclusion Criteria:

  • Adults ≥ age of 18 years.
  • Must have a left ventricular assist device (LVAD).
  • Must be able to consent.


Exclusion Criteria:

  • No LVAD.
  • Unable to consent.
  • Under the age of 18 years.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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Investigating the Effect of Human Umbilical Cord MSCs Derived Exosome / Extracellular Vesicle on Endogenous Neural Cells Proliferation in Rats with Spinal Cord Injury

Umbilical Cord MSC's

Mohamad Bydon
Female
18 years to 35 years old
This study is NOT accepting healthy volunteers
2021-306602-H01-RST
21-012746
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Inclusion Criteria:

  • Healthy, full-term women (18-35 years old) who underwent elective cesarean section.
  • Free of Human Immunodeficiency Virus (HIV) types 1 & 2, Hepatitis A, B, and C, Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhea, and HTLV 1 & 2.
  • Able to give written informed consent prior to collection of the cord.


Exclusion Criteria:
 

  • On chronic, immunosuppressive transplant therapy or having a chronic, immuno-suppressive state, including use of systemic steroids/corticosteroids.
  • Takin anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, Hepatitis, and syphilis.
  • History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.

Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.

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An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

A Study to Evaluate the Effectiveness and Safety of DA-1229 (Evogliptin) in Delaying Progression of Mild or Moderate Calcific Aortic Stenosis (EVOID-AS trial)

Ratnasari Padang
All
35 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-306606-P01-RST
21-012772
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Inclusion Criteria:

  • Male or female adult ≥ 35 years of age at time of screening.
  • Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by Doppler echocardiography results:
    • Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on TTE within 2 weeks prior to randomization; and
    • Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization.
  • Subject provides written informed consent prior to initiation of any study procedures.
  • Subject understands and agrees to comply with planned study procedures.


Exclusion Criteria:

  • Subject has concomitant moderate or more aortic valve regurgitation.
  • Subject has concomitant moderate or severe mitral or tricuspid valve disease.
  • Subjects has left ventricular ejection fraction < 50%.
  • Subject previous history of aortic valve surgery.
  • Subject has NYHA class III or IV heart failure.
  • Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range.
  • Subjects who cannot undergo Cardiac CT.
  • Subjects whose life expectancy is < 2 years.
  • Subjects with ESRD (End-stage Renal Disease) defined as eGFR (calculated using MDRD equation) ≤ 30 mL/min/1.73m^2 or in need of dialysis.
  • Subject has diabetes mellitus
  • Subject has history of pancreatitis.
  • Subjects who are currently taking or anticipated to take any of the following medications for the duration of the study:
    • Insulin, DPP4 inhibitor, oral hypoglycemic agent;
    • Vitamin K;
    • Bisphosphonate;
    • Any medications that impact hepatic metabolism, by way of inducing CYP3A4 system, giving rise to drug-drug interaction (with the exception of focal treatment);
    •  CYP3A4 inducer: barbiturates (phenobarbital), rifampicin/rifabutin, carbamazepine, phenytoin, primidone, St. John’s Wort, Efavirenz, griseofulvin, and chronic (> 1 month) supraphysiologic glucocorticoid use (> 7.5 mg/day prednisone or equivalent glucocorticoid dosing).
  • Subjects with history of severe allergic reaction to DPP4 inhibitors including anaphylaxis and angioedema.
  • Subjects with galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption.
  • Subjects with history of severe cerebrovascular diseases (such as cerebral infarction or transient ischemic attack), severe cardiovascular diseases (such as unstable angina, myocardial infarction and life-threatening arrhythmia) within 6 months of screening.
  • Subjects with history of malignant tumor within the past 3 years prior to Screening Visit (Visit 1) unless cure is expected.
  • Subjects with history of drug or alcohol abuse. History of cannabis/Marijuana use including recreational use in the last 6 months and an unwillingness to abstain during the course of the study.
    • Note: Alcohol abuse is a pattern of drinking that result in harm to one’s health, interpersonal relationships, or ability to work. Manifestations of alcohol abuse include the following: Failure to fulfill major responsibilities at work, school, or home, drinking in dangerous situations, such as drinking while driving or operating machinery, legal problems related to alcohol, such as being arrested for drinking while driving or for physically hurting someone while drunk and continued drinking despite ongoing relationship problems that are caused or worsened by drinking.
  • Subjects with history of medication non-compliance.
  • Pregnant or lactating women
  • Subjects who used investigational drugs or devices within 4 weeks prior to screening or investigational biologics within the last 6 months prior to screening.
  • Inability to provide informed consent or to comply with test requirements.
  • Subjects with physical (severe hepatic, cardiac, renal, pulmonary, hematological, endocrine, gastrointestinal, etc. conditions) or mental (cognitive, psychiatric, etc. conditions) conditions that may impact their ability to take part in the study.
  • Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment
  • Women of child-bearing age who are sexually active but decline to take proper contraceptive measures during the study period.
    • Note: To be eligible for the study, Women of childbearing potential (WOCBP) and Women not of childbearing potential are eligible to participate. Both women of childbearing potential and women of no childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of investigational product).
    • Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners must agree to consistently and correctly use a condom for the duration of the study and for 30 days after taking the study drug. In addition, subjects may not ova or donate sperm for the duration of the study and for 30 days after taking the last dose investigational product.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

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Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (FibroGen095)

Zephyrus II: Effectiveness and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Teng Moua
All
40 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306608-P01-RST
21-012801
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Key

Inclusion Criteria:


1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.

2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.

3. FVCpp value >45% and <95% at Screening and Day 1.

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and
≤90%.

5. Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib)
but discontinued at least 1 week prior to screening, unless neither treatment is
available in the host country.

Key
Exclusion Criteria:


1. Previous exposure to pamrevlumab.

2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.

3. Female participants who are pregnant or nursing.

4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
study.

5. Interstitial lung disease other than IPF.

6. Sustained improvement in the severity of IPF.

7. Other types of respiratory diseases that, in the opinion of the Investigator, would
impact the primary protocol endpoint or otherwise preclude participation in the study,
including diseases of the airways, lung parenchyma, pleural space, mediastinum,
diaphragm, or chest wall.

8. Certain medical conditions, that, in the opinion of the Investigator, would impact the
primary protocol endpoint or otherwise preclude participation in the study (such as,
myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or
cancers).

9. Acute IPF exacerbation during Screening or Randomization including hospitalization due
to acute IPF exacerbation within 4 weeks prior to or during screening.

10. Recent use of any investigational drugs or unapproved therapies, or participation in
any clinical trial.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient.

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

Biologic/Vaccine, Other
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Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults. A Double Blind Randomized Clinical Trial

Effects of Energy Drinks on Sleep and Cardiovascular Health

Anna Svatikova
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306640-H01-RST
21-012902
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Inclusion Criteria:

  • Adults 18 years of age and older.
  • Healthy subjects without known cardiovascular disease and thyroid disease.
  • Subjects who are on no medications (except oral contraceptive pill).
  • Nonsmokers.
  • No prior history of caffeine sensitivity or allergy.


Exclusion Criteria:
           

  • Subjects with known cardiovascular or thyroid disease.
  • Subjects currently taking medications other than oral contraceptive pill.
  • Smokers.
  • Prior history of caffeine sensitivity or allergy.
  • Pregnancy.
      •  
  • Subjects who regularly consume energy drinks.
  • Subjects who typically go to sleep after midnight.
  • Subjects who traveled across 2 time zones in the last 7 days.
  • Shift workers.
  • Subjects who have or are suspected to have sleep apnea.
  • Subjects who have a body mass index > 35kg/m^2.

Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.

 

Other
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A Double-Blind, Randomized, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF-COMFORT)

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Vivek Iyer
All
40 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306667-P01-RST
22-002204
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Inclusion Criteria:


- Diagnosis of IPF established according to the 2018 joint ATS/ERS/JRS/ALAT Clinical
Practice Guideline

- FEV1/FVC ratio ≥0.65 at the screening visit

- Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25%
within 12 months of the screening visit

- Arterial oxygen saturation on room air or oxygen ≥90% at Screening

- Life expectancy of at least 12 months

- Cough that is attributed to IPF, which has not responded to anti-tussive treatment,
and which has been present for at least 8 weeks prior to Screening

- Mean daily IPF Coughing Severity Scale score ≥5.0 during the second week of the
baseline assessment period


Exclusion Criteria:


- Recent respiratory tract infection (<8 weeks prior to Screening)

- Recent acute exacerbation of IPF (<8 weeks prior to Screening)

- Current smokers or ex-smokers with <6 months' abstinence prior to Screening

- Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is
greater than the extent of fibrosis according to the reported results of the most
recent scan

- Mean early morning cough scale score ≥5.0 and rest of the day cough scale score <5
during the second week of the baseline assessment period (assessed at Visit 2)

- Cough that is predominantly productive in nature and attributable to lung pathology
such as chronic bronchitis or bronchiectasis

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A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People with Severe Von Willebrand Disease (VWD) (ATHN 9)

ATHN 9: Severe Von Willebrand Disease Natural History Study

Rajiv Pruthi
All
Not specified
This study is NOT accepting healthy volunteers
2021-306671-P01-RST
21-013017
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Inclusion Criteria:

  • Males and females.
  • Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPIbM or VWF:Ag ≤ 30% of pooled normal control plasma on more than one occasion.
  • Participants with clinically severe VWD as defined by VWF:RCo or VWF:Ag ≤ 40% of normal with severe bleeding phenotype defined as requiring use of recurrent factor concentrates.
  • Co-enrollment in the ATHN dataset.

Exclusion Criteria

  • Diagnosis of platelet-type VWD;
  • Diagnosis of acquired VWD (clinical diagnosis made by the hemophilia health care provider, typically based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity after Tissue Removal (KM-20-001)

In Vitro 3D Cell Culture Models Validation for Tumor Drug Sensitivity after Tissue Removal

Janani Reisenauer
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306681-P01-RST
21-013027
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Inclusion Criteria:


- A demonstrated primary solid cancer for which it is medically indicated and planned to be surgically resected, biopsied, or drained (via malignant pleural effusion).

- The ability to ship the tissue sample within 24 hours of removal from the patient.

- Signed and dated consent to giving tissue as well as allowing for de-identified medical history information regarding administered treatments and treatment outcomes
to be shared.

- Over 18 years of age


Exclusion Criteria:


- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.

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TILT – T563: A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination with Pembrolizumab in Patients with Platinum Resistant or Refractory Ovarian Cancer (PROTA)

A Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) Combined with Pembrolizumab to Treat Refractory Ovarian Cancer

Matthew Block
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306701-P01-RST
22-000078
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Inclusion Criteria:


- Signed and dated informed consent(s) by the participant or legal representative before
any trial-related activities.

- Female over 18 years of age on day of signing informed consent(s).

- Histologically confirmed ovarian cancer (including fallopian tube and primary
peritoneal cancer) resistant to platinum (defined as progression of cancer within 183
days of the most recent dose of cisplatin or carboplatin) or refractory to platinum
(defined as progression of cancer within 30 days of the most recent dose of cisplatin
or carboplatin) ovarian cancer, which cannot be treated with curative intent with
available therapies. Note: Poly(ADP)-ribose polymerase (PARP) inhibitors should be
considered as indicated in clinical practice, prior to trial enrollment.

- At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local
virus injection (intratumoral and/or intraperitoneal).

- The disease burden must be evaluable, but does not need to fulfil RECIST 1.1.

- Have adequate organ function as defined in the following values below. Specimens must
be collected within 10 days prior to the start of study treatment.

a. Hematological laboratory values i. Absolute neutrophil count (ANC): ≥1500/µL ii.
Platelets: ≥ 100 000/µL iii. Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be
met without packed red blood cell (pRBC) transfusion within the prior 2 weeks.
Participants can be on stable dose of erythropoietin (≥ approximately 3 months. iv.
Leukocytes (WBC) > 3.0 b. Renal laboratory values i. Glomerular Filtration Rate (GFR):
>60 ml/min (Cockcroft-Gault formula). c. Hepatic laboratory values i. Total bilirubin:
≤1.5 × Upper Limit of Normal (ULN) OR direct bilirubin ≤ULN for participants with
total bilirubin levels >1.5 × ULN (excluding patients with Gilbert's Disease) ii.
Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT):
≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

- Patients must be willing to use adequate forms of contraception from screening, during
the trial, and for a minimum of 120 days after end of treatment, in accordance with
the following:

i. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be
used in addition to one of the following methods: Intrauterine devices or hormonal
contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings
or long-acting injections). ii. Women not of childbearing potential: Barrier
contraceptive method (i.e. condom) must be used.

- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
score of 0-1 at screening.

- Life expectancy longer than 3 months.

- Capable of understanding and complying with parameters as outlined in the protocol.


Exclusion Criteria:


- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) and inhaled and topical
treatments are not considered a form of systemic treatment and are allowed.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study drug.

- Treated with any anti-cancer therapy within 30 days prior to the first virus
injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. surgery,
chemotherapy, immune-checkpoint inhibitors, kinase inhibitors, PARP inhibitors,
biological therapies, hormonal therapies, radiation, etc.). Continuation of hormonal
therapy or use of bone modifying agents (e.g. bisphosphonate or denosumab) is allowed
if started at least 3 months before.

- Participants must have recovered from all Adverse Events (AE)s due to previous
therapies to ≤Grade 1or baseline. Participants with ≤Grade 2 neuropathy may be
eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or
hormone replacement may be eligible. If the participant had major surgery, the
participant must have recovered adequately from the procedure and/or any complications
from the surgery prior to starting study intervention.

- Treated with a prior radiotherapy, including for palliative purposes, within 2 weeks
of start of study treatment (before or after). Participants must have recovered from
all radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
weeks of radiotherapy) to non-Central Nervous System (CNS) disease. Palliative
radiation is allowed from day 15 during the trial treatment period, if deemed
necessary by the investigator.

- Treated with a prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
Cytotoxic T lymphocyte-associated Antigen (CTLA)-4, Tumor necrosis factor receptor
superfamily, member 4 (OX40), CD137), and was discontinued from that treatment due to
a Grade 3 or higher immune-related Adverse Events (irAE).

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 30 days prior to the first virus
injection. An investigational agent is any drug or therapy that is currently not
approved for use in humans. Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the last
dose of the previous investigational agent.

- Uncontrolled cardiac or vascular diseases.

- History of myocardial infarction or cerebral stroke within the previous 12 months
before screening or is not sufficiently recovered from an older infarction or cerebral
stroke.

- History of severe hepatic dysfunction.

- History of hepatitis B (defined as HBsAg reactive), Hepatitis C (defined as hepatitis
C virus (HCV) RNA [qualitative] is detected) and/or HIV. No testing for Hepatitis B,
Hepatitis C and HIV is required unless mandated by a local health authority.

- History of coagulation disorder.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's
participation for the full duration of the study, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator.

- Female patients who are pregnant, breastfeeding or intend to become pregnant. Women of
childbearing potential who has a positive urine pregnancy test (within 72 hours) prior
to treatment. If the urine test is positive or cannot be confirmed as negative, a
serum pregnancy test will be required.

- Has a known additional malignancy that is progressing or has required active treatment
within the past 5 years. Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not excluded.

- Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 3 months by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.

- Has an active infection requiring systemic therapy.

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study.

- Allergy to ingredients present in the investigational medicinal products (ingredients
are listed in the protocol) ie. severe hypersensitivity (≥Grade 3) to pembrolizumab
and/or any of its excipients.

- Known contraindications to pembrolizumab.

- Has had an allogenic tissue/solid organ transplant.

- Has received a live or live-attenuated vaccine within 30 days prior to the first dose
of study intervention. Administration of killed vaccines are allowed.

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

 

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S2104 Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Timothy Hobday
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306702-P01-RST
21-013251
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Inclusion Criteria:

  • Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam.
  • Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report.
  • Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be ≥ 3% and ≤ 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria.
  • Participants with localized resected pNETS must have a Zaidi score of ≥ 3 derived by the following factors and points:
    • 1 point; symptomatic tumor defined as one of the following:
      • Gastrointestinal bleed;
      • Jaundice;
      • Gastrointestinal obstruction;
      • Pain from primary tumor prior to surgical resection;
      • Pancreatitis.
    • 2 points; primary pancreas tumor size > 2 cm.
    • 1 point; Ki-67 3% to 20% -1 point; lymph node positivity = 1.
    • 6 points; Ki-67 21% to 55%.
  • Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection.
  • Participants must not have unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must have recovered from effects of surgery as determined by the treating investigator.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must be ≥ 18 years old
  • Participants must have Zubrod performance status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to registration.
  • Patients must have adequate organ and marrow function as defined below within 28 days prior to registration:
    • Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration);
    • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration);
    • Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration);
    • Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration);
    • Serum creatinine ≤ 1.5 x institutional ULN (within 28 days prior to registration);
    • Calculated creatinine clearance ≥ 50 ml/min (within 28 days prior to registration).
    • Calculated Creatinine Clearance = (140
      •age) X (weight in kg) † 72 x serum creatinine:
    • * Multiply this number by 0.85 if the participant is female.
    • † The kilogram weight is the participant weight with an upper limit of 140% of the IBW.
    • * Actual lab serum creatinine value with a minimum of 0.8 mg/dL.
  • Participants must be able to swallow pills.
  • Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential."In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  • No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.


Exclusion Criteria:

  • Participants must not have unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Eligibility last updated 12/27/21. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

Evaluating Paternal Antigen Exposure and Maternal Immune Tolerance

Evaluating Paternal Antigen Exposure

Elizabeth Ann Enninga
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306706-H01-RST
21-013107
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Inclusion Criteria:

  • Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems
  • Ability to provide informed written consent
  • Known paternity for pregnancy
  • Singleton pregnancies


Exclusion Criteria:
 

  • Mothers < 18 years of age
  • Multiple fetuses

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

Other
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Mayo Clinic — Rochester, MN

Mayo Clinic Phage Program Biobank (Phagebank)

Mayo Clinic Phage Program Biobank

Gina Suh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306707-H01-RST
21-013112
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Able to provide informed consent.
  • Individual must have a future treatment plan to receive or has historically received phage therapy.


Exclusion Criteria:

  • Individuals , 18 years of age.
  • Unwilling/unable to provide informed consent.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

 

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A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open Label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Eva Carmona Porquera
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306733-P01-RST
21-013316
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Inclusion Criteria:

  • Male or female age ≥ 18 years.
  • Is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
  • Have a ≥ 6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
  • Have high-resolution computed tomography (HRCT) and PET scan consistent with active pulmonary sarcoidosis of the lung parenchyma confirmed by central read.
  • Have FVCp ≥ 50% to ≤ 90% and DLCO ≥ 50%.
  • If receiving prednisone (or equivalent), dose must have been ≤25 mg, and dose must have been stable for at least 4 weeks prior to randomization.
  • Symptomatic as indicated by mMRC Dyspnea scale >1 (i.e., Grade 2 or more) in the prior year.
  • If receiving methotrexate and/or other immunosuppressive therapy (IST) dose must have been stable for ≥ 3 months prior to randomization.
  • Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) throughout the study, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:
    • Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization;
    • Postmenopausal defined as 12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age > 40 years) a documented serum FSH level must be ≥ 30 mIU/mL;
    • Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to the start of dosing, throughout the study, and for 4 months following the last dose of study drug.
  • Males who are sexually active must agree to use one of the allowed BC methods. Male subjects must also agree to sufficiently minimize the risk of pregnancy throughout study participation (and for 4 months following the last dose of study drug).
  • Body Mass Index (BMI) 18 to 40 kg/m^2 at screening.
  • Subjects must agree to steroid taper, and cessation of their IST therapy at randomization.
  • Completion of vaccination for COVID-19 at least 2 weeks prior to randomization.

Exlusion Criteria:

  • Hospitalized for any respiratory illness ≤ 30 days prior to screening.
  • Prednisone dose > 25 mg/day at any time in the previous 4 weeks.
  • ≥ 20% fibrosis as indicated on CT-scan that has been confirmed by central read prior to randomization.
  • eGFR ≤30 mL/min/1.73 m^2 (MDRD equation) or requiring hemofiltration or dialysis.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3 × upper limit of normal range (ULN).
  • Platelet count <100,000 per mm^3.
  • Hemoglobin ≤ 9.5 g/dL.
  • Absolute neutrophil count < 1,000 per mm^3.
  • History of known anti-GM-CSF autoAb or tests positive at screening, or history of pulmonary alveolar proteinosis (PAP).
  • Use of biologic — approved or investigational agents (e.g., anti-TNFα, anti-IL-1, anti-IL-6, anti-IL-17, anti-IL-12/23 or specific anti-IL-23 inhibitors, anti CD20, anti-IL-18) within the 6 months prior to screening.
  • Prior use of immunoglobulin within 6 months prior to screening.
  • Prior use of any investigational immunomodulator (e.g., NRP2 modulator) within 6 months of screening.
  • Prior use of any JAK inhibitor within 3 months of screening.
  • Participation in another interventional clinical trial within 6 months prior to screening.
  • Known left ventricular ejection fraction (LVEF) ≤30% or NYHA class III or IV heart failure.
  • ECG abnormalities that warrant further investigation, in the opinion of the Investigator.
  • Pulmonary hypertension requiring therapy.
  • Systolic blood pressure (SBP)  < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg.
  • Known COVID-19 infection within 3 months prior to screening.
  • Have received any live virus or bacterial vaccinations < 3 months of screening. Age-appropriate non-live vaccinations may be administered during screening so long as the last vaccine dose is administered at least 2 weeks prior to planned randomization.
  • Any infection requiring antibiotics or pulse of OCS where completion of treatment has been < 30 days prior to screening.
  • History of 3 or more lower respiratory tract infections requiring anti-microbial therapy in the past year.
  • Any history of mycetoma or fungal respiratory infection.
  • Requirement for supplemental oxygen at rest.
  • Prior history of, or likely to have any organ transplantation during study including OLE.
  • History of smoking (or vaping) in the prior year or current use. Occasional use (defined as less frequently than once per month) is allowable, though subjects should be counseled to remain abstinent during the study including OLE.
  • Other significant pulmonary disease likely to interfere with the primary endpoint, in the opinion of the Investigator.
  • Other autoimmune disease likely to require therapy during the study.
  • Symptoms and features of extra-PS that may warrant treatment in addition to that required for lung involvement.
  • Significant ischemic heart disease (i.e., myocardial infarction within 6 months, unstable angina or PCTA/stent within 1 month or planned intervention during study).
  • Known or suspected active and untreated/inadequately treated tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may be enrolled if anti-TB therapy is commenced prior to randomization.
  • For women: pregnant or planning to become pregnant during the study or currently breastfeeding.
  • Prior history of any malignancy or lymphoproliferative disorder (not including fully resected basal cell carcinoma of the skin, fully resected intra-epithelial neoplasia or carcinoma in situ) within the past 5 years.

Eligibility last updated 12/23/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
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Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Roberto Benzo
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306737-P01-RST
21-013228
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
  • The ability to read and respond to questions in English or Spanish.
  • Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
  • Life expectancy at least 6 months.


Exclusion Criteria:

  • Individuals < 18 years.
  • Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Eligibility last updated 12/21/21. Questions regarding updates should be directed to the study team contact.

Behavioral
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A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Open Nipple Sparing Mastectomy (NSM)

James Jakub
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-306747-P01-RST
21-006696
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Inclusion Criteria:

  •  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.


Exclusion Criteria:
  

  • Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

 

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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (ABCVILD)

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

Avni Joshi
All
4 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306748-P01-RST
21-013267
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Inclusion Criteria:

  • Diagnosis of CVID according to the international consensus document (ICON):
    • Age 4 years or above;
    • Serum IgG at least 2 standard deviations below the age adjusted normal;
    • Decreased serum IgA and/or serum IgM;
    • Abnormal specific antibody response to immunization;
    • Exclusion of secondary immunodeficiency.
  • On replacement immunoglobulin for at least 6 months and willing to maintain throughout study.
  • Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
  • Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 2 months of study entry.
  • Signed written informed consent.
  • Willing to allow storage of biological specimens for future use in medical research.
  • Females of childbearing potential must use a highly effective form of birth control such as hormone-based contraceptive, intrauterine device, or double barrier method.


Exclusion Criteria:

  • History of hypersensitivity to abatacept or any of its components.
  • Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months.
  • Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months.
  • History of HIV infection (positive PCR).
  • Chronic untreated hepatitis B or C (positive PCR).
  • Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
  • Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart.
  • Other uncontrolled infections.
  • Live vaccine given within 6 weeks of the start of the trial.
  • Malignancy or treated for malignancy within the past year.
  • Currently pregnant or breast feeding.
  • Life expectancy less than 1 month.
  • Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home.
  • Other conditions that the investigators feel contraindicate participation in the study.

Eligibility last updated 12/22/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Cardiovascular and Cognitive Implications of CNS hypersomnias and Their Treatments (CVCOGNARCIH)

Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition

Virend Somers
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306758-H01-RST
21-013321
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Inclusion Criteria:

  • Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
  • Age 18
    •75 years.
  • BMI between 18 and 40 kg/m^2.
  • Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
  • If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
  • If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication before starting new medication.


Exclusion Criteria:
 

  • Any change to medication(s) within the last 45 days.
  • History of chronic alcohol or drug abuse within the prior 12 months.
  • Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
  • Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit.
  • Participation in another study of an investigational drug within the 28 days prior to screening visit or currently.
  • Pregnancy and/or breast-feeding.
  • Subjects who, in the opinion of the Investigator, may not be suitable for the study.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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Mayo Clinic — Rochester, MN

Screening for High Frequency Malignant Disease (SHIELD) (SHIELD)

Screening for High Frequency Malignant Disease

David Midthun
All
50 years to 80 years old
This study is NOT accepting healthy volunteers
2021-306760-P01-RST
22-000772
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Inclusion Criteria:

  • Subject aged 50-80 years at time of consent.
  • Increased risk of lung cancer defined by having at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
  • Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening.
  • Willing to consent to the investigational blood draw during index low dose CT scan screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
  • Willing to consent to a 1-year, 2-year and additional follow-up per protocol.


Exclusion Criteria:

  • Subject has not smoked for 15 or more years.
  • Subject has less than 20 pack-year smoking history.
  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
  • Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer.
  • Preexisting or history of lung cancer.
  • Previously diagnosed high-risk lung lesion.
  • History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
  • Currently receiving treatment for pneumonia.
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  • Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
  • Additional cohorts: inclusion and exclusion criteria will be specified for each cohort as appendixes.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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Tonation Breathing Technique, a Non-pharmacogenic Method to Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms - A Pilot Study (TBT)

Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms

Prema Peethambaram
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306764-P01-RST
21-012300
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Inclusion Criteria:

  • Eligible patients are females with stage I-III breast cancer taking adjuvant AI (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled. Treating physicians determine if pain is secondary to an AI.  
  • ≥ 18 years old.
  • Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment.
  • Patients should have an ECOG performance score of 0-2. 


Exclusion Criteria:

  •  Age less than 18 years.
  • Significant underlying pulmonary disease.

Eligibility last updated 1/14/22.  Questions regarding updates should be directed to the study team contact.

 

Behavioral
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