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596 Study Matches

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A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI) (Ri-CoDIFy 2)

A Study to Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (CDI)

Sahil Khanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121982-P01-RST
19-002968
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Inclusion Criteria:
 

  • At least 18 years of age, at the time of signing the informed consent. 
  • Signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥ 3 Unformed Bowel Movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 hours prior to randomization. 
  • The presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test, produced within 72 hours prior to randomization. 
  • Male or Female
    •Male must agree to use contraception as detailed in the protocol during the treatment period and for at least 5 days after study treatment and refrain from donating sperm during this period.
  • Female patient is eligible to participate if she is not pregnant, not breastfeeding, and either:
  • Not a woman of childbearing potential (WOCBP). A WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 5 days after study treatment. 
  • Documented signed informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).


Exclusion Criteria:
 

  • More than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months.
  • A history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis). 
  • Positive diagnostic test for other gastro intestinal (GI) pathogens within 2 weeks of randomization. 
  • Major gastrointestinal (GI) surgery (e.g., significant bowel resection) within 3 months of randomization (except appendectomy). Presence of a colostomy or ileostomy or likely requirement of an ostomy during the study. 
  • Life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon. 
  • Current history of significantly compromised immune system:
    • HIV positive with a CD4<200 cells/mm3 within 6 months of randomization;
    • Severe neutropenia with neutrophil count < 500 cells/mL;
    • Concurrent immunosuppressive therapy for recent (within previous 6 months) or anticipated solid organ transplant or bone marrow transplant;
    • Concurrent chemotherapy, radiotherapy or biologic for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study;
    • More than one day (24 hours) of dosing of antimicrobial treatment active against CDI for the current episode of CDI prior to randomization;
    • Prior or current use of anti-toxin antibodies including bezlotoxumab;
    • Unable to discontinue products used to affect bowel movement or disease progression;
    • Involved in a clinical trial and received an IMP for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the IMP was for CDI;
    • Received an investigational vaccine against C.difficile;
    • Patients that the Investigator feels are inappropriate for the study for any other reason; e.g., have any conditions that would make the patient unsuitable for inclusion, patients not likely to complete the study for whatever reason, known hypersensitivity or intolerance to study IMPs, patients unwilling or unable to comply with protocol requirements.
Drug, Administration of anti-infective agent, Drug therapy, Infusion of vancomycin
C. difficile infection, Diarrhea, General infectious diseases
Altered bowel function, Clostridioides difficile infection, Clostridium difficile diarrhea, Digestive system, Recurrent Clostridium difficile infection, Ridinilazole [INN], Vancomycin, vancomycin
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Mayo Clinic — Rochester, MN

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

A Study to Evaluate the Safety and Effectiveness of BMS-986165 in Subjects with Moderate-to-Severe Ulcerative Colitis (UC)

Edward Loftus
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-121997-P01-RST
19-003100
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Inclusion Criteria:
 

  • Documented diagnosis of UC at least 12 weeks prior to screening.
  • Active UC with an an adapted Mayo score of 5 to 9 points, endoscopic subscore of ≥ 2. 
  • Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, 5-aminosalicylic acids (ASAs), corticosteroids, immunosuppressants, anti-tumor necrosis factor (TNF)-α agents, integrin inhibitor.


Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, pseudomembranous colitis.
  • Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation. 
  • History or evidence of any extensive colonic resection, subtotal or total colectomy, with or without presence of a stoma or ileoanal pouch.
Drug
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Mayo Clinic Rochester, MN — Rochester, MN

Natural History Study for Pediatric Patients with Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidosis, or Gaucher Disease Type 2

A Study of Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidosis, or Gaucher Disease Type 2 in Pediatric Patients

Marc Patterson
All
up to 99 years old
This study is NOT accepting healthy volunteers
0000-122014-P01-RST
19-003254
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Inclusion Criteria (Group A and B):

  • Patient with either GM1 gangliosidosis, GM2 gangliosidoses (Tay-Sachs, Sandhoff, AB Variant), or GD2.
  • Diagnosis confirmed by either biochemical (enzyme activity) or genetic testing, or both.
  • Date of birth on or after 1 January 2000.
  • Onset of the first neurological symptom within the first 24 months of age.
  • Informed consent of parent or legal guardian as required by local law.


Exclusion Criteria:

  • Any diversion from the above Inclusion Criteria.
Congenital metabolic disorder, Gaucher disease, Tay-Sachs disease
Acute neuronopathic Gaucher's disease, GM 2 gangliosidosis, GM1 gangliosidosis, Sandhoff disease, Tay-Sachs disease, variant AB, GM2 gangliosidosis
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Mayo Clinic — Rochester, MN

Effect of Fasting Free Fatty Acids and Fasting Glucose on Postprandial Glucose Metabolism

A Study to Evaluate the Effect of Fasting Free Fatty Acids and Fasting Glucose on Postprandial Glucose Metabolism

Adrian Vella
All
25 years to 65 years old
This study is NOT accepting healthy volunteers
0000-122021-H01-RST
19-003326
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Inclusion Criteria:

  • Will utilize the Mayo Clinic Biobank to identify randomly- selected individuals encompassing the age span of 25-65 years old.
  • No history of diabetes.
  • Reside within a 100 mile radius of Mayo Clinic, Rochester, MN.
  • Individuals who have expressed interest in participating in research will then be contacted and invited to participate in the study.


Exclusion Criteria:

  • Age < 25 or > 65 years old (to avoid studying subjects who could have latent type 1 diabetes or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≥ 6.5%.
  • Use of glucose-lowering agents.
  • For female subjects, positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Hormone therapy >0.625 mg premarin daily.
Prediabetes
Endocrine system, Prediabetes
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Mayo Clinic — Rochester, MN

Relationship of the Glucose Threshold for Insulin Secretion with Beta-cell Function

A Study to Evaluate the Relationship of the Glucose Threshold for Insulin Secretion with Beta-cell Function

Adrian Vella
All
25 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122022-H01-RST
19-003327
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Inclusion Criteria:

  • Up to 60 weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester will be recruited.
  • Potentially eligible subjects who express a desire to be contacted by the research team will be invited to meet with the PI and / or another member of the study team.
  • Interested subjects will come to the Clinical Research Trials Unit for a screening visit.


Exclusion Criteria:
 

  • Age < 25 or > 65 years old (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≥ 6.5%.
  • Use of glucose-lowering agents.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Hormone therapy >0.625 mg premarin daily.
Other, Glucose measurement, fasting, Insulin measurement
Hyperglycemia, Impaired fasting glycaemia, Impaired glucose tolerance, Impaired fasting glycemia
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Mayo Clinic — Rochester, MN

Surgical Sterility, the Microbiome and Infections After a Deeper Dive into the Mastectomy with Immediate / Tissue Expander Reconstruction Surgical Site Sterility: A Pilot Study Using OR Camera Recording, Surgical Site and OR Microbiome Analysis

A Study to Evaluate Surgical Sterility, the Microbiome and Infections Following Mastectomy with Immediate / Tissue Expander Reconstruction

Basel Sharaf
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-122027-H01-RST
19-003369
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Inclusion Criteria:

  • Female patients age 18 years and greater.
  • Willing and able to give informed consent.
  • Mastectomy with immediate reconstruction using tissue expander or direct to implant.


Exclusion Criteria:

  • Antibiotic use within 14 days of operation.
  • Prior history of breast implant placement.
  • Male patients.
  • Vulnerable subjects (prisoners, institutionalized individuals).
  • Non-English speaking patients without adequate interpreter assistance.
General infectious diseases, Post op infection
Breast cancer surgery, Breast reconstruction with breast implants, Mastectomy, Postoperative infection
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Mayo Clinic — Rochester, MN

An Integrated Assessment of Gastric Functions

A Study to Assess Gastric Functions

David Prichard
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122032-H01-RST
19-003412
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Inclusion Criteria:

  • Male and female volunteers aged 18-80 years old.
  • Persistent upper gastrointestinal symptoms (nausea, vomting, bloating, post prandial fullness or post prandial pain) for > 6 months.
  • Having capacity to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
  • Undergoing a clinically indicated a gastric emptying study or having completed a gastric emptying study.


Exclusion Criteria:

  • Severe nausea or vomiting, which may preclude study assessments.
  • Use of medications that, in the opinion of the investigator have the potential, to alter GI motility (e.g., narcotics, medications with significant anticholinergic effects, prokinetic agents) and which cannot be discontinued for 4 half-lives prior to the imaging studies.
  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  A history of inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis).  However, participants with microscopic or collagenous colitis will be eligible to participate.
  • Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy).  Appendectomy, cholecystectomy, tubal ligation,  hysterectomy, herniorrhaphy, and limited colonic resection are permissible.
  • Participants who are allergic to eggs or decline to consume milk.
  • History of radiation therapy to the abdomen.
  • Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire 11.
  • Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*
  • Pregnant women, breast-feeding women, prisoners and institutionalized individuals.*
  • Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain.
  • Positive tissue transglutaminase antibodies (TTG).
  • Poor peripheral venous access, if central venous access is not available.
  • Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.
Abdominal pain, Gas and gas pains, Nausea and vomiting
Abdominal bloating, Abdominal pain, Digestive system, Disorder of upper gastrointestinal tract, Gastric emptying study, MRI, Nausea and vomiting
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Mayo Clinic — Rochester, MN

Itacitinib Monotherapy for Low Risk Graft-vs-Host Disease

A Study to Evaluate Itacitinib for Low Risk Graft-vs-Host Disease (GVHD)

William Hogan
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122052-P01-RST
19-003577
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Inclusion Criteria:
 

  • Newly diagnosed GVHD that meets criteria for Minnesota standard risk.
  • Ann Arbor 1 GVHD by biomarkers.
  • GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed).
  • Any donor type, HLA-match, conditioning regimen is acceptable.
  • Age 12 years and up (children < 18 years must also weigh 50 kg or more).
  • Patients must be engrafted post-transplant (ANC > 500/μL and platelet count > 20,000). Use of growth factor supplementation to maintain neutrophil count is allowed. 
  • Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment. 
  • ALT/SGPT and AST/SGOT must be < 5 x the upper limit of the normal range within 3 days prior to enrollment. 
  • Signed and dated written informed consent obtained from patient or legal representative.


Exclusion Criteria:

  • Patients currently being treated with any JAK inhibitor including ruxolitinib. 
  • Relapsed, progressing, or persistent malignancy requiring withdrawal of systemic immune suppression.
  • Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis).
  • Severe organ dysfunction including requirement for dialysis, mechanical ventilation or oxygen supplementation exceeding 40% FiO2 within 7 days of enrollment. 
  • Creatinine clearance or estimated glomerular filtration rate < 30 ml/min as calculated by institutional practice (e.g., Cockcroft-Gault equation, CKD-EPI equation, etc.).
  • A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment .
  • Patients receiving corticosteroids >10 mg/day prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds.
  • Patients who are pregnant. 
  • Patients receiving investigational agents within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of itacitinib.
  • History of allergic reaction to itacitinib or any JAK inhibitor.
Drug, Drug therapy, Transplantation of bone marrow
Cancer, Graft versus host disease
At risk of graft-versus-host disease associated with transfusion, Bone marrow transplant, Graft versus host disease, INCB-039110, Malignant tumor of lymphoid hemopoietic and related tissue, Medical Oncology
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Acute Detection of Non-convulsive Seizures with Single-channel EEG

A Study to Detect Non-convulsive Seizures with Single-channel Electroencephalogram (EEG)

Alejandro Rabinstein
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122067-H01-RST
19-003718
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Inclusion Criteria:

  • Patients admitted with encephalopathy concerning for non-convulsive seizures or NCSE who can also undergo conventional multi-lead EEG monitoring.
  • ≥ 18 years of age.


Exclusion Criteria:
 

  • Patients who have dermatologic contraindication to the adhesive by which the portable EEG device is attached.
  • < 18 years of age.

 

Encephalopathy, Seizure
Disorder of brain, EEG, Generalized seizure, Nervous system, Nonconvulsive status epilepticus
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Mayo Clinic — Rochester, MN

A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation

A Study to Evaluate the Effectiveness, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation

Eric Sorenson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122080-P01-RST
19-003849
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Inclusion Criteria - Part A and B:

  • Weakness attributable to ALS and documented SOD1 mutation at Screening Visit 2. 
  • A forced vital capacity (FVC) ≥50% of predicted value as adjusted for sex, age, and height (from the sitting position). Participants with stable FVC <50% but ≥45%, whose FVC has not declined by more than 5% in the last 6 months may be considered for inclusion, at the discretion of the Investigator. 
  • If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit.
  • Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.

Exclusion Criteria - Part A and B:

  • History of or positive test result for human immunodeficiency virus. 
  • History of, or positive test result at Screening, for hepatitis C virus antibody.
  • Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) or vaccination (defined as positive anti-HBs) are eligible to participate in the study. 
  • Treatment with another investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering ribonucleic acid, stem cell therapy, or gene therapy is allowed. 
  • Current enrollment in any other interventional study.
  • Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis (N4-methylthiosemicarbazone)) or pyrimethamine.
  • Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.

Inclusion Criteria
•Part C:

  • Weakness attributable to ALS and confirmed SOD1 mutation at Screening Visit.
  • If taking riluzole, participant must be on a stable dose for ≥ 30 days prior to Day 1 and expected to remain at that dose until the final study visit. 
  • If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study. 
  • Medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.

Exclusion Criteria - Part C:

  • History of or positive test result for human immunodeficiency virus. 
  • History of, or positive test result at Screening, for hepatitis C virus antibody.
  • Current hepatitis B infection (defined as positive for HBsAg and/or anti-HBc). participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive IgM anti-HBc, and positive anti-HBc) or vaccination (defined as positive anti-HBs) are eligible to participate in the study. 
  • Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs), biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering RNA, stem cell therapy, or gene therapy is allowed. 
  • Current enrollment in any other interventional study. 
  • Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis(N4-methylthiosemicarbazone)) or pyrimethamine. 
  • Current or anticipated need, in the opinion of the Investigator, of a DPS during the study period.
    • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Drug, Other, Drug therapy
Amyotrophic lateral sclerosis
Amyotrophic lateral sclerosis, Genetic mutation, Nervous system, Riluzole, Tofersen [USAN], riluzole
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Mayo Clinic Rochester, MN — Rochester, MN

Infant Healthy Growth Assessment and Intervention with Home Visiting

A Study to Screen Infant Healthy Growth Assessment and Intervention with Home Visiting

Brian Lynch
All
Not specified
This study is NOT accepting healthy volunteers
0000-122090-H01-RST
19-003929
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Inclusion Criteria:

  • Infants born at or after 37 weeks gestational age at Methodist hospital in the level 1 nursery, who currently live in Olmsted County, and will receive primary care within Employee Community Health (ECH).
  • Infants born to mothers age 18 or older.
  • For multi-gestation births, only the first born child is eligible.
  • A score of > 3 on the Infant Unhealthy Growth Factor assessment.
  • Families who require interpreter services are eligible for the study as OCPHS Family Home Visiting utilizes interpreters and there are interpreters available in the nursery.


Exclusion Criteria:

  • Those not meeting the inclusion criteria.
  • Families with grandparent(s) as primary caregivers or if infant has been determined in nursery to be going to foster care or CPS.
  • Families who have previously qualified for and participated in on-going home visits over a period of months to years or who have recently accepted OCPH home visits to be scheduled in the near future and anticipated to span over months to years.
Childhood obesity, Obesity
Childhood obesity, Feeding problems in newborn
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Mayo Clinic — Rochester, MN

Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

A Study to Evaluate Single vs. Multiple Dose Regimens of Privigen in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Duygu Selcen
All
2 years to 16 years old
Phase 4
This study is NOT accepting healthy volunteers
0000-122096-P01-RST
19-004000
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Inclusion Criteria:
 

  • Male or female subjects.
  • 2 to < 17 years of age.
  • Having confirmed or possible CIDP.


Exclusion Criteria:

  • Absence of CIDP symptoms.
  • History or family history of inherited neuropathy.
  • Diagnosed developmental delay or regression.
  • History of thrombotic episode.
  • Known or suspected hypersensitivity to Privigen.
  • Known allergic or other severe reactions to blood products.
  • Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study.
  • Pregnant or breastfeeding mother.
Biologic/Vaccine, Administration of immunoglobulin by intravenous route, Drug therapy, Intravenous infusion of human immune serum globulin (IVIg)
Chronic inflammatory demyelinating polyradiculoneuropathy, Demyelinating polyradiculoneuropathy
Chronic inflammatory demyelinating polyradiculoneuropathy, Immunoglobulin G, immunoglobulin G
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Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI

A Study to Compare Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI

David Black
All
18 years to 55 years old
This study is NOT accepting healthy volunteers
0000-122118-H01-RST
19-004228
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Inclusion Criteria:

  • Men and women, aged 18-55 years old.


Exclusion Criteria:
 

  • Patients with safety contraindications to MRI scanning at 3T. 
  • Patients unable to adequately perform the fMRI task due to physical, neurological, or cognitive disability. 
  • Patients that demonstrate 3 mm or greater translational head motion during scanning of the fMRI rhyming task data sets. 
  • Pregnant women.
  • Patients that have implanted medical devices or other safety contraindications for a 7T or 3T MRI exam.
7-tesla MRI, Functional MRI , MRI
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Pulmonary Vascular Disease Phenomics Program - L-PVDOMICS l

A Study of Pulmonary Vascular Disease Phenomics Program

Robert Frantz
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122135-P01-RST
19-004360
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Inclusion Criteria:

  • Only participants who completed the parent PVDOMICS study will be approached for the L-PVDOMICS Study.  This includes all participants:
    • PH, comparators and controls with a minimum 6 months post-enrollment in PVDOMICS. 
  • See the parent PVDOMICS protocol for full details of inclusion/exclusion criteria.
  • Any PH, comparators or control participant previously enrolled in the parent PVDOMICS protocol with a minimum of six months post-enrollment.
  • Dialysis dependent renal function since the parent study acceptable.


Exclusion Criteria:

Participant Level 1

  • Previously received a heart and/or lung transplant
  • In the clinician’s opinion, too ill to perform L-PVDOMICS testing even if limited testing.
  • Participants who withdrew from the parent PVDOMICS study.
  • Pregnant or nursing.
  • Concurrent participation in any pulmonary hypertensioninvestigational drug study or other blinded placebo-controlled drug clinical trial.

Participant Level 2:  

  • Transplant other than heart or lung.
  • Participants who withdrew from the parent PVDOMICS study.

Participant Level 3:  

  • Participants who withdrew from the parent PVDOMICS study.

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QBSAfe: A novel approach to diabetes management focused on Quality of life, Burden of treatment, Social integration and Avoidance of Future Events

A Study to Evaluate Diabetes Management Using Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

Victor Montori
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122153-H01-RST
19-004560
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Inclusion Criteria:

  • Diagnosis of diabetes mellitus; existing appointment with participating clinician.


Exclusion Criteria:
 

  • Do not speak English.
  • Severe vision/hearing impairments.
  • Unable to give informed consent for any reason.
Diabetes, Type 1 diabetes, Type 2 diabetes
Diabetes mellitus, Endocrine system
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Mayo Clinic — Rochester, MN

Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study) (POSEIDON)

A Study to Evaluate the Alfapump® System in the Treatment of Refractory or Recurrent Ascites

Patrick Kamath
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122156-P01-RST
19-004575
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Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria. 
  • Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis. Patients must have a minimum of 2 therapeutic paracenteses in the 30 Days prior to enrollment.
  • Not a candidate for (e.g., refused, contraindicated) Transjugular intrahepatic portosystemic shunt (TIPS) or previously implanted TIPS is permanently obstructed or non-functioning.
  • Screened for esophageal varices and on optimal management. Absence of contraindications to prophylactic antibiotic use from time of pump implant.
  • Life expectancy of at least 6 months following pump implant (approximately 10 months from enrollment).
  • Capable of giving written informed consent, willing to comply with study procedures including the 3-month pre-implant observation period and ability to operate and charge the device. 
  • Women of childbearing age should use adequate contraceptives. Reassessed at time of implant procedure (Pivotal Cohort Only): 
  • Has required a minimum of 5 therapeutic paracenteses in the 3-month observation period prior to pump implant.


Exclusion Criteria:

  • Renal failure defined as serum creatinine higher than or equal to 1.5 mg/dL.
  • More than one episode of spontaneous bacterial peritonitis over the previous 6 months.
  • Recurrent urinary infections as per standard criteria, defined as 2 or more episodes over the last 6 months.
  • Evidence of loculated ascites, as per imaging.
  • Hepatocellular carcinoma, exceeding Milan criteria or for which RF ablation is anticipated.
  • Pregnant females or females anticipating pregnancy during study period.
  • Patients currently enrolled in another interventional clinical study that has not reached the primary endpoint assessment point, or (for pivotal cohort) patients who have previously had an alfapump implanted.
  • Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months (corticosteroids at stable dose over the last 4 months but < 15 mg/day, or in tapering doses are allowed).
  • Known or suspected hepatic or extra hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for ≥ 3 years.
  • History of bladder cancer.
  • BM I > 40 presenting a risk for technical difficulties for surgery or catheter implantation.
  • Contraindications to general anesthesia.
  • Comorbid condition or other reason (example hypertension) that may preclude stopping diuretics after enrollment.
  • MELD-Na Score > 18.
  • Budd Chiari syndrome (Pivotal cohort only).
  • Clostridium difficile infection within the past year.  Assessed or re-assessed at time of pump implant: 
  • Acute gastrointestinal hemorrhage requiring transfusions over the previous 42 days.
  • Condition that prevents continued cessation of diuretic use.
  • Patient condition does not allow the implant procedure to be performed within the limits of acceptable risk (e.g., cardiovascular comorbidities).
  • Hepatocellular carcinoma exceeding Milan criteria or for which RF ablation is anticipated.
  • ICU admission since enrollment.
  • INR ≥ 2.0.
  • Platelet count of < 50,000 /μL at the time of implantation, unless the platelet count is ≥ 30,000 / μL and bleeding risk can be satisfactorily addressed with means such as platelet infusion during the implant procedure and/or thrombopoietin receptor agonists.
  • Bacterial peritonitis within 4 weeks of implant procedure (this includes peritonitis diagnosed at the time of intervention).
    • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of SBP within four weeks of the implant procedure date.
  • Bacterascites within 4 weeks of implant procedure (this includes bacterascites diagnosed at the time of intervention).
    • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of bacterascites within four weeks of the implant procedure date.
  • Serum sodium < 125 mmol/L.
  • Urinary infection within the last 2 weeks.
  • Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
  • Evidence of renal failure, defined as serum creatinine higher than or equal to 1.5 mg/dL, in the preceding 30 days.
  • Evidence of loculated ascites, as per imaging.
  • Pregnant females or females anticipating pregnancy during study period.

Eligibility last updated 11/10/21.  Questions regarding updates should be directed to the study team contact.

Abdominal paracentesis, Drainage of ascites, Device
Cirrhosis, Liver problems
Cirrhosis of liver, Digestive system, Hepatic ascites, Paracentesis, Refractory ascites
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Mayo Clinic — Rochester, MN

Return of Pharmacogenomic Results Through Direct-to-Consumer Online Portal: Consumer Experiences

A Study to Evaluate Return of Pharmacogenomic Results Through Direct-to-Consumer Online Portal: Consumer Experiences

Megan Allyse
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122160-H01-RST
19-004607
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Inclusion Criteria:

  • Consumers of Mayo Clinic GeneGuide who have previously indicated a willingness to be contacted regarding future research AND who have received a positive result for variants in the BCHE gene (associated with pseudocholinesterase deficiency) and CACNA1S and RYR1 genes (associated with malignant hyperthermia).


Exclusion Criteria:
 

  • Not a consumer.
  • Has not consented to be contacted.
  • Has not received a relevant genetic result.

 

Malignant hyperthermia, Pseudocholinesterase deficiency
At risk of disease, Genetic counseling, Genetic testing, Genetic variation, Malignant hyperthermia, Pseudocholinesterase deficiency
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Functionality and Acceptability of a Medical Grade, Smartphone based, Fetal Heart Rate Monitor for Self-Administration by Low Risk Pregnant Women. The HeraBEAT™ USA Trial.

A Study to Evaluate Smartphone-based Fetal Heart Rate Monitor for Self Administration by Low-risk Pregnant Women

Yvonne Butler Tobah
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
0000-122170-H01-RST
19-004708
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Inclusion Criteria:

  • At least 18 years of age.
  • Able to speak, read and understand English.
  • Able to provide informed consent (i.e., no impairments or barriers).
  • Owns a suitable iOS or Android device and demonstrates average control and basic understanding of using a smartphone
  • At least 12 weeks gestation.
  • Pregnancy documented as low risk


Exclusion Criteria:

  • Any observed cranial or cardiac anomalies on formal ultrasound.
  • Multifetal gestation.
  • Maternal history of defibrillation.
  • Maternal history of electro-surgery.
  • Patients with external electrical stimulators, cardiac pacemakers or requiring use of MRI or other high frequency medical equipment.
  • Clinical judgment that determines that the pregnancy is at high risk for complications requiring outpatient or inpatient monitoring for clinical care.
  • Any of the following high risk factors would disqualify the mother for the study:
    • Abnormal fetal anatomy;
    • Chronic hypertension, including severe hypertension (>160/110);
    • Possible ectopic pregnancy or pregnancy of unknown location;
    • Multi-fetal pregnancy;
    • Hypertensive disorders (chronic hypertension, gestational diabetes, preeclampsia);
    • Prior PE/DVT/stroke;
    • Anticoagulation during prior pregnancy (e.g., antiphospholipid antibody syndrome);
    • Prosthetic heart valve (non-bio);
    • Pulmonary hypertension;
    • Mothers currently taking Immunosuppressants, Prednisone > 10mg per day);
    • Women with mental health disorders (including eating disorders, severe depression, on antipsychotics);
    • Recurrent pregnancy loss (> 2 losses);
    • Current maternal malignancy;
    • Prior myocardial infarction/cardiomyopathy;
    • Bio-prosthetic heart valves;
    • Marfan syndrome;
    • Active liver disease (e.g., hepatitis);
    • Congenital heart disease;
    • Coagulopathies including thrombophilias and bleeding disorders;
    • Pre-existing diabetes;
    • Genetic disease/CF testing/anomalies in prior child;
    • Incompetent cervix (prior cerclage);
    • Isoimmunization (Rh, Kell, etc.);
    • History of transplant or currently on Dialysis;
    • Prior 2nd or 3rd trimester loss;
    • Human Immunodeficiency Virus (HIV);
    • Inflammatory bowel disease;
    • Asthma and currently on steroid to control disease;
    • History of preterm delivery < 37 weeks;
    • BMI > 40 (class 3 obesity).
Antepartum care, Finding of fetal heart rate
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A Randomized, Double-Blind, Placebo-Controlled, Single-Administration, Dose-Escalation Study of Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

A Study to Evaluate Entolimod on Immune System Aging in Healthy Geriatric Subjects Receiving Influenza Vaccination

Robert Pignolo
All
65 years to 99 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122180-P01-RST
19-004847
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Inclusion Criteria:

  • Men and women of age 65 years and older at the time of enrollment.
  • Eligible to receive Fluzone.
  • Female subjects must be past menopause and not pregnant.
  • No history of anaphylactic reaction to gelatin, neomycin, or other vaccine component.
  • Must not have had the flu vaccine within the past 90 days.
  • Medically stable with no exacerbations or changes in medication regimen for chronic diseases in the past 3 months and no hospitalizations in the past 6 months.
  • Must be able to read/write English in order to provide informed consent and comply with study procedures.
  • Expected to be available for the duration of the study.


Exclusion Criteria:

Study candidates who meet any of the following criteria within 28 days prior to entolimod administration will not be eligible for participation in this study:

  • Receipt of any other vaccines within the past 30 days prior to enrollment.
  • Acute illness within the last 30 days.
  • History of hypersensitivity to the flu vaccine or its components (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).
  • History of Guillain Barré syndrome (GBS).
  • History of bleeding disorders.
  • Medical contraindication to treatment with vaccine as indicated by a history of autoimmune disease, immune deficiency, or hypersensitivity to other vaccines.
  • Unstable major cardiovascular, renal, endocrine, immunological or hepatic disorder.

Systolic blood pressure (SBP) < 110 mmHg or orthostatic hypotension [> 20 mmHg fall in SBP or > 10 mmHg fall in diastolic blood pressure (DBP) with standing] at the time of screening.

  • Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) (within 14 days prior to entolimod administration).
    • Note: Subjects with localized fungal infections of skin or nails are eligible.
  • Clinical signs of febrile illness (temperature >99.5°F).
  • Baseline vital signs with ³ Grade 2 abnormalities.
  • Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism, venous thromboembolism) within 6 months prior to study drug administration; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥ 3 hypertension (diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥ 160 mmHg) despite antihypertensive therapy.
  • Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation, 2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, or Grade ≥ 2 bradycardia (within 14 days prior to entolimod administration).
  • Inadequate hepatic function (within 14 days prior to entolimod administration):
    • Serum alanine aminotransferase (ALT) ³3 × upper limit of normal (ULN) (Grade ³1);
    • Serum aspartate aminotransferase (AST) ³3 × ULN (Grade ³1);
    • Serum alkaline phosphatase (ALP) ³5 × ULN (Grade ³2);
    • Serum bilirubin ³1.5 × ULN (Grade ³ 1).
  • Positive antiviral serology:
    • Positive hepatitis C virus (HCV) antibody or positive HCV ribonucleic acid (RNA) by quantitative PCR;
    • Positive hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV)deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing;
    • Positive human immunodeficiency virus (HIV) antibody.
  • Use of medication that might interact with the flu vaccine including (but not limited to) specifically: aminopyrine, phenytoin sodium, theophylline, and warfarin sodium.
  • Any ongoing treatment with immunosuppressive or immune-stimulant therapy;
  • Ongoing use of systemic corticosteroids.
  • Blood or blood products given within the three months prior to vaccination and two months after vaccination;
  • Current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e., more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months].
  • Receipt of another investigational pharmaceutical product within 60 days of treatment.
  • Diagnosis of Parkinson’s Disease, previous stroke, or significant cognitive impairment (defined as MMSE < 20).
  • Other concerns that in the opinion of the PI would preclude a subject from participating in study procedures or from completing the study.
Drug, Drug therapy, Geriatric monitoring, Hemagglutination inhibition assay, Influenza vaccination
Influenza
Entolimod [USAN:INN], influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen
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APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

A Study to Evaluate Patisiran in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

Martha Grogan
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122184-P01-RST
19-004903
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Inclusion Criteria:
 

  • Age 18 (or age of legal consent, whichever is older) to 85 years, inclusive.
  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with cardiomyopathy:
    • Hereditary ATTR amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
      • TTR pathogenic mutation consistent with hATTR;
      • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness >12 mm (based on central echocardiogram reading at screening);
      • Amyloid deposits in cardiac or noncardiac tissue (eg, fat pad aspirate, salivary gland, median nerve connective sheath) confirmed by Congo Red (or equivalent) staining OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc] or 99mTc-pyrophosphate [PYP-Tc]) with Grade 2 or 3 cardiac uptake, if monoclonal gammopathy of undetermined significance (MGUS) has been excluded;
      • If MGUS, confirm TTR protein in tissue with immunohistochemistry (IHC) or mass spectrometry.
    • Wild-type ATTR amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
      • Absence of pathogenic TTR mutation;
      • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness >12mm (based on central echocardiogram reading at screening);
      • Amyloid deposits in cardiac tissue with TTR precursor identification by IHC, mass spectrometry, OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid [DPD-Tc] or 99mTc-pyrophosphate [PYP-Tc]) with Grade 2 or 3 cardiac uptake, if MGUS has been excluded;
      • If MGUS, confirm TTR protein in cardiac tissue with IHC or mass spectrometry.
  • Medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure).
  • Clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start.
  • Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥ 6 months with evidence of disease progression while on tafamidis treatment.
  • Able to complete ≥ 150 m on the 6-minute walk test.
  • Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of heart failure severity, > 300 ng/L and < 8500 ng/L.
  • Patient is able to understand and is willing and able to comply with the study requirements and to provide written informed consent; and patient agrees to sign the medical records release form for collection of vital status.


Exclusion Criteria:
 

  • Has known primary amyloidosis (AL) or leptomeningeal amyloidosis.
  • NYHA Class III AND ATTR amyloidosis disease Stage 3 (defined as both NT-proBNP >3000 ng/L and estimated glomerular filtration rate [eGFR] <45 ml/min/1.73 m^2).[Gillmore 2018]
  • NYHA Class IV at the Screening visit.
  • Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV (requires cane or stick to walk, or is wheelchair bound) at the Screening visit.
  • Has any of the following laboratory parameter assessments at screening:
    • Aspartate transaminase (AST) or alanine transaminase (ALT) levels ˃2.0 × the upper limit of normal (ULN);
    • Total bilirubin ˃ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert’s syndrome are eligible if total bilirubin <2 × ULN
    • International normalized ratio (INR) ˃1.5 (unless patient is on anticoagulant therapy, in which case excluded if INR ˃3.5).
  • Has eGFR <30 mL/min/1.73 m^2 (using the modification of diet in renal disease [MDRD] formula).
  • Has known human immunodeficiency virus infection; or evidence of current or chronic hepatitis C virus or hepatitis B virus infection.
  • Tafamidis naïve patients (at baseline) for whom the Investigator actively plans or anticipates commencing treatment with tafamidis during the 12-month double-blind period, taking into consideration clinical status, patient preference and/or commercial availability of tafamidis.
  • Is currently taking diflunisal; if previously on this agent, must have at least a 6-month wash-out prior to dosing (Day 1).
  • Is currently taking doxycycline, or tauroursodeoxycholic acid; if previously on any of these agents, must have completed a 30-day wash-out prior to dosing (Day 1).
  • Received prior TTR-lowering treatment or participated in a gene therapy trial for hATTR amyloidosis.
  • Current or future participation in another investigational device or drug study, scheduled to occur during this study, or has received an investigational agent or device within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). In the case of investigational TTR stabilizer drugs, washout for 6 months prior to dosing (Day 1) is required; this does not apply to patients who are on tafamidis at baseline.
  • Requires treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.
  • Other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzymes and electrocardiogram [ECG] changes).
  • Has non-amyloid disease affecting exercise testing (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation).
  • Recent or planned orthopedic procedure during the double-blind period (e.g., lower extremity or back surgery) that could impact 6-MWT.
  • Unstable congestive heart failure (CHF) (eg, no adjustment of diuretics at time of screening required to achieve optimal treatment of CHF).
  • Had acute coronary syndrome or unstable angina within the past 3 months.
  • Has history of sustained ventricular tachycardia or aborted ventricular fibrillation.
  • Has history of atrioventricular nodal or sinoatrial nodal dysfunction for which a pacemaker is indicated but will not be placed.
  • Has persistent elevation of systolic (˃180 mmHg) and diastolic (˃100 mmHg) blood pressure that is considered uncontrolled by physician.
  • Has untreated hypo- or hyperthyroidism.
  • Prior or planned heart, liver, or other organ transplant.
  • Had a malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
  • Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
  • Is not willing to comply with the contraceptive requirements during the study period.
  • Female patient is pregnant or breast-feeding.
  • Has a known history of alcohol abuse within the past 2 years or daily heavy alcohol consumption (for females, more than 14 units of alcohol per week; for males, more than 21 units of alcohol per week [unit: 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer]);
  • History of illicit drug abuse within the past 5 years that in the opinion of the Investigator would interfere with compliance with study procedures or follow-up visits.

 

Drug
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An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

A Study of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

William Hogan
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122186-P01-RST
19-004906
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Inclusion Criteria:

  • Male or female, 12 years of age or older.
  • Have undergone an allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
  • Clinically suspected all grades acute or chronic GVHD as per Minnesota-Center for International Blood and Marrow Transplant Research (MN-CIBMTR) criteria, that is refractory or intolerant to corticosteroids, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program. Clinical suspicion of GVHD by the treating physician is also sufficient. 
  • Evidence of myeloid engraftment (e.g., absolute neutrophil count ≥ 1.0 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed. 
  • Evidence of platelet engraftment (i.e., platelets ≥ 20 × 10^9/L). 
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3. 
  • Be willing to avoid pregnancy or fathering children based on 1 of the following criteria: 
    • Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea);
    • Woman of childbearing potential who has a negative serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed;
    • Man who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.
  • Able to provide written informed consent and/or assent from the patient, parent, or guardian.

 


Exclusion Criteria:
 

  • Eligible for an existing and actively enrolling Incyte sponsored clinical trial for ruxolitinib for the treatment of GVHD. 
  • Patients or legal guardians unable to review and sign informed consent form.
  • Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant. 
  • Patients with inadequate liver function (alanine aminotransferase above 4 × upper limit of normal (ULN) or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD. 
  • Patients with end stage renal function (creatinine clearance (CrCl) < 15 mL/min or glomerular filtration rate < 15 mL/min), regardless of whether hemodialysis is required. 
  • Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program. 
  • Previous allergic reactions to Janus kinase (JAK) inhibitors or excipients. 
  • Patients who are currently taking any anticancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization). 
  • Patients taking any secondary GVHD therapy due to insufficient response/progression on program treatment including, but not limited to, ibrutinib, filgotinib, and other off-label medications.
  • Concomitant use of any JAK inhibitor.
  • Initiating therapy with any investigational medication. 
  • Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection. 
  • Known HIV infection. 
  • Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Previous test results obtained as part of standard of care before allo-HSCT that confirm a patient is immune and not at risk for reactivation (i.e., hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility.
Drug, Administration of antineoplastic agent, Allogeneic bone marrow transplantation, Drug therapy
Cancer, Graft versus host disease, Leukemia, Lymphoma, Pediatric white blood cell disorders
Allogeneic stem cell transplant, Bone marrow transplant, Cancer treatment, Chemotherapy, Graft versus host disease, Hematologic neoplasm, Hematopoietic system, Malignant neoplastic disease, Medical Oncology, Ruxolitinib [USAN:INN], ruxolitinib
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Endoscopic Image and Pathology Correlation for Duodenal Biopsy Findings Using Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology

A Study to Evaluate Imaging and Pathology Correlation for Duodenal Biopsies Using Fujifilm Device

Kenneth Wang
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122228-P01-RST
19-005311
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Inclusion Criteria:

  • Patients that are undergoing endoscopy with duodenal or small bowel biopsies


Exclusion Criteria:
 

  • Patients that are not undergoing endoscopy with duodenal or small bowel biopsies
Device, Biopsy of small intestine, Endoscopic biopsy, Endoscopic biopsy of duodenum
Biopsy of duodenum, Biopsy of small intestine, Endoscopic biopsy of duodenum
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Mayo Clinic — Rochester, MN

Personalized Molecular Marker Study to Transform Treatment of High Grade Endometrial Cancer

A Study of Personalized Molecular Markers to Transform Treatment of High Grade Endometrial Cancer

Andrea Mariani
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-122229-H01-RST
19-005326
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Inclusion Criteria:  

  • Women age ≥ 18 years.
  • Biopsy-proven high-grade endometrial cancer.
  • Biopsy histology is Grade 3 endometrioid, serous, clear cell, poorly differentiated, or undifferentiated.
  • Scheduled to undergo hysterectomy at Mayo Clinic.
  • Willing to complete pre-op blood sample and follow-up serial blood samples post-operatively.
  • Willing and able to provide signed informed consent.

Exclusion Criteria

  • Biopsy histology is Grade 1 or Grade 2 endometrioid.
  • Change in planned surgical procedure such that hysterectomy is not performed at Mayo Clinic.
  • Pre-op blood sample is not obtained.
  • Tumor quantity or cell viability expected to not be sufficient for the study analyses.

 

Cancer, Endometrial cancer
Alteration of genetic material, Genetic transcription, Medical Oncology, Primary endometrioid carcinoma of endometrium of body of uterus, Primary malignant clear cell neoplasm of endometrium, Primary serous adenocarcinoma of endometrium, Reproductive system, Cancer treatment
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Examining the Objective Diagnosis of Concussions (ODC) in Junior A Hockey Players Related to Concussion History, Player Position, Mechanisms of Injury and Individual Exposure Time (IET)

A Study to Examine Concussion Diagnosis in High School and Junior A Hockey Players

Michael Stuart
All
16 years to 21 years old
This study is NOT accepting healthy volunteers
0000-122261-H01-RST
19-005572
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Inclusion Criteria:

  • All eligible Junior A hockey players (ages 16-21).
  • Medically cleared for hockey when enrolled (21 is the USA Hockey Program age limit).


Exclusion Criteria:

  • Players not medically cleared.
  • Players who are restricted from hockey.
  • Players who decline.

 

 

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

A Study to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Irina Bancos
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122322-P01-RST
19-006092
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Inclusion Criteria:
 

  • Male or female patients.
  • Age ≥ 18 years old at screening.
  • Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed.
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly.
  • Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening.
  • IGF-1 levels ≤ 1 x ULN at screening.
  • Adequate liver, pancreatic, renal and bone marrow functions.
  • Normal ECG.


Exclusion Criteria:

  • GH ≥ 2.5 μg/L at screening (cycle).
  • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer].
  • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g., every 6 weeks or 8 weeks).
  • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening.
  • Patients who have undergone pituitary surgery within 6 months prior to screening.
  • Patients who have received prior pituitary irradiation.
  • Patients with poorly controlled diabetes mellitus (hemoglobin A1c > 8.0%)
Drug, Drug therapy, Medication administration: subcutaneous
Acromegaly
Acromegaly, Endocrine system, Lanreotide, Octreotide, lanreotide, octreotide
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study) (AURORA)

A Study to Evaluate Intravenous Iloprost in Subjects with Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis

Ashima Makol
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122333-P01-RST
19-006168
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Inclusion Criteria:

  • Male or female subjects must be ≥ 18 years of age. 
  • Subjects must have a diagnosis of Systemic Sclerosis as defined by the 2013 American College of Rheumatology criteria/EULAR criteria.
  • Subjects must have a diagnosis or history of Raynaud's Phenomenon, self-reported or reported by a physician, with at least a 2-phase color change in finger(s) of pallor, cyanosis, and/or reactive hyperemia in response to cold exposure or emotion.
  • Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks, documented in the electronic patient-reported outcomes (ePRO) diary, occurring over at least 3 separate days of the 3- to 5-day eligibility period.
  • Subjects must complete a minimum of 80% of the daily ePRO diary entry during the baseline period.
  • Female subjects of childbearing potential and male subjects must agree to use contraception for the duration of the study. 
  • Subjects must be willing and able to comply with the study requirements and give informed consent for participation in the study.


Exclusion Criteria:
 

  • Female subjects who are pregnant or breastfeeding.
  • Subjects with systolic blood pressure < 85 mmHg.
  • Subjects with an estimated glomerular filtration rate <15 mL/min/1.73 m^2 at screening as determined by the Modification of Diet in Renal Disease equation.
  • Subjects with an alanine aminotransferase and/or aspartate aminotransferase value > 3 × the upper limit of normal at screening.
  • Subjects who have a digital ulcer infection within 30 days of screening.
  • Subjects with a history of cervical or digital sympathectomy, or botulism toxin injections in their hands [for RP or digital ulcers] within 90 days of screening. Subjects should not have a planned botulism toxin or sympathectomy during their participation in the study.
  • Subjects with gangrene or digital amputation within 6 months of screening.
  • Subjects with current intractable diarrhea or vomiting.
  • Subjects with a risk of clinically significant bleeding events, including those with coagulation or platelet disorders at screening.
  • Subjects with a history of major trauma or hemorrhage within 30 days of screening.
  • Subjects with clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of screening.
  • Subjects who have had any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening.
  • Subjects with a history of myocardial infarction or unstable angina within 6 months of screening. Subjects should not have a planned coronary procedure during their participation in the study.
  • Subjects with acute or chronic congestive heart failure (New York Heart Association Class III [moderate] or Class IV [severe]) at screening.
  • Subjects with a history of more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device.
  • Subjects with a history of life-threatening cardiac arrhythmias.
  • Subjects with a history of hemodynamically significant aortic or mitral valve disease.
  • Subjects with a history of known pulmonary hypertension, pulmonary arterial hypertension, or pulmonary veno-occlusive disease.
  • Subjects with a history of significant restrictive lung disease, defined as forced vital capacity < 45% predicted and diffusing capacity of the lungs for carbon monoxide <40% predicted (uncorrected for hemoglobin).
  • Subjects with scleroderma renal crisis within 6 months of screening. 
  • Subjects with a concomitant life-threatening disease with a life expectancy < 12 months.
  • Subjects who have a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results.
  • Subjects who have taken or are currently taking any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonists (e.g., epoprostenol, treprostinil, iloprost, and selexipag) within 8 weeks of screening.
  • Subjects who have initiated or had a dose change of any of the following within 2 weeks of screening: oral, topical, or intravenous (IV) vasodilators (e.g., calcium channel blockers, phosphodiesterase-5 (PDE5) inhibitors [e.g., sildenafil, tadalafil, or vardenafil], nitrates, and
  • fluoxetine).
  • Subjects with any history of acetaminophen intolerability (e.g., allergic reaction to acetaminophen).
  • Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening (including excision of skin cancer) or that is currently not in remission.
  • Subjects who have used any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) of screening.
  •  
  •  
Drug, Drug therapy, Medication administration: intravenous
Raynaud's disease, Scleroderma
Circulatory system, Iloprost, Musculoskeletal system, Secondary Raynaud's phenomenon, Systemic sclerosis, iloprost
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CC-92480-MM-002 A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

A Study to Determine Recommended Dose, Regimen and Evaluate the Safety and Preliminary Effectiveness of CC-92480 in Combination With Standard Treatments in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Wilson Gonsalves
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-122349-P01-RST
19-006348
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Inclusion Criteria:

  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  • Females of childbearing potential (FCBP) must:
    • Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence* from heterosexual contact;
    • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two reliable forms of contraception as defined in the Pregnancy Prevention Plan (PPP) without interruption, 28 days prior to starting CC-92480, during the study treatment (including during dose interruptions), and for 28 days after the last dose of CC-92480, 7 months after the last dose of BTZ (for Cohorts A, D and G), 90 days after the last dose of DARA (for Cohorts B and E), 6 months after the last dose of CFZ or ELO (for Cohorts C and F and Cohorts H and J), or 5 months after the last dose of ISA (for Cohorts I and K), whichever is later.
  • Note: A female of childbearing potential (FCBP) is a female who:
    • has achieved menarche at some point; and
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  • Male subjects must:
    • Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 3 months following study treatment discontinuation, even if he has undergone a successful vasectomy.

* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.

  • Males must agree to refrain from donating sperm or semen while on study treatment, and for at least 3 months following last dose of study treatment. Females must refrain from egg cell (ova) donation while on study treatment, and for 28 days after the last dose of CC-92480.
  • All subjects must agree to refrain from donating blood while on study treatment and for 28 days after the last dose of study treatment.
  • All male and female subjects must follow all requirements defined in the PPP. 


Exclusion Criteria:

  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject has any of the following laboratory abnormalities:
    • Absolute neutrophil count (ANC) < 1,000/µL (for Phase 1 without growth factor support for ≥ 7 days [≥ 14 days for pegfilgrastim]);
    • Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to reach this level);
    • Hemoglobin < 8 g/dL (< 4.9 mmol/L);
    • Creatinine clearance (CrCl) < 45 mL/min (< 30 mL/min for Cohort G);
    • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L);
    • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN;
    • Serum total bilirubin > 1.5 x ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome;
    • Prothrombin time (PT)/international normalized ration (INR) > 1.5 x ULN or partial thromboplastin time (PTT) > 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
  • Note: Subjects receiving therapy for a thromboembolic event that occurred > 3 months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin or other approved therapeutic anticoagulation regimen.
  • Subject has peripheral neuropathy ≥ Grade 2.
  • Subject with gastrointestinal disease that may significantly alter the absorption of CC92480. 7. Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies:
    • Basal cell carcinoma of the skin;
    • Squamous cell carcinoma of the skin;
    • Carcinoma in situ of the cervix;
    • Carcinoma in situ of the breast;
    • Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative.
  • Subject has plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis. 
  • Subject with known central nervous system (CNS) involvement with myeloma.
  • Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. The following are exceptions to this criterion:
    • Intranasal, inhaled, topical or local corticosteroid injections (e.g., intra-articular injection);
    • Systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or the equivalent;
    • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
  • Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
    • Left ventricular ejection fraction (LVEF) < 45% as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at Screening;
    • Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiogram (ECG) finding at Screening;
    • A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval > 470 milliseconds (msec) using Fridericia’s QT correction formula; a history of or current risk factors for Torsades de Pointe (e.g., heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval;
    • Congestive heart failure (New York Heart Association Class III or IV);
    • Myocardial infarction within 12 months prior to starting study treatment.
    • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris;
    • History of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, pericardial disease or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker. 
  • Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment. 
  • Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480.
  • Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study.
  • Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C.
  • Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, BTZ (for Cohorts A, D and G), DARA (for Cohorts B and E), CFZ (for Cohorts C and F), ELO (for Cohorts H and J), ISA (for Cohorts I and K), or dexamethasone.
  • Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-92480, BTZ (for Cohorts A, D and G), DARA (for Cohorts B and E), CFZ (for Cohorts C and F), ELO (for Cohorts H and J), ISA (for Cohorts I and K), or dexamethasone.
  • Contraindications to the standard treatment regimens, per local prescribing information. 
  • Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Multiple myeloma, Plasma cell disorders
Cancer treatment, Hematopoietic system, Immune system, Medical Oncology, Relapse multiple myeloma, Targeted drug therapy
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The Effect of Flooring on Office Workers' Health and Behaviors

The Effect of Flooring on Office Workers' Health and Behaviors

Kenton Kaufman
All
18 years to 60 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122391-H01-RST
19-006733
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Inclusion Criteria:

• Ability to provide informed consent
• Must be adults between the ages of 18 and 60
• Ability to relocate to the Well Living Lab for 9 consecutive weeks
• Full-time Mayo Clinic employees (35+ hours per week)
• Report working a sedentary job (e.g., sit for >= 50% of their work time).
• Have a working mobile phone that can receive text messages
• Must be present for 80% of the study (minimum of 4 days per week)
Exclusion Criteria:

• Individuals who are shift-workers
• Individuals diagnosed with vascular diseases (i.e., Raynaud''s disease, peripheral artery disease, etc.)
• Individuals with diagnosed neurological and psychiatric disorders that may have physical limitations
• Drug (illegal or prescription narcotic), nicotine, or alcohol dependency
• Women who are lactating, pregnant or intend to become pregnant during the duration of the study
• Individuals who are taking medications (either prescribed or over-the-counter) which may affect comfort levels (e.g., opiate based medications)
• Working in occupation requiring standing/stepping >50% of work time
• Report < 1 year at current job
• Hospitalization from either a physical or mental disorder in the past six months
• History of cardiovascular, pulmonary, metabolic, neurological, or orthopedic limitations that would prohibit occupational physical activity (e.g., standing, stepping, etc.)
Other
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A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

Katherine Nickels
All
6 months to 36 months old
Phase 2
This study is NOT accepting healthy volunteers
0000-122427-P01-RST
19-007102
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Inclusion Criteria:

  • Male or female between 6 months through 36 months of age at the time of informed consent as clinical diagnosis of IS, confirmed by video-electroencephalogram (EEG) analysis, and hypsarrhythmia on EEG at screening according to the Burden of Amplitudes and Epileptiform Discharges (BASED) scale score.
  • As assessed by the investigator has no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or has no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and is contraindicated to and/or refused by the patient’s legal representative(s) for treatment with one or both other 2 therapies.
  • Patient has general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on physical and neurological examinations, medical history, normal renal function and electrocardiogram (ECG), and clinical laboratory values completed during the Screening Period visit (Visit 1).


Exclusion Criteria:

 

  • Patient considered by the investigator, for any reason (including, but not limited to, the risks described as precautions and warnings in the current version of the investigator’s brochure for investigational product) to be an unsuitable candidate to receive the investigational product.
  • Patient has known or suspected allergy to the investigational product or apple juice.
  • Patient has clinically significant renal impairment, defined as creatinine > mg/dL or blood urea nitrogen > 2 × upper limit of normal (ULN); clinically significant liver dysfunction, defined as total bilirubin ≥ 2 × ULN, or aspartate aminotransferase or alanine aminotransferase ≥ 3 × ULN; has clinically significant abnormal laboratory values; the investigator may deem the patient eligible if he/she judges the laboratory values to be not clinically significant.
  • Patient has an ongoing or known history of human immunodeficiency virus infection, or chronic hepatitis B or C.
  • Patient has a clinically significant abnormality on ECG that, in the opinion of the investigator, increases the safety risks of participating in the study.
  • Patient has a neurodegenerative disorder as the underlying cause of IS.
  • Patient has a known history of aspiration pneumonia within the past year.
  • Patient has previously participated in another clinical study of the investigational product or received any investigational drug or device or investigational therapy within 30 days of study entry.
  • Patient has received therapy with felbamate, cannabinoids, ketogenic diet or vagus nerve stimulation within 14 days of screening.
  • Patient has received therapy with a medication known to be a CYP3A4 substrate and whose PK has been shown to be impacted in the presence of a CYP3A4 inhibitor within 14 days impacted in the presence of a CYP3A4 inhibitor within 14 days of screening.
  • Patient has not remained at stables doses of all drugs used for treating epileptic seizures for at least 14 days prior to screening (except for rescue medications used for acute treatment of breakthrough seizures which are not known to be CYP3A4 substrates and whose PK has not been shown to be impacted in the presence of a CYP3A4 inhibitorist of CYP3A4 substrates]).
  • Patient has a lethal or potentially lethal condition other than infantile spasms, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia.
  • Patient has an underlying metabolic disease associated with glucose intolerance (e.g., glucose transporter deficiencies).
  • Patient has a body weight below 5 kg.
Drug therapy, Drug
JBPOS-0101, Refractory infantile spasms, West syndrome
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Estimation of Sleep Timing and Duration Using Actigraphy in Patients with Symptoms of Autonomic Dysfunction

A Study Using A Motion Device to Estimate Sleep Timing and Duration in Patients with Autonomic Dysfunction

Robin Lloyd
All
12 years to 18 years old
This study is NOT accepting healthy volunteers
0000-122436-H01-RST
19-007233
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Inclusion Criteria:

  • Adolescent patients between 12 and 18 years old, inclusive.
  • Patients being evaluated at the Pediatric Diagnostic Referral Clinic for symptoms of suspected orthostatic intolerance (OI), postural orthostatic tachycardia syndrome (POTS), or autonomic dysfunction or already carry diagnosis of OI, POTS, or autonomic dysfunction. Identified with pre-appointment triaging to have any of the following symptoms: dizziness, lightheadedness, fainting, heart racing, shortness of breath, vision changes, fatigue, exercise intolerance, and chest pain when standing.


Exclusion Criteria:

  • Age not within 12-18 years old.
  • Lack of assent from child to participate/wear actigraph.
Dysautonomia, Orthostatic intolerance, POTS
Disorder of autonomic nervous system, Postural orthostatic tachycardia syndrome
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