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

612 Study Matches

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Role of Gut Microbiome in Irinotecan Pharmacology

A Study of the Gut Microbiome in Chemotherapy Treatment

Wen Wee Ma
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122222-H01-RST
19-005263
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Able to consent.
  • Receiving irinotecan for cancer treatment within 4 weeks of enrollment.


Exclusion Criteria:

  • Unable to provide informed consent.
  • Vulnerable patients.
  • Patients who received irinotecan treatment within 12 weeks of enrollment.

 

Cancer
Cancer treatment, Chemotherapy, Irinotecan [INN:BAN], Malignant neoplastic disease, Medical Oncology, irinotecan
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Mayo Clinic — Rochester, MN

Counseling and Uptake of Low Dose Tamoxifen by Patients at High Risk for Breast Cancer

A Study of Low Dose Tamoxifen for Patients at High Risk for Breast Cancer

Sandhya Pruthi
Female
35 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122225-H01-RST
19-005289
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Inclusion Criteria:

  • Women ≥ 35 years old and ≤ 75 years old.
  • Women that meet at least one of the following:
    • NCI-BCRAT 5-year risk (> 3%) or that shows at least moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force or IBIS (version 8) risk calculator (> 8% for the 10-year risk);
    • History of atypical hyperplasia (30% lifetime risk for developing breast cancer);
    • LCIS (approximately 20% lifetime risk for developing breast cancer);
    • Status post-surgery (lumpectomy or unilateral mastectomy) for ER positive DCIS;
    • Status post-surgery (lumpectomy or unilateral mastectomy) for pleomorphic LCIS.

Exclusion Criteria:

  • Women whose BCRAT falls below the threshold moderate according to the US Preventative Task Force or IBIS (version 8) 10 year risk of < 8%; OR do not have a surgical finding that demonstrates increased risk of developing invasive breast cancer.
  • Women with known BRCA1 and BRCA2 mutations.
  • Women with known contraindications to tamoxifen, raloxifene, exemestane or anastrozole.
  • Women unable to give informed consent.
  • Prior history of invasive breast cancer.
  • At-risk women due to prior radiation therapy to the chest.
  • Prior use of preventive medications (tamoxifen, raloxifene, exemestane or anastrozole) for breast cancer prevention.

 

Atypical hyperplasia of the breast, Breast cancer, Cancer, Ductal carcinoma in situ, Lobular carcinoma in situ
At high risk for breast cancer, Atypical hyperplasia, Atypical hyperplasia of breast, Cancer treatment, Intraductal carcinoma in situ of breast, Intraductal carcinoma, noninfiltrating, Lobular carcinoma in situ of breast, Medical Oncology, Pleomorphic lobular carcinoma in situ of breast, Tamoxifen [INN:BAN], tamoxifen, Hormone therapy for breast cancer, Targeted drug therapy
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Development of a Patient-reported Outcome (PRO) Instrument for Symptomatic Small Bowel Stricturing Crohn’s Disease (CD)

A Study to Develop a Patient-reported Outcome Tool for Symptomatic Small Bowel Stricturing Crohn’s Disease (CD)

Joel Fletcher
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122226-P01-RST
19-005306
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Inclusion Criteria:

  • Be a male or non-pregnant female.
  • 18 to 75 years of age.
  • A diagnosis of CD (established by conventional clinical, radiologic, endoscopic and histologic diagnostic criteria) as defined by the clinical guidelines of the European Crohn’s and Colitis Organization OR the American College of Gastroenterology.
  • Be proficient in the English language (i.e., ability to read, write, speak, and understand English well enough to complete informed consent and take part in the interview process).
  • Have documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., starts within 15 cm of the ileocecal valve or the ileocecal anastomosis) within 6 months of study enrollment, with stricturing disease confirmed by cross-sectional imaging (CT, CTE, MR, MRE) read by study radiologists using diagnostic criteria as follows:
    • Localized luminal narrowing [luminal diameter reduction of at least 50% relative to a normal adjacent bowel loop]; AND
    • Bowel wall thickening [25% increase relative to adjacent nonaffected bowel]; AND either:
      • Pre-stricture dilation [luminal diameter greater than 3 cm]);
      • Inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation and unequivocal proximal small bowel dilation [but may be less than 3 cm].Endoscopic diagnosis of stricture based on inability to pass the colonoscope through the narrowed area should be within 6 months of cross-sectional imaging, and no endoscopic or surgical intervention has been performed since the time of the endoscopic examination.
  • Have an anastomotic (post-surgical) and/or naïve stricture(s). Patients with only post-surgical stricture(s) must be at least one year past the date of previous surgery.
  • Have known diagnosis of CD for at least 3 months.
  • Have experienced clinical symptoms consistent with intestinal obstruction (e.g., bloating, abdominal distension, cramping, dietary restrictions, nausea/vomiting, abdominal pain, postprandial abdominal pain)2 within 6 months of study enrollment leading to most recent cross sectional imaging (i.e., computed tomography enterography [CTe] or MRe]; OR have experienced obstructive symptoms co-occurring with a pre-scheduled cross sectional imaging test.
  • Have provided written informed consent prior to study participation.


Exclusion Criteria:

  • Internal penetrating disease as shown by fistula, abscess or inflammatory mass (phlegmon) detected by CTE or MRE.
  • History of advanced abdominal malignancies, or receipt within the last year of chemotherapy, radiation, or other therapy which may interfere with symptoms of CD, in the opinion of the investigator.
  • More than two distal ileal strictures at the time of baseline MRE or CTE (where 2 strictures within 3 cm are considered the same stricture; a long segment with multiple areas of narrowing or multiple strictures that have inflammation between them is counted as one stricture).
  • Any colonic strictures.
  • Cross sectional imaging findings not consistent with the stricture criteria for inclusion.
  • Any ostomy.
  • Active perianal disease.
  • Diagnosis of ulcerative colitis.
  • History of alcohol or drug abuse that in the opinion of the investigator or study director may interfere with the patient’s ability to comply with the study procedures.
  • Any other comorbid condition or factor that, in the opinion of the investigator or study director, may confound participant’s experience of stricturing CD symptoms or otherwise interfere with ability to participate fully in a 90-min qualitative interview.
Crohn's disease, Inflammatory bowel disease
Crohn's disease, Crohn's stricture of colon, Digestive system, Inflammatory bowel disease
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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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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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Treatment of Delayed Sleep-Wake Phase Syndrome with Melatonin in Patients with Comorbid Alcohol Use Disorders: A Feasibility Study

A Study to Evaluate Treatment of Delayed Sleep-Wake Phase Syndrome with Melatonin in Patients with Comorbid Alcohol Use Disorders

Bhanuprakash Kolla
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122230-H01-RST
19-005329
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Inclusion Criteria:

  • Subjects 18 years or older admitted to the IAP, an outpatient addiction treatment program.
  • Primary diagnosis of moderate to severe Alcohol Use Disorder.
  • If the subject qualifies for the CRU visit, they must agree to abstain from caffeine during the CRU visit to proceed.


Exclusion Criteria:

  • Currently on melatonin and unwilling to discontinue at least 2 weeks prior to completing the CRU visit.
  • Currently on hypnotic medications (benzodiazepines and trazadone) and unwilling to discontinue for 5 days prior to the CRU visit and for the duration of the study if they meet requirements and begin melatonin treatment following the CRU visit.
  • Unable or unwilling to provide informed consent.
  • Pregnant or considering pregnancy.
  • Diagnosis of any SUD, other than alcohol and mild cannabis use disorder, that has been active in the past 30 days.
Alcohol use disorder, Delayed sleep phase syndrome, Sleep disorders
Alcoholism, Hypersomnia, Melatonin, Nervous system, Sleep-wake schedule disorder, delayed phase type, melatonin
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Mayo Clinic — Rochester, MN

A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions (TARGET-DERM)

A Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions (IMISC)

Megha Tollefson
All
Not specified
This study is NOT accepting healthy volunteers
0000-122231-P01-RST
19-005338
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Inclusion Criteria:
 

  • Adults and children (all ages).
  • Have Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions and have been prescribed any dermatologic treatment.
  • Participant has plans for future visits at the site for continued management of IMISC.


Exclusion Criteria:

  • Inability to provide written informed consent/assent. 
  • Subjects participating in any interventional study or trial for Immune-Mediated Inflammatory Skin Conditions (IMISC)treatment trial at the time of enrollment. Patients may be enrolled in TARGET-DERM once participation in the trial is complete.
    • Note: Participants may be enrolled in other registries or studies where IMISC treatment outcomes are observed and/or reported (such as center-based registries).
Atopic dermatitis, Autoimmune disease, Dermatitis
Atopic dermatitis, Autoimmune reaction mediated by immune complex, Inflammation of skin and/or subcutaneous tissue, Inflammatory dermatosis, Integumentary system, Skin condition
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Mayo Clinic — Rochester, MN

Clinical Pilot of Augmented Human Intelligence in Major Depressive Disorder (AHI/Depression Pilot)

Augmented Human Intelligence in Major Depressive Disorder

Paul Croarkin
All
18 years to 64 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122232-H01-RST
19-005341
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Inclusion Criteria:

  • Outpatients with nonpsychotic MDD. Outpatient status assumes that the subject is not psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization.
  • A total score of > 10 on the QIDS-CR and on the QIDS-SR (equivalent to a HAMD17 score of 13 [ids-qids.org, accessed on April 12, 2019]) given that when medication exceeds the effect of  placebo in primary care, participants have a 17-item HAMD score > 12.  We added 2 HAMD points to take into account the possibility of measurement error. This is a very similar approach taken to the successful recruitment of subjects into the PGRN-AMPS trial.
  • Antidepressant treatment is deemed appropriate by the study clinician.
  • Adults who are between 18-64 years of age. 
  • Ability to provide informed consent
  • Ability to understand English.


Exclusion Criteria:

  • A medical contraindication that precludes SSRI or SNRI treatment.
  • Presence of a general medical condition that, in the opinion of this study clinician, is the cause of their depressive symptoms, will be exclusionary.
  • People with treatment-resistant depression will be excluded from participating. For this study, treatment resistance will be defined as failure to respond to two or more adequate therapeutic trials of SSRIs and at least on SNRI therapeutic trial (sufficient antidepressant dose, for 6 weeks or longer) during the current depressive episode.  Failure to tolerate a therapeutic trial of a given medication (resulting in discontinuation due to adverse effects) will not be counted as exclusionary. Persons who have failed to respond to two or more adequately designed and executed therapeutic trials of SSRIs but have no history of least one failure to respond to SNRI treatment during the current depressive episode will be eligible to receive treatment with an SNRI in this study.
  • Diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II disorder, or bipolar disorder NOS (including other specified or other unspecified bipolar disorders) or a primary psychiatric condition that requires a different initial treatment than an antidepressant. 
  • Currently taking an antidepressant medication with subtherapeutic results in terms of antidepressive efficacy and unwilling to undergo a medication taper and discontinuation prior to initiation of a study drug from this protocol.  The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The design of the medication taper will be at the discretion of the study clinician.  Subjects who cannot be safely tapered from their medication or who experience adverse effects during the taper that make further tapering infeasible will be excluded from the study. 
  • Use of antidepressant medication primarily for management of nicotine dependence, chronic pain, migraine prophylaxis or other diagnoses. 
  • Active substance use disorder. Persons in sustained full remission (> 12 months) and a negative urine drug of abuse screen at the screening visit will be considered eligible.
    • Note: An additional urine drug screen will not be necessary for individuals with a negative urine drug screen documented in the medical record where the date of testing occurred within 12 weeks (84 days) of the screening/ baseline study visit. However, study clinicians can still obtain a urine drug screen based on their clinical judgement even in participants with a negative drug screen within the 12 weeks preceding the screening/baseline study visit.
  • Trazadone, melatonin, low-dose quetiapine (< 100 mg QHS), z-drugs (zolpidem, zopiclone, eszopiclone, etc.), ramelteon, and diphenhydramine may be used as rescue medications for insomnia. Benzodiazepines may be used for treatment of anxiety, and atomoxetine may be used for the treatment of attention deficit disorder.  Study subjects currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs, other than low-dose quetiapine for insomnia) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine) are not eligible for the study
  • Pregnant subjects and those who are currently breastfeeding and who plan to continue breastfeeding will be excluded.
  • Persons currently undergoing ECT, TMS or DBS as acute series or for maintenance.
  • Patients currently psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization in the opinion of the study clinician. 
  • As an additional stipulation, individuals whose total QIDS-CR and total QIDS-SR scores are 10 or higher at the screening visit but decrease (improve) to total scores less than 10 on either the QIDS-CR or QIDS-SR at the baseline visit will be excluded.
Other
Depression
Major depressive disorder
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A Phase 1, Open-Label Study To Evaluate the Safety, Tolerability, and Activity of Escalating Doses of AK002 in Patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE)

A Study to Evaluate the Safety, Tolerability, and Activity of Escalating Doses of AK002 in Patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE)

Joseph Murray
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122238-P01-RST
19-005392
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Inclusion Criteria:

 

  • Provide written informed consent.
  • Male or female aged ≥ 18 and ≤ 80 years at the time of signing consent.
  • Average weekly score of ≥ 3 recorded for either abdominal pain, diarrhea, and/or nausea on the PRO questionnaire during at least 2 of the last 3 weeks of PRO collection during the Screening period. A minimum of 4 questionnaires must be completed each qualifying week.
  • Eosinophilia of the gastric mucosa ≥ 30 eosinophils/HPF in 5 HPFs and/or eosinophilia of the duodenal mucosa ≥ 30 eosinophils/HPF in 3 HPFs from the EGD performed during the screening period, without any other cause for the gastric eosinophilia (e.g., parasitic or other infection or malignancy).
  • Subjects must have failed or not be adequately controlled on standard of care treatments for EG and/or EGE symptoms (including but not limited to PPIs, systemic or topical corticosteroids, and/or diet).
  • If on allowed treatments for EG and/or EGE at the time of enrollment, stable dose for at least 5 half-lives prior to screening and willingness to continue on that dose for the duration of the study.
  • If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible.
  • Able and willing to comply with all study procedures.
  • Female subjects must be either post-menopausal for at least 1 year with FSH level >40 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
  • Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.


Exclusion Criteria:

 

  • Known hypersensitivity to any constituent of the study drug.
  • Previous exposure to AK002.
  • Diagnosis of celiac disease or active H. pylori infection as determined by screening EGD or a history of celiac disease diagnosed by prior EGD.
  • Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils > 1500/μL with involvement of either the heart, nervous system, and/or bone marrow).
  • Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
  • Grade 2 or higher lymphopenia (< 0.8 × 109/L lymphocytes).
  • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the subject at increased risk.
  • History of malignancy, exempting carcinoma in situ, early stage prostate cancer, non-melanoma skin cancers, and cancers in remission for >5 years and considered cured (except for breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy.
  • Treatment with chemotherapy or radiotherapy in the preceding 6 months.
  • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening and/or a positive helminthic test at screening.
  • Use of any medications that may interfere with the study such as immunosuppressive or immuno-modulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE antibodies, omalizumab) or systemic corticosteroids with a daily dose >10 mg of prednisone or equivalent, during 5 half-lives prior to screening or during the screening period, except for omalizumab taken for asthma and/or urticaria when their asthma and/or urticaria cannot be controlled on other medications, If on omalizumab, the dose must have been stable for at least 4 weeks prior to screening.
  • Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives of the study drug administration.
  • Known history of alcohol, drug, or other substance abuse or dependence.
  • Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products).
Drug, Drug therapy
Eosinophilic gastroenteritis, Gastritis, Gastroenteritis, Viral gastroenteritis
Digestive system, Eosinophilic gastritis, Eosinophilic gastroenteritis
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NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

A Study to Evaluate NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

Carl Rose
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
0000-122240-H01-RST
19-005429
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Inclusion Criteria:

  • Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group).


Exclusion Criteria:
 

  • Non-pregnant patients.
  • Non-English-speaking patients.
  • Maternal age < 18 years or > 50 years old.
  • Patients with hypertensive complications of pregnancy.
  • Maternal peripartum cardiomyopathy.
  • Multiple gestation.
Congenital heart defects in adults, Heart disease in pregnancy
Cardiac complication, Cardiovascular system, Congenital heart disease, Congenital heart disease in pregnancy
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Arterial Stiffness and Atrial Fibrillation

A Study to Analyze Arterial Stiffness and Atrial Fibrillation

Hon-Chi Lee
All
18 years to 95 years old
This study is NOT accepting healthy volunteers
0000-122241-H01-RST
19-005443
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Inclusion Criteria:

  • Male and female patients.
  • Ages 18 to 95 years old.
  • Patients with persistent atrial fibrillation (AF).
  • Patients scheduled for electrical cardioversion.


Exclusion Criteria:
 

  • Unable to provide informed consent.
  • Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.

 

Atrial fibrillation, Heart arrhythmias, Heart arrhythmia
Cardiovascular system, Cardioversion, Persistent atrial fibrillation
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Pilot Investigation of the Use of Diaphragm Muscle Shear Wave Elastography to Assess Duration of Liposomal Bupivacaine Induced Phrenic Nerve Block

A Study to Investigate the Use of Diaphragm Muscle Ultrasound to Assess the Duration of a Diaphragm Nerve Block

Carlos Mantilla
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122244-H01-RST
19-005454
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Inclusion Criteria:

  • Adult patients (18 years of age and older).
  • Undergoing shoulder arthroplasty.
  • Have consented to interscalene blockade for postoperative analgesia.


Exclusion Criteria:
 

  • Patient refusal.
  • Contraindications of interscalene blockade due to patient factors such as: significant pulmonary insufficiency, pre-existing hemidiaphragmatic paralysis, brachial plexus or degenerative neuropathy, allergy to proposed local anesthetic medication, severe cervical spine disease, BMI >40 kg/m2, neck circumference >50cm, pre-existing thoracic/diaphragmatic operations, and failed preoperative interscalene blockade.
  • Patient is pregnant and/or breastfeeding.
  • Patient is unable to provide informed consent.
Bupivacaine, Nerve block, Postoperative care, Shoulder replacement, bupivacaine liposome, Shoulder replacement surgery
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A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS) (EASE SBS 2)

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Ryan Hurt
All
18 years to 90 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122247-P01-RST
19-005470
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Inclusion Criteria:

  • Signed informed consent.
  • Either of the following:
    • Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence; OR
    • Completed the Phase 2 trial (ZP1848-15073).


Exclusion Criteria:

  • Withdrew consent from lead-in or Phase 2 trial.
  • Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confounds planned assessments of the trial.
  • Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3 months.
    • Note: Prior glepaglutide trial drug is allowed.
  • Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • An employee of the sponsor or Investigator or otherwise dependent on them.

Additional Exclusion Criteria Applicable for Patients from the Phase 2:

Trial Patients from the ZP1848-15073 trial (Phase 2 trial) must be excluded from this trial if any of the following criteria are met:

  • Not having a diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm [equal to 79 inches] with the latest intestinal resection being at least 6 months prior to Screening;
  • Restorative surgery planned in the trial period;
  • SBS-related hospitalizations within 30 days prior to screening;
  • Not maintaining a stable PS volume for at least 2 weeks.
    • Note: PS volume is considered stable if both of the criteria below are fulfilled:
    • Actual PS usage (volume and content) matches prescribed PS (± 10% deviation in volume is acceptable); and
    • Urine volume is on average ≥ 1 L per day and ≤ 2.5 L per day.
  • Not willing to adhere to an individual pre-defined drinking menu during 48-hours measurement periods;
  • Not having a colonoscopy performed during Screening (for patients with remnant colon).
    • Note: The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to Screening and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator.
  • Not being able to separate stool and urine during the 48-hours measurement periods;
  • Any history of colon cancer;
  • History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years;
  • Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or having a fistula interfering with the trial assessments;
  • Bowel obstruction or recent history of sub-ileal events;
  • Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease;
  • Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening;
  • Clinically significant abnormal screening ECG as judged by the Investigator;
  • Repeated (2 or more consecutive measurements) systolic blood pressure measurements >180 mm Hg;
  • Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening;
  • Unstable biological therapy (e.g., TNF-α (anti-tumor necrosis factor), natalizumab, etc.), including significant changes in doses or switch of drug within 6 months prior to Screening;
  • Unstable doses within 2 weeks prior to screening:
    • Antimotility drugs; e.g., loperamide, diphenoxylate, codeine or other opiates;
    • H2 antagonists;
    • Anti-diarrheal agents;
    • Bile acid sequestering agents;
    • Oral glutamine;
    • Proton pump inhibitors;
    • Diuretics;
    • Systemic antibiotics or antibiotics affecting the gastrointestinal tract;
    • Oral rehydration fluids.
  • Estimated creatinine clearance (CLcr; by the Cockcroft-Gault formula) < 30 mL/min.;
  • Hepatic impairment defined as:
    • Total bilirubin ≥ 2 × the upper limit of normal (ULN); or
    • Aspartate aminotransferase (AST) ≥ 5 × ULN; or
    • Alanine aminotransferase (ALT) ≥ 5 × ULN.
Drug therapy, Drug
Short bowel syndrome
Glepaglutide, Short bowel syndrome
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Fertility, Sexual Function, and Endothelial Health in Premenopausal Women with Kidney Disease

A Study to Evaluate Fertility, Sexual Function, and Endothelial Health in Premenopausal Women with Kidney Disease

Andrea Kattah
Female
18 years to 51 years old
This study is NOT accepting healthy volunteers
0000-122255-H01-RST
19-005515
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Inclusion Criteria (Aim 1):

  • Female.
  • Ages 18
    •51 years old.
  • Current diagnosis of CKD stages 3b-5 (estimated glomerular filtration rate < 45).

Inclusion Criteria (Aim 2):

  • Female.
  • Ages 18 – 44 years old.
  • Currently being evaluated for kidney transplant (eGFR < 20ml/min).

Exclusion Criteria (Aim 1 & 2):

  • Women who are currently pregnant.
  • Prior history of hysterectomy.
  • Prior history of oophorectomy.
  • Currently using hormonal contraceptives or hormone therapy.
  • Inability to attend both study visits.
Chronic kidney disease, Female infertility, Female sexual dysfunction, Infertility, Sexual dysfunction
Abnormal female sexual function, Awaiting transplantation of kidney, Chronic kidney disease, Female infertility, Kidney transplant, Primary infertility, Reproductive system, Secondary infertility, Transplanted kidney present, Urinary system
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Mayo Clinic — Rochester, MN

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection

A Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection

Sahil Khanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122256-P01-RST
19-005540
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Inclusion Criteria:

  • ≥ 18 years old.
  • Medical record documentation of either:
    • recurrent CDI per the study definition, that includes at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy; or
    • has had at least two episodes of severe CDI resulting in hospitalization.
  • A positive stool test for the presence of toxigenic C. difficile or C. difficile toxin within 30 days prior to or on date of enrollment.
  • Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.
    • Note: Subject’s CDI diarrhea must be controlled (<3 unformed/loose, i.e., Bristol Stool Scale type 6-7, stools/day for the two consecutive days prior to the washout period) while taking antibiotics during screening.
  • Willing and able to have an enema(s).
  • Willing and able to complete the stool and blood testing required for the study.
  • Agrees to not take non-dietary probiotics through 8 weeks after receiving the last study enema (including OTC and prescription).
  • Agrees to not take any oral vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide, bezlotoxumab, or IVIG through the 8-week follow-up assessment unless newly prescribed by a treating investigator during the course of the study as a result of recurrent CDI diagnosis.
    • Note: Use of IVIG for treatment of a non-CDI indication is allowed.
  • Agrees to practice a form of effective contraception during study participation; does not apply to persons with documented non-child bearing potential.
  • Has a negative urine pregnancy test at the time of enrollment and on the day of each enema prior to administration (persons of child-bearing potential only).
  • Willing and able to provide informed consent, and local privacy authorization as applicable.
  • Willing and able to complete the required Subject Diary.
  • Willing and able to meet all study requirements, including attending all assessment visits and telephone calls.


Exclusion Criteria:

  • A known history of refractory CDI.
  • Currently has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  • Requires systemic antibiotic therapy for a condition other than CDI.
  • Fecal microbiota transplant (FMT) within the past 6 months.
  • FMT with an associated serious adverse event related to the FMT product or procedure.
  • Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
  • Disease symptoms (diarrhea) caused by a confirmed intestinal pathogen other than C. difficile.
  • Currently has a colostomy.
  • Intraabdominal surgery within the last 60 days.
    • Note: laparoscopic procedures that do not involve the GI tract are permitted.
  • Planned surgery requiring perioperative antibiotics through the 8-week follow-up assessment.
  • Life expectancy of < 6 months.
  • CD4 count <200/mm3 during Screening.
  • An absolute neutrophil count of <1000 cells/μL during Screening.
  • Known or suspected current (< 90 days) illicit drug use.
    • Note: marijuana use is allowed.
  • Pregnant, breastfeeding, or intends to become pregnant during study participation.
  • Participating in a clinical study of another investigational product (drug, device or other) and has not completed the required follow-up period.
  • Subject is eligible for another RBX2660 study.
  • Subject, in the opinion of the investigator, for whatever reason, should be excluded from the study.
Drug, Drug therapy, Fecal microbiota transplantation, Behavioral
C. difficile infection, General infectious diseases
Fecal transplant, Recurrent Clostridium difficile infection, Recurrent infectious disease
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CT Scalar Localization of the Electrode Array Following Cochlear Implantation

A Study to Assess CT Scalar Localization of the Electrode Array Following Cochlear Implantation

John Lane
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122257-H01-RST
19-005543
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Inclusion Criteria:

  • Currently scheduled for a cochlear implant or currently have a cochlear implant
  • 18 years of age and over
  • Male and female
  • Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician.   Consent will be signed after all questions have been answered and the participant indicates they understand.


Exclusion Criteria:

  • Younger than 18 years of age.
  • Current criteria for cochlear implantation.
  • Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant.
Other
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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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Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

A Study to Identify Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

David Bruining
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
0000-122266-P01-RST
19-005613
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Inclusion Criteria:
 

Aim 1 (CD participants)

  • Aged 8-70 years old.
  • Undergoing first surgical distal (ileal) small bowel resection for structuring (B2 phenotype) Crohn's disease as determined by CTE or MRE or ileocolonoscopy.
  • English speaking.

Aim 2 (CD participants)

  • Age 8 to 70 years old.
  • Uncomplicated inflammatory small bowel CD based on clinical CTE or MRE or ileocolonoscopy performed within 6 months prior to enrollment (CD participants only).
  • English speaking.

Aim 2 (Control participants)

  • Age 8 to 70 years old. 
  • English speaking.


Exclusion Criteria:
 

Aim1 (CD participants)

  • B1 or B3 (i.e., fistula, abscess, phlegmon/inflammatory mass) CD phenotype.
  • Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture.
  • Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water).
  • Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening).
  • Contraindication for MRI (e.g., surgical implant, claustrophobia).
    • Note: To be determined based on local procedures. 

Aim 2 (CD participants)

  • Stenotic ileocecal valve at colonoscopy.
  • Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture.
  • Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water).
  • Known pregnancy.
    • Note: Institutional policies/procedures will be followed for pregnancy screening.
  • Contraindication for MRI (e.g., surgical implant, claustrophobia).
    • Note: To be determined based on local procedures.

Aim 2 (Control participants) 

  • Any known gastrointestinal tract disease.
  • Any known inflammatory/autoimmune disease involving another organ system (e.g., rheumatoid arthritis, scleroderma, multiple sclerosis).
  • Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.
Crohn's disease, Inflammatory bowel disease
Complication due to Crohn's disease of small intestine, Crohn's disease of small intestine, Digestive system, Enteritis of small intestine, Inflammation of scar, Intestinal obstruction due to Crohn's disease of small intestine, MRI, Small bowel resection
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APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) (APOLLO)

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

Sandra Taler
All
Not specified
This study is NOT accepting healthy volunteers
0000-122267-P01-RST
19-005624
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Inclusion Criteria for Living Donors: 

  • Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion.

Exclusion Criteria for Living Donors: 

  • Participants who are unable or unwilling to provide informed consent.

Inclusion Criteria for Recipients: 

  • Recipients of a kidney transplant from an eligible living or deceased donor with recent African ancestry.
  • Recipients of multi-organ transplants including a kidney plus an additional organ (i.e., liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants.

Exclusion Criteria for Recipients: 

  • Participants who are unable or unwilling to provide informed consent.
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TROPHY Registry: Treatment of Post-hemorrhagic Hydrocephalus in Neonates (TROPHY)

A Study to Establish a Registry for Treatment of Post-hemorrhagic Hydrocephalus in Neonates

Edward Ahn
All
up to 287 days old
This study is NOT accepting healthy volunteers
0000-122268-P01-RST
19-005635
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Inclusion Criteria:

 

  • No previous surgical treatment for hydrocephalus (HC).
  • Gestational age < 41 weeks at 1st neurosurgical  intervention.
  • IVH documented by US.
  • Hydrocephalus with progressing ventricular size (US ventricular indices above 97th percentile) diagnosed by pre-operative ultrasonography.
  • The ultrasonography represents the standard screening method and is obligatory to make the diagnosis. The following standard ventricular parameters should be gathered: bilateral Ventricular Index (VI); bilateral Anterior Horn Width (AHW); third Ventricle Width (TVW); bilateral Thalamo-Occipital Distance (TOD).
  • Surgically treated with any of the following: NEL, EVD, VAD, VSGS.
  • Ability to follow-up 5 years after initial surgical treatment.


Exclusion Criteria:

  • Comorbidity related instability forbidding surgical intervention.
  • Diagnosed impaired hemostasis in most recent laboratory results within up to 5 days before surgery (platelet counts < 50000/ml; prothrombin time (Quick) > 20 sec.; PTT > 50 sec.).
  • Proven CNS tumor.
  • Proven vascular malformation.
Hemorrhage, Hydrocephalus, Pediatric hydrocephalus
Communicating hydrocephalus due to and following traumatic hemorrhage, Endoscopic procedure, Nervous system
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A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome (AeroFact)

A Dose-Ranging Study to Determine the Effectiveness, Safety and Tolerability of AeroFact

Ellen Bendel-Stenzel
All
26 weeks to 31 weeks old
Phase 2
This study is NOT accepting healthy volunteers
0000-122273-P01-RST
19-005673
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Inclusion Criteria:

1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)

2. 26 0/7 to 30 6/7 weeks of gestational age

3. Weight < 2000 grams

4. Weight appropriate for gestational age (AGA)

5. twenty-four hours at the initiation of study treatment

6. RSS (MAP x FiO2) 1.4 – 2.0 on nCPAP or nIMV


Exclusion Criteria:

1. Apgar score <=5 at five minutes after birth

2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room

3. Premature rupture of membranes (PROM) > 7 days, or known maternal sepsis with PROM prior to 7 days

4. Evidence of chorioamnionitis (maternal temperature >38.9ºC or between 38.0ºC and 38.9ºC with foul-smelling amniotic fluid)

5. Base deficit > -10 mEq/L on clinically indicated blood gas at time of randomization

6. Need for intubation and/or mechanical ventilation prior to enrollment

7. HFNC and RAM Cannula or are not allowed to determine eligibility

8. Prior instillation of surfactant

9. Enrollment in another treatment study with competing outcomes

10. Active pneumothorax requiring chest tube

11. Significant congenital anomaly

12. Known or suspected chromosomal abnormality

13. Other diseases interfering with cardiopulmonary functions (hydrops fetalis, toxoplasmosis, rubella, cytomegalovirus, herpes simplex)

14. Concomitant treatment with inhaled nitric oxide

15. Suspected PPHN with sustained pre/post SpO2 ductal differences > 10%

Drug, Other, Aerosol therapy, CPAP nasal oxygen cannula, Drug therapy
Premature birth
Premature delivery, Reproductive system
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Whole Methylome Analysis for Identification of Epigenetic Variations in Undiagnosed Congenital Disorders

A Study to Analyze Whole Methylome for Identification of Epigenetic Variations in Undiagnosed Congenital Disorders

Linda Hasadsri
All
Not specified
This study is NOT accepting healthy volunteers
0000-122274-H01-RST
19-005716
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Inclusion Criteria:
     

Both of the following criteria must be met for inclusion in this study:

  • Clinically documented suspected diagnosis of a genetic disorder; 
  • All genetic testing performed to date has been negative and/or equivocal.  Examples of “equivocal” results include: borderline hypo- or hypermethylation on a previous targeted methylation assay such as methylation-sensitive MLPA, or a single mutation identified in a gene of interest, such as via Sanger sequencing, next generation sequencing, or chromosomal microarray, associated with an autosomal recessive disorder in which two mutations must be present in order to be causative (i.e., no second mutation was identified).   


Exclusion Criteria:
     

Any of the following:

  • Previously positive genetic testing yielding a known diagnosis;
  • Blood transfusion within the past 4 months;
  • Previous bone marrow transplant; 
  • Chemotherapy or radiation therapy within the past 6 months; 
  • Currently pregnant.
Genetic disorders, Genetic disorder, Congenital disorder
Autosomal recessive hereditary disorder, Congenital disease, Disease type AND/OR category unknown, Genetic mutation, Genetic testing
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Impedance Monitoring in Cochlear Implants

A Study to Evaluate Impedance Monitoring in Cochlear Implants

Aniket Saoji
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122279-H01-RST
19-005759
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Inclusion Criteria:

  • Adults age 18 or older.
  • Have already received a cochlear implant.
  • Must be able to provide consent to participate.


Exclusion Criteria:
 

  • Additional handicap that would limit the patient from being able to follow study instructions.

Cochlear implant procedure, Cochlear prosthesis in situ, Cochlear prosthesis procedure, Hearing implant surgery
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Letrozole in Patients with Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial

A Study to Evaluate Letrozole in Patients with Hepatopulmonary Syndrome

Hilary DuBrock
All
18 years to 100 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122281-H01-RST
19-005779
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Inclusion Criteria

- Diagnosis of moderate to very severe hepatopulmonary syndrome which consists of having
all 3 of the following conditions:

- Presence of liver disease or portal hypertension

- Intrapulmonary shunting on contrast-enhanced echocardiogram

- Hypoxemia [A-a gradient ≥15mmHg (or ≥20mmHg if age >64) and PaO2<80mmHg on
arterial blood gas testing]

- Child-Pugh class A or B liver disease

- MELD score < 20

- ≥ 18 years old

- Female subjects must be post-menopausal (defined as 12 months of spontaneous
amenorrhea or 6 weeks postsurgical bilateral oophorectomy without or without
hysterectomy)

- Ability to provide informed consent

Exclusion Criteria

- Enrollment in a clinical trial or concurrent use of another investigational drug or
device therapy (i.e., outside of study treatment) during, or within 28 days of
baseline

- Current hepatic encephalopathy

- Expectation of liver transplant within six months of randomization

- MELD exception score > 28

- Concomitant lung disease defined as restriction (TLC < 70%) or obstruction (FEV1 < 80%
& FEV1/FVC < 70%)

- Inability to comply with the study protocol

- Osteoporosis

- Premenopausal women (those who have not reached 1 year absence of menarche)

- Vulnerable study population, including imprisoned individuals, non-English speaking
patients

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

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

Drug
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The Effect of POSE2 on Long Term Gastric Motor Function

A Study to Evaluate the Effect of POSE2 on Long-term Gastric Motor Function

Barham Abu Dayyeh
All
22 years to 60 years old
This study is NOT accepting healthy volunteers
0000-122286-H01-RST
19-005818
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Inclusion Criteria:

Adults who are receiving the POSE2 as part of the main study on POSE2 safety and feasibility (IRB 19-001254).  Inclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the addition that they must be able to safely undergo non-contrasted MRI testing.

  • Provision of signed and dated informed consent form.
  • Subject agrees to be compliant with study requirements and adhere to post-operative dietary & exercise recommendations for the duration of the study.
  • Subjects between the ages of 22-60 years old.
  • If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
  • Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)).
  • Pre-diabetes – Fasting plasma glucose test > 100 mg/dl but ≤ 125 or oral glucose tolerance test ≥ 140 mg/dl but < 200.
  • Diabetes – Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose > 126 mg/dl.
  • Hypertension – SBP >140 or DBP > 90 or the use of an antihypertensive medication.
  • Dyslipidemia – Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications.
  • Sleep Apnea – A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
  • Venous Stasis Disease – Presence or history of pretibial venous stasis ulcers.
  • Chronic Joint Disease – Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
  • Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
  • Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  • Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
  • Subjects must be willing to possibly forego any future weight loss procedures (i.e., Vertical Sleeve Gastrectomy) given the unknown long-term effects.
  • Residing within a reasonable distance from the Investigator’s treating office (~50 miles) and willing and able to travel to the Investigator’s office to complete all routine follow-up visits.
  • Must be able to safely undergo non-contrasted MRI testing.


Exclusion Criteria:
 

Exclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the additional exclusion of patients who cannot safely undergo non-contrasted MRI.

  • History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  • Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
  • Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
  • Large hiatal hernia (> 3 cm) by history or as determined by pre-enrollment endoscopy.
  • Pancreatic insufficiency/disease.
  • History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
  • Pregnancy or plans of pregnancy in the next 12 months.
  • History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
  • Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
  • Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
  • History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
  • Active gastric erosion, lesion, or gastric/duodenal ulcer.
  • History of or current platelet or coagulation dysfunction, such as hemophilia.
  • History or present use of insulin or insulin derivatives for treatment of diabetes.
  • Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.
  • If smoker, plans to quit smoking in the year after enrollment.
  • Portal hypertension and/or varices.
  • Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  • Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
  • Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
  • Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI).
  • Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes.
  • Non-ambulatory or has significant impairment of mobility (i.e., cannot ambulate for 30 minutes).
  • Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  • Participating in another clinical study.
  • Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
  • Physician’s assessment that the subject is not an appropriate candidate.
  • Subjects who are unable to safety undergo or who would not tolerate non-contrasted MRI.
  • 1If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution’s standard procedure.

 

Obesity
Bariatric surgery, Gastric emptying study, Impaired gastric emptying, Obesity, SPECT scan
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Genomic Profiling of Mitochondrial Disease - Quantitative Biomarkers for Precise Mitochondrial Medicine

A Study to Evaluate Genomic Profiling of Mitochondrial Disease

Ralitza Gavrilova
All
15 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122291-H01-RST
19-005839
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Inclusion Criteria:

  • 15-80 years of age.
  • Confirmed or highly suspected mitochondrial disease.


Exclusion Criteria:
 

  • Outside of the age range.
  • No mitochondrial disease.

 

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Molecular Characterization of Spinal Tissue

A Study of Molecular Characterization of Spinal Tissue

Annalise Larson
All
up to 17 years old
This study is NOT accepting healthy volunteers
0000-122293-H01-RST
19-005845
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Inclusion Criteria:

  • Children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. Material from adults may be collected as a control group.


Exclusion Criteria:

  • Surgeries where spinal tissues are not being removed.
Spine deformity
Deformity of spine, Operative procedure on spinal structure, Procedure on spine, Spinal deformity correction surgery, Spine procedures, Spine procedure
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Relationships Between Patient-Provider Plan of Care Agreement Following Hospital Ward Rounds and Patient Readiness for Discharge

A Study to Evaluate Relationships Between Patient-Provider Plan of Care Agreement Following Hospital Ward Rounds and Patient Readiness for Discharge

John Ratelle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122294-P01-RST
19-005847
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Inclusion Criteria:

 

  • Patients 18 years or older.
  • Hospitalized patients on general medicine, chest and gastrointestinal services at Mayo Clinic Hospital
  • The providers caring for them.


Exclusion Criteria:

  • Age younger than 18 years old.
  • Pregnant female.
  • Tnability to speak English.
  • Currently a prisoner or a patient at Federal Medical Center in Rochester, Minnesota.
  • Cognitive impairment, as defined by a positive score determined with the Confusion Assessment Method.
  • Medical students will be excluded from the provider survey.

 

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Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors

A Study to Develop a Cohort Database and Study Platform in Breast Cancer Survivors Using Multiscale Omics

Brent Bauer
Female
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122295-H01-RST
19-005860
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Inclusion Criteria:

  • Adult females enrolled in the Mayo Clinic Biospecimen Resource for Breast Disease (IRB # 1815-04).
  • Current ages 18-75 years.
  • Have a prior diagnosis of stage 0-3 (in situ or invasive) breast cancer (BCS).
  • Have completed active therapy (surgery, radiation, and/or chemotherapy) (8-30  months approximately) prior to provision of the samples).
  • Age-matched females with no history of cancer (other than non-melanoma skin cancer) may be selected from the PRISM Study (IRB #18-002366 The Predicting Risk after Screening Mammogram (PRISM) Study) or the Mayo Clinic Breast Mammography practice.


Exclusion Criteria:
 

  • Male biological sex or gender.
  • Pregnant females (insufficient #s, skewed estrogen levels).
  • Unwilling to travel to Mayo Clinic Rochester to provide the blood and urine samples.
Breast cancer, Cancer, Ductal carcinoma in situ, Invasive lobular carcinoma, Lobular carcinoma in situ
Breast cancer supportive therapy and survivorship service, Chemotherapy, Chemotherapy for breast cancer, History of antineoplastic chemotherapy, History of carcinoma in situ of breast, History of invasive malignant neoplasm of breast, History of mastectomy, History of radiation therapy to breast area, Malignant tumor of breast, Mammogram, Medical Oncology
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A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

AXIOS? for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

Andrew Storm
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122296-P01-RST
19-005863
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Inclusion Criteria:

  • Patient requiring intervention for the management of symptoms associated with acute cholecystitis.
  • Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health.
  • Eligible for endoscopic intervention.
  • Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines [3]: -AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met. -AC Grade II (moderate) defined by any one of the following characteristics -Leukocytosis (>18,000 cells per mm3) -Palpable, tender mass in right upper quadrant -Symptom duration >72 hours -Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis).
  • Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion.
  • 18 years of age or older.
  • Willing and able to comply with the study procedures and provide written informed consent form (ICF) to participate in the study. 


Exclusion Criteria:

  • AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems: -Cardiovascular
    •Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine -Neurologic
    •decreased level of consciousness -Respiratory
    •PaO2/FiO2 <300 -Renal
    •Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter) -Hepatic
    •International normalized ratio >1.5 -Hematologic
    •Platelet count <100,000/mm3.
  • Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder.
  • Hepatic abscess.
  • Ascites.
  • Advanced liver disease.
  • Subjects with abnormal coagulation or who require ongoing complete anticoagulation.
  • Bleeding diathesis.
  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum that might preclude endoscopic drainage.
  • Prior surgical, interventional radiology or endoscopic procedures for the treatment of acute cholecystitis.
  • Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage.
  • Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location.
  • Patients that have allergies or are sensitive to any of the device materials.
  • Patients with contraindications to use of electrical devices.
  • Pregnancy.
  • Prisoners and other vulnerable populations.
Endoscopic insertion of stent into bile duct, Open insertion of bile duct stent, Percutaneous cholecystostomy, Device
Cholecystitis, Peritonitis
Abscess of liver, Acute cholecystitis, Acute emphysematous cholecystitis, Acute gangrenous cholecystitis, Bile peritonitis, Digestive system, Gallbladder tube placement, Pericholecystic abscess
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Mayo Clinic — Rochester, MN