Sleep Health, Symptoms, and Functional Performance in People With Inflammatory Bowel Disease (Sleep Health in IBD)
Sleep Health in Inflammatory Bowel Disease
Inclusion Criteria:
- Age ≥ 18 and < 60 years.
- Diagnosed with IBD (Crohn’s disease, ulcerative colitis, or indeterminate colitis).
- Living in the United States.
- Patients with current ostomies or ileal pouches.
- Currently in a medication trial for non-FDA approved medication for IBD.
- Who are blind
- With current cancer treatment.
- Pregnant or breastfeeding.
- Work night or rotating shifts.
- Diagnosed with severe psychiatric (bipolar disorder, schizophrenia).
- Neurological conditions affecting the non-dominant hand (due to actigraphy monitoring).
- Those who do not read and write in English
- Those without internet access or email address (due to use of internet surveys).
- Note: We will delay data collection for at least four weeks for those who have had surgery, and 2 weeks for those who have traveled across a time zone or due to daylight savings.
Eligibility last updated 6/9/22. Questions regarding updates should be directed to the study team contact.
A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
Assessing the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
- 18 years of age or older undergoing an IUI procedure.
- IUI must be performed in the REI offices at Mayo Clinic in Rochester.
- IUI procedure must be on a weekday.
- IUI procedure is scheduled to be completed by a nurse in the REI Department.
- Non-English speaking.
- IUI procedure on a weekend day.
- IUI procedure is scheduled with an MD provider (known or expected to be difficult).
- Planned IUI procedure is cancelled prior to undergoing the procedure.
- The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
- The patient has previous participated or declined enrollment in the study during a prior IUI procedure.
Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04)
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
- Individuals with locally advanced, inoperable, or metastatic triple-negative breast
cancer (TNBC) who have not received previous systemic therapy for advanced disease and
whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
- Individuals must have completed treatment for Stage I to III breast cancer, if
indicated, and ≥ 6 months must have elapsed between completion of treatment with
curative intent and first documented local or distant disease recurrence.
- Individuals presenting with de novo metastatic TNBC are eligible for this study.
- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed
centrally on a recent or archival tumor specimen.
- Individuals must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors
(RECIST) Version 1.1 criteria as evaluated locally.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Demonstrates adequate organ function.
- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.
- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.
- Positive serum pregnancy test or women who are lactating.
- Received prior therapy with an agent directed to another stimulatory or coinhibitory
T-cell receptor.
- Individuals may not have received systemic anticancer treatment within the previous 6
months or radiation therapy within 2 weeks prior to enrollment.
- Individuals may not be participating in a study with an investigational agent or
investigational device within 4 weeks prior to randomization. Individuals
participating in observational studies are eligible.
- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor.
- Have an active second malignancy.
- Have active serious infection requiring antibiotics.
- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
Multicentric Castleman Disease.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.
AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
- Patients must be < 50 years at the time of enrollment.
- Patient must have eligibility confirmed by rapid central imaging review.
- Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size.
- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
- Patients must have a histological diagnosis of osteosarcoma.
- Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
- Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
- Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
- Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least
equivalent to MAP.
- Patients with unresectable primary tumor.
- Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central
lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
- Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.
- Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy.
Note: Once the patient has been enrolled on the study,
additional computed tomography (CT) scans are not anticipated prior to thoracic surgery.
Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
- Patients with evidence of extrapulmonary metastatic disease.
- Patients who received pulmonary surgery for lung metastasis prior to enrollment.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.
Development of a droplet digital PCR (ddPCR) assay for the detection of mutant circulating tumor (ct)DNA in patients with uveal melanoma
Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay
- Patients seen in Ophthalmology including ones referred to Oncology with metastatic uveal melanoma
-
< 18 years of age.
Eligibility last updated 7/11/22. Questions regarding updates should be directed to the study team contact.
A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO) (MARIO)
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
- Subject is a male or female adult ≥ 18 years of age on the day the study informed
consent is signed.
- Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site
(excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).
- Subject has any of the following forms of invasive candidiasis at Screening:
- Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed);
- Osteomyelitis;
- Endocarditis or myocarditis;
- Meningitis, endophthalmitis, or any central nervous system infection;
- Chronic disseminated candidiasis;
- Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract;
- Patients with a sole diagnosis of mucocutaneous candidiasis; i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or
Candida isolated solely from respiratory tract specimens;
- Patients with concurrent invasive fungal infection other than Candida spp.; e.g., cryptococcosis, mold infection or endemic fungal infection;
- Patients who failed a previous antifungal therapy for the same infection;
- Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive
candidiasis.
- Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
- Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
- Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding
initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
- Baseline QTcF ≥ 500 msec.
Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.
Developing a Platform for Remote at Home Preoperative Evaluation for Obstructive Sleep Apnea
Preoperative Evaluation for Obstructive Sleep Apnea at Home
- ≥ 18 years of age
- Patients participating in the virtual preoperative evaluation process at Mayo Clinic
- Undergoing virtual preoperative evaluation
- Surgery date ≥ 2 weeks from participation
- STOPBANG score > 4.
- Patients less than age 18 years.
- Subjects who are not able to provide consent.
- Patients without the ability to connect to Wi-Fi to transmit home sleep study data.
Eligibility last updated 7/5/22. Questions regarding updates should be directed to the study team contact.
Predicting Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) after Hematopoietic Stem Cell Transplantation (HSCT)
Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) Following Hematopoietic Stem Cell Transplantation
- Adult (age 18 or greater) patients who consent for enrollment in the study.
- Have undergone allogeneic HSCT within 100 days or autologous HSCT within 30 days.
Exclusin Criteria:
- Subject transferred from another institution having already been admitted there for > 24h. This proposal seeks to create a biorepository whose purpose will be to determine mechanism of ARF/ARDS development based on initial hospital course. If a substantial part of a patient’s hospital course preceeds enrollment (and is affected by care received at another institution), we may not get meaningful insights into the ARDS mechanism by enrolling them well into the disease processes that are involved in the pathogenesis of ARDS.
- ARDS at the time of hospital admission. Since this study is looking at the mechanisms of ARDS development, we would seek to enroll patients before ARDS develops.
- Patient’s goals of care are such that ICU transfer (and specifically use of noninvasive or mechanical ventilation) would not be considered. As such, these patients would not be able to develop the outcome of interest (ARDS).
- Admitted for:
- Admission only for chemotherapy administration.
- Control of symptoms related to diarrhea, vomiting, dehydration due to inability to swallow, dysphagia, pain or mucositis.
Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.
Is Meeting the Spinal Cord Injury Physical Activity Guidelines Associated with Health-Related and Psychosocial Outcomes?
Spinal Cord Injury Physical Activity Guidelines in Association with Health-Related and Psychosocial Outcomes
- All SCIMS participants following completion of their regularly scheduled Form II follow-up during the enrollment period for this module.
- SCIMS participants who do not complete their regularly scheduled Form II follow-up within the enrollment period for this module will not be included (e.g., lost to followup, declined to participate in the Form II follow-up, deceased).
Eligibility last updated 6/17/22. Questions regarding updates should be directed to the study team contact.
Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
Characterization of Chronic Kidney Disease With Renal Microvessel Imaging
- Healthy volunteersor Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
- ≥ 18 years of age.
- Subjects lacking capacity to consent.
- Vulnerable subjects such as prisoners; pregnant women; nursing mother.
- Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
- Patients with high-risk cardiac diseases.
Eligibility last updated 6/22/22. Questions regarding updates should be directed to the study team contact.
Impact of POCUS and artificial intelligence-enabled electrocardiogram on detection of asymptomatic patients with aortic stenosis.
Function of Artificial Intelligence-enabled Electrocardiogram in Early Detection of Patients With Aortic Stenosis
- ≥ 18 years of age.
- Patients with positive AI-ECG for AS within 1 year or current will be retrospectively and prospectively identified.
- Patients with previous valve surgery, permanent pacemaker, active infective endocarditis, or those who have already been diagnosed as AS.
Eligibility last updated 6/20/22. Questions regarding updates should be directed to the study team contact.
Smartwatch and Physician Well-Being: Are Wearables Part of the Solution?
Smartwatches as Part of the Solution for Physician Well-Being
- Physician (residents/fellows or practicing faculty physician) employed by the University of Colorado School of Medicine or Mayo Clinic with no anticipated departure within 18 months of enrollment.
- Physicians must be employed full-time or part-time (at 60% FTE or higher) and have an Android or iOS smart phone.
- Not in the age range.
- Not a physician employed by the University of Colorado School of Medicine or Mayo Clinic.
- Does not own an Android or iOS smart phone. Non-reading subjects.
- Residents/fellows in their last final year of their respective training program.
Eligibility last updated 6/22/22. Questions regarding updates should be directed to the study team contact.
3D Ultrasound Imaging of the Axillary Lymph Nodes
3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer
- Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care.
- Age of 18 or older.
- Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
- Patients over the age of 18 years.
- Ability to provide written, informed consent.
- Currently taking lactulose daily for prevention of hepatic encephalopathy.
Exclusion Criteria:
- Recent change in dosing of opioid medication.
- Previous Colorectal Surgery.
- Active diarrheal illness.
- Lack of smartphone or other smart device at home.
Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.
Managing Multiple Seizure Types with Wearable Devices
Development of a Practical, Minimally Invasive Seizure Gauge
- Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g.,
NeuroPace RNS, Medtronic PC+S, Medtronic RC+S).
- Pediatric subjects 7 years of age or older.
- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
- Presence of open or healing wounds near monitoring sites (infection risk).
Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.
Registry of Asthma Patients Initiating DUPIXENT® (RAPID) (RAPID)
Registry of Asthma Patients Initiating DUPIXENT®
- Willing and able to comply with the required clinic visits, study procedures and assessments.
- Able to understand and complete study-related questionnaires.
- Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required.
- Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information.
- Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information.
- Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
- Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.
Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
- Patients ≥ 18 years or older.
- Patients who speak English and are willing to sign the consent form
- Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 3 months from surgery; symptoms < 3 weeks in duration) of a total knee or total hip arthroplasty, defined as:
- A sinus communicating with the prosthesis OR
- Two positive cultures obtained from the prosthesis OR
- 4 of 5 criteria:
- Elevated ESR (> 30mm/hr) and CRP (> 10mg/L);
- Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on;
- leukocyte esterase strip;
- Elevated synovial neutrophil percentage (> 80%);
- One positive culture;
- Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high;
- Power field in 5 high power fields x 400).
- OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR
- Patients with a chronic PJI, defined as:
- Presentation of symptoms > 4 weeks in duration.
- Revision surgery or previous two-stage reimplantation.
Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.
Real-World Functional Activity in Adult Spinal Deformity Surgery
Adult Spinal Deformity Surgery Real-World Functional Activity
- Ages ≥ 18 years.
- Diagnosis of degenerative thoracolumbar deformity.
- Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis.
- Unable to return to Mayo Clinic for follow-up evaluation.
Eligibility last updated 8/5/22. Questions regarding updates should be directed to the study team contact.
Identification of the optimal analgesic dose of intrathecal hydromorphone for pediatric patients undergoing posterior spine surgery for idiopathic scoliosis
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.
- Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
- Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
- Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.
Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.
GMROR2261: Stereotactic Accelerated radiotherapy in GlioblastomA (SAGA)
Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study
- Age ≥ 18 years.
- Histological confirmation of glioblastoma.
- ECOG Performance Status (PS) ≤ 2.
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Postoperative/post-biopsy tumor plus surgical bed size ≤ 6 cm in maximum diameter.
Exclusion Criteria
- Unable to undergo MRI scans with contrast.
- Unable to undergo an 18F-DOPA-PET scan.
- Example reasons for inability to complete this scan: Parkinson’s Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists);
- NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the On-Study form.
- Any of the following:
- Men or women of childbearing potential who are unwilling to employ adequate contraception;
- Nursing women;
- Pregnant women.
- IDH mutation identified in the tumor on surgical pathology.
Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.
Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy. (PIVOINE)
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥ 14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
- Participant has completed the EOS or End of Treatment Visit of Study PVO-1A-301 or
PVO-1A-202 (PVO-1A-202 Parts C and D correspond to Study PVO-1A-204 in France) and did
not previously withdraw consent from any of the parent studies to be eligible for
Study CLIN-60120-452.
- Participant must be ≥ 14 years of age (aligned with the age of treated participants in
the ongoing parent studies PVO-1A-301 and PVO-1A-202/PVO-1A-204) and qualify as 100%
skeletally mature (if < 18 years, based on assessments carried out at parent EOS Visit;
if ≥ 18 years, automatically considered 100% skeletally mature) or have reached final
adult height based on investigator's assessment, at the time the Study CLIN- 60120-452
informed consent is signed.
- History of allergy or hypersensitivity to retinoids, gelatin, lactose (note that
lactose intolerance is not exclusionary) or palovarotene, or unresponsiveness to prior
treatment with palovarotene.
- Uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine,
metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease.
- Intercurrent known or suspected non-healed fracture at any location;
- Any other medical condition/clinically significant abnormalities that would expose the
participant to undue risk or interfere with study assessments.
- Amylase or lipase > 2 × above the upper limit of normal (ULN) or with a history of
chronic pancreatitis.
- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN.
- Fasting triglycerides > 400 mg/dL with or without therapy.
- Suicidal ideation (type 4 or 5) or any suicidal behaviour at the Inclusion Visit as
defined by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Current use of vitamin A or beta carotene, multivitamins containing vitamin A or beta
carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use
of these products during palovarotene treatment.
- Exposure to synthetic oral retinoids other than palovarotene within 4 weeks of the
Inclusion Visit.
- Concurrent treatment with tetracycline or any tetracycline derivatives due to the
potential increased risk of pseudotumor cerebri.
- Use of concomitant medications that are strong inhibitors or inducers of cytochrome
P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib.
- Palovarotene is commercially available in the country where the study is being
conducted.
- Any reason that, in the opinion of the investigator, would lead to the inability of
the participant and/or family to comply with the protocol.
Eligibility last updated 7/1/22. Questions regarding updates should be directed to the study team contact.
A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy (METRE-PL)
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With PL
- Diagnosis of Partial Lipodystrophy.
- Previous treatment with metreleptin.
Eligibility last updated 7/7/22. Questions regarding updates should be directed to the study team contact.
Efficacy of Peripheral Nerve Blocks for Acute Episodic Migraine Treatment and Prophylaxis
Efficacy of Nerve Blocks for Episodic Migraine
- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater.
- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
- History fits the definition of migraine:
- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe
intensity, aggravation by/causing avoidance of routine physical activity; and
- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels
better).
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
- Intrauterine device (IUD);
- Total hysterectomy or tubal ligation;
- Abstinence (no sex).
- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or
corticosteroids.
- Previously received peripheral nerve blocks (PNBs).
- Currently anticoagulated.
- Currently receiving Botox for migraine prophylaxis.
- Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study.
- Currently using opiate medications for pain.
- History of drug or alcohol abuse within the prior two years.
- Have unstable medical or surgical diseases that could impair participation in this study.
- History of craniotomies, burr holes, skull fractures and/or have open skull defects.
- Patients with implanted nerve stimulators or shunts.
- Phobia of needles.
- Active skin or soft tissue infection overlying injection sites.
- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Disease (PF-ILDs)
1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the study (and prior to any study procedure including shipment of high-resolution
computed tomography (HRCT) to reviewer).
2. Patients (male/female), aged ≥ 18 years when signing the informed consent, with a
physician diagnosed progressive fibrosing Interstitial Lung Disease (PF-ILD) other
than Idiopathic Pulmonary Fibrosis (IPF) (presence of reticular abnormality with
traction bronchiectasis with or without honeycombing on HRCT, performed within 12
months of Visit 1) AND who fulfil at least one of the following criteria for PF-ILD
within 24 months of Visit 1 despite management according to current clinical practice
to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):
1. Clinically significant decline in Forced Vital Capacity (FVC) % predicted (pred)
based on a relative decline of ≥ 10%;
2. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined
with worsening of respiratory symptoms;
3. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined
with increasing extent of fibrotic changes on chest imaging;
4. Worsening of respiratory symptoms as well as increasing extent of fibrotic
changes on chest imaging.
3. Patients need to be either:
-- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to
Visit 1 and during screening and planning to stay on this background treatment after
randomization. Combination of nintedanib plus pirfenidone is not allowed;
[*stable therapy is defined as the individually and general tolerated regimen of
either nintedanib or pirfenidone (no dose changes) for at least 12 weeks]; OR
-- not on a therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit
1 or during the screening period. (e.g., either antifibrotic (AF)-treatment naïve or
previously discontinued) and start or re-start of an antifibrotic is not planned.
4. Patients treated with permitted immunosuppressive agents for the underlying disease
(e.g. Mycophenolat-Mofetil (MMF), methotrexat (MTX), azathioprine (AZA) ?) need to be
on a stable treatment for at least 12 weeks prior to visit 1 and during screening
period:
For oral corticosteroids, the dose should not have been > 20 mg prednisolone/day (or
equivalent) within 4 weeks prior to visit 1 For patients with underlying Connective
Tissue Disease (CTD), the CTD should be stable, defined as no initiation of new
therapy or withdrawal of therapy for CTD within 12 weeks prior to Visit 1 and during
the screening period.
5. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.
6. Diffusing capacity for carbon monoxide (DLCO) corrected for Haemoglobin (Hb) [visit 1]
≥ 25% and <90% predicted of normal at Visit 1.
7. Female and male patients: Women of childbearing potential (WOCBP) and men able to
father a child must be ready and able to use highly effective methods of birth control
per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly. A list of contraception methods meeting these criteria and
instructions on the duration of their use is provided in the patient information.
1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume (FEV)1/FVC <
0.7) at Visit 1.
2. In the opinion of the Investigator, other clinically significant pulmonary
abnormalities.
3. Acute IPF or Interstitial Lung Disease (ILD) exacerbation within 3 months prior to
screening and/or during the screening period (investigator-determined).
4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit
1 and/or during the screening period.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and
viral hepatitis and a confirmed infection with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) within the 4 weeks prior to Visit 1 or during the screening
period.
A patient can be re-screened if the patient was treated and/or cured from the acute
infection.
6. Any documented active or suspected malignancy or history of malignancy within 5 years
prior to Visit 1, except appropriately treated basal cell carcinoma of the skin,
"under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
7. Major surgery (major according to the investigator's assessment) performed within 3
months prior to Visit 1 or planned during the course of the trial. Being on a
transplant list is allowed.
8. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) > 2.5 x upper
limit of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.
Additional Exclusion Criteria may apply.
Eligibility last updated 7/7/22. Questions regarding updates should be directed to the study team contact.
Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
An Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
- Age ≥ 14 years old. Subjects speaking any language will be offered participation.
- Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient’s parents/guardian.
- Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.
- Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).
- Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
- The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study):
- Recent surgical procedures (< 3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery. The presence of previously known respiratory disorders including pulmonary embolism (< 6 months), pleural effusion, pneumothorax, hemoptysis.
- Recent myocardial infarction (< 1 month), new cardiac arrythmia (< 3 months), recent cardiac pacemaker implantation (< 3 months).
- Heart failure symptoms, significant shortness of breath, tachycardia, or angina
- The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases.
Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
- Subject is 18 years or older at the time of the procedure.
- Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
- Pulmonary nodule ≤ 2 cm in largest diameter.
- Subject able to understand and adhere to study requirements and provide informed consent.
- Planned lymph node staging performed before nodule biopsy.
- Nodule is a pure ground glass opacity.
- Plan to biopsy multiple nodules.
Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.
The 4th Dimension: How Do Our Faces Change Over Time?
Mayo Employee Aging Facial Changes
- ≥ 18 years of age.
- < 18 years of age.
Eligibility last updated 7/12/22. Questions regarding updates should be directed to the study team contact.
A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)
AVTX-803 in Patients with Leukocyte Adhesion Deficiency Type II
- Subject must have completed protocol AVTX-803-LAD-301.
- Subject must be between 6 months and 75 years old.
- Subject or parent (for subjects under legal age for consent) has provided written informed consent for this study. Additionally, written informed assent has been provided, as appropriate, for minors of older age, per local institutional review board (IRB)/ethics committee (EC) policy and requirements.
- Subject has biochemically and genetically proven LAD II (SLC35C1-CDG).
- Subject is willing and able to comply with the protocol.
- Women of childbearing potential (WOCBP) meeting the criteria below:
- Non-lactating and has a negative pregnancy test at screening; AND
- Uses an acceptable double-barrier method of contraception as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
- Male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
- Subject has severe anemia defined as hemoglobin < 8.0 g/dL (< 4.9 mmol/L).
- Subject has impaired renal function as defined by an eGFR < 90 mL/min.
- Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product.
- In the investigator’s opinion, subject has a history of failure to respond to fucose at adequate dosing.
- In the investigator’s opinion, subject is not able or not willing to comply with the study requirements.
- Subject is pregnant.
Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.
Pilot project for multiomics analyses of exhaled breath condensate in patients with lung cancer or lung fibrosis
Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate
- In the Lung Cancer group, any patient of 18 years or older with lung cancer.
- In the control group, any 18 year or older volunteer with no history of Lung Cancer.
- Anyone with a history of lung disease, such as emphysema. Also, anyone with a history of cancer except Lung Cancer in the experimental group.
Eligibility last updated 7/15/22. Questions regarding updates should be directed to the study team contact.
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With MTAP Homozygous Deletion
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
- Histologically confirmed diagnosis of a solid tumor malignancy with homozygous
deletion of the MTAP gene detected in tumor tissue or ctDNA.
- Unresectable or metastatic disease.
- Patients must have received standard therapies appropriate for their tumor type and
stage with disease progression on or after the most recent treatment.
1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease.
2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease.
- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation
at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Prior treatment with a PRMT5 or MAT2A inhibitor therapy (Phase 2 only).
- Active brain metastases or carcinomatous meningitis.
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of
study treatment.
- Major surgery within 4 weeks of first dose of study treatment.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or
other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption
syndrome) likely to alter absorption of study treatment or result in inability to
swallow oral medications.
- Cardiac abnormalities.
Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.