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.
This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.
Muhammad Affan
All
18 Years to old
Phase III
STUDY00008000
STUDY00008000
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Primary
Inclusion Criteria:
Male or female subjects ≥18 years of age
Clinical diagnosis of ischemic stroke involving cerebral cortex
Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke
Primary
Exclusion Criteria:
Presence of a lacunar or a brainstem infarct
Comatose state
Brain hemorrhage
Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study
We are doing this study to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.
Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same.
Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe.
Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly.
The study is expected to last for 2.5 to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits.
Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram).
Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Daniel Duprez
All
18 Years to old
Phase III
STUDY00013843
STUDY00013843
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Inclusion Criteria:
Chronic kidney disease defined by one of the below:
Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
Urinary albumin-to-creatinine ratio (UACR) >= 200 milligrams per gram (mg/g) and eGFR >= 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation)
Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligram per liter (mg/L)
Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following:
a) Coronary heart disease defined as at least one of the following: i. Documented history of MI ii. Prior coronary revascularisation procedure iii. greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke of atherosclerotic origin ii. Prior carotid artery revascularisation procedure iii. greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.
c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest ii. Intermittent claudication with a greater than or equal to 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularisation procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
Exclusion Criteria:
Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2).
Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
Emily Nagel
All
28 Weeks to 32 Weeks old
STUDY00016926
STUDY00016926
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Inclusion Criteria:
preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery and b) pre-gravid or first trimester BMI between 18.5 to 40 kg/m^2
Exclusion Criteria:
infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
mothers: a) alcohol consumption >1 drink per week or any tobacco consumption during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
The purpose of this research study is to compare the transfusion of cold-stored (refrigerated) platelets to standard room temperature stored platelets. The goal of the trial is to determine whether platelets stored cold are similar or better at stopping bleeding compared to platelets stored at room temperature and, if so, to determine the maximum duration of cold storage that maintains a similar effect on bleeding
Claudia Cohn
All
29 Days to 84 Years old
Phase 3
STUDY00013172
STUDY00013172
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Inclusion Criteria:
Age greater than 28 days and less than 85 years
Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:
Expected order for washed or volume reduced platelets
Patient with known anti-platelet antibodies
Platelet transfusion refractoriness due to anti-HLA antibodies
Known or suspected pregnancy
Previously randomized in this study
Conscious objection or unwillingness to receive blood products
Known IgA deficiency
Known congenital platelet disorder
Known congenital bleeding disorder
Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
Patients intended to receive whole blood either intra-operative or post-operative for bleeding
Platelet transfusion (of any type) within 24 hours prior to the date of surgery
Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.
Biological: Cold Stored Platelets, Biological: Room Temperature Platelets
Acute Blood Loss
platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery
The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.
Lucie Turcotte
All
to 21 Years old
Phase 3
STUDY00008859
STUDY00008859
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Inclusion Criteria:
Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
Patient must be between 0-21 years of age.
Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.
Exclusion Criteria:
Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of:
Steroid pretreatment: Systemic glucocorticosteroids (prednisone, methylprednisone, dexamethasone, etc.) for less than or equal to 120 hours (5 days) in the 7 days prior to initiating protocol therapy or for less than or equal to 336 hours (14 days) in the 28 days before the initiation of protocol therapy does not affect eligibility. The dose of steroid previously given does not affect eligibility. Patients who have only received surgical or radiation therapy, intralesional injection of steroids, inhalational steroids, systemic mineralocorticoids (hydrocortisone), or topical steroids may also be enrolled.
Patient may not have disease limited to a single skin or bone site, with the following exceptions:
Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study.
Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy.
Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy/surgery as described), as long as no systemic therapy was previously given per protocol guidelines.
Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance < 50 ml/m2/1.73m^2).
Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH.
Female patients may not be pregnant or breastfeeding.
Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study.
Patients who are HIV positive may not be enrolled.
NOTE: Patients excluded for laboratory abnormalities or performance score only may be enrolled on the study with written approval from the Coordinating Center PI or Vice-Chair.
The purpose of this study is to better understand how varying levels of common sugars found in cigarettes affect how you smoke the cigarette and your responses to them.
Irina Stepanov
Male or Female
18 Years and over
NA
This study is also accepting healthy volunteers
STUDY00011825
STUDY00011825
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Inclusion Criteria:
Male or female age 21 years or older
Smoking cigarettes that have been evaluated to have medium levels of sugar content
No quit attempts in the past month nor intentions to quit smoking in the next month
Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
Stable vitals sign measurements (systolic BP ≤ 160 and >90 mmHg, diastolic BP ≤ 100 and >50 mmHg and heart rate ≤105 and > 45 bpm) as determined by the licensed medical professional
Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
Participants have provided written informed consent to participate in the study.
Exclusion Criteria:
Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
Women who are pregnant or nursing or planning to become pregnant.
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment.
This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.
Maneesh Bhargava
Male or Female
18 Years and over
STUDY00016463
STUDY00016463
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Inclusion Criteria:
Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, defined by the following criteria: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
Patients must be receiving treatment with OCS of ≥ 3 months with a starting dose between ≥ 7.5 and ≤ 25 mg/day.
Body weight ≥ 40 kg and < 160 kg
Exclusion Criteria:
Treatment with > 1 oral immunosuppressant therapy
Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis > 20% within the last 12 months; FVC percent predicted (FVCPP) < 50% and KSQ-Lung score < 30
Clinically significant pulmonary hypertension requiring treatment with vasodilators
Patients with cardiac sarcoidosis, neurosarcoidosis, or renal sarcoidosis
Clinically significant cutaneous and ocular sarcoidosis
History of Addisonian symptoms that precluded previous OCS taper attempts
Is an active, heavy smoker of tobacco/nicotine-containing products
History of anti-synthetase syndrome or Jo-1 positive at baseline
The goal of this research is to determine if consuming one of the two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents. If our research supports this idea, this drink could be an inexpensive dietary component, which could promote good health.
Dorothy Hatsukami
Male or Female
18 Years and over
Phase 2
This study is also accepting healthy volunteers
STUDY00003508
STUDY00003508
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Inclusion Criteria:
Adult Male or female. Participants can be smokers or non-smokers
In good physical health
In stable and good mental health
Not using any medications that may affect the Nrf2 pathway
Women who are not pregnant or nursing or planning to become pregnant
Participants have provided written informed consent to participate in the study
Exclusion Criteria:
Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
Vital signs outside of the allotted range
Not willing to abstain from eating cruciferous vegetables during the course of the study
Arteriovenous fistulas are a type of arteriovenous malformation whereby blood is shunted directly from the arterial
system to the venous system, bypassing the capillary bed. Dural arteriovenous fistulas (dAVFs) are a rare type of
acquired intracranial vascular malformation consisting of a pathologic shunt located within the dura mater of the
brain. 1 These lesions have been categorized by Awad et al 2, Borden et al 3, and Cognard et al 4 according to their
locations and patterns of venous drainage. Dural arteriovenous fistulas (dAVFs) can be observed anywhere on the
dural layer meninges of the cranium and spine. This condition accounts for 10-15% of all intracranial arteriovenous
malformations diagnosed. 5 These fistulas can be congenital or acquired diseases. When observed as acquired
diseases, they are most often encountered in males between the age of 50 and 60 years old. DAVFs present with a
wide spectrum of symptoms or none at all, and come with varying range of risk of clinical sequalae. A thorough
evaluation of the anatomy and venous drainage is crucial to determining the best treatment strategy. Acute
presentation with intracranial hemorrhage occurs in up to 65% of patients, and patients with a previous intracranial
hemorrhage may have up to a 35% risk of another neurologic event within 2 weeks. 6 Endovascular embolization has
become the primary treatment approach for DAVFs. The goal of endovascular therapy is to achieve complete
obliteration of the fistulous point between the feeding arteries and the draining veins. This can be safely
accomplished by occluding the draining veins, which often results in complete closure of the lesion, unlike in cerebral
arteriovenous malformations.
The PHIL® device is a non-adhesive liquid embolic agent comprised of a Triiodophenol-(lactide-co-glycolide) acrylate
and hydroxyethyl methacrylate (HEMA) co-polymer dissolved in DMSO (dimethyl sulfoxide). An iodine component
is chemically bonded to the co-polymer to provide a radiopacifier element during fluoroscopic visualization. The
PHIL® Liquid Embolic System consists of a sterile, pre-filled, 1.0 mL syringe of PHIL® liquid embolic, a sterile, prefilled
1.0 mL syringe of DMSO, and microcatheter hub adaptors.
Intracranial dAVFs may produce a wide variety of symptoms. Individual risk is evaluated by a precise analysis of the
venous drainage. The decision to treat is based on this analysis. Treatment strategy is decided by a multidisciplinary
neurovascular team and must consider the individual risk of each dAVF. Embolization is, in most cases, proposed as
the first treatment option and often succeeds to obtain a complete and definitive cure of the dAVF. Surgery may be
required in some locations or in the case of embolization failure. Radiosurgery is rarely indicated because it is not
always efficient and because of the time required for shunt obliteration and the risk of bleeding in this period.
Liquid embolics have distinct characteristics that make them a principle treatment option in the obliteration of
dAVFs. They can flow through complex vascular structures so that the surgeon does not need to target the catheter
to every single vessel. 10 There is little choice available in the US market for the liquid embolic treatment of dAVF.
Currently, nBCA (TRUFILL n-Butyl Cyanoacrylate, Cordis) and Onyx (Medtronic) are the only liquid embolic agents
available. Both are approved by FDA for presurgical embolization of cerebral arteriovenous malformations. However,
they have been used off-label for dAVFs. This use demonstrates the unmet medical need for the patients suffering
with dAVFs.
The aim of this study is to evaluate the use of PHIL in the management of intracranial dural AVFs.
Ramu Tummala
All
22 Years to 80 Years old
Phase I/II
STUDY00003548
STUDY00003548
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Inclusion Criteria:
Age 22 - 80 years.
Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
Subject has an intracranial dAVF
Exclusion Criteria:
Subject having multiple dAVFs to be treated.
Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
Subject has known allergies to dimethylsulfoxide, iodine.
Subject is currently participating in another clinical study
Female subject is currently pregnant.
Subject has co-morbid conditions that may limit survival to less than 24 months.
The purpose of our research study is to increase our understanding on the human immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from blood of healthy volunteers to perform immune experiments.
Monica Campo Patino
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00016965
STUDY00016965
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Inclusion Criteria:
- A healthy person between the ages of 18-49 years.
- People that are able to consent to be part of the study and that do not meet the exclusion criteria.
Exclusion Criteria:
- People with positive HIV tests, and people that are pregnant or lactating.
- People with chronic or comorbid illnesses disease including cardiac disease, cancer, seizure disorder, hypertension, diabetes mellitus, auto-immune disease, immune deficiency, and others.
- People using more medication for diabetes, heart, lungs, liver, immune, and kidney problems will be excluded.
- People who present signs of active TB or any history of active TB.
- People that have asthma, chronic obstructive lung disease, chronic bronchitis, or another chronic lung disease.
- People that have gotten vaccinated within 6 weeks, or that had a respiratory infection such as an upper or lower respiratory infection within 3 weeks before the procedure.
We are studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication. Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.
Claudia Fox
Male or Female
up to 18 Years old
Phase 2
STUDY00006824
STUDY00006824
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Inclusion Criteria:
Provision of signed and dated informed assent form;
Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
Stated willingness to comply with all study procedures and availability for the duration of the study;
BMI >/= 1.2 times the 95th percentile or BMI >/= 35 Kg/m2, whichever is lower;
Tanner stage >/= 2;
Male or female, aged 12-17 at time of consenting;
For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria:
Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
Diabetes (type 1 or 2);
Presence of cardiac pacemaker;
Current or recent (<6 months prior to enrollment) use of weight loss medication(s);
Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
Seizure disorder (other than infantile febrile seizure);
Previous bariatric surgery;
Recent initiation of change in dose (< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
Tobacco use
History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
Unstable depression or anxiety that has required hospitalization in the past year;
Any history of suicide attempt;
Suicidal ideation or self-harm within 12 months prior to enrollment;
Bicarbonate < 18 mmol/L;
Creatinine > 1.2 mg/dL;
History of cholelithiasis;
History of nephrolithiasis;
Untreated thyroid disorder;
Hyperthyroidism;
Breastfeeding
We propose to develop an informatics system to assist people with memory impairment. Early stages of Alzheimer's and Alzheimer's related dementia often causes memory concerns. Persons with Memory Concern often cannot match names with faces or cannot recognize faces with a sure feeling of familiarity. Persons with Memory Concern (PWMC) may have difficulty remembering the names of family members and friends or may address them with a wrong name. They recognize the faces they see daily, such as a spouse or caregiver, but they may confuse visiting friends and
grandchildren. The inability to remember names or relationships contributes to isolation and deeply affects their social lives. The proposed solution is a Smartwatch Reminder (SR) system to conspicuously provide this information to the PWMC when needed. This system will automatically transmit pictures and relevant information to a smartwatch worn by the PWMC when family or friends visit. The system will be evaluated on the target persons with memory concern population to measure engagement and improvements in social interactions and quality of life.
Jude Mikal
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00006318
STUDY00006318
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Inclusion Criteria:
Inclusion criteria for Persons with Memory Concerns are as follows: 1) English speaking; 2) a physician diagnosis of early-stage Alzheimer?s disease or mild-to-moderate cognitive impairment; 3) live in the community (including at home with or without the care partner, in a retirement community, etc.); 4) no history of serious mental illness (i.e., any major psychiatric disorder) and 5) must have some level of cellular connection in their place of residence (if known).
Care Partners of PWMC must: 1) speak English; 2) be 21 years of age and over; 3) self-identify as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ``care partners,?? as these individuals may or may not provide the intensive hands-on care typical of ``caregivers??); and 5) indicate a willingness to use the smartwatch system as well as to being randomized to a control group.
Exclusion Criteria:
Does not meet inclusion criteria.
Device: Smartwatch Reminder (SR) system
Community Health, Prevention & Wellness, Brain & Nervous System
CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions
Guru Trikudanathan
All
18 Years to old
STUDY00012592
STUDY00012592
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Inclusion Criteria:
Medical history of chronic pancreatitis (CP).
Diagnosis of Exocrine Pancreatic Insufficiency (EPI).
The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.
David Walk
All
21 Years to 75 Years old
1306M35941
1306M35941
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Inclusion Criteria:
21 to 75 years of age inclusive.
Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
ALS patients:
A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.
Exclusion Criteria:
Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.
The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.
The study will be evaluating the safety and efficacy of Pitolisant drug in patients with Myotonic Dystrophy type I.
Peter Karachunski
All
18 Years to 65 Years old
Phase 2
STUDY00013984
STUDY00013984
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Inclusion Criteria:
Is able to provide voluntary, written informed consent.
Has a diagnosis of DM1 confirmed by genetic testing (cytosine-thymine-guanine [CTG] repeat of ≥100) from the Screening Visit.
Male or female patients ages 18 to 65 years at the time of enrollment.
Has a Clinical Global Impression of Severity (CGI-S) assessment of moderate or severe for overall severity of EDS at Screening.
If on a wake-promoting treatment that could affect EDS (including stimulants, modafinil, and armodafinil):
Must be on a stable dose for at least 2 months prior to Screening and agree to continue the stable dose for the duration of the Double-Blind Treatment Phase of the study (dose adjustments will be permitted in the OLE Phase).
If not on a stable dose for 2 months prior to Screening, washout for 5 half-lives prior to randomization and agree to remain off these treatments for the duration of the Double-Blind Treatment Phase of the study.
Washout of cannabidiol and tetrahydrocannabinol for 28 days prior to randomization and agree to remain off for the duration of the Double-Blind Treatment Phase of the study.
Able to walk independently with or without an assistive device (e.g., cane, walker, orthoses allowed).
A patient who is a female of child-bearing potential (FCBP) must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test at the Baseline Visit and agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug.
In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug.
Exclusion Criteria:
Has a diagnosis of another genetic or chromosomal disorder that is distinct from DM1 and that is not being managed adequately in the opinion of the Investigator.
Experiences <6 hours on average of sleep per night based on their sleep diary during Screening (patients need to record at least 7 of 10 consecutive nights including 2 nights that fall on a weekend in their sleep diary during Screening).
Consistently consumes >600 mg of caffeine per day and is unable/unwilling to reduce caffeine intake to <600 mg per day for the duration of the Double-Blind Treatment Phase of the study; caffeine intake should remain consistent during Screening and throughout the Double-Blind Treatment Phase of the study.
Does not agree to discontinue any prohibited medication or substances listed in the protocol.
Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study (Double-Blind Treatment Phase and OLE Phase) and for 21 days after final dose of study drug.
Participation in an interventional research study involving another investigational medication or device in the 28 days prior to enrollment; patients who undergo a washout of an investigational medication of at least 5 half-lives can be enrolled in the Double-Blind Treatment Phase of the study. Patients considering participation in another interventional research study in the OLE Phase must consult with the Investigator who will consult with the Medical Monitor.
Has a primary diagnosis of severe psychiatric illness.
Patients taking antidepressants who have not been on a stable dose of their antidepressant for at least 12 weeks prior to Screening; for patients on a stable dose of their antidepressant for at least 12 weeks prior to Screening, must agree to continue their stable dose for the duration of the Double-Blind Treatment Phase of the study. Dose adjustments will be permitted in the OLE Phase. In the Double-Blind Treatment Phase of the study, antidepressants that are strong CYP2D6 inhibitors are exclusionary.
Has a history of sleep-disordered breathing or another underlying sleep disorder that in the opinion of the Investigator is a main contributory factor to the patient's EDS.
Has a diagnosis of end-stage renal disease (ESRD; estimated glomerular filtration rate [eGFR] of <15 mL/minute/1.73 m2) or severe hepatic impairment (Child-Pugh C).
Has a diagnosis of moderate or severe renal impairment (eGFR ≥15 to ≤59 mL/minute/1.73 m2) or moderate hepatic impairment (Child-Pugh B) at Screening or during the Double-Blind Treatment Phase.
Has a family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member (i.e., first degree relative such as parent, sibling, or offspring).
Has a history of unexplained syncope.
Has a history of long corrected QT interval (QTc) syndrome or corrected QT interval using Fridericia's formula (QTcF) >450 msec for males or >470 msec for females (QTcF = QT / 3√ RR) sustained atrial fibrillation (AF) or left ventricular ejection fraction <50%.
Has a history of documented symptomatic arrhythmias (e.g., ECG, Holter monitor).
Electrocardiogram abnormalities during a 10-second, 12-lead ECG at Screening of first degree atrioventricular block (AVB; PR interval >220 msec), QRS >120 msec, heart rate (HR) <50 beats per minute (bpm), marked T-wave abnormalities, more than single atrial premature complexes (APCs) or premature ventricular contractions (PVCs), left bundle branch block, or Brugada pattern type 1.
Note: Patients with 1st degree AVB with a PR interval >220 msec, who are treated prophylactically with an allowable implanted device are not excluded from the study.
Based on Holter monitor, any episode of 3rd degree AVB, any prolonged episode of second degree AVB (>2 episodes during waking hours, >6 episodes during sleep), any prolonged episode of 2nd degree AVB (>10 seconds), any asystole longer than 3.5 seconds, any run of ventricular tachycardia (VT) >6 beats, frequent runs of non-sustained VT (>5/24 hour), >400 PVCs/24 hours, AF or paroxysmal AF, or frequent or complex atrial arrhythmias.
Has history of New York Heart Association (NYHA) class III or class IV heart failure.
Has an implanted defibrillator or implanted biventricular pacemaker. Note: Patients with implanted univentricular pacemakers that are used prophylactically to prevent or treat bradycardia or heart block may be included.
Is receiving a medication known to prolong the QT interval.
Has a history of clinically significant hypokalemia or hypomagnesemia that cannot be adequately controlled by supplementation.
Has serum potassium or magnesium levels that are outside of the normal reference ranges and considered clinically significant at Screening. Patients with mild hyperkalemia that, in the opinion of the Investigator, does not pose an arrhythmia threat may be included.
Is receiving a concomitant medication that is known to be a strong cytochrome P450 (CYP) 2D6 inhibitor, a strong CYP3A4 inducer; or a centrally acting histamine 1 receptor (H1R) antagonist (sedating antihistamine).
Note: Patients who undergo a washout of these medications of at least 5 half-lives may be enrolled in the Double-Blind Treatment Phase of the study.
Note: Use of strong CYP2D6 inhibitors and strong CYP3A4 inducers is allowed during the OLE Phase; however, adjustment of pitolisant dose is required. Although not prohibited during the OLE Phase of the study, use of centrally acting or sedating H1R antagonists should be avoided.
Is a known CYP2D6 poor metabolizer (PM).
Regular use (more than twice per week) of any sleep-promoting treatments that could affect EDS and not willing to limit use to no more than twice per week during Screening and for the duration of the Double-Blind Treatment Phase of the study (use of sleep-promoting agents are not allowed within one day prior to study-related assessments).
Has abnormal laboratory values at Screening that are clinically significant as determined by the Investigator.
Has initiated any new or change in allied health therapies or interventions that can interfere with the study outcomes within 28 days prior to randomization and that are prohibited during the Double-Blind Treatment Phase of the study, based on the Investigator's judgment.
Has a current or recent (within 1 year) history of a substance use disorder or dependence disorder, including alcohol and caffeine use disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V).
Has planned surgery during the Double-Blind Treatment Phase of the study; planned surgery is permitted during the OLE Phase.
Has a significant risk of committing suicide or suicidality based on history, routine psychiatric examination, Investigator's judgment, or who has an answer of "yes" on any question other than questions 1 to 3 on the Columbia-Suicide Severity Rating Scale.
Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the patient, or compromise the integrity of the study.
The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works.
High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders.
If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.
Jesse Hoffmeister
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00015206
STUDY00015206
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Inclusion Criteria:
Patients with adductor laryngeal dystonia:
• Have experienced improvement in voice quality
following injection of botulinum toxin into the thyroarytenoid complex
• Have received their most-recent injection within
6 months
• Age 18-80 years old
• Able to participate in informed consent
• Able to read and write in English
Healthy Controls
• Age 18-80
• Have no known voice problem
• Have a VHI-10 score of 10 or below
• Able to participate in the informed consent
process
• Able to read and write in English
Exclusion Criteria:
Patients with adductor laryngeal dystonia:
• Diagnosis of vocal tremor, abductor laryngeal
dystonia, any type of vocal fold lesion, or vocal fold paralysis
• Known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to
study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or
esophageal surgery
• Known nasal, pharyngeal, or esophageal
obstruction
Healthy Controls
• VHI-10 Score of 11 or above
• Report having a current voice or swallowing
disorder
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to
study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or
esophageal surgery
• Known nasal, pharyngeal, or esophageal
obstruction
The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.
Logan Spector
Male or Female
Not specified
This study is also accepting healthy volunteers
STUDY00000877
STUDY00000877
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Inclusion Criteria:
• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:
• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.
Emily Greengard
All
12 Months to 30 Years old
Phase 1/Phase 2
STUDY00015023
STUDY00015023
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Inclusion Criteria:
Parts A and B1: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
Part B2 (relapsed/refractory osteosarcoma): Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible
Part B1: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy
Part B2: Patients with relapsed or refractory osteosarcoma
Part A: Patients must have either measurable or evaluable disease
Part B1 and B2: Patients must have measurable disease
Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. Patients must have a Karnofsky or Lansky score >= 50%
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately
Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive
Solid tumor patients: >= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment
Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
Stem cell Infusions (with or without total body irradiation [TBI]):
Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
Autologous stem cell infusion including boost infusion: >= 30 days
Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.)
Radiation therapy [XRT]/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine [131I MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
Patients must not have received prior exposure to CBL0137
For patients with solid tumors without known bone marrow involvement:
Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment unless otherwise indicated)
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
For patients with solid tumors without known bone marrow involvement:
Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows (performed within 7 days prior to enrollment unless otherwise indicated):
Age: Maximum serum creatinine (mg/dL)
1 to < 2 years: 0.6 (male); 0.6 (female)
2 to < 6 years: 0.8 (male); 0.8 (female)
6 to < 10 years: 1 (male); 1 (female)
10 to < 13 years: 1.2 (male); 1.2 (female)
13 to < 16 years: 1.5 (male); 1.4 (female)
>= 16 years: 1.7 (male); 1.4 (female)
Patients with solid tumors:
Bilirubin (sum of conjugated + unconjugated or total) =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)
Patients with solid tumors:
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (performed within 7 days prior to enrollment unless otherwise indicated)
Shortening fraction of >= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated)
Ejection fraction of >= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)
Corrected QT (QTC) < 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)
Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible
Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration
Exclusion Criteria:
Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy
Patients who are receiving drugs that prolong QTc are not eligible. QTc- prolonging drugs are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy
Patients with known peripheral vascular disease are excluded
Patients with a history of pro-thrombotic disorder are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Drug: FACT Complex-targeting Curaxin CBL0137
Diffuse Midline Glioma, H3 K27M-Mutant, Metastatic Malignant Neoplasm in the Central Nervous System, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Recurrent Primary Malignant Central Nervous System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Osteosarcoma, Refractory Primary Malignant Central Nervous System Neoplasm
This early phase I trial compares a new method for dosing vincristine in infants and young children to the standard dosing method based on body size in older children. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The same dose of a drug cannot be given to all children because they vary a lot in size from infancy to adolescence. The dose of most anticancer drugs is based on a measure of body size called the body surface area (BSA). BSA is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so adjustments have to be made to safely give anticancer drugs to the youngest patients. A new method for dosing anticancer drugs in infants and young children has been developed that uses body size to determine the dose. Collecting blood samples over time may help researchers understand how the new vincristine dosing method affects drug levels in the blood over time in infants and young children compared to older children.
Emily Greengard
All
to 12 Years old
STUDY00017658
STUDY00017658
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Inclusion Criteria:
Patients must be =< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups:
0 to 6 months
6 months and 1 day to 12 months
12 months and 1 day to 36 months
36 months and 1 day to 12 years
Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m^2 dose level
Any disease status
Patients must have a Lansky performance status of 50 or higher
Patients must be receiving a treatment regimen that includes 1.5 mg/m^2 vinCRIStine (maximum dose 2 mg)
Patients with a BSA < 0.6 m^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine
Note: Patients can be studied after any dose of vinCRIStine
Patients who are NOT enrolled on a COG clinical trial and who have a BSA < 0.6 m^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vincristine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment
Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days
Nervous system toxicities (Common Terminology Criteria for Adverse Events [CTCAE]) version (v)5 resulting from prior therapy must be grade =< 2
Central venous access device in place (e.g., percutaneous indwelling central catheter [PICC], port, Broviac) that can be used for pharmacokinetic (PK) sampling
VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling
Exclusion Criteria:
Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible
CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study. Note: dexamethasone for central nervous system (CNS) tumors or metastases, on a stable dose, is allowed
Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible.
Patients with Charcot-Marie-Tooth disease
A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities
Patients receiving a modified dose (< 1.5 mg/m^2) of vinCRIStine due to prior toxicity
Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.
Michelle Rheault
Male or Female
Not specified
STUDY00009629
STUDY00009629
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Inclusion Criteria:
• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
Exclusion Criteria:
• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Institutionalized patient
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
o Diabetes mellitus (except gestational or diet controlled)
o Histopathologic findings of diabetic glomerulosclerosis
o Systemic lupus erythematosus
o HIV infection
o Active malignancy, except for non-melanoma skin cancer
o Active Hepatitis B or C infection, defined as positive viral load
The scalp microbiome is made up of bacteria, viruses, and fungi that live on the scalp, and it is an important part of overall scalp health. The purpose of this research study is to test if cleansing the scalp with the Venus Glow™ changes the composition of the scalp microbiome and improves scalp health.
Ronda Farah
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00014160
STUDY00014160
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Inclusion Criteria:
ages 18-35
Exclusion Criteria:
Unhealthy scalp
Dermatology (Skin, Hair & Nails)
hair, healthy scalp, scalp cleaning, Clinics and Surgery Center (CSC)
This is a prospective, observational multicenter study to collect blood from patients with mucopolysaccharidosis type IH (MPS-IH) undergoing laronidase therapy and a stem cell transplant.
Silvia Illamola
All
0 Years to 3 Years old
STUDY00016560
STUDY00016560
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Inclusion Criteria:
Between 0 to 3 years of age
Meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
Planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course.
Exclusion Criteria:
Patient's parent/ legal guardians are unable to provide informed consent.
Drug: Laronidase therapy and a stem cell transplant
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
Peter Gordon
All
1 Year to 25 Years old
Phase 3
STUDY00008473
STUDY00008473
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Inclusion Criteria:
B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol.
APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
Patients must be > 365 days and < 25 years of age
White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
Age 1-9.99 years: WBC >= 50,000/uL
Age 10-24.99 years: Any WBC
Age 1-9.99 years: WBC < 50,000/uL with:
Testicular leukemia
CNS leukemia (CNS3)
Steroid pretreatment.
White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
Age 1-24.99 years: any WBC.
Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016 criteria) with >= 25% blasts on a bone marrow (BM) aspirate;
OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
Patient has newly diagnosed B-LLy Murphy stages III or IV.
Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
All patients and/or their parents or legal guardians must sign a written informed consent.
All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells.
Patients with acute undifferentiated leukemia (AUL) are not eligible.
For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
T-lymphoblastic lymphoma.
Morphologically unclassifiable lymphoma.
Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
Patients with known Charcot-Marie-Tooth disease.
Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
Patients requiring radiation at diagnosis.
Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.
This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
Joanne Billings
Female
16 Years to old
STUDY00012925
STUDY00012925
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Inclusion Criteria:
Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes
Kathryn Dusenbery
All
18 Years to old
STUDY00002191
STUDY00002191
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Inclusion Criteria:
Diagnoses of Dupuytren's disease
English-speaking
Exclusion Criteria:
• Patients with Dupuytren's disease who are not currently seeking treatment
Other: Evaluation of Dupuytren's Disease Treatment
Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger, Dupuytren Disease of Finger, Dupuytrens Contracture of Both Hands, Dupuytren's Disease of Palm of Right Hand, Dupuytren's Disease of Palm of Left Hand, Dupuytren Contracture of Right Palm, Dupuytren Contracture of Left Palm, Dupuytren's Contracture Left, Dupuytren's Contracture Right
The central hypothesis of this project is that VA-ECMO support significantly reduces preload and transpulmonary flow while prompting a clinically insignificant rise in afterload, therefore leading to an overall decline in myocardial stroke work and energy expenditure at higher levels of support, contrary to the prevailing opinion. We will test this hypothesis in patients treated with VA-ECMO for cardiogenic shock in our institution due to ACS related presentations. The rationale is that a refined understanding of the hemodynamic mechanisms of short-term mechanical support can better aid treatment of patients for VA-ECMO, thus mitigating morbidity and mortality and optimizing outcomes for patients in cardiogenic shock.
Demetri Yannopoulos
All
18 Years to old
STUDY00016153
STUDY00016153
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Inclusion Criteria:
Age 18-75 years
SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
MAP >65 mmHg on <3 vasopressors/inotropes at the time of consent
Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
Exclusion Criteria:
VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
CS due to other (non-ACS) etiologies
Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
Profound vasoplegia with MAP <65 mmHg on 3 vasopressors/inotropes
Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
Bleeding complications requiring ongoing transfusions of blood products
Ischemic lower extremities
Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
Evidence of sepsis or septic shock
Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Other: Physiological Assessment
Acute Coronary Syndrome, Cardiogenic Shock
Acute Coronary Syndrome, Cardiogenic Shock, Left ventricle, VA-ECMO
This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.
Marie Hickey
Female
18 Years and over
Pilot
This study is also accepting healthy volunteers
STUDY00016313
STUDY00016313
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Inclusion Criteria:
? Pregnant women (please see description of safeguards in Section: Vulnerable populations) in their second or third trimester with a diagnosis of gestational diabetes. Gestation is determined by either self-report of estimated delivery date, or from medical records information (last menstrual period, ultrasound dating or other sources of information on date of conception), depending on which method of recruitment is used.
Screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) approach is commonly used. A 50-g oral glucose challenge test (OGCT) is performed between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive the oral glucose tolerance test (OGTT). During the OGTT, a fasting glucose level is obtained, followed by administration of a 75-g or 100-g glucose load, then evaluation of glucose levels after 1, 2, and often 3 hours. A diagnosis of gestational diabetes is made when 2 or more glucose values fall at or above the specified glucose thresholds (ACOG 2017).
? BMI 18.5-45 kg/m2 at first prenatal visit
? Age 21-45 at time of delivery
? Pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
? Singleton pregnancy
Exclusion Criteria:
? Alcohol consumption >1 drink per week during pregnancy/lactation
? Tobacco consumption during pregnancy/lactation
? Inability to speak/understand English
? Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
? History of type I Diabetes
? Mothers currently taking over the counter probiotic preparation
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglio-neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Emily Greengard
All
to 30 Years old
0807M39682
0807M39682
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Inclusion Criteria:
All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
Exceptions
In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
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
Exclusion Criteria:
Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.
Emily Greengard
All
to 18 Months old
Phase 3
1410M54605
1410M54605
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Inclusion Criteria:
Patients must be:
< 12 months (< 365 days) of age at diagnosis with INRG stage L1; or
< 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients
Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index
"Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above
"Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)
Only patients with MYCN non-amplified tumors are eligible for this study
Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin
Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma
No prior tumor resection or biopsy
Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes
Group A1:
> 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR
Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR
< 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter
Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter.
Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:
No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise
No prior tumor resection, tumor biopsy ONLY
Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1
Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma
No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
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
Exclusion Criteria:
Patients with MYCN amplified tumors are not eligible
Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study
The proposed research will measure and compare differences in visual performance and associated neural processing in participants who do or do not experience Visual Snow Syndrome, using a series of well-established psychophysical and imaging paradigms.
Michael-Paul Schallmo
All
16 Years to old
N/A
STUDY00014113
STUDY00014113
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Inclusion Criteria:
16 years or older
Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
Stable fixation (+/- 1 deg) using their PRL.
No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
Satisfactory calibration achievable using eye tracker
Exclusion Criteria:
Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
Poor fixation (worse than+/- 1 deg) using their PRL.
Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
Satisfactory calibration not achievable using eye tracker
Behavioral: Personalized Remapping, Behavioral: Traditional Remapping
Age-related Macular Degeneration
Scotoma, Remapping, Reading, Low vision, Visual aid
