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

402 Study Matches

EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)

A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.

Jacob Cogan
12 years and over
STUDY00017896
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Inclusion Criteria:
Diagnosis of severe congenital hemophilia A or B (FVIII <1% or FIX level ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence. For participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months prior to screening. Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of participants under the age of legal consent, per local and national requirements
Exclusion Criteria:
Known co-existing bleeding disorders other than congenital hemophilia A or B History of arterial or venous thromboembolism, not associated with an indwelling venous access History of intolerance to SC injection(s). Current participation in immune tolerance induction therapy (ITI) Prior gene therapy Current or prior participation in a fitusiran trial Current or prior participation in a gene therapy trial Received an investigational drug or device within 30 days prior to the screening visit or within 5 half-lives of the investigational drug (or device) prior to the screening visit, whichever is longer Presence of clinically significant liver disease AT activity <60% at Screening Co-existing thrombophilic disorder Hepatitis C virus antibody positive, except participants who have negative Hepatitis C viral load and no evidence of cirrhosis Presence of acute hepatitis, ie, hepatitis A, hepatitis E. Presence of acute or chronic hepatitis B infection Known to be HIV positive with CD4 count <200 cells/μL. Reduced renal function The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care

The purpose of this study is to learn more about the safety and effectiveness of human growth hormone treatments, in routine practice.

Brad Miller, MD, PhD
Not specified
This study is NOT accepting healthy volunteers
STUDY00016116
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Inclusion Criteria:

• prescribed human growth hormone (hGH) to treat growth hormone deficiency (GHD)
Exclusion Criteria:

• participation in any interventional clinical trials
Rare Diseases
GHD, Growth Hormone Deficiency, hGH, Human Growth Hormone
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Accelerating Therapies for Refractory SJIA Patients

This research study aims to learn more about the causes of Systemic Juvenile Idiopathic Arthritis (sJIA) including its complications such as Macrophage Activation Syndrome (MAS) and sJIA associated lung disease and identify new therapeutic targets. The study is asking for biological samples from those diagnosed with sJIA as well as their family members.

Mona Riskalla
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001576
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Inclusion Criteria:

• at least 6 months old
• new onset SJIA or established SJIA with or without lung and/or liver complications
• parent or sibling of the enrolled child will also be asked to participate
Exclusion Criteria:

• illness sufficient to prohibit study participation
• inability to cooperate with the study
Arthritis & Rheumatic Diseases, Rare Diseases
SJIA, Systemic Juvenile Idiopathic Arthritis
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Vasomotor symptoms of menopause and cardiovascular disease: What is the link?

Study to examine the physiological responses that occur during a hot flush in postmenopausal women

Manda Keller-Ross
18 years and over
This study is also accepting healthy volunteers
STUDY00013742
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Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
Exclusion Criteria:

• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ? 35 kg/m2
Blood Disorders, Brain & Nervous System, Women's Health
autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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AAML18P1: Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Peter Gordon
Up to 25 years old
SITE00001982
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Inclusion Criteria:
Patient must have been diagnosed with CML-CP at < 18 years of age. Patient must have histologic verification of CML-CP at original diagnosis Patient must be in molecular remission (MR) with a BCR-ABL1 level of =< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for >= 2 consecutive years at the time of enrollment Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =< 0.01% BCR-ABL1 and be able to report results in =< 2 weeks Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment Patient agrees to discontinue TKI therapy REGULATORY REQUIREMENTS 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 FOR PATIENT-REPORTED OUTCOMES (PROs): Age >= 8 years at the time of enrollment Ability to understand English or Spanish Cognitive ability to complete instruments according to the primary team ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY: Patient must be 5 years or older at the time of enrollment English-, French- or Spanish-speaking No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down syndrome, Fragile X, William syndrome, mental retardation) No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
Exclusion Criteria:
Known T3151 mutation Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) cells at any time prior to enrollment that include "major route" abnormalities (second Ph, trisomy 8, isochromosome 17q, trisomy 19), complex karyotype or abnormalities of 3q26.2 History of accelerated phase or blast crisis CML Female patients who are pregnant Lactating females are not eligible unless they have agreed not to breastfeed their infants Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
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Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in pediatric patients with AHL or SSD. The HA phase occurs over a minimum of 4 months prior to obtaining a CI. The CI phase occurs over the 15-month period after initial stimulation of the CI. One statistical analysis (HLM) requires a minimum of 5 test intervals. For the HA phase, these are the Baseline evaluation (visit #1), three shorter evaluations (visits #2, #3, #4) and the Final HA evaluation (visit #5). The five HA phase test intervals will occur across a minimum of 4 months with at least 3 weeks between visits. For the CI phase, the test intervals are the Pre-implant evaluation (occurs at the same time as the Final HA evaluation) and the 3, 6, 9, 12, and 15-month post-implant evaluations. Approximately 40 AHL and 40 SSD will be implanted. We also use longitudinal data from matched NH participants collected at the 3-, 9-, and 15-months postimplant time periods to provide additional information about outcome trajectory due to development alone. NH and AHL/SSD participants are matched for age, gender and parent education. The study length for individual participants will be approximately 2 years. The overall study is expected to last approximately 5 years.

Kristin Gravel
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00010956
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Inclusion Criteria:

• Parents and child fluent in English
• Parents desire functional hearing in both ears for their child
• Severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear
• If older than 5 years, documentation of progressive hearing loss (i.e. passed newborn hearing screening, or significant change in hearing)
Exclusion Criteria:

• Medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• Already using a cochlear implant
• Inability to complete study procedures
• Unrealistic expectations related to the benefits and limitations of cochlear implantation
• Unwillingness or inability to comply with all investigational requirement
Ear, Nose & Throat
Pediatric audiology, Audiology, Cochlear Implant, Single-Sided Deafness
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Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)

Feasibility study to test our overall hypothesis that time restricted eating (TRE) presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients with metformin-only treated Type 2 diabetes (T2DM).

Lisa Chow
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014853
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Inclusion Criteria:

• adults who are overweight/obese and have type 2 diabetes treated only with metformin
• 18-65 years old
• BMI between 25-40 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
Exclusion Criteria:

• women who are pregnant or are planning to become pregnant
• eating disorders
Diabetes & Endocrine
time restricted eatin, Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction
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Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)

There are currently two main ways of measuring nutrition in the Cystic Fibrosis (CF) population: body mass index (BMI) and laboratory values. This study plans to look at more ways to measure nutrition, and body composition, like the percentages of fat, bone and muscle in your body. One of the ways we will measure these items is by using dual energy X-ray absorptiometry (DXA) scan, which is a type of x-ray. This study hopes to provide researchers with more detailed information about nutrition and body composition in adults with CF.

Joanne Billings
18 years and over
This study is NOT accepting healthy volunteers
SITE00001806
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Inclusion Criteria:

• diagnosed with Cystic Fibrosis
• clinically stable with no significant changes in health status within the 14 days prior to the first study visit
Exclusion Criteria:

• no prior solid organ transplantation
• no initiation of an investigation drug within 28 days before
• no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days
• no acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days
Respiratory System, Rare Diseases, Rare Diseases
cystic fibrosis
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Real-Time Feedback (RTFB) to Improve Colonoscopy

To test whether real-time feedback during the withdrawal phase of colonoscopy improves quality of colonoscopy and the adenoma detection rate.

Piet de Groen
18 years and over
STUDY00007271
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Inclusion Criteria:

• Any endoscopist willing to parcipate and performing routine colonscopy
Exclusion Criteria:

• No exclusion criteria
Digestive & Liver Health
Clinics and Surgery Center (CSC)
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Testing for otolith organ dysfunction in gravitational Insecurity

Gravitational insecurity is a condition of life-long balance problems that has been identified by occupational therapists. This study will determine if one source of these problems may be deficiencies in the input from the otolith organs of the inner ear that determine the orientation of the head to gravity. This determination will be made using the psychophysical test of setting a pointer to the visual vertical, which normally depends on otolith organ input.

Michael Potegal
18 years and over
This study is also accepting healthy volunteers
STUDY00018681
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Inclusion Criteria:

• Adults 18 to 70 yrs old with and without lifelong balance problems
Exclusion Criteria:

• Diseases affecting the central nervous system (Parkinson's disease, MS, stroke, epilepsy, brain tumor or history of brain surgery).
• Other exclusions include: balance problems due to hip, knee, or other leg injuries; vestibular migraines; frequent or chronic vertigo (explained as the world seeming to spin around); pregnancy.
Brain & Nervous System
fear of heights, lifelong balance problems
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Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)

People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006831
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Inclusion Criteria:

• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
Exclusion Criteria:

• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Membranous Nephropathy, Nephrotic Syndrome
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The role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer

We are looking at the relationship between cytomegalovirus (CMV) and the symptoms reported by women who received chemotherapy for ovarian cancer. We are also looking at specific blood tests and their association with women’s symptoms and cancer recurrence.

Rachel Vogel
18 years and over
This study is NOT accepting healthy volunteers
SITE00001495
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Inclusion Criteria:

• at least 18 years old
• able to read and write in English
• newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
• treatment plan includes chemotherapy
• either within 2 years of completing initial chemotherapy or haven't started chemotherapy
Exclusion Criteria:

• previously had chemotherapy
• in hospice or nursing home
Cancer, Women's Health
Clinics and Surgery Center (CSC), CMV, cytomegalovirus, Ovarian Cancer
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Assess Pituitary Function in COVID-19 Patients and Correlate Results with Clinical Symptoms Fatigue

We are studying hormone levels and fatigue of people who have recently had COVID-19. Participants will complete questionnaires and have blood drawn to determine hormone levels. Participants who are experiencing high levels of fatigue or who have abnormal hormone levels will complete questionnaires and have blood drawn every three months for a year. We are hoping to determine how COVID-19 affects hormone levels and the pituitary gland, which is responsible for releasing hormones.

Takako Araki
18 years and over
This study is NOT accepting healthy volunteers
SITE00001460
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Inclusion Criteria:

• People who have COVID-19 documented with a positive SARS-CoV-2 test.
Exclusion Criteria:

• People with pituitary abnormalities diagnosed prior to the diagnosis of COVID-19.
• People receiving hormone replacement therapy, including thyroid hormone, estrogen replacement, (including oral contraceptives), testosterone, or growth hormone.
• People who are on active treatment with oral, topical, inhaled, or injectable corticosteroids (injection within 4 weeks of screening)
• People who have current and continuous (> 3 months) opioid use
• People who are not able to complete study procedures necessary for the study, such as an early morning blood draw.
COVID-19, Diabetes & Endocrine, Infectious Diseases
COVID, COVID-19, Fatigue
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Seasonal influenza vaccine high dose boosting in solid organ transplant recipients

This is a prospective, randomized control trial that will assess neutralizing antibody titers in solid organ transplant (SOT) recipients that receive 2 doses of the high-dose (HD) influenza vaccine during a influenza season. We will evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. The control group will receive 1 HD influenza vaccine and a placebo injection.

Lauren Fontana
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017687
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Inclusion Criteria:

• at least 18 years old
• history of a solid organ transplant (liver, lung, heart, kidney, pancreas) at least 1 year before starting the study
Exclusion Criteria:

• women who are pregnant
• received ATG or carfilzomib in the past 3 months
• received rituximab or basiliximab in the past 3 months
• prednisone dose is greater than 20mg/ day
• history of a severe allergy to influenza vaccine (e.g., Guillain-Barre syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
Infectious Diseases
Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 21 (LGMD21) (Fortify)

This study will use BBP-418 study drug in patients with LGMD to assess the clinical biomarkers, efficacy and safety of BBP-418 during the 36 months treatment phase.

Peter Kang
Not specified
This study is NOT accepting healthy volunteers
STUDY00018570
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Inclusion Criteria:

• 12 to 60 years of age
• genetically confirmed diagnosis of limb girdle muscular dystrophy
• have clinical symptoms of weakness
• weight at least 30 kg (66 lbs.)
• willing to use a highly effective method of birth control until 12 weeks after last dose of study medication
Exclusion Criteria:

• any significant medical or mental health diagnosis including abnormal lab values (study staff will review)
• surgery for scoliosis or other indication planned during the time of the study
• use of ribose or other sugar alcohol-containing supplement within 90 days of staring the study
• use of a systemic corticosteroid for the treatment of muscular dystrophy within 90 days of starting the study
Rare Diseases
Clinics and Surgery Center (CSC), Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), Muscular Dystrophy
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Arthritis & Rheumatic Diseases, Cancer
juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

This is a new type 1 diabetes onset study for ages 12-35 years old. We are looking at JAK inhibitor drugs to see if they can preserve beta cell function.

Antoinette Moran
Not specified
This study is NOT accepting healthy volunteers
SITE00001949
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Inclusion Criteria:

• age 12-35 years (inclusive)
• diagnosis of T1D within 100 days of first study visit
• positive for at least one islet cell autoantibody
• HbA1c no more than 10 %
• body weight at least 35kg (77 pounds)
• willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)
• up to date on recommended immunizations (including flu and COVID-19)
• willing to use highly effective contraception for 3 months after the last dose of study medication
Exclusion Criteria:

• current use of a medication that affects glucose control
• treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids
• current history of infection (HIV, Hepatitis B, TB, herpes etc.)
• current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day
• current or past medical or mental health conditions (study staff will review)
• women who are pregnant, breast feeding, or planning to become pregnant
Children's Health, Diabetes & Endocrine
T1D, new onset, type 1 diabetes,
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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

This is a minimal risk, prospective, non-randomized, open label, multi-center study designed to assess the performance of the PrevisEA device in the prediction of GII. MH4 levels recorded by the device at 12 hours after placement of the device will provide a prediction of no GII development or GII development within 10 days after the procedure and is based on a previously optimized and validated MH4 cutoff level. PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later. The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.

Wolfgang Gaertner, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012967
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Inclusion Criteria:

• 18 to 90 years of age
• having an elective intestinal resection surgery (specific types, study staff will review)
Exclusion Criteria:

• allergy to skin adhesive
• unable to have device applied to the skin on the abdomen
• evidence of infection before surgery, including a deep wound infection or urinary tract infection
• specific types of surgery (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bowel surgery
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Genetic Modifiers and Glycemic Variability in Turner Syndrome

This study is looking at glucose (blood sugar) patterns in participants with Turner Syndrome between the ages of 3-80 years old. This will be done by obtaining 2 hours frequent blood sampling by completing an Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test. Participants will also wear a continuous glucose monitor for 2 weeks. Along with the OGTT and MMTT, participants are asked to provide a blood sample for DNA and RNA testing. Participant’s parents are asked to provide a saliva sample for DNA testing

Kyriakie Sarafoglou
Not specified
This study is NOT accepting healthy volunteers
STUDY00013812
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Inclusion Criteria:

• Participants with a diagnosis of Turner syndrome by karyotype
• Ages 3 to 80
Exclusion Criteria:

• Additional genetic diagnosis detected on karyotype, CMA, or FISH
• Prior diabetes diagnosis
• Current or recent (last 72 hours) use of systemic glucocorticoids
• Current use of hypoglycemic agents
• History of solid organ or bone marrow transplant
• Currently pregnant
• Non English-speaking
Diabetes & Endocrine, Rare Diseases
Turner Syndrome
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Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.

This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study includes two phases: Lung EpiCheck assay development and clinical validation. Samples collected under this protocol will support both phases. The study includes two subject groups: a Cases Series and a Screening Series.

Abbie Begnaud
18 years and over
This study is NOT accepting healthy volunteers
SITE00001631
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Inclusion Criteria:

• Current or past smokers, with at least 20 pack-years
• People who have with either a high suspicion for lung cancer, with surgery planned for biopsy or removal
• People who have lung cancer that hasn't been treated yet
Exclusion Criteria:

• People who have diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
• Current lung cancer is known to be stage III or IV by pathology.
• People having regular screening to monitor a lung nodule
Cancer, Respiratory System
Lung Cancer Screening, Clinics and Surgery Center (CSC)
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PEPN2113: A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy

A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy

Emily Greengard
Up to 17 years old
SITE00001697
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Inclusion Criteria:
Patient must be enrolled on APAL2020SC (NCT04726241) Patients must be < 18 years of age at the time of study enrollment Patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane according to APAL2020SC screening results and meet one of the following: Second or greater relapse or refractory AML as defined below, including isolated extramedullary disease (EMD), but excluding isolated central nervous system (CNS) or isolated testicular disease Second or greater relapse or refractory myelodysplastic syndrome (MDS) Second or greater relapse or refractory mixed phenotype acute leukemia (MPAL) Bone marrow relapse: (patients must meet one of the following criteria to be defined as having relapse disease) A single bone marrow sample showing >= 5% leukemic blasts by flow cytometry performed at the central laboratory, fluorescence in situ hybridization (FISH) testing or other molecular method A single bone marrow with at least two tests showing >= 1% leukemic blasts; examples of tests include: Flow cytometry showing leukemia >= 1% by multidimensional flow cytometry (MDF) performed at the central laboratory (performed at Hematologics Inc. through the screening study APAL2020SC) Karyotypic abnormality with at least one metaphase similar or identical to diagnosis FISH abnormality identical to one present at diagnosis Polymerase chain reaction (PCR) or next generation sequencing (NGS)-based demonstration of leukemogenic lesion identical to diagnosis and >= 1% In cases where a bone marrow aspirate cannot be obtained because of extensive fibrosis, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy. A complete blood count documenting the presence of at least 1,000/ uL (i.e., a white blood count [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) can also be used if a bone marrow aspirate or biopsy cannot be performed Extramedullary relapse: Biopsy proven extramedullary disease after documented complete remission Refractory disease: Following a re-induction cycle after a second relapse, presence of ≥1% leukemic blasts by flow cytometry performed at the central laboratory (performed only at Hematologics through the screening study APAL2020SC), OR there is persistent extramedullary 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 Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Patients must have a performance status corresponding to Eastern 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 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: >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea NOTE: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy Anti-cancer agents not known to be myelosuppressive (e.g., 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 Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (eg. 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: >= 30 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer [NK] cells, dendritic cells, etc.) External beam 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 Patients must not have received prior exposure to uproleselan (GMI-1271). NOTE: Prior therapy with fludarabine and/or cytarabine is permitted For patients with leukemia: Platelet count >= 25,000/uL (may receive platelet transfusions) Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows: Age: 1 month to < 6 months; Maximum serum creatinine (mg/dL): 0.4 (male); 0.4 (female) Age: 6 months to < 1 year; Maximum serum creatinine (mg/dL): 0.5 (male); 0.5 (female) Age: 1 to < 2 years; Maximum serum creatinine (mg/dL): 0.6 (male); 0.6 (female) Age: 2 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female) Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 225 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L Albumin >= 2 g/dL Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
Exclusion Criteria:
Patients with any of the following diagnoses Patients with isolated or refractory central nervous system (CNS) disease or isolated or refractory testicular relapse Patients with acute promyelocytic leukemia (APL) Patients with juvenile myelomonocytic leukemia (JMML) Patients with a known congenital bone marrow failure syndrome 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 and for 3 months after the last dose of uproleselan (GMI-1271). 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 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 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
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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT (RECONNECT)

The purpose of this study is to investigate how effective and safe ZYN002, a transdermal gel, is in participants with FXS. The drug product ZYN002 is a pharmaceutically manufactured CBD. It is being developed as a clear gel that can be applied to the skin (called transdermal delivery), to provide consistent, controlled levels of CBD in the blood when it is given twice a day. Participants will be assigned by chance to get one of the following study treatments: Active study drug – ZYN002 or placebo. Assigning study drug by chance is called “randomization,” and it is an important part of testing an experimental study drug. Participants will be randomly assigned to study treatment according to a computer program and will have 1 in 2 chance of receiving the active study drug.

Amy Esler
3 years to 23 years old
This study is NOT accepting healthy volunteers
SITE00001338
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Inclusion Criteria:

• ages 3 to less than 23 years
• resides with caregiver who will continue to provide consistent care throughout the study
• diagnosis of Fragile X Syndrome (FXS) through molecular documentation
• body mass index between 12-30 kg/m2
• in generally good health based upon the results of medical history, physical exam, 12-lead ECG and clinical laboratory test results
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant, nursing or planning a pregnancy
• has transitioned to independent living or living in a residential facility such as a university setting or congregate care
• use of cannabis or any THC or CBD-containing product within 3 months first study visit or during the study
• positive drug screen, including ethanol, cocaine, THC, barbiturates, amphetamines (unless prescribed), benzodiazepines (except midazolam or comparable administered for blood draws and ECG collection), and opiates
• additional medical or mental health diagnosis (study staff will review)
Rare Diseases
Fragile X Syndrome
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CMRR Healthy Participant Registry

The purpose of this Health Participant Registry is to collect the names, contact information and answers to safety screening questions that assist in the determination of magnetic resonance (MR) compatibility of individuals who have expressed interest in MR research.

Jeramy Kulesa
18 years and over
This study is also accepting healthy volunteers
00015977
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Inclusion Criteria:

• at least 18 years old
• English speaking
• able to have a MRI scan, must complete assessment
Exclusion Criteria:

• women who are pregnant
Imaging, MRI
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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.

Nathaniel Gaeckle
18 years and over
This study is NOT accepting healthy volunteers
SITE00001599
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Inclusion Criteria:

• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
Exclusion Criteria:

• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs
Respiratory System
COPD
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A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study (COMPLETE TAVR)

The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.

Greg Helmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012707
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Inclusion Criteria:

• at least 18 years old
• diagnosis of severe symptomatic aortic valve stenosis and coronary artery disease
• successful transfemoral transcatheter aortic valve replacement (TAVR) defined as the implantation of a single transcatheter aortic valve within the past 96 hours
Exclusion Criteria:

• percutaneous coronary intervention (PCI) already completed less than 90 days before TAVR
• planned PCI or cardiac surgery
• additional significant heart or medical diagnosis (study team will review)
Heart & Vascular
Clinics and Surgery Center (CSC), Aortic Stenosis, Coronary Artery Disease, TAVR, transfemoral transcatheter aortic valve replacement
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Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

A pilot study looking at an adult-based non-pharmacologic interventional trial in collaboration with psychologist who has expertise in cognitive behavioral therapy (CBT) for adolescents with chronic disease and intellectual disability and developing processes towards independence in non-Sickle Cell Disease settings.

Alexander Boucher
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018692
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Inclusion Criteria:

• 18 to 24 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Blood Disorders, Mental Health & Addiction
SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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Ten Thousand Families Study

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.

Jen Poynter
Not specified
This study is also accepting healthy volunteers
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
Cancer, Microbiota, Prevention & Wellness
Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
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MT2005-25 Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

To determine the incidence of engraftment (defined as achieving donor derived neutrophil count >500/uL by day 42) in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.

Christen Ebens
Up to 3 years old
0511M77206
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Inclusion Criteria:
Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority: 1st priority: 4/6 matched unit, cell dose >5 x 10-7 nucleated cells/kg 2nd priority: 5/6 matched unit, cell dose > 4 x 10-7 nucleated cells/kg 3rd priority: 6/6 matched unit, cell dose > 3 x 10-7 nucleated cells/kg Patients aged ≤ 3 years at diagnosis (not age of transplant) with hematological malignancy as detailed below: Acute myeloid leukemia: high risk CR1 as evidenced by: High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., <15% blasts in BM). Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); >1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology. Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: Patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy. MRD will be defined by either flow cytometry (>0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (PCR or FISH) or conventional cytogenetics (g-banding). New Leukemia Subtypes: A major effort in the field of pediatric hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee. Recipients must have a Lansky score ≥ 50% and have acceptable organ function defined as: Renal: glomerial filtration rate > 60ml/min/1.73m^2 Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal, Pulmonary function: oxygen saturation >92% Cardiac: left ventricular ejection fraction > 45%. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Exclusion Criteria:
Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days). History of HIV infection or known positive serology Myeloablative transplant within the last 6 months. Evidence of active extramedullary disease (including central nervous system leukemia).
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Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The purpose of this research study is to test the efficacy of the study drug, Brivaracetam, to reduce nerve pain in SCI. We also want to determine whether Brivaracetam impacts mood, brain, and genes to help us design more research with this study drug in the future. We will assign you randomly to one of 2 groups: the group that receives the active study drug (Brivaracetam) or the group that receives a placebo (sugar pill). There is a 50-50 chance that you will be assigned to one group or the other, similar to flipping a coin. Participation in this study will last approximately 11 weeks and will include 3 study visits to the study site; however, participation in the study can also be entirely virtual which would require no visits to the study site.

Ricardo Battaglino
18 years and over
This study is NOT accepting healthy volunteers
SITE00001486
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Inclusion Criteria:

• spinal cord injury occurred at least 3 months earlier
• completed inpatient rehabilitation and living in the community
• experiencing chronic neuropathic pain for three months or more
• for people of child-bearing potential: currently practicing an effective form of two types of birth control
Exclusion Criteria:

• progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
• brain injury or cognitive impairment limiting the ability to follow directions
• women who are pregnant or breastfeeding
• medical and mental health diagnosis that may interfere with study drug (study staff will review)
Brain & Nervous System
Neuropathic Pain, Spinal Cord Injuries
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First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method

We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.

Corey McGee, PhD, MS, OTR/L, CHT
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006741
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Inclusion Criteria:

• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
Exclusion Criteria:

• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Arthritis & Rheumatic Diseases
Arthritis, CMC, CMC/Carpometacarpal, Osteoarthritis
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