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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.

142 Study Matches

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)

To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)

Principal Investigator: Nattawat Klomjit
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020504
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Inclusion Criteria:

• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
Keywords: Clinics and Surgery Center (CSC), Glomerulonephritis, IC-MPGN
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A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)

The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.

Principal Investigator: Joshua Hou
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00002014
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Inclusion Criteria:

• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
Exclusion Criteria:

• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
Conditions: Vision & Eyes
Keywords: Cornea, Persistent Corneal Epithelial Defect, Vision Loss
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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001674
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Inclusion Criteria:

• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
Exclusion Criteria:

• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Conditions: Cancer
Keywords: lung cancer, osteosarcoma, pulmonary metastases, thoracotomy
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MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes

Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001766
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Inclusion Criteria:

• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
Exclusion Criteria:

• documented HIV infection
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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Validation of Flexible, Wearable Sensors to Detect and Monitor Tics

The goal of this study is to design wearable, comfortable sensors to measure muscle movement during tics. Small, flexible EMG sensors (the size of the head of a pin) will be embedded in a “band-aid like” plastic sticker which is placed on the side of the face. Participants will be video recorded as they complete movement tasks. The entire visit will take approximately 2 hours.

Principal Investigator: Brianna Wellen
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022783
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Inclusion Criteria:

• 10 to 21 years old
• must have chronic tics present for at least 1 year
• must have at least one facial tic that occurs at least approximately once every 2-5 minutes
Exclusion Criteria:

• active acute skin disorders
• previous diagnosis of psychosis or cognitive disability
• currently suicidal
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: Tic disorders, Tics, Tourette Syndrome
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MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)

CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001764
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Inclusion Criteria:

• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CGD, Chronic Granulomatous Disease, Gene Therapy, GT, HCT, Hematopoietic Cell Transplant
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Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback

The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.

Principal Investigator: Jerica Berge
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00000706
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Inclusion Criteria:

• Child 5-10 years old
• Have a sibling who lives in the home with the child
• Live in the Metro area
• Speaks English or Spanish
Conditions: Prevention & Wellness, Children's Health
Keywords: family, family meals, nutrition, primary care
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LTx READY CF 2: A Multi-Site RCT: Lung Transplant Resources for Education And Decision-making for Your CF 2 Study: A Multi-Site Randomized Controlled Clinical Trial

The primary study objective is to determine whether “Take on Transplant” (ToT), a CF-specific Lung Transplant (LTx) educational website, improves patient-reported preparedness for LTx discussions, as measured by the Preparation for Decision Making (PrepDM) Scale at 3 months after randomization, compared to an attention control transplant website (unos.org, UNOS).

Principal Investigator: Jordan Dunitz
IRB Number: SITE00001827
Conditions: Rare Diseases
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MN CF Center Consent (PortCF) Cystic Fibrosis (CF) Center Program Accreditation and Funding

This retrospective, longitudinal project is to collect certain demographic and clinical health status information for entry into the CF Foundation Patient Registry (also known as PortCF). The registry has played an important role in CF research and will continue to do so. In addition, much of the same information is entered into the University of Minnesota Cystic Fibrosis Center Research Database. This patient database has been maintained since 1975.

Principal Investigator: Jordan Dunitz
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 7405M00054
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Inclusion Criteria:

• possible diagnosis of Cystic Fibrosis (CF) or CF-related complications
• receive care at the MN CF Center
Keywords: Clinics and Surgery Center (CSC), cystic fibrosis, CF, MNCF
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CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)

The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.

Principal Investigator: Susan Kline, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001888
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Inclusion Criteria:

• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
Exclusion Criteria:

• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Conditions: Infectious Diseases, Rare Diseases
Keywords: Sudan Virus Disease, SVD
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Principal Investigator: Byron Vaughn
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013632
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's disease
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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.

Principal Investigator: Peter Kang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), Muscular Dystrophy
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Amblyopia Treatment Study (ATS23): A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

Amblyopia (sometimes called 'lazy eye') is reduced vision in one eye caused by abnormal visual development early in life. The weaker (or 'lazy') eye often wanders inward and outward. Amblyopia is the leading cause of reduced vision in children and can lead to blindness if not treated. Treatments for amblyopia are glasses, and if needed, further treatment with part-time patching or penalization with atropine eye drops. Patching or atropine are administered to the stronger eye to force the child to use the weaker (amblyopic) eye. In recent years, an alternative type of therapy has emerged. It is called dichoptic treatment and involves stimulating both eyes simultaneously but with different stimuli. When it was first introduced, it was done in an office-based setting. Home-based technologies utilizing games and movies have been developed and studied to a limited extent in younger children with amblyopia. In this study, we will use a system called Luminopia. It uses a virtual reality headset to view web-based videos in which the contrast of the image seen by the stronger eye is reduced by 15% from that of the weaker eye. Luminopia has been available for use in the U.S. since 2022 and has been approved by the FDA for the treatment of amblyopia in this age group. In a previous large randomized trial, home-based dichoptic movies were shown to be superior to glasses alone but treatment effectiveness compared to patching (the gold standard for treating amblyopia) has not yet been established. If dichoptic therapy using the Luminopia system is confirmed to be at least as effective as patching, it would be an appealing alternative for treating amblyopia in young children, as it shows promise of better adherence and an easier treatment experience for the parent and the child. Children in this study would be randomized 1:1 to either the Patching Group or the Luminopia Group and followed for at least 6 months. Children in the Patching Group will have the option to do the Luminopia treatment after 6 months of patching. They will be followed for an additional 6 months. Thus, their participation will last for a total of 1 year.

Principal Investigator: Raymond Areaux
Age Group: Up to 18 years old
IRB Number: STUDY00022243
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Inclusion Criteria:

• children 4 to 7 years old
• amblyopia (lazy eye) associated with strabismus, anisometropia, or both (previously treated or untreated)
• parent has phone (or access to phone) and is willing to be contacted
Exclusion Criteria:

• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
Conditions: Children's Health, Vision & Eyes
Keywords: Amblyopia, Lazy Eye
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A US Multi-center, Prospective, Non-interventional, Long-term, Effectiveness and Safety Study of Patients Treated with SKYTROFA (lonapegsomatropin) (SkybriGHt) (SkybriGHt)

Skytrofa is approved in the U.S. for sale and use in children with growth hormone deficiency (GHD). This study is being done to find out how safe and useful Skytrofa is for long-term treatment. A child’s care will follow the normal treatment practices at the clinic. There is no new treatment or medicine involved and no additional visits will be performed.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002031
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study
Conditions: Rare Diseases
Keywords: growth hormone, growth hormone deficiency
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Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Principal Investigator: Williams Dobyns
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011194
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Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Conditions: Brain & Nervous System, Rare Diseases, Children's Health
Keywords: Genetic disorders, developmental brain disorders, developmental disorders
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A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015869
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Inclusion Criteria:

• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
Exclusion Criteria:

• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Alport Syndrome, Focal Segmental Glomerulosclerosis
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Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Principal Investigator: Kristin Gravel
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00010956
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Inclusion Criteria:

• ages 4 to 14 and 11 months old
• 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)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• already using a cochlear implant
Conditions: Ear, Nose & Throat
Keywords: Pediatric audiology, Audiology, Cochlear Implant, Single-Sided Deafness
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Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)

We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.

Principal Investigator: Christine Conelea
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020646
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Inclusion Criteria:

• 12 to 21 years old
• right-handed
• currently have OCD symptoms
Exclusion Criteria:

• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: Obsessive-compulsive disorder, OCD, psychology, therapy, TMS, transcranial magnetic stimulation
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Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

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.

Principal Investigator: Emily Nagel
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016926
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Inclusion Criteria:

• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
Exclusion Criteria:

• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use 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
Conditions: Children's Health, Women's Health
Keywords: Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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Udall P1A4

Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.

Principal Investigator: Jerrold Vitek
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019735
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Inclusion Criteria:

• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
Exclusion Criteria:

• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
Conditions: Brain & Nervous System
Keywords: DBS, Dystonia, Essential Tremor, ET, Movement Disorders, Parkinson's, Parkinson's Disease, PD
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Self-Weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot

This study will test whether adding in daily weighing (5-7 days per week) is helpful in weight loss. In adults, it has been found to be helpful to have individuals who are obese to be more successful with their weight loss efforts if they weigh themselves at home every day. We want to see if this could be helpful in children as well. This research will last for about 12 weeks (3 months).

Principal Investigator: Carolyn Bramante
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012679
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Inclusion Criteria:

• aged 12 to <18 years
• BMI at the 95th percentile or greater
• weight loss or maintenance determined as the treatment goal by PWMC provider
Exclusion Criteria:

• any unhealthy weight control behaviors
• participation in other PWMC study
• developmental delay
• diagnosis that might cause weight fluctuations in weight
• severe anxiety or depression
Conditions: Children's Health
Keywords: children's health, obesity, weight, weight management
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Testing ACL Reconstruction Outcome PredicTions (TAROT)

The purpose of this study is to see how accurately orthopaedic surgeons predict outcomes for people who have an anterior cruciate ligament (ACL) reconstruction. Patients will be asked to complete post-surgery surveys about occurrence of side effects, return to activity, reoperation, and satisfaction with the surgery at 4 months, 2 years, and 5 years.

Principal Investigator: Richard Kyle Martin
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021757
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Inclusion Criteria:

• patients undergoing primary ACLR (anterior cruciate ligament reconstruction) at the University of Minnesota, Tria and CentraCare.
Conditions: Bone, Joint & Muscle
Keywords: ACL, anterior cruciate ligament, anterior cruciate ligament reconstruction, Clinics and Surgery Center (CSC), ortho surgeon prediction
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Humanitarian Use Device: Medtronic DBS Therapy for Dystonia (HDE #H020007) (Dystonia IRB)

Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions affecting fewer than 4,000 patients per year. The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Effective treatment of symptoms, however, has not been studied in formal clinical trials. Medtronic DBS Therapy delivers electrical stimulation to areas in the brain to help control symptoms of various movement disorders. You may be a candidate for Medtronic DBS Therapy for Dystonia if you have been diagnosed with chronic, intractable (drug refractory) primary dystonia. You or your third party payer (health insurance, Medicare, Medicaid or other) must provide payment for hospital, office and other medical costs related to this therapy.

Principal Investigator: Jerrold Vitek
Age Group: 7 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1207M17701
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Inclusion Criteria:

• 7 to 99 years old
• diagnosed with chronic, intractable (drug refractory) primary dystonia determined by a neurologist or neurosurgeon
Exclusion Criteria:

• patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist
• patients who have not had an adequate trial of medical or non-surgical treatment
Conditions: Brain & Nervous System
Keywords: DBS, Deep Brain Stimulation, Dystonia
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Causal Modeling of Ecological Momentary Assessment and Wearable Data in Youth

Researchers want to find out more about how physical, cognitive, and emotional factors affect eating.

Principal Investigator: Amy Gross
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021073
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Inclusion Criteria:

• 13-17 years old
• BMI at or above the 95th percentile
• own a smartphone
• willing to wear a FitBit or Garmin that we provide, download the FitBit or Garmin app on your smartphone and allow transfer of data to study staff
Exclusion Criteria:

• medication changes in the last 28 days for medications that are likely to affect appetite, mood, and attention
Conditions: Brain & Nervous System, Children's Health
Keywords: adolescents, Eating behaviors
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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)

The purpose of this multicenter study is to compare outcomes between patients who will undergo different types of ACL reconstruction. All patients will have a tendon from their own knee used to reconstruct the ACL. Prior to knee surgery, researchers will randomize (i.e. a coin toss) to determine if ACL reconstruction will be done with patellar or quadriceps tendon and if the lateral extra-articular tenodesis will or will not be added to the ACL surgery. We will follow-up with participants as they undergo treatment and recovery after surgery for 2 years.

Principal Investigator: Jeffrey Macalena
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000971
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Inclusion Criteria:

• age 14-25
• ACL deficient knee
• at least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity
Exclusion Criteria:

• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
Conditions: Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), ACL, Anterior cruciate ligament reconstruction, joint instability
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An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease

PR001A is designed to deliver a normal GBA1 gene copy into the body to increase the activity of GCase, which is low in Type 2 Gaucher Disease (GD2) patients. The new GBA1 gene will remain a child’s body cells for many years and possibly for the rest of their life. A participant will need one surgery during which the study drug will be given and will stay in the hospital for at least 48 hours following the surgery.

Principal Investigator: Chester Whitley, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00008823
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Inclusion Criteria:

• 0 to 24 months of age
• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
Exclusion Criteria:

• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
Conditions: Rare Diseases
Keywords: Gaucher disease, Type 2 (GD2)
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A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)

The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002030
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study for short stature
Conditions: Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
Keywords: growth hormone and growth hormone deficiency

Projecting Outcomes in Respiratory Technology Dependent Children After Serious Illness (Project ORCAS)

We are hoping to understand more about how being in the ICU impacts children who use breathing support at home and their families. As part of this research study, families will be asked to complete the following during the four study periods: - Complete questionnaires - Airway oscillometry will be used to test your child’s breathing - Complete short daily surveys

Principal Investigator: Julia Heneghan
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021472
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Inclusion Criteria:

• Current pediatric ICU admission of at least 24 hours
• Presence of CRTN (any use of supplemental respiratory support, from nasal cannula to around-the-clock mechanical ventilation via a tracheostomy, when the child is at his or her clinical baseline)
• age at least 4 weeks (and at least 40 weeks corrected gestational age) and <17 years at the time of enrollment;
• Presence of at least one parent or legal guardian in the home who would be able to provide information about the child’s daily activities outside the hospital via web- and texting-based interfaces
Exclusion Criteria:

• Child is enrolled in an interventional study related to provision of pediatric critical care services
• Family does not speak English to an extent to be able to adequately participate in consent discussions or study protocols
Conditions: Children's Health, Respiratory System
Keywords: critical care, outcomes
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Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Principal Investigator: Sonya Wang
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020174
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Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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The TrialNet Natural History Study of the Development of Type 1 Diabetes

TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: SITE00000016
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Inclusion Criteria:

• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:

• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Conditions: Diabetes & Endocrine
Keywords: T1DM, Type 1 Diabetes