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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.

414 Study Matches

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.

Sonya Wang
Up to 18 years old
This study is NOT accepting healthy volunteers
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
Brain & Nervous System, Children's Health, Mental Health & Addiction
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.

Antoinette Moran
Not specified
This study is also accepting healthy volunteers
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
Diabetes & Endocrine
T1DM, Type 1 Diabetes

Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Greg Helmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013236
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Inclusion Criteria:

• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
Exclusion Criteria:

• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
Heart & Vascular
Clinics and Surgery Center (CSC), Dilated Cardiomyopathy, Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)

MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

People planning to undergo a bone marrow transplant and are at risk for developing problems with the lungs related to this planned therapy. The types and seriousness of lung problems that may develop after transplant can be very different and currently, we don’t exactly know what risk factors influence who develops them or how they may respond to therapy. Also, we do not know what the best test is to monitor lung function after transplant, especially in children and young adults. The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what is the best method for diagnosing lung problems and following how well the lungs are working. In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.

Samuel Goldfarb
This study is NOT accepting healthy volunteers
SITE00001589
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Inclusion Criteria:

• up to 24 years old
• undergoing allogeneic or autologous HSCT
Breathing, Lung & Sleep Health
Diffuse Alveolar Hemorrhage, Hematopoietic Stem Cell Transplant (HSCT), Interstitial Pneumonitis
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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
Visit study website
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Electronic Platform for Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long‐Acting Growth Hormone Therapy (LAuGH TRACK UMN) (LAuGH TRACK)

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00011784
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Inclusion Criteria:

• girls ages 2-11 years
• boys ages 2-13 years
• established diagnosis of pediatric growth hormone deficiency (GHD).
• For this study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of <10 ng/mL Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance.
Exclusion Criteria:

• any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
• current treatment with long-acting growth hormone
• currently pregnant or breastfeeding
Children's Health, Diabetes & Endocrine
Growth Hormone Deficiency
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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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A Retrospective Follow-Up Study of the Durability of Antiviral Therapy on Long-Term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

The purpose of this study is to find out if treatment of congenital cytomegalovirus (cCMV) with an antiviral medicine has any impact on hearing, development of cancers, overall development and sexual maturity development. No treatment for cCMV will be provided in this study.

Mark Schleiss
Not specified
This study is NOT accepting healthy volunteers
SITE00002065
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Inclusion Criteria:

• at least 2 years old
• received intravenous ganciclovir or oral valganciclovir to treat congenital cytomegalovirus (CMV) infection
• may have participated in the CASG study of the treatment of congenital CMV
Exclusion Criteria:

• unable to comply with study-related procedures
Children's Health, Infectious Diseases
CMV, Cytomegalovirus
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Efficacy and safety of SGLT2 inhibitor therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study

In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) (generic name: empagliflozin) for patients who are overweight/obese and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).

Amir Moheet
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019241
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Inclusion Criteria:

• 18 years or older
• diagnosis of cystic fibrosis related diabetes (CFRD)
• BMI >25 kg/m2
• woman who could become pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study
Exclusion Criteria:

• acute respiratory exacerbation requiring IV antibiotics or systemic glucocorticoids within prior 4 weeks
• less than 12 weeks since start of a new CFTR corrector/modulator therapy
• type 1 diabetes
• history of diabetic ketoacidosis
• history of recurrent genital or urinary tract infections
• women who are pregnant or breastfeeding
• history of eating disorder
• there are additional exclusion criteria (study staff will review)
Rare Diseases, Diabetes & Endocrine
CF, CFRD, Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Diabetes
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Diaphragmatic Breathing Exercises for post-COVID-19 Diaphragmatic Dysfunction (DD)

There is evidence that dysfunction of the diaphragm following COVID infection that leads to the shortness of breath and chest tightness. The diaphragm is the main muscle of respiration. This study involves muscle stretching of the diaphragm and associated muscles to improve the quality of respiration. Half of the participants will receive PT twice a week, for 12 weeks, for 1 hour (in person) and a half hour via telehealth. A control group will undergo traditional treatment as recommended by your provider.

Farha Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017641
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Inclusion Criteria:

• age 18 and above
• PCR positive 4 weeks prior to the development of the respiratory symptoms
• new diagnosis of PASC (new-onset symptoms of fatigue, shortness of breath, chest tightness or persistence of symptoms 4 weeks following a positive PCR test for COVID-19)
• did not need hospitalization of 5 days or more and did not need ICU admission
• nose breathers
• symptoms include shortness of breath, chest tightness, and fatigue
Exclusion Criteria:

• pre-existing lung disease such as COPD, IPF, Asthma, Exercise induced Asthma, Lung cancer, or history of Lung transplant
• history of current smoking and pack years of 10
• history of coronary artery disease
• general anxiety disorder
• unable to have full range of motion of the shoulders
• on antidepressants prior to covid-19 infection
• women who are pregnant
• unable to read and speak English
• previously diagnosed severe cognitive deficits such as dementia, developmental defects
• acute medical conditions, psychiatric disorders such as schizophrenia, mania, and psychosis, neurologic disorders such as stroke, Parkinson?s disease and Multiple sclerosis
Respiratory System
COVID-19, shortness of breath
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A Phase 1/2, Multi-Center, Dose-Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to < 18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations (Protocol Number: AC220-A-U202/ADVL1822)

This is an open-label, multi-center, single arm, Phase 1/2 study to evaluate the safety, PK, PD, and efficacy of quizartinib administered in combination with fludarabine and cytarabine (FLA) (Re-Induction Cycles 1 and 2) chemotherapy for re-induction, with optional consolidation chemotherapy, and as a single agent continuation therapy (after optional, but strongly encouraged, HSCT per standard of care), in pediatric relapsed/refractory AML subjects aged ≥1 month old to <18 years old (and young adults up to 21 years old) with FLT3-ITD mutations.

Robin Williams
Not specified
This study is NOT accepting healthy volunteers
STUDY00005937
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Inclusion Criteria:

• one month to 21 years old
• diagnosis of AML
• first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted
• fully recovered from the acute clinically significant toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• diagnosed with isolated central nervous system relapse, acute promyelocytic leukemia (APL), juvenile myelomonocytic leukemia with translocation, or with myeloid proliferations related to Down syndrome
• has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment
• known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C)
• known history of human immunodeficiency virus (HIV)
Cancer
Acute Myeloid Leukemia
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ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)

This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.

Gregory Vercellotti
This study is NOT accepting healthy volunteers
SITE00001194
Digestive & Liver Health, Rare Diseases
Clinics and Surgery Center (CSC)
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COG ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Brenda Weigel, MD, MSc
Not specified
This study is NOT accepting healthy volunteers
SITE00001858
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Inclusion Criteria:

• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
Exclusion Criteria:

• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant
Cancer, Cancer, Children's Health
Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
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Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

This trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs and has a change (mutation) in a gene called EGFR. Sometimes, mutations in this gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly.

Nicole Hartung
18 years and over
This study is NOT accepting healthy volunteers
MMCORC040
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Inclusion Criteria:

• confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
• have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive therapy, or recurrent disease
• no prior systemic treatment for metastatic disease
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional inclusion criteria (study staff will review)
Cancer
Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer, NSCLC, Stage III or Stage IV Lung Cancer
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R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis

This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis.

Maneesh Bhargava
18 years and over
This study is NOT accepting healthy volunteers
SITE00001283
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Inclusion Criteria:

• age 18-80
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:

• history/current use of cigarette, e-cigarette, vaping or marijuana smoking
• history/current use of nicotine products
• presence of underlying chronic condition
• inability to undergo procedure using IV sedation
• weight < 110 lbs. & BMI > 35 kg/m2
• pregnant and/or breast feeding
• history/current use of chronic immunosuppressive medications
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Lung, Pulmonary, Sarcoidosis, Clinics and Surgery Center (CSC)
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Personalized immunomodulation in pediatric sepsis-induced MODS (PRECISE)

This is a large-scale multi-center study of personalized, targeted immune modulation in childre with sepsis-induced multiple organ dysfunction syndrome (MODS). This study is titled the “PeRsonalizEd immunomodulation in pediatriC sepsIS-inducEd MODS (PRECISE)”. The study includes two concurrent, immunophenotype-driven placebo controlled randomized controlled trils (RCTs) that will address the central hypothesis that individualized, pathophysiology-specific immunomodulation will improve outcomes from sepsis-induced MODS in children

Marie Steiner
SITE00001419
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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.

Susan Kline, MD
Not specified
This study is NOT accepting healthy volunteers
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)
Infectious Diseases, Rare Diseases
Sudan Virus Disease, SVD
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AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00001972
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Inclusion Criteria:

• 5 to 60 years old
• newly diagnosed untreated confirmed Hodgkin lymphoma
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• patients with nodular lymphocyte predominant Hodgkin lymphoma
• patients with a history of active interstitial pneumonitis or interstitial lung disease
• administration of prior chemotherapy, radiation, or antibody-based treatment for classic Hodgkin Lymphoma (cHL)
• prior solid organ transplant
• prior allogeneic stem cell transplantation
• women who are pregnant or breast feeding
Cancer
cHL, Hodgkin Lymphoma, Hodgkin's, Lymphoma
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MT2019-38: Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)

The purpose of this study is to develop a questionnaire specifically designed for children and adolescents, which will help health care providers to better measure how bothersome symptoms of cGVHD are for children and adolescents living with cGVHD. Another purpose of this study is to design a caregiver companion questionnaire, to allow caregivers to measure how bothersome the symptoms of cGVHD are for their child/adolescent.

Margaret MacMillan, MD
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00000722
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Inclusion Criteria:

• children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
• clinical diagnosis of Graft vs Host Disease (cGVHD)
• currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months -eligible caregiver proxy who is willing to participate in the study
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• participant's cognitive ability would compromise their ability to participate in study related procedures
• study staff will review
Cancer
cGVHD, Graft vs Host Disease
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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).

Jordan Dunitz
SITE00001827
Rare Diseases
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MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.

Veronika Bachanova, MD
Not specified
This study is NOT accepting healthy volunteers
1611M99805
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Inclusion Criteria:

• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease

The purpose of this study is to test a new drug, called ST-920, to see if it is safe and if it works to treat Fabry disease. ST-920 is a gene therapy treatment, which means that ST-920 replaces the missing or broken gene you have because you have Fabry disease, with a version or copy that works.

Chester Whitley, MD, PhD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007094
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Inclusion Criteria:

• at least 18 years of age
• diagnosis of Fabry disease
• one or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma
• fully vaccinated for COVID- 19 per CDC guidance
• additional requirements apply for cardiac and renal groups (study staff will review)
Exclusion Criteria:

• history of liver disease
• current or history of use in the last six months of systemic steroids
• other significant medical & mental health diagnosis (study staff will review)
Rare Diseases
Fabry Disease
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A prospective, randomized, controlled, blinded study to assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.

The purpose of this study is to assess the safety and effectiveness of the Butterfly study device in reducing the symptoms that are associated with the BPH condition. Another purpose is to assess sexual function and quality of life following the use of the Butterfly study device. The Butterfly study device includes a metal (nitinol) implant that looks like a butterfly. The implant is inserted through the urethra - the tube that carries pee out of the body, and resides at the area of the prostate.

Deepak Agarwal
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017389
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Inclusion Criteria:

• men who are 50 to 80 years old
• symptomatic BPH
• additional criteria apply, study staff will review
Exclusion Criteria:

• known sensitivity to Nickel
• current urinary retention
• urinary stress incontinence
• currently active bladder tumor or intravesical instillation
• additional exclusion criteria related to prostate or urinary tract function (study staff will review)
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)
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Tissue biopsies for the study of FSHD

A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of Fascioscapulohumeral Muscular Dystrophy (FSHD) muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.

Michael Kyba
Not specified
This study is also accepting healthy volunteers
STUDY00000409
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Inclusion Criteria:

• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
Exclusion Criteria:

• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Rare Diseases, Heart & Vascular
Fascioscapulohumeral Muscular Dystrophy (FSHD), Clinics and Surgery Center (CSC)
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Ida-Arlaine Fonkoue
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014457
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Inclusion Criteria:

• female
• 18 years and older
• pre-menopausal
• must have experienced a past trauma, with or without PTSD Diagnosis
Exclusion Criteria:

• pregnant or breastfeeding
• severe traumatic brain injury
• hypertension
• diabetes
• heart disease
• vascular disease
• illicit drug use within the past 6-months prior to participation
• inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3
Mental Health & Addiction, Women's Health
Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)

We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.

Les Forgosh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001919
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Inclusion Criteria:

• at least 18 years old
• diagnosis of heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
Exclusion Criteria:

• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
Heart & Vascular
Heart Failure
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NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.

Elizabeth Neil
18 years and over
This study is NOT accepting healthy volunteers
MMCORC043
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Inclusion Criteria:

• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
Exclusion Criteria:

• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Brain & Nervous System, Cancer
Brain Cancer, Brain Cancer, Glioblastoma
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Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
MMCORC058
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Inclusion Criteria:

• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
Exclusion Criteria:

• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Cancer
Immune checkpoint inhibitor, Cancer, Disparities
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Treatment of Refractory Nausea

We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.

Kiran Lassi
18 years and over
This study is NOT accepting healthy volunteers
MMCORC057
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Inclusion Criteria:

• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
Exclusion Criteria:

• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Cancer
Breast Cancer, Breast Cancer, Chemotherapy, Nausea
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Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.

Nicole Hartung
18 years and over
This study is NOT accepting healthy volunteers
MMCORC068
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Inclusion Criteria:

• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
Exclusion Criteria:

• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Cancer
Immunotherapy, Lung Cancer, Lung Cancer, Non Small cell lung cancer, NSCLC, Stage IV lung cancer
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