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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.

412 Study Matches

BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

The purpose of this study is to test whether the investigational drug, tegoprubart, in combination with the same standard immunosuppressive medicines (anti-thymocyte globulin, corticosteroids, and mycophenolate) is safe, tolerable and effective compared to tacrolimus. The study will specifically look at the function of the implanted kidney in the tegoprubart group compared to the tacrolimus group and will also assess how well tegoprubart prevents diabetes and prevents rejection.

Andrew Adams
18 years and over
This study is NOT accepting healthy volunteers
SITE00001922
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Inclusion Criteria:

• 18 to 100 years old
• recipient of first kidney transplant from a living or deceased donor
• agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
Exclusion Criteria:

• previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
• medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
• additional criteria apply (study staff will review)
Kidney, Prostate & Urinary
kidney transplant
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Efficacy and safety of GLP-1 agonist therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study

In this study we will be looking at the safety and effectiveness of the medication GLP-1 (Semaglutide) in patients who are overweight and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).

Amir Moheet
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018575
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Inclusion Criteria:

• diagnosis of cystic fibrosis
• diabetic using insulin
• BMI 26 kg/m2 or greater
• able to read & speak English
Exclusion Criteria:

• personal or family history of medullary thyroid cancer
• chronic GI problems requiring hospitalization in the past year
• history of suicide attempts or active ideas of suicide
Rare Diseases, Breathing, Lung & Sleep Health
Cystic Fibrosis, Clinics and Surgery Center (CSC)
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Transdiagnostic Cognitive Biomarkers

This study aims to test the use of electrophysiology and TMS (transcranial magnetic stimulation) in discovering biomarkers for cognitive impairment in chronic pain and depression. Total time anticipated for the study is around 15 hours.

David Darrow
18 years and over
This study is also accepting healthy volunteers
STUDY00011759
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Inclusion Criteria:
Chronic refractory pain or depression:
• chronic pain that is not controlled with oral pain medications or
• diagnosis of major depression
• Healthy participants: adults at least 18 years old
Exclusion Criteria:
Contraindication to TMS:
• Metallic hardware in close contact to the discharging coil (such as cochlear implants, deep brain stimulator, medication pumps)
• History of seizures
• Epilepsy
• Contraindications to MRI
• Inability to complete tasks associated with study
• Pregnancy
• Pediatric participants
• Adult lacking ability to consent
• Non-English speaking
• Blindness Healthy Controls:
• diagnosis of chronic pain or depression
Mental Health & Addiction, Brain & Nervous System
MRI, Depression, Pain, imaging, brain, TMS, stimulation, fMRI
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A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019273
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Inclusion Criteria:

• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
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Chilled Platelet Study (CHIPS)

The purpose of this research study is to compare the transfusion of cold-stored (refrigerated) platelets to standard room temperature stored platelets. The goal of the trial is to determine whether platelets stored cold are similar or better at stopping bleeding compared to platelets stored at room temperature and, if so, to determine the maximum duration of cold storage that maintains a similar effect on bleeding

Claudia Cohn
Not specified
This study is NOT accepting healthy volunteers
SITE00001231
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Inclusion Criteria:

• age greater than 28 days and less than 85 years
• planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:

• known or suspected pregnancy
• conscious objection or unwillingness to receive blood products
• known congenital platelet disorder or bleeding disorder
• additional exclusion criteria (study staff will review)
Heart & Vascular
CABG, cardiac surgery, cardiopulmonary bypass
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Dissecting the role of acetaldehyde in oral carcinogenesis

The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, in order to identify DNA damage that might be crucial to cancer formation.

Silvia Balbo
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012972
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Inclusion Criteria:

• 21 to 45 years of age: alcohol drinker of Eastern Asian descent who experiences flushing (reddening or warming of face) when drinking
• 21 years of age and older: alcohol drinker who have Fanconi Anemia
• 18 to 45 years of age: non-drinkers
Exclusion Criteria:

• Tobacco or nicotine users
Prevention & Wellness
Alcohol, Fanconi Anemia, drinking
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INHALE-1: A 26-week Primary Treatment Phase, with 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza? Versus Rapid-acting Insulin Analog Injections, Both in Combination with a Basal Insulin, in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus (INHALE-1)

To assess the safety of Afrezza in a pediatric population when compared to the usual standard of care insulin.

Muna Sunni
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001625
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Inclusion Criteria:

• 4 years to under 18 years old
• diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM)
• using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
• treated with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
• bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
• basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
• HbA1c between 7.0% and 11%
• average prandial dose of insulin 2 or more units per meal
• used CGM for at least 70% of the time over a consecutive 14-day period before starting the study
• access to stable WiFi connection
Exclusion Criteria:

• history of recent blood transfusions (within previous 3 months)
• recent history of asthma (defined as using any medications to treat within the last year) or any other clinically important lung disease
• history of serious complications of diabetes
• any other illness that isn't stable (study staff will review)
• uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
• current drug or alcohol abuse or a history of drug or alcohol abuse
• smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months
Diabetes & Endocrine
diabetes, insulin, type 1 diabetes, type 2 diabetes
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A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of the Safety and Pharmacodynamic Activity of Gene Therapy for Congenital Adrenal Hyperplasia through Administration of an Adeno-associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene

This is a study designed to evaluate the safety, tolerability, and efficacy of a one-time gene therapy (BBP-631) for adult patients diagnosed with classic congenital adrenal hyperplasia (CAH). The goal of gene therapy for CAH is to give the body a functioning CYP21A2 gene using a vector (an agent used to deliver a gene into the body). Having a functioning CYP21A2 gene in the adrenal gland may allow the body to naturally produce its own cortisol and aldosterone. The study treatment and follow-up lasts 1 year with a long-term follow-up of 4 more years.

Kyriakie Sarafoglou
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012144
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Inclusion Criteria:

• adults with classic Congenital Adrenal Hyperplasia (CAH)
• on stable oral hydrocortisone (HC) regimen as the only glucocorticoid (GC) maintenance therapy
• no prior gene therapy or AAV-mediated therapy
Exclusion Criteria:

• positive for anti-AAV5 (Adeno-Associated Virus Type 5) antibodies
• history of adrenalectomy and/or significant liver disease
• women who are pregnant
Diabetes & Endocrine
Congenital Adrenal Hyperplasia
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A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis (VOCAL)

The aim of this study is to investigate whether voclosporin, added to standard treatment, is able to reduce activity of lupus nephritis over a study treatment period of 24 weeks, and to determine its safety as well as the best dose for treatment of lupus nephritis in children or adolescents.

Michelle Rheault
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001866
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Inclusion Criteria:

• 12 to 17 years old
• diagnosis of systemic lupus erythematosus (SLE)
• active lupus nephritis confirmed by a kidney biopsy
Exclusion Criteria:

• currently need dialysis
• clinically significant active medical or mental health conditions (study staff will review)
• certain medications, including: immunosuppression biologic agents, cyclophosphamide, calcineurin inhibitors (CNIs), start or change dose of ACE inhibitors/ARBs within 4 weeks prior to starting study, IV corticosteroids and IV immunoglobulin within 2 weeks of starting study
Immune Diseases, Kidney, Prostate & Urinary
Adolescent Lupus Nephritis, Lupus, Nephritis
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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
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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An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

One goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. Researchers will look at how enfortumab vedotin can act in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4, commonly found in cancer cells. Another goal of this study is to find out if enfortumab vedotin is effective and safe when combined with another US Food and Drug Administration (FDA) approved medicine, pembrolizumab (brand name KEYTRUDA®), and used as a treatment for people with head and neck cancer who have not received previous chemotherapy treatment other than the chemotherapy that may have been given in combination with radiation therapy or right before or right after surgery in the past.

Naomi Fujioka
18 years and over
This study is NOT accepting healthy volunteers
SITE00001051
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Inclusion Criteria:

• locally advanced or metastatic disease of breast, lung, head and neck, gastric, gastroesophageal junction, or esophagus, that is not amenable to curative intent treatment
• evidence of progression on or after the last regimen received
• restricted strenuous activity but able to walk carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of cancer
Exclusion Criteria:

• study staff will review
Cancer
Clinics and Surgery Center (CSC), Locally Advanced or Metastatic Malignant Solid Tumors, Metastatic Cancer
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Collaborative Solutions for Breaking Up Sedentary Time in Black Older Adults with Type 2 Diabetes: The Interrupt T2D Study

Black Americans are 60% more likely to be diagnosed with Type 2 Diabetes (T2D) and 2 times more likely to die from T2D than non-Hispanic White Americans. Recent research has shown that sedentary behavior (such as sitting or lying down) have a significant negative impact on health. We are doing a small study with older people who identify as Black or African American and have T2D to look at ways to reduce sedentary behavior. The study will last about 1-2 months for each participant.

Mary Whipple
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021174
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Inclusion Criteria:

• self-identify as Black or African American.
• 55 years and older
• speak and read English.
• self-reported diagnosis of type 2 diabetes (T2D)
Exclusion Criteria:

• evidence of cognitive impairment that could impact ability to consent and/or participation
• physical impairment or disability that interferes with ability to engage in physical activity such as severe osteoarthritis, lower extremity amputation (other than toe(s) or partial foot), regular use of a walker or wheelchair, etc.
• unstable medical or mental health condition (study staff will review)
Diabetes & Endocrine, Heart & Vascular, Prevention & Wellness
behavior change, community engaged research, diabetes, physical activity, sedentary behavior, T2D
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MT2022-54 A MULTINATIONAL, MULTICENTER, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF FP-045 IN PATIENTS WITH FANCONI ANEMIA (FuschiA Study)

The purpose of this research study is to determine the best dose of FP-045 for Fanconi anemia pediatric and adolescent participants. The study will look at whether the participants have any side effects and if there are any possible changes in something called “biomarkers,” which are blood proteins that will be checked to see if they change when taking FP-045 and that may indicate if FP-045 can delay or prevent disease symptoms. Every participant will receive FP-045.

Meera Srikanthan
Not specified
This study is NOT accepting healthy volunteers
SITE00001887
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Inclusion Criteria:

• 3 to 25 years old
• documented Fanconi anemia by chromosome breakage analysis
• women of child-bearing potential and males required to use highly effective birth control
Exclusion Criteria:

• history of any cancer except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of cervix
• myelodysplastic syndrome or acute leukemia
• history of any significant medical conditions
• history of bone marrow or stem cell transplant
• see link to clinicaltrials.gov for complete criteria
Blood Disorders, Rare Diseases
Fanconi Anemia
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A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK) (EPPIK)

Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK) trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.

Michelle Rheault
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001245
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Inclusion Criteria:

• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
Exclusion Criteria:

• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required
Children's Health, Kidney, Prostate & Urinary, Rare Diseases
Alport Syndrome, Glomerulosclerosis, IgA Vasculitis, Immunoglobulin A Nephropathy
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A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF) (NICE-CF)

We are comparing the results of stool sample testing to colonoscopy for people who have Cystic Fibrosis (CF). We want to find out how effective stool sample testing is in detecting adenomas, including colorectal cancer.

Shahnaz Sultan
18 years and over
This study is NOT accepting healthy volunteers
SITE00001560
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Inclusion Criteria:

• Ages 18 - 75 years of age without history of transplant, or adults with CF age 18 - 75 who have had a transplant
• Diagnosis of Cystic Fibrosis with a sweat chloride test result of at least 60 mmol/L and/or documented CF-causing CFTR mutations and clinical
• Speak and write English or Spanish
• Having a screening or surveillance colonoscopy for colorectal cancer (CRC)
Exclusion Criteria:

• Women who are pregnant
• Active inflammatory bowel disease (Crohns Disease or Ulcerative Colitis)
• History of colon cancer diagnosis and treatment within 5 years of enrollment
• Symptoms that indicate colonoscopy is for diagnostic purposes rather than as screening for CRC
Digestive & Liver Health, Rare Diseases
Clinics and Surgery Center (CSC), colon cancer screening, cystic fibrosis
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COG ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Christopher Moertel, MD
Not specified
This study is NOT accepting healthy volunteers
SITE00001839
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Inclusion Criteria:

• ages 2 to 21 at time of starting the study
• diagnosis of low-grade glioma or low-grade astrocytoma brain tumor
• tumor size increased or returned after treatment with at least one cancer therapy
• high blood pressure (hypertension) must be under control
• must be able to swallow whole capsules
• contact study staff for additional criteria
Exclusion Criteria:

• treatment for another tumor in the past year
• any serious medical or mental health diagnosis, including substance use disorders or ophthalmological conditions (study staff will review)
• women who are pregnant or breast feeding
Cancer
Astrocytoma, Glioma, Low Grade Astrocytoma, Low Grade Glioma
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Senolytics To slOw Progression of Sepsis

Researchers hope that using Fisetin, an antioxidant, will reduce inflammation in the body caused by sepsis, which could help your body and organs have more time to recover. Placebo in this study will be something that looks similar to the study treatment, but does not contain any active drug. Everyone will receive 4 pills, but your group will determine how many of the pills are Fisetin. Researchers will look at the potential effects Fisetin or placebo has on inflammation in the body and how sick participants are at 7 days and 28 days.

Michael Puskarich
18 years and over
This study is NOT accepting healthy volunteers
SITE00001869
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Inclusion Criteria:

• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
Exclusion Criteria:

• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
Infectious Diseases
Fisetin, Sepsis
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Identifying hearing loss through neural responses to engaging stories

This research study will develop an efficient electroencephalographic (EEG) method that uses narrated stories to identify frequency-specific hearing loss.

Melissa Polonenko
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017008
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Inclusion Criteria:

• Adults aged 18-70 years, hearing loss with thresholds better than 70 dB HL, no history of neurological problems or ANSD, doesn?t wear a cochlear implant
Exclusion Criteria:

• Neurological problems
• ANSD
• Wears a cochlear implant
Ear, Nose & Throat
Hearing, Hearing loss, Listening, electrophysiology, books, audible, stories
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Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Hyun Kim
18 years and over
This study is NOT accepting healthy volunteers
1408M52921
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Inclusion Criteria:

• at least 30 years old
• new diagnosis of Idiopathic Pulmonary Fibrosis (IPF) -diagnosis of a non-IPF Interstitial Lung Disease (ILD) of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis
Exclusion Criteria:

• Cancer, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• currently waiting for lung transplantation
• currently enrolled in a clinical trial
Respiratory System
Clinics and Surgery Center (CSC), Idiopathic Pulmonary Fibrosis (IPF) Interstitial Lung Disease
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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.

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)

MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00013494
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Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Cancer, Infectious Diseases
Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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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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Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

This study will enroll children aged 6 to 12 years who have difficulty in maintaining a healthy weight and see if the medication Vyvanse may help them to reduce their weight.

Claudia Fox
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019097
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Inclusion Criteria:

• children 6 to 12 years old
• severe obesity defined as BMI greater than or equal to 1.2 times the 95th percentile
• failed attempt of lifestyle therapy
Exclusion Criteria:

• significant congenital or structural heart disease or arrhythmia
• hypertension
• history of chemical dependency
• Diabetes mellitus (type 1 or 2)
• current or recent ( less than 3 months ago) use of anti-obesity medication(s)
• additional medical or mental health conditions (study staff will review)
Children's Health, Diabetes & Endocrine
healthy weight, Obesity
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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&#8208;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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