StudyFinder

Search Results

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.

435 Study Matches

MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016450
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Conditions: Cancer
Keywords: Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
I'm interested
Share via email
See this study on ClinicalTrials.gov

PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA

The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.

Principal Investigator: Frank Ondrey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001771
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: Clinics and Surgery Center (CSC), Oral Leukoplakia
I'm interested
Share via email
See this study on ClinicalTrials.gov

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial (APOLLO)

The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.

Principal Investigator: Greg Helmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017497
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
Exclusion Criteria:

• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Intrepid, Mitral valve, Mitral Valve Replacement, TAVR

AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025612
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
Exclusion Criteria:

• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: Acute Lymphoblastic Leukemia, ALL
I'm interested
Share via email
See this study on ClinicalTrials.gov

HM2024-36 A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY AND ADMINISTERED AS MAINTENANCE THERAPY IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD NEGATIVE ACUTE MYELOID LEUKEMIA (QuANTUM-WILD)

The purpose of this research is to test how well the investigational study drug, quizartinib, works in patients with AML without a FLT3-ITD mutation who have not received any prior treatment for the disease. The study will test how it works when taken with standard chemotherapy and then taken alone to prevent the disease from coming back.

Principal Investigator: Naveen Premnath
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023711
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 70 years old
• newly diagnosed, primary Acute Myeloid Leukemia (AML)
• at least able to walk do selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• any other type of leukemia
• AML caused by prior chemotherapy or radiotherapy or myelodysplastic syndrome (MDS)
• prior treatment for leukemia, with some exceptions
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML, Leukemia, Clinics and Surgery Center (CSC)
I'm interested
Share via email
See this study on ClinicalTrials.gov

MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma

This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020893
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma
I'm interested
Share via email
See this study on ClinicalTrials.gov

MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis (Regulate-RA)

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Principal Investigator: Daniel Mueller
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023753
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Arthritis & Rheumatic Diseases, Immune Diseases
Keywords: Autoimmune, Clinics and Surgery Center (CSC), RA, Rheumatoid Arthritis
I'm interested
Share via email
See this study on ClinicalTrials.gov

MT2023-46: A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma

We want to find out whether lifileucel is safe and works in treating untreated, unresectable or metastatic melanoma. Lifileucel is a type of medicine, known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece of your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including fight cancer.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021773
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 70 years old (in certain cases, people older than 70 may be able to enroll)
• diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma
• may not be able to do physically strenuous activity but walking and able to do light or sedentary work, e.g., light house work, office work
• participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• melanoma of uveal/ocular (eye) origin
• symptomatic untreated brain metastases
• had another cancer in the previous 3 years
• history of allogeneic cell or organ transplant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Melanoma, Metastatic Melanoma, Clinics and Surgery Center (CSC)
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025446
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 Years to 83 years old
• male or female of non-childbearing potential
• diagnosis of Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
• Chronic medication for heart failure or cardiovascular disease is at a stable dose
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• started a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study
• history or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular disease liver disease, infectious disease, or malignancy
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), diagnosis of PH-HFpEF, Heart Failure, Pulmonary Hypertension
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella&#8482; Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II Heart Failure Patients (PROACTIVE- HF-2 Trial)

The Cordella™ Pulmonary Artery Sensor System is a possible treatment for New York Heart Association (NYHA) Class II and III heart failure. The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure hospitalizations.

Principal Investigator: Tamas Alexy
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021914
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Heart Failure NYHA Class II or Class III
Exclusion Criteria:

• ACC/AHA Stage D refractory Heart Failure (HF)
• history of multiple pulmonary embolism (PE)
• resting systolic blood pressure less than 90 mmHg
Conditions: Heart & Vascular
Keywords: Cardiovascular, Clinics and Surgery Center (CSC), Heart Failure, HF
I'm interested
Share via email
See this study on ClinicalTrials.gov

STOP PEDS RCT (Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial) (STOP PEDS RCT)

In this study, we are going to compare two ways of treating mild respiratory illnesses in children with Cystic Fibrosis (CF). One is immediate antibiotics (increase airway clearance and start oral antibiotics right away) and the other is tailored therapy (increase airway clearance right away but only start oral antibiotics if symptoms worsen or do not improve). We are looking at how safe each option is and how well each one works. To do this, we will randomize participants (like flipping a coin) to one of these two approaches if a mild respiratory illness happens over the next 12 months.

Principal Investigator: Samuel Goldfarb
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023173
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: for main study group and non-HEMT group: age 6 to less than 19 years old OR for preschool group: age 3 to less than 6 years old
• diagnosis of Cystic Fibrosis (CF)
• for main study group and non-highly effective modulator therapy (HEMT) group, able to do spirometry
• able to receive text messages and access the internet
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of solid organ transplant
• positive culture for Mycobacterium abscessus in the prior 12 months
• three or more IV antibiotic-treated pulmonary exacerbations (PEx) in the prior 12 months
• treatment with chronic oral antibiotics other than azithromycin at enrollment
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Children's Health, Respiratory System
Keywords: CF, Cystic fibrosis
I'm interested
Share via email
See this study on ClinicalTrials.gov

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.

Principal Investigator: Samuel Goldfarb
Age Group: Up to 24 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001589
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Up to 24 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 24 years old
• undergoing allogeneic or autologous HSCT
Conditions: Breathing, Lung & Sleep Health
Keywords: Diffuse Alveolar Hemorrhage, Hematopoietic Stem Cell Transplant (HSCT), Interstitial Pneumonitis
I'm interested
Share via email
See this study on ClinicalTrials.gov

MT2017-17:T Cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in patients with Inherited Bone Marrow Failure (BMF) Disorders

The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003182
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 65 years of age
• have a diagnosis of Fanconi anemia
• have a suitable donor for peripheral blood cells
• women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• see link to clinicaltrials.gov for additional criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• cancer within previous 2 years
Conditions: Blood Disorders, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes

The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.

Principal Investigator: Antoinette Moran
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024994
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
I'm interested
Share via email
See this study on ClinicalTrials.gov

The effects of vagus nerve stimulation on intrinsic lower leg spinal motoneuron excitability in Parkinson's disease

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson’s disease (PD) and test if stimulation of a nerve at the neck (vagus nerve) can improve muscle activation, walking and balance. People can participate in one of two experiments, or both. Both experiments will test the muscle activation patterns in the lower leg when producing low levels of force. We will also assess walking and balance. Experiment 2 will test muscle activation patterns, walking and balance before and after vagus nerve stimulation. We are also asking people who don’t have PD and are 21 to 76 years old and match in age and sex to participants to undergo the same study procedures.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00026350
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• healthy volunteers will be age matched to people in the study who have PD and must be able to walk without the use of an assistive device for more than 50 meters (164 feet)
• diagnosis of Parkinson's disease (PD)
• age 21 to 76 years old
• on stable medication for the preceding month and anticipated over the next 3 months
• able to walk without the use of an assistive device for more than 50 meters (164 feet)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of another significant neurological disorder including stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor
• severe orthopedic or other related musculoskeletal disease that significantly affects gait
• women who are pregnant
• history of substance abuse in the past two years
• unable to comprehend English
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), Parkinson's Disease PD
I'm interested
Share via email
See this study on ClinicalTrials.gov

Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial

This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020724
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
Exclusion Criteria:

• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Radical Cystectomy, Urinary Diversion, UTI. bladder cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov

Neurodevelopmental Outcomes for CMV Infections Identified by Newborn Screening

This research study is about early development in children diagnosed with congenital cytomegalovirus infection (cCMV), identified by newborn screening that has been confirmed with a follow-up test. Study visits, when the child is 12, 24 and 36 months of age, will include questionnaires, direct assessment of child and interviews with parent(s). A brain MRI will also be completed at about 12 months. Parents will receive a report summarizing a child’s developmental, language, and behavioral assessments, reported as within normal ranges or if clinical follow-up is recommended.

Principal Investigator: Meghan Swanson
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026268
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 14 months old
• tested positive for congenital cytomegalovirus (also called cCMV or CMV) on the newborn heel / blood spot screening test
• parent/guardian is able to complete study visits, interviews and questionnaires in English
Exclusion Criteria:

• certain medical conditions that study staff will screen for during the process of joining the study
Conditions: Brain & Nervous System, Children's Health, Infectious Diseases
Keywords: Cytomegalovirus, CMV, Sensorineural hearing loss, Infant, Baby, Schleiss
Visit study website
I'm interested
Share via email

MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.

Principal Investigator: Ashish Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023330
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
Exclusion Criteria:

• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), SCD, Sickle cell disease
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)

The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.

Principal Investigator: Faysal Haroun
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025046
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Non-Small Cell Lung Cancer, NSCLC
I'm interested
Share via email
See this study on ClinicalTrials.gov

Multimodality Therapy with Immunotherapy in Stage I-IIIA Pleural Mesothelioma

The purpose of this study is to learn the effects, good or bad, of the study drug, vosoritide, for treating children who have hypochondroplasia. This condition affects the growth of bone and cartilage and in which kids who have it are shorter than other kids of the same age. In this study, your child will get either the study drug or placebo, which is an inactive medicine.

Principal Investigator: Robert Kratzke
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026290
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• daignosis of Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma
• have not received treatment
• not pregnant or breastfeeding
• able to do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• people who are not able to have surgical treatment
• history of symptomatic interstitial lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), lung cancer, Mesothelioma
I'm interested
Share via email
See this study on ClinicalTrials.gov

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

We are doing this study because we want to find out if observation is as good as the usual care for breast cancer. The usual approach for patients with early-stage triple-negative breast cancer (TNBC) who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery. Participants will either get pembrolizumab for up to 27 weeks, or will not receive any treatment and will be observed for up to 27 weeks. We will continue to follow participants every 6 months for 5 years and watch for side effects or cancer coming back. After that, participants will be checked every year for a total of 10 years after the study.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021547
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• 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
• no cancer remaining in the breast or lymph nodes after the completion of neoadjuvant therapy (complete response)
• Estrogen (ER) and progesterone (PR) no more than 10% and HER2-negative
• if cancer was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
• must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles
• not pregnant and not nursing
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• known active liver disease -medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) (I CAN)

To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN

Principal Investigator: Sahar Koubar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021814
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Immunoglobulin A Nephropathy (IgAN) diagnosis established on kidney biopsy
• stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to starting the study
• if receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diagnosis of rapid progressive glomerulonephritis
• clinically significant renal disease other than IgAN
• uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
• history of kidney transplant or planned kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), iga Nephropathy, igan, Immunoglobulin A Nephropathy

A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) (ACTION3)

A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024254
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12-80 years old;
• Primary FSGS, genetic FSGS or FSGS of undetermined cause
• Receiving an ARB, or willing to take one for the study
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• Secondary FSGS
• Not previously treated with standard of care therapies (including steroids)
• Unable to swallow oral medication
• see clinical to clinicaltrials.gov for complete exclusion criteria
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: Focal Segmental Glomerular Sclerosis, FSGS

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary symptoms of Long COVID (REVERSE-LC) (REVERSE-LC)

The purpose of this study is to understand if a drug called baricitinib can help with thinking and memory problems after COVID-19 infection for people suffering with Long COVID. Some people have thinking and memory problems along with possible difficulty breathing, a racing heart, dizziness, and/or fatigue after COVID-19 called Long COVID. This includes things like having a hard time remembering people’s names, managing money, or keeping a job. For some patients, these issues may last several years. We still do not understand why these problems happen and why they last longer in some people. This study will look at the changes in brain function, heart function, and daily activities after taking baricitinib or placebo for people who experience Long COVID.

Principal Investigator: Carolyn Bramante
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022496
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• documented COVID infection 6 or more months prior
• clinical evidence of Long COVID such as fatigue, chills, post-exertional malaise, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance, chest pain, palpitations, shortness of breath, cough, fainting spells, muscle aches, joint pain, nausea, diarrhea
• symptoms must have started after January 2020 and be present for at least 6 months prior starting the study
• symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• severe cognitive, physical, or psychological disability preventing participation
• currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study
• admission to an ICU for treatment of acute COVID-19 infection
• cancer diagnosis in the past 5 years
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Community Health, Infectious Diseases
Keywords: Coronavirus Infections, COVID-19, Long Covid

NRG-GU012: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (SAMURAI)

The primary purpose of this study is to find out if adding a highly focused form of radiation therapy (called SABR) to the main kidney tumor, along with immunotherapy, helps people with advanced kidney cancer live longer or do better than using immunotherapy by itself.

Principal Investigator: Ian Okazaki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025313
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of renal cell cancer with positive lymph nodes that can't be removed or metastasis to another area
• not recommended for or refused immediate nephrectomy
• must agree to use a highly effective contraception while on study drug and for 6 months following the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• untreated or unstable brain metastases
• prior radiotherapy to the kidney
• systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before starting the study
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Kidney Cancer, Metastatic Renal Cell Carcinoma
I'm interested
Share via email
See this study on ClinicalTrials.gov

MT2024-38: A Phase 1/2 Open-Label, Single-Ascending-Dose Study of EN-374, a Helper-Dependent Adenoviral-Based Gene Therapy, in Participants with X-Linked Chronic Granulomatous Disease

To evaluate the safety of the EN-374 treatment regimen (HSC mobilization, immune prophylaxis, EN-374 dose and administration, and enrichment of HSCs with O6BG/TMZ).

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025676
Show full eligibility criteria
Hide eligibility criteria
Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old for initial phase of the study and then at least 3 months old for later phase
• diagnosis of X-CGD
• history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
• does not have a suitable, available and willing human related donor
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active infection
• history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• had investigational gene therapy
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases
Keywords: chronic granulomatous disease, recurrent bacterial or fungal infections, X-CGD
I'm interested
Share via email
See this study on ClinicalTrials.gov

An Open-Label Multiple-Dose, 52-Week Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)

This is a study to see if a new drug, named XYOSTED Injection (study drug) will help in the treatment of male adolescents ages 12 to less than 18 years old who have low or no testosterone due to a medical condition called Hypogonadism. Male Hypogonadism is a condition in which the body doesn’t produce enough of the hormone called testosterone that plays a key role in masculine growth and development during puberty. Participation in the study will last 52 weeks.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025680
Show full eligibility criteria
Hide eligibility criteria
Sex: Male
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:
-12 to < 18 years of age
• diagnosed with a deficiency or absence of testosterone due to hypogonadism
• if receiving testosterone treatment, must be on a stable dose for at least 12 weeks before starting the study
• body mass index (BMI)-for-age greater than the 5th percentile and weigh at least 40 kg (88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• suspected or known constitutional growth delay in growth and puberty (CDGP)
• possible nutritional or gastrointestinal disorder that may impact growth
• allergy to foods or products containing sesame seeds or sesame oil
• history of suicidal behavior suicide attempts
• have a history of drug or alcohol abuse
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine, Rare Diseases
Keywords: hypogonadism, testosterone
I'm interested
Share via email
See this study on ClinicalTrials.gov

Health Beliefs and Behaviors of Lung Cancer Screening in Chinese Americans

The rate of lung cancer screening is not optimal among Chinese American high-risk smokers, although there is a high lung cancer rate among this population. We want to validate the adapted Chinese Lung Cancer Screening Health Belief Scale, enable its usage in Chinese Americans, and further explore the relationship between lung cancer screening health beliefs and health behavior among Chinese Americans. We will also aim to identify the differences in health beliefs regarding lung cancer screening between high-risk populations in China and Chinese Americans, and to examine factors influencing these differences.

Principal Investigator: Fang Lei
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022062
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 50 to 80 years old
• self- identified as a descendent of Chinese
• live in the United States
• current smoker or quit in the past 15 years
• can read Chinese/English
Exclusion Criteria:

• history of lung cancer
• cognitive problems
Conditions: Cancer, Prevention & Wellness
Keywords: Chineses, Lung Cancer Screening
I'm interested
Share via email

A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome

People who have Prader-Willi Syndrome (PWS) and have completed study treatment through Visit 6 on the AVK-101-301 study are being asked to join this study. The goals of this study are to see how ARD-101 affects eating behaviors in people with hyperphagia and PWS by looking at their scores on a 9-question survey, and to understand how safe (how many side effects participants have) and tolerable (how well participants can tolerate any side effects) ARD-101 is over the long-term.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026579
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must have completed treatment through End of Treatment [EoT] in Study AVK-101-301
• willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and procedures related to study evaluations
• female of childbearing potential, must have a negative urine pregnancy test before receiving treatment
• all male patients and female patients of childbearing potential must agree to consistent use of a highly effective method of contraception during the entire duration of the study and for 90 days after the last dose of study drug
• female patients must also refrain from egg donation and in vitro fertilization from the time of signing the informed consent form through the duration of the study and for at least 90 days after the last dose of study drug.
• male patients must also refrain from donating sperm during the study and for at least 90 days after the last dose of study drug
• see link to clincialtrials.gov for complete Inclusion criteria
Exclusion Criteria:

• received an investigational drug, other than ARD-101, within 30 days of the first study visit
• see link to clinicaltrial.gov for complete exclusion criteria
Conditions: Children's Health, Diabetes & Endocrine, Rare Diseases
Keywords: Prader-Willi Syndrome, PWS
I'm interested
Share via email
See this study on ClinicalTrials.gov

A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

This study is testing the study drug BDTX-4933 in people with locally advanced (unresectable) or metastatic solid tumors that are characterized by a KRAS, BRAF, or NRAS mutation/alteration(s). The primary objective of the study is to assess how well participants tolerate the drug and if it is effective.

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021016
Show full eligibility criteria
Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• recurrent or advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations
• exhausted all available standard-of-care therapies
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• cancer that has a known MEK1/2 mutation
• ongoing anticancer or radiation therapy
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastatic cancer, RAS or BRAF mutations, Recurrent cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov