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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.

136 Study Matches

A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.

Emmanuel Antonarakis
18 years and over
This study is NOT accepting healthy volunteers
SITE00001890
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Inclusion Criteria:

• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Cancer
Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Scott Cooper
18 years and over
This study is NOT accepting healthy volunteers
1611M00822
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Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• candidate for DBS
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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MT2023-10: A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma

We are studying FT522 - a new product that is made by modifying cells in a laboratory - both with and without additional drugs, to see if it can help treat people with B-cell lymphoma. This study is for people who have had at least one treatment for their lymphoma, but the cancer either returned or did not respond to the treatment. We are testing this product to see what side effects it might have, as well as to see whether it is effective at treating B-cell lymphoma.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001976
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Inclusion Criteria:

• diagnosis of B-cell lymphoma (BCL)
• at least 1 prior systemic regimen of treatment
• men and women participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
Exclusion Criteria:

• women who are pregnant or breastfeeding
• capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• body weight less than 50 kg (110 lb.)
• additional medical diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lymphoma, Relapsed/Refractory B-Cell Lymphoma
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A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)

The purpose of this research study is to look at the safety and effectiveness of pritelivir given orally (by mouth for a maximum of 42 days) for people with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.

Jo-Anne Young, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00020605
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Inclusion Criteria:

• at least 16 years old
• immunocompromised or body is unable to fight off infection
• have lesions that can been seen in order to determine if they are healing
• willing to use highly effective birth control
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
Rare Diseases, Infectious Diseases
Clinics and Surgery Center (CSC), Herpes, Herpes Simplex Virus, HSV Infection
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Seasonal influenza vaccine high dose boosting in solid organ transplant recipients

We know that patients who have undergone a solid organ transplant are at higher risk for severe influenza infections and may not develop a robust antibody response to a single dose of the influenza vaccine. The purpose of this study is to better understand the body’s response to two doses of the high-dose influenza vaccine compared to one dose during an influenza season.

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

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

• women who are pregnant
• received ATG or carfilzomib in the past 3 months
• received rituximab or basiliximab in the past 3 months
• prednisone dose is greater than 20mg/ day
• history of a severe allergy to influenza vaccine (e.g., Guillain-Barre syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
Infectious Diseases
Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2

We hope to identify patterns in the brain that may be related to symptoms of PD, such as problems with walking. We are also testing different stimulation settings to see if they might be more effective than the settings that are currently used for treatment. This research may aid in our understanding of PD and how to treat it more effectively with DBS.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016988
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Inclusion Criteria:

• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
Exclusion Criteria:

• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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A Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysema (ELEVAATE)

This study is for people who have emphysema (a disorder where too much air collects deep in the lungs) that is caused by the lack of a protein called alpha-1 antitrypsin (AAT) in the body. A deficiency of AAT (AATD) can damage lung and liver if not treated. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in subjects with AATD emphysema when compared with current approved AATD therapy with A1PI, known as Zemaira®.

Ronald Reilkoff
18 years and over
This study is NOT accepting healthy volunteers
SITE00001985
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Inclusion Criteria:

• age 18 to 80
• diagnosis of Alpha 1-Antitrypsin Deficiency (AATD)
• symptoms of emphysema related to AATD
• currently not smoking
Exclusion Criteria:

• diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
• on waiting list for lung or liver transplant
• active cancers or has a history of cancer within past 5 years
• significant congestive heart failure
• additional exclusion criteria (study staff will review)
Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), Alpha 1-Antitrypsin Deficiency, Emphysema, AATD
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Research Evaluating Vagal Excitation and Anatomical Links

We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.

John Osborn Jr.
18 years and over
This study is NOT accepting healthy volunteers
SITE00002000
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Inclusion Criteria:

• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
Exclusion Criteria:

• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
Brain & Nervous System, Mental Health & Addiction
Clinics and Surgery Center (CSC), Depression, Epilepsy, Vagal Nerve Stimulator, VNS
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A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy (SunRISe-4)

This study investigates a new treatment (TAR-200) for Muscle-Invasive Urothelial Carcinoma (bladder cancer). It assesses whether TAR-200 + Cetrelimab (experimental drug), is effective for patients scheduled for bladder removal surgery who can't undergo standard chemotherapy. The study compares two groups: one receiving TAR-200 + Cetrelimab, and the other receiving only Cetrelimab. The goal is to determine if this combination can provide an alternative treatment option for these patients with bladder cancer.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020697
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Inclusion Criteria:

• diagnosed with urothelial cancer of the bladder within past 120 days
• restricted in strenuous physical activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• thyroid function tests within normal range or stable on hormone supplement
Exclusion Criteria:

• have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within prior 2 weeks
• prior systemic chemotherapy for urothelial cell carcinoma of the bladder
• additional criteria apply (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer, Cystectomy, Urinary Bladder Neoplasms
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Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

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

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

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

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Blood Disorders, Mental Health & Addiction
SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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A 6-Month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone (Cortexolone 17A-Propionate) Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-Month Single-Blind Treatment with Clascoterone or Vehicle BID Solution. (SCALP 1) (SCALP1)

We are studying a new topical drug, Clascoternone, to treat adult males who have male pattern baldness. Participants randomly (by chance) receive the drug or an inactive solution that is applied to the area of hair loss twice a day for six months. We will compare the effectiveness and side effects of the two groups. Men who have regrowth of hair may also participate in a second six-month treatment to look at the long-term effectiveness of the drug.

Maria Hordinsky
18 years and over
This study is NOT accepting healthy volunteers
SITE00002038
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Inclusion Criteria:

• men who are 18 or older
• have mild to moderate Androgenic Alopecia (AGA) in temple and top region of the scalp
• willing to maintain the same hairstyle, hair length and hair color throughout the study
• agree to continue shampoo frequency and other general hair care products and regimen for the entire study
• agree to maintain same dietary and supplement pattern
Exclusion Criteria:

• any dermatological disorders at the temple or the top of the scalp
• current or recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding -scalp hair transplants at any time
• see link to clinicaltrials.gov for additional exclusion criteria (study staff will review)
Dermatology (Skin, Hair & Nails)
Clinics and Surgery Center (CSC), Alopecia, Androgenetic Alopecia, Male Alopecia, AGA
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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.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00016450
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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
Cancer
Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations

The purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and Bone Marrow Transplant (BMT) databases for patients undergoing a transplant for the treatment of Dyskeratosis Congenita (DC) or Severe Aplastic Anemia (SAA). The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
1404M50183
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Inclusion Criteria:
-0 to 70 years old
• acceptable hematopoeitic stem cell donor identified
• Dyskeratosis Congenita (DC) with evidence of bone marrow failure
• Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• women who are pregnant or breast feeding
• uncontrolled infection
Blood Disorders
Clinics and Surgery Center (CSC), Aplastic Anemia, DC, Dyskeratosis Congenita, SAA
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MT2013-06C : Treatment of graft Failure after HSCT

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients undergoing a second transplant using a haploidentical donor, an unrelated donor or umbilical cord blood. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Troy Lund
Not specified
This study is NOT accepting healthy volunteers
1404M49341
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Inclusion Criteria:

• patients with primary or secondary HSCT graft failure
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled infection at the time of transplant
• patients with Fanconi Anemia or other DNA breakage syndromes
Clinics and Surgery Center (CSC), Failure, Hematopoietic Stem Cell Transplantation, HSCT
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Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients with EPI due to Chronic Pancreatitis (CP) (CisCP)

CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions

Guru Trikudanathan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012592
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Inclusion Criteria:

• at least 18 years old
• history of chronic pancreatitis (CP).
• diagnosis of Exocrine Pancreatic Insufficiency (EPI)
Exclusion Criteria:
-history of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Exocrine Pancreatic Insufficiency (EPI)
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Stephanie Misono
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012174
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Inclusion Criteria:

• adults aged 18-80
• more than 8 weeks of non-productive cough
• chest x-ray or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available)
• clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinus or nasal issue is not the reason for the cough
• able to read and speak English
Exclusion Criteria:

• current smoker or quit less than 3 months ago
• infectious cause for cough (e.g., TB, pertussis, COVID)
• history of known or suspected aspiration pneumonia
• recent intubation/neck surgery (within 8 weeks)
• neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
• untreated carotid artery disease
• electronic implants (e.g., pacemaker)
• specific medications (study staff will discuss)
• anticipate use of new medications to treat the cough during the period of the study
• currently having speech therapy for cough
• BMI > 40 (for transmission of VTS through soft tissue)
• allergy to adhesives
• drug/alcohol dependency or abuse
• pregnant
• without regular access to wifi and internet
Breathing, Lung & Sleep Health, Ear, Nose & Throat
chronic cough, cough, larynx, vibrotactile stimulation, Clinics and Surgery Center (CSC)
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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.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00003182
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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
Blood Disorders, Rare Diseases
Clinics and Surgery Center (CSC), Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017906
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Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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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.

Anne Blaes, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021547
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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
Cancer
Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
1608M93561
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)

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

Jeffrey Macalena
Not specified
This study is NOT accepting healthy volunteers
SITE00000971
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Inclusion Criteria:

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

• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
Bone, Joint & Muscle
Clinics and Surgery Center (CSC), ACL, Anterior cruciate ligament reconstruction, joint instability
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.

Keith Skubitz, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001953
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Inclusion Criteria:

• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)

The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019751
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
Exclusion Criteria:

• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
Immune Diseases
Clinics and Surgery Center (CSC), Lupus, Lupus Nephritis, SLE, Systemic Lupus Erythematosus
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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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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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A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.

Gregory Beilman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003956
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Inclusion Criteria:

• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
Exclusion Criteria:

• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
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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.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020724
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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
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Radical Cystectomy, Urinary Diversion, UTI. bladder cancer
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Transcatheter Mitral Valve Replacement with the Medtronic Intrepid&#8482; TMVR System in patients with severe symptomatic mitral regurgitation &#8211; 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.

Greg Helmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017497
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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%
Heart & Vascular
Clinics and Surgery Center (CSC), Intrepid, Mitral valve, Mitral Valve Replacement, TAVR

HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts

There are certain genetic changes in the leukemia cell thought to drive the disease in patients with acute myeloid leukemia. Ziftomenib is an investigational drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. The purpose of this study is to determine the safe dose of an investigational new drug (ziftomenib) used in combination with other study drugs i.e., venetoclax and azacitidine, to treat cancer. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and how ziftomenib works in combination with the other study drugs (venetoclax and azacitidine).

Mark Juckett
18 years and over
This study is also accepting healthy volunteers
SITE00001987
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Inclusion Criteria:

• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• 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
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• other types of leukemia
• active involvement of central nervous system
• clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• women who are pregnant or breast feeding
• additional criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, AML, Leukemia
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