Search Results
AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP (PHARMATOP)
Topiramate is a commonly prescribed medication at weight management clinics. While doctors know that some people respond better to topiramate in terms of weight loss and changes in eating behaviors, the reasons WHY some respond better than others are not known. Knowing more about the relationships between topiramate doses, concentrations of topiramate in the blood stream, and an individual’s response to this medicine will help doctors determine those who may be more likely to benefit. Doctors also want to know if someone’s genes (their DNA) may help explain why some people respond better to topiramate than others. We expect that you will be in this research study for about 14 weeks (3.5 months).
• ages 12 to less than 18 years old
• Body mass index (BMI) greater than or equal to 1.2 times the 95th percentile (age and sex-adjusted) and/or BMI greater than or equal to 35 kg/m2
• deemed appropriate candidates to receive topiramate (without contraindications) for weight loss by an obesity medicine specialist at the University of Minnesota
• history of metabolic/bariatric surgery
• obesity associated with a diagnosed genetic disorder
• clinically diagnosed hyperthyroidism or uncontrolled hypothyroidism
• history of acute angle closure glaucoma
• see link to clinicaltrials.gov for additional exclusion criteria
Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord
The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.
• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
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).
• 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
• 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)
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).
• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
• 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)
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.
• 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
• women who are pregnant or breastfeeding
• cancer within previous 2 years
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.
• 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
• 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
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.
• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
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.
• 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
• 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)
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.
• 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
• 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
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.
• 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
• 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
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.
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• 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
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.
• 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
• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
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.
• 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
• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
Cardiac Sarcoidosis Consortium
This is a registry study. The Cardiac Sarcoidosis Consortium (CSC) is an international, multicenter partnership among physicians and allied professionals at major medical centers with the unifying purpose to learn more about cardiac sarcoidosis through collaborative research.
• People who have been diagnosed with Cardiac sarcoidosis (CS)
• History of ventricular tachycardia or fibrillation
• Ventricular arrhythmias treated medically or with an implanted device
COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
2020IS043; MT2020-06; A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF JSP191 FOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONING TO ACHIEVE ENGRAFTMENT AND IMMUNE RECONSTITUTION IN SUBJECTS WITH SCID
This study is looking at whether giving a new type of experimental medicine, called JSP191, can prepare the body to help the stem cell transplant work better, so the immune system can grow and fight infections. The study doctor and Sponsor also want to see how safe and well tolerated this experimental medicine is. They will study whether it is safe to give to patients and look at how much medication to give and what side effects may occur. During this study, the optimal dose of JSP191 will be determined and additional patients will be enrolled in this study using that dose level.
• at least 3 months old
• diagnosis of typical Severe Combined Immunodeficiency (SCID)
• patient with human leukocyte antigen (HLA) matched related or unrelated donors
• acute or uncontrolled infections
• patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• patients with active malignancies
• active Graft-versus-host disease (GVHD) within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)
We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.
• 12 to 21 years old
• right-handed
• currently have OCD symptoms
• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes. Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.
• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method
We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.
• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Phase 1/2 Study to Evaluate Palbociclib (IBRANCE) in Combination With Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients With Recurrent or Refractory Solid Tumors Protocol No.: ADVL1921/A5481092
This is a Phase 1/2 multicenter, open-label study to evaluate palbociclib in combination with either irinotecan (IRN) and temozolomide (TMZ) or topotecan (TOPO) and cyclophosphamide (CTX) chemotherapy in children, adolescents and young adults with recurrent or refractory solid tumors. The study consists of a non- randomized Phase 1 portion for recurrent or refractory solid tumors followed by potential non- randomized tumor specific cohort(s) and a randomized, Phase 2 portion for recurrent or refractory EWS.
• 2 years to 20 years of age
• confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas)
• recovered to CTCAE Grade 1 or less, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia
• serum/urine pregnancy test (for all girls 8 or older) negative at screening and at the baseline visit
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• prior irradiation to >50% of the bone marrow
• major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries
• patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days
• fertile male patients or female patients of childbearing potential who are unwilling or unable to follow contraceptive requirements
• pregnant or breastfeeding women
• additional exclusion criteria apply (study staff will review)
MT2022-49: Early identification of cognitive side-effects of immunotherapy
This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.
• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
• presence of speech or hearing problem
• diagnosis of cognitive impairment
MT2023-33 A Phase II Study of Reduced Dose Post Transplantation; Cyclophosphamide as GvHD Prophylaxis in Adult Patients with Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (OPTIMIZE)
Cyclophosphamide is a chemotherapy (chemo) drug often given after a transplant to prevent graft-versus-host disease (GvHD). We are doing this study to see if a lower dose of cyclophosphamide after transplant is as safe and works just as well. This study does not include any new or untested drugs. The drugs and procedures in this study are standard for people who receive a transplant.
• between 18 and 66 years old
• receiving an unrelated Donor Peripheral Blood Stem Cell Transplantation
• willing to comply with all study procedures and availability for the duration of the study
• see link to clinicaltrials.gov for complete Inclusion Criteria
• prior allogeneic transplant
• autologous transplant within the past 3 months
• women who are pregnant or breast feeding
• HIV+ with persistently positive viral load
• study staff will review
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer
The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.
• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Immune Modulation Associations With Urinary tract Infection In People With Neurogenic Bladder.
The goal of this study is to understand how urine and bladder tissue changes from infection, or a bladder that does not function normally, in people who use a catheter to empty their bladder. This may help future people because it can help determine who needs antibiotics to treat an infection in the bladder, and will help avoid the cost and side effects of using antibiotics in people who do not have a true infection. This study will take less than 1 hour – the time required to provide a urine sample in clinic. Or, if a participant is undergoing bladder Botox injection, the time necessary to participate in the study will add approximately 5 minutes to the total surgery time.
• at least 18 years old
• use clean intermittent catheterization (CIC) to empty the bladder
• without diagnosis of neurogenic bladder (NGB)
• OR NGB managed with bladder botulinum toxin injections with/without recurrent urinary tract infection (UTI) (may have an active UTI)
• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement
The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the longterm outcomes and complications over a 5-year period. There are no expected direct benefits to participation in this study however knowledge gained from this research may beneficial to future patients undergoing this procedure. This study does not involve any investigational drugs.
• at least 18 years old
• scheduled to undergo a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure
• women who are pregnant
• undergoing TIPS placement as part of an investigational study
MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. 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.
• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF) (REHAB-HFpEF)
The purpose of this research study is to assess the effect of a physical rehabilitation program for people admitted to the hospital with a diagnosis of heart failure. After completing baseline tests, participants will be randomly assigned to one of two study groups. Randomization means that you are put into a group by chance. (It is like flipping a coin.) You will have an equal chance of being placed into either group. Participants are assigned to a rehabilitation intervention (treatment) group, or to the attention control group, that will receive usual care.
• at least 60 years old
• in the hospital for at least 24 hours to treat acute heart failure
• heart failure episode included symptoms getting worse and the need to add or increase drugs to treat it
• able to walk 4 meters (13 feet) with or without a cane or walker when the study starts
• discharge to an independent living situation
• acute heart attack in the past 3 months, or planned intervention in the next 6 months
• severe valve disease
• advanced kidney disease with dialysis planned in the next 6 months
• dementia
• already actively exercising at least 30 minutes at a time, twice a week for the past 6 weeks