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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.

423 Study Matches

ROWAN: An Open-Label, Prospective, Multi-Center, Randomized Clinical Trial To Evaluate The Efficacy and Safety Of TheraSphereTM followed by Durvalumab (Imfinzi®) With Tremelimumab, Versus TheraSphereTM Alone For Hepatocellular Carcinoma (HCC). (ROWAN)

We are studying a treatment for people who have hepatocellular carcinoma that will be treated with TheraSphere™, a device that delivers radiation directly to the tumor. The study will determine if adding immunotherapy medications after TheraSphere™ treatment is safe and can improve results.

Principal Investigator: Siobhan Flanagan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016193
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Inclusion Criteria:

• not a candidate for liver resection, thermal ablation, or transplantation
• not able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• body weight >30 kg (66 lbs) and BMI ≥18 kg/m2
• must use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• metastasis of the cancer outside the liver
• history or organ or bone marrow transplant
• active or prior documented autoimmune or inflammatory disorders
• women who are pregnant or breastfeeding and who do not want to stop breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: HCC, Hepatocellular cancer, Liver Cancer
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Online intervention on lung cancer screening among high-risk smokers: A pilot intervention study

Researchers from the University of Minnesota are looking for adult volunteers to participate in a lung cancer screening online educational intervention study.

Principal Investigator: Fang Lei
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020835
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Inclusion Criteria:

• between 50 and 80 years old
• smoke or did smoke for a long time
• can read/understand English
Exclusion Criteria:

• diagnosed with lung cancer or other diseases which substantially impact participants’ life expectancy
Conditions: Cancer
Keywords: Smoking
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)

The purpose of this study is to compare the effects of 2 different levels of exercise intensity and to learn more about effects of aerobic exercise for people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001163
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Inclusion Criteria:

• 40 to 80 years old
• diagnosis of idiopathic Parkinson Disease (PD)
• less than 3 years since disease diagnosis
Exclusion Criteria:

• currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics
• expected to start medication within six months of starting the study
• previous use of medications for PD for more than 60 days
• exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months
• known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program
• uncontrolled hypertension (resting blood pressure greater than 150/90 mmHg)
• any medical, mental health, drug or alcohol abuse, assessment or laboratory abnormality that indicates a problem that could limit ability to participate in the exercise program (study staff will evaluate)
• women who are breast-feeding, pregnant, or plan to become pregnant in the next 12 months
• unable to have a brain scan
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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AHOD2131, A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

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

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001972
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Inclusion Criteria:

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

• patients with nodular lymphocyte predominant Hodgkin lymphoma
• patients with a history of active interstitial pneumonitis or interstitial lung disease
• administration of prior chemotherapy, radiation, or antibody-based treatment for classic Hodgkin Lymphoma (cHL)
• prior solid organ transplant
• prior allogeneic stem cell transplantation
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: cHL, Hodgkin Lymphoma, Hodgkin's, Lymphoma
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The Lung Cell Study (TLC)

The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.

Principal Investigator: Monica Campo Patino
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016947
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Inclusion Criteria:

• healthy volunteers without systemic or respiratory disease
• non-smokers or former smokers who quit more than 6 months ago (including marijuana)
• ages 18-50
• preferred but not required: have lived in countries in Africa, Latino America or South East Asia
• preferred but not required: history of positive tuberculosis (TB) skin or blood test
Exclusion Criteria:

• recent illness, bleeding disorders, or a history of heart, lung, or systemic disease
• weakened immune system or use of immunosuppressant medication
• use of inhaled substances in the past six months or history of heavy smoking
• allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl
• pregnancy
Conditions: Immune Diseases, Infectious Diseases, Respiratory System
Keywords: blood, blood donation, blood draw, bronchoscopy, Healthy Volunteer, TB, TLC, Tuberculosis
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.

Principal Investigator: Hamed Ahmadi
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020255
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Inclusion Criteria:

• at least 18 years old
• having bowel diversion urologic surgery
Exclusion Criteria:

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Conditions: Kidney, Prostate & Urinary
Keywords: bowel diversion urologic surgery, ileostomy, stoma
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A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial) (ROCC)

This study is to investigate if robotic assisted laparoscopy (small incision surgery), is worse than open surgery (otherwise known as a laparotomy) when performing a radical hysterectomy for cervical cancer. Previous research has been done and shown that patients receiving laparoscopy had an increased risk of recurrence of their cervical cancer. But since that time a lot has been learned and improvements have been made, hence why we are relooking at the differences between the two surgical approaches.

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001439
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Inclusion Criteria:

• 18 years or older
• confirmed cervical cancer with the histological type of adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma (Including glassy cell)
• Stage IA2, IBI, IB2 cancer
• able to care for self and do light work
Exclusion Criteria:

• unable to have a MRI
• history of prior pelvic or abdominal radiotherapy
• history of cancer less than 5 years ago with the exception of non-melanoma skin cancer.
Conditions: Cancer, Women's Health
Keywords: Cervical Cancer
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Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)

The purpose of this research is to learn more about the immune function of patients who are critically ill and may or may not have sepsis through assessment of blood samples at the time of their illness. We will use the blood to determine whether the immune system is suppressed (slowed or stunted) and measure the amount of suppression. Our research team will compare blood from healthy participants to people who are critically ill to better understand immune system suppression.

Principal Investigator: Thomas Griffith
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001746
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Inclusion Criteria:

• Adults age 45 and older
• Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria:

• Current, chronic steroid use
• Pregnancy
• Current or recent (within 7 days) use of antibiotics.
Conditions: Immune Diseases
Keywords: Sepsis
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CPDPC16-04: Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabeTes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)

Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The goal of this study is to develop a blood test to distinguish these various causes of diabetes.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
IRB Number: SITE00001191
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Inclusion Criteria:

• 30 to 84 years old
• diabetes diagnosed less than 3 years ago with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR longstanding diabetes diagnosed 3 or more years ago, with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR people don't have diabetes but have Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• currently receiving oral steroid medications
• previous treatment for pancreatic cancer, including chemotherapy or radiation
• on treatment for any cancer
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Diabetes & Endocrine
Keywords: Chronic Pancreatitis, Diabetes Mellitus Type 3c, Pancreatic Cancer
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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.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001730
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Inclusion Criteria:

• 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
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)

A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.

Principal Investigator: Jacob Cogan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017896
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Inclusion Criteria:

• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
Exclusion Criteria:

• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)
Conditions: Blood Disorders
Keywords: Hemophilia
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Impact of a full-mouth electronic toothbrush on indicators of gingivitis and patient perceptions: A randomized clinical trial

The purpose of this trial is to investigate a full-mouth electronic toothbrush (FMET) and foam system compared to a conventional electronic toothbrush (ETB) and dentifrice during a 30-day period to evaluate the impact on clinical indicators of gingivitis, plaque, safety, and patient perceptions.

Principal Investigator: Michelle Arnett
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022906
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Inclusion Criteria:

• diagnosis of mild to moderate gingivitis
• minimum of five natural teeth in each quarter of the mouth
• willing to stop all professional oral hygiene care
• willing to stop use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.)
• access to personal email account and a device connected to the internet
Exclusion Criteria:

• aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition
• unable to independently brush teeth
• fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment
• pregnant, planning to become pregnant, or unsure of pregnancy status
• use of cigarettes within the last year
Conditions: Rare Diseases, Dentistry
Keywords: Feno Smartbrush, teeth, tooth brush, dental hygiene, gingivitis
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Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

This study looks at how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC082
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Inclusion Criteria:

• planning to receive Immune Checkpoint Therapy (ICI) for a solid tumor cancer
• if received prior ICI-based therapy must have completed it at least 180 days before starting the study
• must be able to complete Patient-Reported Outcome (PRO) forms in English, Spanish, or French
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: cancer, ICI, Immune Checkpoint Therapy, solid tumor
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Registry Study of Childhood Cancer in Minnesota

The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.

Principal Investigator: Erin Marcotte
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00018811
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Inclusion Criteria:

• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
Conditions: Cancer
Keywords: blood specimen, cancer, tumor
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FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

This ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting).

Principal Investigator: Peter Friedell
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC081
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Inclusion Criteria:

• must have enrolled onto clinical trial EAY191 and have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of specific mutation as defined in EAY191
• disease has progressed on gemcitabine based first-line regimen
• adequate contraception is required
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
Conditions: Cancer
Keywords: Biliary Cancer, Gall Bladder cancer
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Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease

The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.

Principal Investigator: Takako Araki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022764
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Inclusion Criteria:

• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
Exclusion Criteria:

• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
Conditions: Breathing, Lung & Sleep Health, Diabetes & Endocrine, Rare Diseases
Keywords: CD, Cushing Disease
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Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients

The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.

Principal Investigator: Susan Kline, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019575
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Inclusion Criteria:

• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
Exclusion Criteria:

• surgery scheduled less than 10 days after the baseline cultures
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NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)

Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.

Principal Investigator: Patrick Nachman
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000599
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Inclusion Criteria:

• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
Exclusion Criteria:

• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Focal Segmental, Focal Segmental, Glomerulosclerosis, Glomerulosclerosis, Minimal Change Disease (MC
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Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia

The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.

Principal Investigator: Luke Johnson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018981
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Inclusion Criteria:

• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
Exclusion Criteria:

• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Parkinson's Disease, Sleep Apnea
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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

Levosimendan has not been approved by the FDA to treat people who have PH-HFpEF or approved to be taken by mouth (orally). In this study, we will measure the amount of levosimendan in blood at various times and evaluate the change in participants 6-Minute Walk Distance.

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020954
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Inclusion Criteria:

• 18 to 85 years old
• diagnosis of pulmonary arterial hypertension
• on stable doses of heart medication for at least 30 days
• there are specific requirements for birth control for women and men
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• ability to walk is limited by anything other than symptoms (shortness of breath and fatigue) related to pulmonary hypertension
• other diagnosis related to heart function such as valve disease, cardiomyopathy, etc.
• current lung disease
• study staff will review additional inclusion & exclusion criteria
Conditions: Heart & Vascular, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), levosimendan, PH-HFpEF, pulmonary arterial hypertension, pulmonary vascular disease
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Characterization of spleen motion and anatomy using imaging and sensors

This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013252
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Inclusion Criteria:

• at least 18 years old
Exclusion Criteria:

• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Conditions: Digestive & Liver Health
Keywords: Imaging, Spleen
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Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter

This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.

Principal Investigator: Jayanthi Sasisekaran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00013042
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Inclusion Criteria:

• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Conditions: Children's Health, Community Health
Keywords: adults, attention, fluency, language, memory, speech production, Stuttering, children
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A Randomized Phase III Trial of Intravesical BCG VeRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) (BRIDGE)

We want to see if we can lower the chance of bladder cancer growing or spreading by using a type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel. The usual approach for patients who are not in a study is treatment with Transurethral surgery of bladder tumor (TURBT) followed by instillations of Bacillus Calmette-Guerin (BCG) immunotherapy into the bladder via a catheter.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021094
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Inclusion Criteria:

• at least 18 years old
• diagnosis of confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder
• have not received prior intravesical therapy for bladder cancer
• capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• must not have any prior or current history of muscle-invasive, locally advanced unresectable, or metastatic urothelial cancer
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: bladder cancer, Clinics and Surgery Center (CSC), urothelial Cancer
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COG AALL2121: A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia

This phase II trial tests the safety and best dose of revumenib when given together with chemotherapy, and how well the treatment regimen works for infants and young children with leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in test tubes and animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial is being done to find out if the combination of revumenib and chemotherapy may help to treat the cancer cells better than either treatment alone.

Principal Investigator: Peter Gordon
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021176
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Inclusion Criteria:

• Age: Patients must be 1 month to less than 6 years old at the time of study enrollment and must have had initial diagnosis of leukemia less than 2 years old.
• Diagnosis: Patients must have KMT2A-rearranged acute lymphoblastic leukemia (ALL), acute leukemia of ambiguous lineage (ALAL), or mixed phenotype acute leukemia (MPAL), which is determined to be refractory or in first marrow relapse.
• Disease status: First relapse, refractory or failure to achieve remission
• See link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Patients with isolated extramedullary leukemia.
• Patients diagnosed with Down syndrome.
Conditions: Cancer
Keywords: ALAL, ALL, leukemia, MPAL, relapse
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Rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia for pain control following pancreatoduodenectomy: a prospective, randomized, non-inferiority trial

In this study, we are comparing two different numbing techniques performed by anesthesiologists. Patients in the study are randomly selected to receive one or the other type of numbing injection. One group of patients will receive an epidural, which is a numbing injection done in the back, similar to that which women receive when they give birth. The other group of patients will receive a rectus sheath block, which is a numbing injection done on the abdomen. Both of these types of numbing injections are performed regularly by our anesthesiologists at the University.

Principal Investigator: James Flaherty
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019488
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Inclusion Criteria:

• pancreaticoduodenectomy at the University of Minnesota
Exclusion Criteria:

• chronic opioid use
• women who are pregnant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: duodenal cancer, pancreatic cancer
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Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma

There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.

Principal Investigator: Stephanie Terezakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00010991
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Inclusion Criteria:

• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and 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 additional requirements
Exclusion Criteria:

• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
Conditions: Cancer
Keywords: Bone Pain, Metastatic Malignant Neoplasm in the Bone, Multiple Myeloma, Plasma Cell Myeloma
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BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

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

Principal Investigator: Andrew Adams
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001922
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Inclusion Criteria:

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

• previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
• medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
• additional criteria apply (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: kidney transplant
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A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.

Principal Investigator: David Perlman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020802
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Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Pregnancy or breast-feeding
Conditions: Breathing, Lung & Sleep Health, Rare Diseases, Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Sarcoidosis
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MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

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

Principal Investigator: Samuel Goldfarb
Age Group: Up to 24 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001589
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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
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A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma

This is an early study of a new drug, RGDCRAdCOX2F, as a single tumor injection in persons with adenocarcinoma of the pancreas. The main goal of the study is to find a safe dose of the study drug.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021119
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Inclusion Criteria:

• documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes
• one prior line of therapy is permitted
• normal cardiac and pulmonary function
• participants with partners of childbearing potential must be willing to use at least two forms of effective birth control
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• other types of pancreatic cancer
• history of human immunodeficiency virus (HIV) infection
• history of or active acute or chronic active hepatitis B or C infection
• taking 10mg/day or more of prednisone for more than one week
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Pancreas, Pancreatic Cancer
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