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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.

410 Study Matches

Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
MMCORC058
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Inclusion Criteria:

• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
Exclusion Criteria:

• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Cancer
Immune checkpoint inhibitor, Cancer, Disparities
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Treatment of Refractory Nausea

We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.

Kiran Lassi
18 years and over
This study is NOT accepting healthy volunteers
MMCORC057
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Inclusion Criteria:

• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
Exclusion Criteria:

• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Cancer
Breast Cancer, Breast Cancer, Chemotherapy, Nausea
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Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.

Nicole Hartung
18 years and over
This study is NOT accepting healthy volunteers
MMCORC068
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Inclusion Criteria:

• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
Exclusion Criteria:

• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Cancer
Immunotherapy, Lung Cancer, Lung Cancer, Non Small cell lung cancer, NSCLC, Stage IV lung cancer
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Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

We are studying an internet-based pain coping skills program with pain education for cancer survivors who have persistent pain. Pain severity and interference will be compared to people who receive only pain education. The pain coping program has 8 sessions that are completed in the first 10 weeks of starting the study. The group that receives only pain education will receive access to the program after 6 months. Everyone is followed for 9 months

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
MMCORC055
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Inclusion Criteria:

• diagnosis of invasive cancer that has been treated with either single therapy or any combination of surgery, radiation, chemotherapy/drug therapy
• may be either off all treatment OR actively receiving anticancer therapy in an adjuvant (after surgery) setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive
• less than/equal to 5 years since the completion of their anticancer therapy
• experiencing continued pain
Exclusion Criteria:

• cancer history of only superficial skin cancers or in situ malignancy
• only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia)
• known or suspected diagnosable substance use disorder or opioid overuse disorder
• enrolled in hospice care or end-of-life palliative care
Cancer
Cancer Pain, Cancer Survivorship
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A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

We are studying how well radiation therapy with or without olaparib works in treating people with inflammatory breast cancer. Olaparib may keep cancer cells from repairing themselves, making them die. We want to see if adding this drug to radiation therapy is more effective.

Kiran Lassi
18 years and over
This study is NOT accepting healthy volunteers
MMCORC051
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Inclusion Criteria:

• diagnosis of inflammatory breast cancer without distant metastases
• completed neoadjuvant chemotherapy prior to mastectomy
• radiation therapy has not been given to the affected breast
• able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
Exclusion Criteria:

• active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• history of uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung disease
Cancer
Breast Cancer, Breast Cancer, Inflammatory Breast Cancer
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CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)

We are enrolling people who have had complete surgical removal of a stage II or stage III colorectal cancer. We will draw blood samples for circulating tumor DNA (ctDNA) to find out if this blood test can be used to detect recurrence of the cancer. People will be followed for at least 3 years and up to 5 years.

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
MMCORC050
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Inclusion Criteria:

• diagnosis of cancer of the colon or rectum (CRC)
• complete surgical resection, with last surgery occurring within 180 days prior to enrollment
Exclusion Criteria:

• started adjuvant (after surgery) therapy for current CRC diagnosis
• women who are pregnant or breastfeeding
• history of any invasive cancer except non-melanoma skin cancer
Cancer
Colon Cancer, Colon Cancer, Colorectal Cancer
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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

We are comparing treatment of early stage, hormone positive breast cancer with and without radiation therapy. One group will receive radiation therapy with endocrine therapy and the other group will receive endocrine therapy alone. We want to find out if there is any difference in how often breast cancer recurs in the same breast.

Jocelin Huang
18 years and over
This study is NOT accepting healthy volunteers
MMCORC044
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Inclusion Criteria:

• completed surgery to remove a breast tumor and there isn't any evidence of remaining tumor.
• Early stage (T1) tumor without lymph node involvement and a Oncotype DX Recurrence Score of less than or equal to 18
• ER and/or PgR positive and HER2 negative tumor
Exclusion Criteria:

• tumor size larger that T1
• surgical procedure was a mastectomy
• any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy given for the currently diagnosed breast cancer prior to study entry
• Women who are pregnant or breast feeding
Cancer
Breast Cancer, Breast Cancer, Radiation, Stage 1 breast cancer. Hormone positive breast cancer
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Testing Effective Methods to Recruit Sexual and Gender Minority Cancer Patients for Cancer Studies: Aim 1 SGM Interviews

This is a study about how to recruit sexual and gender diverse people into cancer research studies. You will be asked to participate in a secure Zoom interview; if you do not have access to Zoom an interview may occur over the phone. The interview will take about 60-90 minutes, and we will ask questions about your experience with participating in cancer research studies and your experience during treatment.

B R Simon Rosser
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016416
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Inclusion Criteria:

• people who identify as LGBT
• at least 18 years of age
• currently living in the US
• diagnosed with and treated for cancer.
• speak English
Exclusion Criteria:

• people who have been diagnosed with cancer but haven't been treated
Cancer, Community Health
Cancer, LBGT
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Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention

The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).

Deanna Teoh
Not specified
This study is NOT accepting healthy volunteers
STUDY00013006
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Inclusion Criteria:

• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
Exclusion Criteria:

• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
Cancer, Children's Health
Clinics and Surgery Center (CSC), cancer survivors, HPV, vaccination
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Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)

This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00012932
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Inclusion Criteria:

• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:

• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Diabetes & Endocrine, Children's Health
Obesity, Overweight, weight loss
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A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors; Protocol Number: LOXO-RET-18036 (J2G-OX-JZJJ) (LIBRETTO-121)

This is an open-label, multi-center, Phase 1/2 study of oral LOXO-292 in pediatric patients with an activating RET alteration and an advanced solid or primary CNS tumor.

Emily Greengard
6 months to 21 years old
STUDY00008874
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Inclusion Criteria:
Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies Evidence of an activating RET gene alteration in the tumor and/or blood Measurable or non-measurable disease Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50 Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days Adequate hematologic, hepatic and renal function. Ability to receive study drug therapy orally or via gastric access Willingness of men and women of reproductive potential to observe conventional and effective birth control
Exclusion Criteria:
Major surgery within two weeks prior to planned start of LOXO-292 Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 Active uncontrolled systemic bacterial, viral, fungal or parasitic infection Clinically significant active malabsorption syndrome Pregnancy or lactation Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) Uncontrolled symptomatic hypercalcemia or hypocalcemia Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s])
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ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis

This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.

Lucie Turcotte
Not specified
This study is NOT accepting healthy volunteers
SITE00001984
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Inclusion Criteria:

• 180 days to < 22 years (at time of study enrollment)
• patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• history of solid organ or hematopoietic bone marrow transplantation
• female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• lactating females who plan to breastfeed their infants are ineligible
• see link to clinicaltrials.gov for complete exclusion criteria
Cancer
LCH, Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
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A Phase 1/2A, (Part B, participant-, investigator-, and sponsor-blind) study; to investigate the safety, pharmacokinetics, and efficacy (Part B only) of UCB1381 in study participants with moderate to severe atopic dermatitis;(Part B)

This is an early study of a new drug called UCB1381. In the first part of the study, we are looking at increasing doses of the drug when compared to an inactive drug (placebo) when given to healthy participants. In the second part, we will look at the safety and effectiveness of one dose of UCB1381 compared to an inactive drug (placebo) when given to people who have moderate to severe Atopic Dermatitis.

Paul Bigliardi
18 years and over
This study is NOT accepting healthy volunteers
SITE00001885
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Inclusion Criteria:

• 18-65 years of age
• moderate to severe itch
Exclusion Criteria:

• diabetes not well controlled with diet
• history of Crohns disease or Colitis
Dermatology (Skin, Hair & Nails)
Atopic Dermatitis
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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

1.1 Purpose: This protocol will carry out Aim 2 (Experiments 1 and 3) of Udall Project 2, leveraging the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over 4 weeks).

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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Validation of the Autism Diagnostic Interview: 3rd Edition

The goal of this study is to support the validation of a revision to the Autism Diagnostic Interview – Revised (ADI-R). The ADI-R is a highly validated diagnostic tool used in clinical assessments for autism spectrum disorder and widely used in research for participant characterization and inclusion. Aims: 1. To explore the validity of the ADI-3 (concurrent validity with ADI-R and other autism instruments; predictive validity with best estimate clinical diagnosis). 2. To explore the reliability of the ADI-3 (interrater, test-retest, internal consistency) 3. To derive diagnostic algorithms that better match DSM-5 criteria and maximize sensitivity and specificity 4. To ensure that changes (e.g., reduced length, new format to codes) yield sufficient information to inform diagnoses.

Amy Esler
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00018321
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Inclusion Criteria:

• ages 1 to 17 who have an adult (parent or caregiver) who is also willing to participate
• able to read and communicate in English
• Autism group: children with a previous diagnosis or concern about autism
• Non-autism group: children with or without a previous diagnosis or concern about another developmental or psychiatric condition
Exclusion Criteria:

• significant visual or auditory impairments that would make it difficult to complete standard testing
• severe mental illness or medical condition that is not currently managed and would interfere with the completion of the testing
Children's Health, Mental Health & Addiction
Autism
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CANADIAN-AUSTRALASIAN RANDOMISED TRIAL OF SCREENING KIDNEY TRANSPLANT CANDIDATES FOR CORONARY ARTERY DISEASE (CARSK)

Cardiovascular disease is the most common cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly, to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after, kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues.

Arthur Matas, MD
18 years and over
STUDY00018456
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Inclusion Criteria:
adults aged 18 years of age or older Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list expected to require further screening for CAD prior to transplantation (by current standard of care); able to give consent; anticipated to undergo transplantation more than 12 months from date of enrolment
Exclusion Criteria:
patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease; patients who "on-hold" for transplantation due to a medical problem; patients with other solid organ transplants; multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates); patients with planned living donor transplant; patients unable to give consent.
Clinics and Surgery Center (CSC)
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Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (PACIFIC)

The purpose of this study is to find out the safety and tolerability (the degree to which side effects affect a participant’s willingness to continue taking study drug) of the study drug EP547 in patients with itch associated with cholestatic liver disease and to determine the amount of EP547 in the blood after dosing. EP547 is an experimental drug that is not approved by the Food and Drug Administration (FDA) for the treatment of itch associated with liver disease or of any other conditions. This study will have 9 study visits which includes a screening period of up to 4 weeks long, a 12-week treatment period, and a follow-up visit 2 weeks after stopping study treatment.

Mary Thomson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016629
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Inclusion Criteria:

• diagnosed with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC
• consistent moderate to severe pruritus (itching)
Exclusion Criteria:

• prior or planned liver transplantation
• liver cirrhosis
• significant small bowel resection or short bowel syndrome
Dermatology (Skin, Hair & Nails), Digestive & Liver Health
Clinics and Surgery Center (CSC), Itching, Pruritus
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A Phase 1b, Randomized, Vehicle-Controlled, Double-Blind, Pharmacokinetics, Pharmacodynamics, and Safety Study of ARQ-255 Topical Suspension in Healthy Volunteers and Subjects with Alopecia Areata

This study is being done to evaluate the safety and tolerability of twice daily application of the study drug, ARQ-255 topical suspension 3% people with alopecia areata. There are 2 study drugs in this study: ARQ-255 topical suspension 3% and vehicle (placebo). Participants will be randomized (like drawing straws) to either ARQ-255 topical suspension 3% or vehicle to be applied twice daily for 12 weeks. A vehicle is a study treatment that looks like the test drug and is made from the same base products used to make ARQ-255 topical suspension 3%, but it does not contain any active study ingredients.

Maria Hordinsky
18 years and over
This study is NOT accepting healthy volunteers
SITE00001818
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Inclusion Criteria:

• 18 to 70 years of age
• have alopecia areata
• able to apply topical study medication
Exclusion Criteria:

• alopecia totalis
• alopecia universalis
Dermatology (Skin, Hair & Nails)
alopecia areata
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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.

Sean Elliott
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019225
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Inclusion Criteria:

• 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)
Exclusion Criteria:

• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Neurogenic Bladder, Self Catheterization, Urinary Tract Infection, UTI
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Eugenia Shmidt
Not specified
This study is NOT accepting healthy volunteers
STUDY00013632
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease
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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

We are testing whether treating people who have FSGS with plasmapheresis and rituximab before or shortly after kidney transplant can prevent the recurrence of FSGS after kidney transplant. All participants will receive plasmapheresis. Each participant has a 50% chance of receiving rituximab and a 50% chance of receiving no additional treatment. Rituximab is given by infusion. If a participant is assigned to receive rituximab, it will be given one time immediately after plasmapheresis.

Michelle Rheault
Not specified
This study is NOT accepting healthy volunteers
STUDY00004388
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Inclusion Criteria:

• 1 to 65 years old
• biopsy proven diagnosis of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease
• history of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
• first kidney transplant or second or third transplant with a history of recurrent FSGS in the first or second kidney transplant
• males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab
Exclusion Criteria:

• known genetic cause of FSGS
• FSGS secondary to another condition (obesity, viral infection, medications, etc.)
• received rituximab within 1 year prior to transplant
• women who are pregnant, lactating, or refuse use of birth control
• additional medical or mental health diagnosis (study staff will review)
Kidney, Prostate & Urinary
Focal Segmental Glomerulosclerosis
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MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol (CSIDE)

To determine the incidence of humoral immune reconstitution by 2 years post-transplant in 2 SCID cohorts (IL2RG/JAK3, RAG1/RAG2) undergoing alternative donor HCT by randomized assignment to a busulfan preparative regimen targeted at cumulative area-under-the-curve (cAUC) exposure of 25-35 mg*h/L vs 55-65 mg*h/ L.

Christen Ebens
0 years to 2 years old
SITE00000541
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Inclusion Criteria:

• Infants with SCID, either typical or leaky or Omenn syndrome. Typical SCID is defined as either of the following Absence or very low number of T cells (CD3+ T cells <300/microliter AND no or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin OR Presence of maternally derived T cells Leaky SCID is defined as the following • Absence of maternally derived T cells • AND either one or both of the following (i, ii): i) <50% of lower limit of normal T cell function as measured by response to PHA OR <30% of lower limit of normal T cell function as measured by response to CD3 ii) Absent or <10% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens (must document post vaccination or exposure for this criterion to apply) • AND at least two of the following (i through iii): i) CD3 T cells < 1500/microliter ii) >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (at < 4 years of age) AND/OR are oligoclonal T iii) Low TRECs and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower level of normal. Omenn syndrome • Generalized skin rash Maternal lymphocytes tested for and not detected. >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (<2 years of age) Absent or low (up to 30% lower limit of normal (LLN)) T cell proliferation to antigens (Candida, tetanus) to which the patient has been exposed IF: Proliferation to antigen was not performed, but at least 4 of the following 8 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the patient is eligible as Omenn Syndrome. Hepatomegaly Splenomegaly Lymphadenopathy Elevated IgE Elevated absolute eosinophil count *Oligoclonal T cells measured by CDR3 length or flow cytometry (upload report) *Proliferation to PHA is reduced to < 50% of lower limit of normal (LLN) or SI < 30 *Low TRECs and/or percentage of CD4+/RA+ CD31+ or CD4+/RA+ CD62L+ cells below the lower level of normal
• Documented mutation in one of the following SCID-related genes a. Cytokine receptor defects (IL2RG, JAK3) b. T cell receptor rearrangement defects (RAG1, RAG2) 3. No available genotypically matched related donor (sibling) 4. Availability of a suitable donor and graft source Haploidentical related mobilized peripheral blood cells 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells 5. Age 0 to 2 years at enrollment Note: to ensure appropriate hepatic metabolism, age at time of busulfan start: For IL2RG/JAK3: 8 weeks For RAG1/RAG2: 12 weeks
• Adequate organ function defined as: Cardiac: Left ventricular ejection fraction (LVEF) at rest ≥ 40% or, shortening fraction (SF) ≥ 26% by echocardiogram. Hepatic: Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert's Disease are allowed to exceed this limit) and AST and ALT < 5.0 x ULN for age. Renal: GFR estimated by the updated Schwartz formula ≥ 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m2. Pulmonary No need for supplemental oxygen and O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care).
Exclusion Criteria:
Presence of any serious life-threatening or opportunistic infection at time of enrollment and prior to the initiation of the preparative regimen. Serious infections as defined below that occur after enrollment must be reported immediately to the Study Coordinating Center, and enrollment will be put on hold until the infection resolves. Ideally enrolled subjects will not have had any infection. If patients have experienced infections, these must have resolved by the following definitions: a. Bacterial i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site must be negative and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). ii. Tissue-based clinical infection (e.g. cellulitis): Complete resolution of clinical signs (e.g. erythema, tenderness, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). iii. Pneumonia, organism not identified by bronchoalveolar lavage: Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). If possible, radiographic resolution should also be demonstrated. b. Fungal i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site is negative and patient has completed appropriate course of antifungal therapy (typically at least 14 days). The patient may be continued on antifungal prophylaxis following completion of the treatment course. c. Pneumocystis i. Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of therapy (typically at least 21 days). If possible, radiographic resolution should also be demonstrated. The patient may be continued on prophylaxis following completion of the treatment course. d. Viral i. Viral PCRs from previously documented sites (blood, nasopharynx, CSF) must be re-tested and are negative. ii. If re-sampling a site is not clinically feasible (i.e. BAL fluid): Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.). If possible, radiographic resolution should also be demonstrated. Patients with HIV or HTLV I/II infection will be excluded.
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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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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

TMS x DPX

We will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while we are measuring the change in brain function with EEG. Please fill out the linked screening questionnaire to determine if you are eligible.

Alik Widge
18 years and over
This study is also accepting healthy volunteers
STUDY00019156
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Inclusion Criteria:

• age 18 to 65
Exclusion Criteria:

• diagnosed with a psychiatric disorder
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of, or recent withdrawal from, medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or have an implanted medical device
Mental Health & Addiction
cognition, EEG, rTMS
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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.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion 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)
Cancer
Germ Cell Tumor, Malignant Germ Cell Tumor
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Robotic Gait Training to Improve Functional Outcomes after SCI

We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.

Leslie Morse
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018674
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Inclusion Criteria:

• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
Exclusion Criteria:

• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Spinal Cord Injury (SCI)
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Ankle Position Sense Acuity in People with Parkinson's Disease Experiencing Freezing of Gait and Its Relationship to Gait

This study aims to investigate whether there is difference in ankle position sense acuity between people with Parkinson's with freezing of gait and without freezing of gait. It also examines the relationship between position sense acuity and severity of freezing of gait, and gait measurements.

Juergen Konczak
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019098
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Inclusion Criteria:

• 50 to 80 years old
• diagnosis of idiopathic Parkinsons Disease (PD) as determined by a movement disorder neurologist
• PD severity is mild to moderate
Exclusion Criteria:

• significant central or peripheral nervous system disease
• previous exposure to chemotherapy
• history of lower limb surgery or lower limb fractures within the last 6 months
• amputation or joint replacement of any part of the leg
• implanted deep brain stimulation or other neurosurgery to treat PD
• additional medical factors (study team will review)
Bone, Joint & Muscle, Brain & Nervous System
Parkinson's, Parkinson's Disease
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Profiling of Adipose Tissue Depots and Immune Correlates

This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009134
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Digestive & Liver Health, Diabetes & Endocrine, Prevention & Wellness
abdominal surgery, fat collection
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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.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
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
Brain & Nervous System
Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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