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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.

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Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

This study is being done to learn more about the influence of the menopausal transition on autonomic and vascular function in midlife females. Participants will have their vitals taken and height, weight and waist-to-hip ratio measurements done, complete questionnaires, have blood draws, have electrical activity of a nerve in the leg measured (optional), have blood vessel function measured in the arm, perform breathing exercises, and complete a cold pressor test (putting a hand in ice-cold water). Participants will also have a scan to measure body composition and bone density.

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022683
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Inclusion Criteria:

• women who are 45-55 years old
• premenopausal
• currently have a normal menstrual cycle
• not planning to become pregnant for the duration of participation in the study
• able to read, write & speak English
Exclusion Criteria:

• diabetes
• pregnant or breastfeeding
• cardiac or lung disorders
• severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
• hypertension
• obstructive sleep apnea
• current use of heart or blood pressure medications or antidepressants
• history of treatment with chemotherapy/radiation
• coagulopathy disorders and/or use of anticoagulant medications
• current use of hormonal contraceptives
• nicotine/tobacco use in the last six months
• current alcohol abuse
Conditions: Women's Health
Keywords: Menopause, Pre menopause, Clinics and Surgery Center (CSC)

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

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

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024254
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Inclusion Criteria:

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

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

Effect of Kava on Anxiety and Stress in Cancer Survivors

Anxiety and stress are significant problems for cancer survivors. The purpose of this study is to learn what effect a 14-day course of kava can have on anxiety and stress in cancer survivors, and about the side effects of kava for cancer survivors.

Principal Investigator: Naomi Fujioka
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015828
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Inclusion Criteria:

• Adult ≥ 18 years old
• Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
• Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
Exclusion Criteria:

• Known allergy to kava
• Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
• Use of herbal supplements within 14 days of study registration,
• Anti-cancer therapy within 28 days prior to registration and/or during study participation, except for aromatase inhibitors
• Known liver disease such as cirrhosis
• Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
• Chronic use of high-intensity statin therapy
• Women who are pregnant, intend to become pregnant, or are nursing
Conditions: Cancer
Keywords: anxiety, cancer survivor, Clinics and Surgery Center (CSC), kava
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Principal Investigator: Colleen Correll
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Conditions: Arthritis & Rheumatic Diseases, Cancer
Keywords: juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00008043
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Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Conditions: Brain & Nervous System
Keywords: Parkinson
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Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma

To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.

Principal Investigator: Clay Hoerig
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1606M89501
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Inclusion Criteria:

• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
Exclusion Criteria:

• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
Conditions: Cancer, Cancer
Keywords: OPG, Optic Pathway Glioma
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MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study

The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014365
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Inclusion Criteria:

• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute-graft-versus-host Disease, aGVHD, HCT, Hematopoietic Cell Transplant
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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Inclusion Criteria:

• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), Acquired Amegakaryocytic Thrombocytopenia, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, SA
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An interventional efficacy and safety Phase 3 double-blind 2-arm study to investigate IV followed by oral fosmanogepix compared with IV caspofungin followed by oral fluconazole in adult participants with candidemia and/or invasive candidiasis.

The purpose of this study is to compare effects of the study drug fosmanogepix with already-approved drugs caspofungin and fluconazole to find out if fosmanogepix is safe and effective in treating patients with candidemia and/or invasive candidiasis.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023155
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Inclusion Criteria:

• diagnosis of candidemia and/or invasive candidiasis
• see link to cliinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• require hemodialysis, peritoneal dialysis, or hemofiltration
• received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Infectious Diseases
Keywords: Candidemia, fungal infection, Clinics and Surgery Center (CSC)
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A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)

One type of infection that is possible after bone marrow transplant is called an invasive fungal disease (IFD), a type of fungal infection that has the ability to spread throughout the body. In this study, rezafungin will be compared with the currently approved drugs for the prevention of IFD. The currently approved drugs are referred to as the standard antimicrobial regimen (SAR) which is posaconazole or fluconazole. We want to learn if rezafungin is safe and tolerable, if it is effective in preventing IFD compared to the standard treatment and to find out how much rezafungin is in blood over time after study drug has been given.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021347
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Inclusion Criteria:

• receiving a human leukocyte antigen (HLA) matched or unmatched peripheral bone marrow transplant (BMT)
• diagnosis of one of the following underlying diseases: acute myeloid leukemia (AML), acute lymphoblastic leukemia, acute undifferentiated leukemia, acute biphenotypic leukemia, or chronic myelogenous leukemia
• women and men must agree to use birth control for 120 days after last dose of study drug
• see link to clinicaltrials.gov for completed inclusion and exclusion criteria
Exclusion Criteria:

• diagnosis of AML not in remission
• significant heart or lung disease
• previous allogeneic BMT
• ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease)
Conditions: Infectious Diseases
Keywords: BMT, Bone Marrow Transplant, Candidemia, Fungal Infection, Infection, Infectious Disease, Mycoses
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A Phase 1, Open-label, Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Recombinant Human Heparan N-Sulfatase (rhHNS, GC1130A) Via Intracerebroventricular Access Device in Patients with Sanfilippo Syndrome Type A (MPS IIIA).

The purpose of the study is to see if GC1130A, delivered directly to the central ventricle of the brain is safe and tolerable as a means of treating the neurologic disease in MPS 3A.

Principal Investigator: Chester Whitley, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022733
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Inclusion Criteria:

• documented MPS IIIA diagnosis
• ≥ 24 months and ≤ 72 months of age
Exclusion Criteria:

• significant non-MPS IIIA related central nervous system impairment
• previous complication from intraventricular drug administration
• contraindications for MRI scans and for neurosurgery
• received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days
• received a hematopoietic stem cell or bone marrow transplant or received gene therapy
Conditions: Rare Diseases, Rare Diseases
Keywords: MPS IIIA, Sanfilippo Syndrome
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome (HERO)

This study is for people who feel very hungry all the time, have trouble controlling eating (hyperphagia) and have Prader-Willi Syndrome (PWS). ARD-101 is being studied to see if it can help the body release certain gut hormones that may help reduce excessive hunger and food-seeking behaviors in people with PWS. The investigational treatment is a tablet taken by mouth and swallowed whole. The study will continue for up to 20 weeks (about 5 months).

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024946
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Inclusion Criteria:

• at least 13 years of age
• confirmed diagnosis of Prader-Willi Syndrome (PWS)
• living in a stable care setting with the same caregiver(s) for at least 6 months and one designated caregiver is willing and able to adhere to study-related procedures and is willing to participate in all study visits and complete study-related questionnaires
• females must not be pregnant when starting the study and willing to use effective birth control for 90 days after the last dose of study drug
• males engaged in sexual relations with a female of childbearing potential must utilize a highly effective method of contraception until 90 days after the last dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• difficulty swallowing or inability to swallow oral medication
• significant medical or mental health diagnosis
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Keywords: PWS, Prader-Willi Syndrome

PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001846
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Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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Biorepository to Support ALS Research in Minnesota

The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022317
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Inclusion Criteria:

• people living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders
Exclusion Criteria:

• age less than 18 or greater than 90
Conditions: Brain & Nervous System, Rare Diseases, Rare Diseases
Keywords: ALS, amyotrophic lateral sclerosis, Clinics and Surgery Center (CSC)
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A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017568
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Inclusion Criteria:

• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
Exclusion Criteria:

• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Conditions: Breathing, Lung & Sleep Health, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), antifungal therapy, aspergillosis, fungal infection, lung infection, pulmonary aspergillosis
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Bupropion for the Prevention of Postpartum Smoking Relapse

Currently, more than half of all women who are able to quit smoking cigarettes during pregnancy start smoking again within six months after they give birth. We want to find out if the drug bupropion (a commercially-available medicine) can help women who quit smoking during pregnancy to continue not smoking after they give birth. All study visits can be completed either in-person or virtually.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007684
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Inclusion Criteria:

• age 18 to 40
• lifetime history of smoking at least 100 cigarettes, quit smoking during current pregnancy
• uncomplicated delivery, at least 37 weeks gestation
• home within 10 days of delivery
• don't want to start smoking again
Exclusion Criteria:

• currently use other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• currently use cessation aids
• currently use illicit drugs or alcohol dependence
• taking an antidepressant
• family history of seizures or seizure disorder
Conditions: Mental Health & Addiction, Women's Health
Keywords: postpartum, smoking, smoking cessation
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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 4 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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The Women Kidney Program

The purpose of this study is to capture clinical information on how kidney disease affects the health of women, focusing on menstrual and reproductive health, the transition to menopause (the time when your menstrual periods stop permanently), and menopause itself. We also wish to learn more about how women’s health affects their kidney disease, bone and heart health.

Principal Investigator: Angie Lobo Romero
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020957
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Inclusion Criteria:

• female as biological sex
• diagnosis of a kidney disease or after kidney transplant
• at least 18 years old
Exclusion Criteria:

• unable to speak English
Conditions: Kidney, Prostate & Urinary, Women's Health
Keywords: Clinics and Surgery Center (CSC), Kidney disease, kidney transplant
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MT2024-16: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa (Regulate-HS)

This research study is for people who have Hidradenitis Suppurativa (HS) and it is moderate or severe in intensity and have been treated with at least one conventional therapy for HS. This study involves the investigational drug SBT777101, which is created by genetically modifying a patient’s own immune cells. The word “investigational” means that this drug has not been approved by the U.S. Food and Drug Administration (FDA) for marketing. SBT777101 is being developed to treat people with hidradenitis suppurativa (HS).

Principal Investigator: Noah Goldfarb
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021432
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Inclusion Criteria:
Diagnosis of Hidradenitis Suppurativa
Exclusion Criteria:
History of Crohns disease
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Clinics and Surgery Center (CSC), Hidradenitis suppurativa
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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)

We want to study if lower doses of a chemotherapy drug called busulfan will help babies with SCID achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to succeed with this approach and offers them transplant early in life before they get severe infections or later if their infections are under control. It includes only patients receiving unrelated or mismatched related donor transplants.

Principal Investigator: Christen Ebens
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00000541
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Inclusion Criteria:

• 0 to 2 years old
• infants with SCID, either typical or leaky or Omenn syndrome
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• any serious life-threatening or opportunistic infection at time of enrollment
• HIV or HTLV I/II infection
Conditions: Cancer, Cancer
Keywords: SCID, Severe Combined Immunodeficiency
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Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants with Locally Advanced (Unresectable) or Metastatic Solid Tumors

The purpose of this screening study is to collect samples to conduct the testing of specific human leukocyte antigen (HLA). TScan Therapeutics is developing cellular therapies across multiple solid tumors in which the eligibility criteria require that participants have specific HLA types. The results from this screening study will be used to determine if participants meet the eligibility criteria and could potentially be enrolled in a future TScan treatment study.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019929
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Inclusion Criteria:

• have one of the following confirmed locally advanced (unresectable) or metastatic solid tumor: Head and neck cancer, cervical cancer, non-small cell lung cancer, melanoma, ovarian cancer, HPV positive anogenital cancer HPV positive anogenital cancers
Exclusion Criteria:

• undergoing anticancer therapy with curative intent
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), anal, Cervical, genital, Head and Neck, HPV16, Melanoma, Non Small Cell Lung, Ovarian, Solid Tumor
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)

The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022419
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Inclusion Criteria:

• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Exclusion Criteria:

• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
Conditions: Rare Diseases, Infectious Diseases
Keywords: C. Diff Infection, CDI, Clostridium Difficile, Clostridium Difficile Infections, Diarrhea
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A randomized, double-blind, placebo- controlled study of LMN-201 for prevention of C. difficile infection recurrence (RePreve)

This study is recruiting people who have developed an infection of the lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff). The standard treatment for this infection is with antibiotics, but in some people, the infection keeps coming back. The purpose of this research is to test whether an investigational drug can prevent a return of the infection. We want to make sure LMN-201 is safe when used as part of standard of care for C. diff, and we want to see if we can improve treatment and reduce re-infection.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022202
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Inclusion Criteria:

• diagnosis of Clostridioides Difficile Infection (CDI) defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency and a positive stool C. difficile toxin B immunoassay and no other likely explanation for diarrhea
• able to take oral medication and willing to adhere to the study medication
• have access to a mobile smartphone
• women and men of reproductive potential must use of highly effective contraception during study participation and for an additional 4 weeks after the end of study drug administration
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• violent diarrhea from C. difficile colitis
• Underlying gastrointestinal disorder characterized by diarrhea such as chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, etc.
• women who are pregnant, trying to get pregnant or breast feeding
Conditions: Infectious Diseases
Keywords: C-Diff, CDI, Clostridioides Difficile Infection
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PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) (PRECIDENTD)

People with type 2 diabetes have a higher risk for heart disease than people without diabetes. We are doing this research to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease for people with type 2 diabetes. People who are in the study will be randomly (by chance) assigned to take one of two types of diabetes medications that have been approved by the FDA. Your usual care provider will continue to manage your diabetes care.

Principal Investigator: Elizabeth Rogers
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024423
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Inclusion Criteria:

• 40 to 80 years old with -diagnosis of Type 2 diabetes, HbA1c ≥6% measured in the past 12 months,
• AND one of the following:
• diagnosis of coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
• OR: -60-80 years old and at least 1 additional high-risk feature:
• active smoking, HbA1c ≥ 8% measured within past 12 months or chronic kidney disease
• willing to be randomly (by chance) assigned to a class of medication and fill the prescription with personal pharmacy insurance plan
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• any other type of diabetes
• history of diabetic ketoacidosis
• active diabetic foot ulcer
• history of pancreatitis
• active treatment for cancer
• history of solid organ or bone marrow transplant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: ASCVD, Atherosclerotic Cardiovascular Disease, Diabetes, Type2Diabetes
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

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

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016450
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Inclusion Criteria:

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

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Conditions: Cancer
Keywords: Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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Assessing recall, minimum clinically important difference, and non-inferiority margin of healthcare contact days among people with cancer

We are hoping to gain a better understanding of what patients with cancer, their care givers, and clinicians value and how they make decisions regarding different treatment options. We are interested in your opinion since you understand what it is like for people to undergo cancer treatment. You will be asked a series of questions that will take about 30 minutes.

Principal Investigator: Arjun Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021546
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Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced stage (stage 4/ metastatic/ unresectable/ incurable) solid tumor
• receiving treatment with oral or intravenous systemic agents (chemotherapy, immunotherapy, targeted agents)
• treated at MHealth Fairview
Conditions: Cancer
Keywords: Cancer
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ASSESS ALL ALS Study

We are doing this research to collect a wide range of samples, clinical information, and measurements that will be used for future research into ALS and related neurological diseases. Participants will be asked to complete 7 in-person study visits and monthly remote self-assessment activities. Access to a personal device (computer and/or smartphone or tablet) that is connected to the internet is needed to complete the monthly remote activities.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023160
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Inclusion Criteria:

• diagnosis of Amyotrophic Lateral Sclerosis (ALS) by a physician
• access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient
• for HEALTHY participants: no diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS), no family history ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes, and access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient
• see link to clinicaltrials.gov
Exclusion Criteria:

• cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of starting the study,
• clinically significant unstable medical condition
Conditions: Brain & Nervous System, Rare Diseases
Keywords: ALS, Amyotrophic Lateral Sclerosis, Clinics and Surgery Center (CSC)
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PREVENT ALL ALS

Individuals who are carriers of ALS causative gene variants have an increased lifetime risk of developing ALS or a related disorder, Frontotemporal Dementia (FTD). We are doing this research to collect a wide range of biofluid samples, clinical information, and other health and wellbeing information to look for measurable differences that will help us understand how and when the body changes in response to ALS causative gene variants.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023161
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Inclusion Criteria:

• first-degree relative of a known carrier of any Amyotrophic Lateral Sclerosis (ALS) causative gene1 (regardless of whether ALS or Frontotemporal Dementia FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
• access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
Exclusion Criteria:

• evidence of neurological signs or symptoms concerning for ALS of FTD
• significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days (about 3 months)
• clinically significant, unstable medical condition
Conditions: Rare Diseases, Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), ALS, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, FTD
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ALTE22C1, Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.

Principal Investigator: Karim Sadak
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024697
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Inclusion Criteria:

• Age: Patients age >= 6 and < 40 years at the time of enrollment.
• A diagnosis of Down Syndrome is required; all patients must be DS-AL survivors and have been treated for ALL or AML.
• All cancer treatment must have been completed at least 36 calendar months prior to enrollment.
Exclusion Criteria:

• Patients with history of Hematopoietic Stem Cell Transplant (HSCT) are excluded.
• Patients with a history of cancer prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded.
• Patients whose parents or guardians are unable to complete the required forms are excluded.
Conditions: Blood Disorders, Cancer
Keywords: ALL, AML, Clinics and Surgery Center (CSC), Down Syndrome, DS-AL survivors, leukemia
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