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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.

406 Study Matches

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

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).

Noah Goldfarb
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021432
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Inclusion Criteria:
Diagnosis of Hidradenitis Suppurativa
Exclusion Criteria:
History of Crohn?s disease
Dermatology (Skin, Hair & Nails)
Clinics and Surgery Center (CSC), Hidradenitis suppurativa
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MT2023-31: A multi-center, randomized, active controlled clinical trial to evaluate the efficacy and safety of OTL-203 in subjects with mucopolysaccharidosis type I, Hurler syndrome (MPS-IH) compared to standard of care with allogeneic hematopoietic stem cell transplantation (allo-HSCT) (HURCULES)

This research study is designed to compare a new gene therapy, known as OTL-203 (study drug), with a standard treatment called “allogeneic hematopoietic stem cell transplant” (allo-HSCT), to find out which is better for the treatment of MPS-IH.

Ashish Gupta
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00020015
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Inclusion Criteria:

• at least 28 days old to no more than 30 months old
• confirmed laboratory diagnosis of MPS-IH
• evidence of altered GAG metabolism
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous allo-HSCT or gene therapy
• diagnosis of HIV, Hepatitis B, Hepatitis C, or Mycoplasma
• history of uncontrolled seizures
• contraindications for MRI scans
• study staff will review additional exclusion criteria
Rare Diseases
Hurler syndrome, MPS-IH, mucopolysaccharidosis type I
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MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

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

Samuel Goldfarb
Up to 24 years old
This study is NOT accepting healthy volunteers
SITE00001589
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Inclusion Criteria:

• up to 24 years old
• undergoing allogeneic or autologous HSCT
Breathing, Lung & Sleep Health
Diffuse Alveolar Hemorrhage, Hematopoietic Stem Cell Transplant (HSCT), Interstitial Pneumonitis
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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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HM2023-07: Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy (MonumenTAL-3)

Talquetamab is an experimental medication being studied to see if it may be beneficial in the treatment of multiple myeloma.

Daniel O'Leary
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018679
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Inclusion Criteria:

• diagnosed with multiple myeloma that has not responded to treatment or has reoccurred after at least one treatment
• able to care for self with some assistance
Exclusion Criteria:

• active cancer in central nervous system or clinical symptoms
• maximum amount of steriods taken in the past two weeks (study staff will review)
• disease hasn't responded to this type of drug (anti-CD38 monoclonal antibody)
Cancer
Multiple Myeloma
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Boris Winterhoff
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014893
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Inclusion Criteria:

• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:

• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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MT2023-22: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers

There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, either daratumumab in subjects with relapsed/refractory MM or rituximab in subjects with relapsed/refractory NHL. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM or NHL when given in combination with daratumumab or rituximab, respectively.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019972
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Inclusion Criteria:

• diagnosis of Multiple Myeloma (MM) that has relapsed or is refractory disease after 3 or more prior lines of therapy
• OR Non-Hodgkin Lymphoma (NHL) that has relapsed or is refractory after 2 or more lines of chemotherapy
• restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
Exclusion Criteria:

• significant cardiac disease
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
• untreated central nervous system, epidural tumor metastasis, or brain metastasis
Cancer
Clinics and Surgery Center (CSC), MM, Multiple Myeloma, NHL, Refractory Multiple Myeloma, Refractory Non-Hodgkin Lymphoma
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HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts

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

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

• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

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

Punita Grover
Not specified
This study is NOT accepting healthy volunteers
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
Cancer
Clinics and Surgery Center (CSC), Acute-graft-versus-host Disease, aGVHD, HCT, Hematopoietic Cell Transplant
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MT2020-06: A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF JSP191 FOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONING TO ACHIEVE ENGRAFTMENT AND IMMUNE RECONSTITUTION IN SUBJECTS WITH SCID

This study is looking at whether giving a new type of experimental medicine, called JSP191, can prepare the body to help the stem cell transplant work better, so the immune system can grow and fight infections. The study doctor and Sponsor also want to see how safe and well tolerated this experimental medicine is. They will study whether it is safe to give to patients and look at how much medication to give and what side effects may occur. During this study, the optimal dose of JSP191 will be determined and additional patients will be enrolled in this study using that dose level.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
STUDY00010559
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Inclusion Criteria:

• at least 3 months old
• diagnosis of typical Severe Combined Immunodeficiency (SCID)
• patient with human leukocyte antigen (HLA) matched related or unrelated donors
Exclusion Criteria:

• acute or uncontrolled infections
• patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• patients with active malignancies
• active Graft-versus-host disease (GVHD) within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
Immune Diseases, Rare Diseases
SCID, Severe combined immunodeficiency
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MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors

This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.

Benjamin Manning
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019932
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Inclusion Criteria:

• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
Cancer
Clinics and Surgery Center (CSC), advanced cancer, cancer, metastatic cancer, solid tumors
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A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

This trial will evaluate other treatment options for high-risk NMIBC patients who were unresponsive to Bacillus Calmette Guerin (BCG therapy). We are studying two different drugs in combination with pembrolizumab. Participants will receive up to 35 doses of the trial drug and have tumor assessments for about 2 years. This will be followed by treatment tumor assessment for another 3 years for a total trial duration of 5 years.

Joseph Zabell
18 years and over
This study is NOT accepting healthy volunteers
1604M87002
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Inclusion Criteria:

• confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ) transitional cell carcinoma of the bladder
• tumor has been completely removed with bladder surgery
• BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy
• ineligible for radical cystectomy or refusal of radical cystectomy
• able to care for self, up and about for at least half of the day
• participants of child bearing age must be willing to use effective birth control
Exclusion Criteria:

• received intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT)
• active autoimmune disease that has required systemic treatment in the past 2 years
• active infection requiring systemic therapy
• pregnant or breast feeding
• contact study staff for additional study eligibility criteria
Cancer, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Bladder Cancer
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Multicenter ALS Imaging Study

The purpose of the study is to test new biomarkers of ALS using MRI scans at 3 Tesla (3T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers in ALS will help test new treatments and may help us make diagnoses earlier.

Pramod Pisharady
18 years and over
This study is also accepting healthy volunteers
STUDY00021637
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Inclusion Criteria:

• for people who have Amyotrophic Lateral Sclerosis (ALS): less than 24 months since symptoms started, and diagnosis of probable or definite ALS
• for people with ALS and healthy volunteers: able to read, write and speak English, and able to have a MRI
Exclusion Criteria:

• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
Brain & Nervous System, Rare Diseases
ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
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Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)

People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006831
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Inclusion Criteria:

• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
Exclusion Criteria:

• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Membranous Nephropathy, Nephrotic Syndrome
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MT2022-30: A double-blind, randomized, placebo-controlled, interventional, multicenter, phase llI clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB)", allo-APZ2-EB-III

This is a study of an investigational drug (also known as the “study drug”) called allo-APZ2-OTS as a possible treatment for RDEB. The study drug contains allogeneic dermal ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs). These cells suppress inflammation and produce proteins that are important for wound healing. The study drug is expected to counteract local inflammation, improve wound healing and skin strength, and speed up wound closure.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
SITE00001758
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Inclusion Criteria:

• confirmed diagnosis of RDEB or JEB
• wound meeting the following criteria: 5-50 cm, present for at least 21 days and less than 9 months without signs of acute infection
• women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial
Exclusion Criteria:

• current cancer diagnosis including squamous cell carcinoma and basal cell carcinoma
• women who are pregnant or breast feeding
• clinically significant or unstable medical or mental health diagnosis (study staff will review)
Rare Diseases
EB, Epidermolysis Bullosa, RDEB
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

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

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

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

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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Phase 1, Multi-Center, Open-Label Study of VT3989 in Patients with Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the Neurofibromatosis Type 2 Gene (mutant NF2 or mNF2)

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Robert Kratzke
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019430
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Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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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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Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

Emmanuel Antonarakis
18 years and over
This study is NOT accepting healthy volunteers
SITE00001730
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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A Multicenter, Multinational, Observational Study to Characterize Growth in Children with Idiopathic Short Stature

This research is being done to learn more about how children with idiopathic short stature grow. About 600 children with idiopathic short stature will be in this study across the world. The study will last a minimum of 6 months (i.e., three study visits). After a child has been in this study for at least 6 months, participants may be offered the option to exit this study and enroll in a different study with growth promoting agents.

Nishitha Pillai
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021903
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Inclusion Criteria:

• participants must be at least 2 years old
• no more than 14 years old if female, or less than16 years old if male
• height Z-score is at least -2.5 SDs compared to age and sex matched norms
• able to walk ambulatory stand without assistance (not applicable for children who are less than 5 years of age and less than 104 cm i.e. 41 inches in length)
Exclusion Criteria:

• systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic or metabolic disease
• presence of one or more pituitary hormone deficiencies (ACTH [adrenocorticotropic hormone], ADH [antidiuretic hormone], FSH [follicle-stimulating hormone], GH [growth hormone], LH [luteinising hormone], TSH [thyroid-stimulating hormone]).
• diagnosis of hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated).
• Growth Hormone (GH) level below 10 ng/mL following a stimulation test. This does not apply to potential participants who are currently being treated with hGH for ISS
• known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turners syndrome, disproportionate skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis, Rasopathy (including Noonan?s Syndrome), or absence of GH receptors
• bone age advanced over chronological age by more than 3 years
• active cancer, chemotherapy or radiation therapy
Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Growth, Growth Hormone, Idiopathic Short Stature, ISS
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014879
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Inclusion Criteria:

• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa

We are looking at a new intravenous drug, Bacteriophage, to treat Pseudomonas Aeruginosa in people at least 18 years of age who have cystic fibrosis. The drug is given one time and different doses will be evaluated to see if they work and to look at side effects.

Joanne Billings
18 years and over
This study is NOT accepting healthy volunteers
SITE00001310
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Inclusion Criteria:

• Cystic Fibrosis (CF) diagnosis based on clinical symptoms and confirmed by either an abnormal sweat chloride test or CFTR gene variations
• P. aeruginosa isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
Exclusion Criteria:

• body weight less than 30 kg
• Forced Expiratory Volume 1 second less than 20% of predicted value
• women who are pregnant, planning to become pregnant during the study, or breastfeeding
• anticipate change chronic antibiotic regimens during the study
Respiratory System, Rare Diseases
CF, Cystic Fibrosis, P. aeruginosa, Pseudomonas Aeruginosa
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A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)

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

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

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

• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
Rare Diseases, Infectious Diseases
Clinics and Surgery Center (CSC), Herpes, Herpes Simplex Virus, HSV Infection
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

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

Hamed Ahmadi
This study is NOT accepting healthy volunteers
STUDY00020255
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Inclusion Criteria:

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

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Kidney, Prostate & Urinary
bowel diversion urologic surgery, ileostomy, stoma
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A Phase 1, Open-label Study of Oral BDTX-4933 in Patients with KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

This study is testing the study drug BDTX-4933 in people with locally advanced (unresectable) or metastatic solid tumors that are characterized by a KRAS, BRAF, or NRAS mutation/alteration(s). The primary objective of the study is to assess how well participants tolerate the drug and if it is effective.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021016
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Inclusion Criteria:

• recurrent or advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations
• exhausted all available standard-of-care therapies
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• cancer that has a known MEK1/2 mutation
• ongoing anticancer or radiation therapy
• women who are pregnant or breastfeeding
Cancer
Clinics and Surgery Center (CSC), metastatic cancer, RAS or BRAF mutations, Recurrent cancer
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MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019229
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Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
Cancer
Solid Tumors, Clinics and Surgery Center (CSC)
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018 / ACTIV: A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

We are studying an investigational medicine for treatment of people in the hospital with COVID-19. This medicine is investigational because it can only be used in research. We are trying to find out if this investigational medicine is effective when given in addition to the current standard treatment for COVID-19. We are also trying to make sure it is safe for people who are sick in the hospital to take. The treatment being tested in this study is not yet approved by the U.S. Food and Drug Administration (FDA) or any other national government agency.

Mahsa Abassi
18 years and over
This study is NOT accepting healthy volunteers
SITE00001781
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Inclusion Criteria:

• admitted to the hospital with symptoms of respiratory infection
• positive test for SARS-CoV2 infection (COVID) within the prior 14 days
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• expect to be discharged in the next 24 hours
• unable to swallow tablets
• women who are pregnant or breast feeding
• liver or kidney failure
• men and women who are unwilling to use contraception to prevent pregnancy
Infectious Diseases, Respiratory System
Clinics and Surgery Center (CSC), COVID, hospitalized, inpatient, pneumonia, respiratory infection
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A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

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

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

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

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Cancer
Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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MT2023-42: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

Parastoo Fazeli
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020865
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Inclusion Criteria:

• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ?2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
Exclusion Criteria:

• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
Immune Diseases
Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
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