Search Results
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.
• 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
• 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
MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.
• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests.
• at least 18 years old
• able to understand, speak, read, and write in English
• have undergone hysterectomy, or plan to have a hysterectomy
• people who are transgender and gender diverse
• on the study’s community advisory board
BEETroot juice to reverse functional impairment in PAD: The BEET PAD Trial (BEET PAD)
The BEET PAD Trial is a multi-centered double-blind randomized clinical trial of beetroot juice vs. placebo in 210 people with PAD. We hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. Our primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. Our primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, we will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling), and gastrocnemius muscle health. We will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion (1). Inter-individual variability exists in the extent of metabolic conversion of nitrate to nitrite (1,2). Therefore, we will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively. To achieve our specific aims, we will randomize 210 participants age 50 and older with PAD to one of two groups: beetroot juice vs placebo. Participants will be followed for 4.5 months.
• Diagnosis of peripheral artery disease (PAD)
• 50 years of age or older
• Above- or below-knee amputation
• Critical limb ischemia symptoms of rest pain
• Wheelchair or walker is needed to walk
• Walking is limited by a symptom other than PAD
• Current foot ulcer on bottom of foot
• Planned major surgery, coronary or leg revascularization during the next five months
• Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
• Major medical illness including lung disease requiring oxygen, Parkinson’s disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years
• Allergy to beetroot juice
• Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study
• Currently eating one cup or more of beets daily
• Non-English speaking
• Participation in or completion of a clinical trial in the previous three months
• Visual impairment that limits walking ability
• Participation in a supervised treadmill exercise program in previous three months or planning to begin a supervised treadmill exercise program in the next five months
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
Hidradenitis Suppurativa (HS) is a chronic condition that causes bumps or boils, often in the folds of armpits, chest, breasts, groin, stomach, back or sides, or buttocks. This Study is being done to compare the safety and effectiveness of a Study Drug called ruxolitinib cream with a vehicle cream for people with hidradenitis suppurative. A vehicle cream looks like the Study Cream but does not have active drug in it. Participants will be in the Study for approximately 60 weeks. This includes a 28-day screening period, 16 weeks of receiving either the Study Cream or vehicle cream, 36 weeks of receiving the Study Cream, and a 30-day follow-up.
• diagnosis of Hidradenitis Suppurativa (HS) at least 6 months before starting the study
• see link to clincialtrials.gov for complete inclusion criteria
• people who have cancer
• women who are pregnant or breastfeeding
• see link to clincialtrials.gov for complete exclusion criteria
Evaluation of an oral microbiota-based therapeutic as a treatment option for primary sclerosing cholangitis
We are studying the safety and feasibility of microbiota transplant therapy (MTT) for patients with Primary Sclerosing Cholangitis (PSC). The purpose of this study is to evaluate whether MTT from a healthy donor is safe and can be used to restore the healthy composition of microbiota to help decrease disease severity and improve symptoms. All patients in this study will receive capsules of the drug, MTT.
• ages 18-76
• serum total bilirubin ≤ 2x the upper limit of normal
• expect to maintain current medication regimen for the duration of the study
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received antibiotic therapy (except vancomycin) in the past 3 months
• complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
• viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
• liver disease such as metabolic or inherited disease or cirrhosis
• women who are pregnant, breast feeding, or trying to become pregnant -active cancer
• active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women)
MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)
This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.
• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
A double-blind, randomized, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics and efficacy of BI 765423 administered intravenously on top of standard of care in patients with idiopathic pulmonary fibrosis
The purpose of this study is to find out if a study drug called BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis (IPF). This study compares BI 765423 with a placebo to see if there is a difference in lung function or blood test results related to lung health after 3 month. The placebo looks like BI 765423 but does not contain any active drug.
• at least 40 years old
• diagnosis of idiopathic pulmonary fibrosis (IPF)
• women can only be included if they are unable to become pregnant i.e. post hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, or post menopausal
• men who have woman of childbearing potential (WOCBP) sexual partners must use contraception
• see link to clinicaltrials.gov for complete Inclusion criteria
• acute exacerbation of IPF within at least 12 weeks prior
• significant cardiovascular disease such as severe hypertension, myocardial infarction, stroke, TIA
• significant pulmonary hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Vosoritide in Infants and Young Children with Hypochondroplasia, Aged 0 to < 36 Months
The purpose of this study is to learn the effects, good or bad, of the study drug, vosoritide, for treating children who have hypochondroplasia. This condition affects the growth of bone and cartilage and in which kids who have it are shorter than other kids of the same age. In this study, your child will get either the study drug or placebo, which is an inactive medicine.
• 0 months to less than 36 months old
• confirmed genetic diagnosis of Hypochondroplasia (HCH)
• participant's weight must be ≥ 3 kg (6.6 pounds)
• see link to clinicaltrials.gov for complete inclusion criteria
• short stature condition other than HCH
• have an unstable medical condition
• see link to clinicaltrials.gov for complete exclusion criteria
Neural Mechanisms of Closed-loop Phase-locked Transcranial Magnetic Stimulation
This research aims to develop a personalized transcranial magnetic stimulation (TMS) protocol that delivers stimulation timed to a certain phase of an endogenous brain rhythm and explores the utility of physiologically informed neuromodulation in psychiatric disorders.
• adults ages 18 to 65
• 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 an implanted medical device
HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027
Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.
• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors (BEHOLD-1)
This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.
• diagnosis of high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube or endometrial cancer that is metastatic or not able to have surgical treatment
• received or are intolerant to 1 but no more than 3 lines of prior systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
• pleural/abdominal effusion/ascites requiring clinical intervention or presence of pericardial effusion
• brain metastasis unless asymptomatic
• heart arrhythmias or ECG abnormalities
• Left ventricular ejection fraction (LVEF) < 50%
• see link to clinicaltrials.gov for complete exclusion criteria
Phase I Clinical Trial of iPSC-Based Therapy (MyoPAXon) for Duchenne Muscular Dystrophy
This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.
• diagnosed with Duchenne muscular dystrophy (DMD) and non-ambulatory
• age 18 or older
• off investigational treatments for at least 30 days
• presence of HLA antibodies directed toward HLA antigens on MyoPAXon
• active treatment with another investigational therapy
• known allergy to MyoPAXon components
HM2025-16: Phase Ib/II Trial of Epcoritamab plus Ibrutinib in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma.
This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).
• diagnosis of B-cell non-Hodgkin lymphoma
• have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody
• treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days
• capable of all selfcare and able to walk but unable to carry out any work activities; up and about more than 50% of waking hours
• women of child-bearing potential and men must agree to use adequate contraception 2 weeks before starting treatment, for the duration of study participation and for 12 months after completing treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• active central nervous system (CNS) involvement
• active uncontrolled infection
• current uncontrolled or symptomatic cardiovascular conditions
• liver cirrhosis with moderate to severe liver impairment
• significant lung disease
• treatment with coumadin/warfarin
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases
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.
• 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
• 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
MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb 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).
• 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
• see link to clinicaltrials.gov for additional Inclusion 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)
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-06: Postmarketing, Prospective, Observational, Study to Assess and Characterize the Risk of Secondary Malignancies, and Long-term Safety Following Treatment with atidarsagene autotemcel (Lenmeldy )
To assess and characterize the risk of malignancies, and long-term safety following treatment with atidarsagene autotemcel (Lenmeldy).
• live in the United States
• has been or will be treated for MLD with Lenmeldy
MT2025-26: A LONG-TERM FOLLOW-UP STUDY IN PATIENTS WITH HEMOGLOBINOPATHY WHO RECEIVED AUTOLOGOUS CD34+ EDITED HEMATOPOIETIC STEM CELLS
To evaluate the long-term safety of BEAM-101 up to 15 years after treatment.
• received BEAM-101 in Study BTX-AUT-001 and are in the process of completing the last visit for the study
A Pilot Study of Treatment of Bone Metastases in Spine: Radio Frequency Ablation/ Bone Augmentation plus Radiotherapy Vs. Radiotherapy
This clinical study is for adults whose cancer has spread to the bones of the middle or lower back (spine). Doctors are comparing two common treatments: (1) a needle procedure to treat the tumor and strengthen the bone, followed by radiation, and (2) radiation therapy alone. The goal is to see which option better relieves pain, protects the spine, and improves quality of life. The treatment you receive will be chosen at random (by chance), meaning you will be placed into a study group by chance.
• confirmed metastatic disease in the thoracic or lumbar region of the spine
• associated bone pain
• persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• prior radiation therapy to the same area of the spine
• spine stabilization surgery is being considered
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)
The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).
• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
ANBL2131/MT2024-35- A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.
• Age: less than or equal to 30 years at the time of initial diagnosis with high-risk disease Diagnosis
• Must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
• Newly diagnosed, HRNBL defined as one of the following: a. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification b. Age:: greater than or equal to 547 days and INRG Stage M regardless of biologic features c. Any; age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy d. Age: greater than or equal to 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy BSA: Patients must have a BSA greater than or equal to 0.25 m2
• Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
• Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
• Patients with known bone marrow failure syndromes.
• Patients on chronic immunosuppressive medications
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.
• Female patients who are pregnant or breastfeeding their infant.
MT2024-19: Registry and Biological Specimen Repository for Inherited Disorders with High Risk for Squamous Cell Carcinoma Development
This study is for people who have Epidermolysis Bullosa (EB), Fanconi Anemia (FA) or a bone marrow failure disorder that puts them at a higher risk of developing a form of skin cancer called squamous cell carcinoma (SCC). To learn more about these disorders and their relationship to cancer, researchers are collecting skin and blood samples to study in the lab. Blood and skin donated to the will be used by researchers at the University of Minnesota in studying the causes, diagnosis, prevention, and treatment of these disorders. We expect that this study will take about two hours, or the amount of time it takes to check in for a clinic visit and collect the specimens.
• at least 2 years of age
• inherited disorders that have an increased risk for squamous cell carcinoma (SCC) development, including, but not limited to, epidermolysis bullosa (EB), Fanconi anemia (FA), and telomere biology disorders/dyskeratosis congenita (TBD/DC)
• women who are pregnant
• people who are a ward of the state
• a prisoner
• an employee, student or trainee of the researcher
RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA
We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.
• diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
National Liver Cancer Screening Trial (TRACER)
Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.
• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
MT2025-24: A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
This study is for people who have been diagnosed with advanced cancer that has not has not responded to standard treatment. FT836 is a type of cell product made up of “T cells” which are part of the immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells. We want to test the safety of FT836 at different doses, to understand how the body processes and responds to FT836, and to find out what effects FT836 may have on participants and the cancer. The study will also find out what effects FT836, when given alone and with or without chemotherapy treatment (paclitaxel) and/or a monoclonal antibody (cetuximab or trastuzumab.
• confirmed locally advanced or metastatic cancer including breast cancer, ovarian cancer, endometrial carcinoma, gastric/GEJ cancer, head & neck cancer, non small cell lung cancer, or colorectal cancer
• women & men of childbearing age must use highly effective birth control
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• other cancer in the past two years
• significant cardiac (cardiac arrhythmias, myocardial infarction, unstable angina or congestive heart failure) or neurological disease (stroke, epilepsy, CNS vasculitis, or neurodegenerative disease)
• active central nervous system (CNS) involvement
• see link to clinicaltrials.gov for complete Exclusion criteria
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).
• 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
• 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
Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments
This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.
• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons with Colorectal Cancer
The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer and their caregiver. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services as part of this research. Participation in this study lasts for up to 3 months.
• Participant has a diagnosis advanced stage (Stage III or Stage IV) colorectal cancer in the past 3 months, starting or planning to start systemic cancer therapy, able to identify a caregiver for study participation, and able to understand, speak, read, and write in English
• Caregiver: identified as a caregiver by a person who has colorectal cancer and able to understand, speak, read, and write in English
• see link to clinicaltrials.gov for complete Inclusion criteria
• does not have the ability to provide informed consent
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.
• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria