Search Results
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.
• 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
• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Udall P1A4
Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.
• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes
The primary objective of this study is to estimate the overall survival (OS) of PIRD patients from the time of diagnosis. Patients may be treated with Best Available Therapy (BAT) or Hematopoietic Cell Transplant (HCT).
MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)
CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.
• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
A Phase 1/2, Multi-Center, Dose-Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to < 18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations (Protocol Number: AC220-A-U202/ADVL1822)
This is an open-label, multi-center, single arm, Phase 1/2 study to evaluate the safety, PK, PD, and efficacy of quizartinib administered in combination with fludarabine and cytarabine (FLA) (Re-Induction Cycles 1 and 2) chemotherapy for re-induction, with optional consolidation chemotherapy, and as a single agent continuation therapy (after optional, but strongly encouraged, HSCT per standard of care), in pediatric relapsed/refractory AML subjects aged ≥1 month old to <18 years old (and young adults up to 21 years old) with FLT3-ITD mutations.
ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)
This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.
COG ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant
The MyGender Dolls: Development of a Therapeutic Intervention for Transgender and Gender Diverse Children and their Caregivers
The goals of the current proposal are to systematically approach the development and iterative testing of a novel, culturally-responsive, evidence-informed psychotherapeutic activities (MyGender Dolls) for transgender and gender diverse (TGD) children (ages 5-10) and their caregivers. There are two primary objectives: 1) to develop and refine the MyGender Dolls psychotherapeutic activities based on feedback from community stakeholders, and 2) to assess the initial feasibility, acceptability, and usability of the MyGender Dolls with TGD children and their caregivers.
• child aged 5 to 10 years old who identifies as transgender or gender diverse
• parent of a child aged 5 to 10 years old who identifies as transgender or gender diverse
• child younger than 5 years old and older than 10 years old
• child who does not identify as transgender or gender diverse
ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
This trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs and has a change (mutation) in a gene called EGFR. Sometimes, mutations in this gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly.
• confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
• have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive therapy, or recurrent disease
• no prior systemic treatment for metastatic disease
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional inclusion criteria (study staff will review)
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety,and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin-Dependent) Precocious Puberty
The study drug FP-001 (Leuprolide mesylate) is being developed for children that are suffering from central (gonadotropin-dependent) precocious puberty (CPP). Leuprolide has been approved in the United States (US) and the European Union (EU) as treatment for prostate cancer already, and other forms of Leuprolide from other companies have been approved for the treatment of CPP. In this clinical study, Leuprolide will be used in the form of a 6-month depot injection.
• females aged 2 to 8 years or males aged 2 to 9 years old
• diagnosis of Central Precocious Puberty (CPP) within 12 months
• additional inclusion criteria (study staff will review)
• major medical or psychiatric illness that could interfere with study visits
• history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
• specific prior treatments (study staff will review)
Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer
We are studying how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating people with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.
• diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), with or without bevacizumab
• tumor determined to be mismatch-repair deficient (dMMR)
• able to walk & do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional criteria apply (study staff will review)
• women who are pregnant or breast feeding
• treatment with oxaliplatin chemotherapy within 6 months prior to randomization
• history of significant liver, heart, lung, or autoimmune disease etc. (study staff will review)
A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
This study will investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. This study is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study with two cohorts: Cohort A followed by Cohort B. The purpose of Cohort A is to provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the correct dose, population, sample size, and endpoint for the confirmatory part of the study (Cohort B). Additional goals for Cohort A are to assess effects of food on drug absorption. The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.
• at least 12 years old weighing at least 40 kg (88 pounds)
• progressive meningioma that is amenable to volumetric analysis
• see link to clinicaltrials.gov for complete inclusion criteria
• progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation - therapy within the next 3 months
• received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening
• see link to clinicaltrials.com for all exclusion criteria
A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared with its Placebo in Male or Female AlopeciaAreata Participants Aged 18 Years and Older with 50% or Greater Scalp Hair Loss (FAST-AA)
The main purpose of the study is to see whether farudodstat, taken orally for 12 weeks, can help people with alopecia areata and to find out if farudodstat is safe and tolerable when compared to placebo. The placebo is a pill that looks like farudodstat tablet but has no drug or other active ingredient in it.
• at least 18 years old
• weight at least 40 kg (88 lbs)
• severe or very severe Alopecia Areata (AA)
• contact study staff for additional criteria for AA
• history of androgenic alopecia or female pattern hair loss prior to AA or other types of hair loss
• history or presence of hair transplants
• other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)
Listening effort in people with hearing impairment
The purpose of this research is to understand the effort needed to understand speech if hearing is impaired. Listening effort is higher in people with hearing impairment and has wide-ranging negative consequences across many aspects of a person’s life. The goal of this project is to explore factors that make listening effortful, with special focus on the need to repair perceptual mistakes by relying on context.
• There are two categories of participants: either people with cochlear implant (one or two cochlear implants) or people with normal hearing in both ears. All participants must be 50-75 years old.
• non native English speakers
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C). Protocol Number: I3Y-MC-JPCS
The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumor and abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C).
• Parts A and B only: participants must be less than or equal to 18 years of age and with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies
• Part C only: participants must be less than (<) 21 years of age and with first relapse/refractory neuroblastoma and with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies Parts A, B & C:
• participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade = < 1 at the time of enrollment
• able to swallow and/or have a gastric/nasogastric tube
• received allogenic bone marrow or solid organ transplant
• diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers
• pregnant or breastfeeding
R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis
This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis.
• age 18-80
• contact umnsarc@umn.edu for inclusion/exclusion criteria
• history/current use of cigarette, e-cigarette, vaping or marijuana smoking
• history/current use of nicotine products
• presence of underlying chronic condition
• inability to undergo procedure using IV sedation
• weight < 110 lbs. & BMI > 35 kg/m2
• pregnant and/or breast feeding
• history/current use of chronic immunosuppressive medications
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Visual Perception in Visual Snow Syndrome
This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.
A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)
The purpose of the study is to see if ianalumab, compared to placebo, is effective and safe for treating wAIHA. A placebo looks like the study drug, ianalumab, but does not contain any active ingredient. Ianalumab belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are molecules that can recognize and stick to a specific protein expressed on the cell surface or released free in the body. Participants will receive study drug (ianalumab or placebo) through the vein every 4 weeks (4 doses in total) during the treatment period.
• people with documented primary or secondary wAIHA
• had an insufficient response to or relapsed after one or more treatments
• Hemoglobin concentration at screening between 5 g/dL and 10 g/dL and experiencing symptoms of anemia
• dose of supportive medication must be stable for at least 4 weeks
• wAIHA due to disease involving bone marrow
• prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to starting the study
• active viral, bacterial or other infections that require systemic treatment at time of screening, or a history of recurrent clinically significant infection
• positive for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb)
• contact study staff for additional criteria
Personalized immunomodulation in pediatric sepsis-induced MODS (PRECISE)
This is a large-scale multi-center study of personalized, targeted immune modulation in childre with sepsis-induced multiple organ dysfunction syndrome (MODS). This study is titled the “PeRsonalizEd immunomodulation in pediatriC sepsIS-inducEd MODS (PRECISE)”. The study includes two concurrent, immunophenotype-driven placebo controlled randomized controlled trils (RCTs) that will address the central hypothesis that individualized, pathophysiology-specific immunomodulation will improve outcomes from sepsis-induced MODS in children
CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.
• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
A multicenter, single arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who have Hb >=10 g/dL in response to anti-C5 antibody and switch to iptacopan
This is a multicenter, single-arm, open label trial, with iptacopan treatment for 24 weeks in adult PNH patients. Eligible participants must have a mean Hb ≥10 g/dL in response to a stable regimen with anti-C5 for at least 6 months and must be transfusion free for the same period.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis (VALOR)
In this study, brepocitinib will be compared to a placebo. Brepocitinib is an investigational medicine because it has not yet been approved by any regulatory agency for use. Researchers will compare the results of taking the placebo to the results of taking the study medicine to see if there are any differences. This medicine may be helpful for your disease, but we do not have any information about this yet. 67% of participants will receive brepocitinib and 33% will receive the placebo which will be decided randomly by chance. Participation will last for up to 64 weeks (15 months). Visits will be scheduled about every 4 to 6 weeks.
• diagnosis of dermatomyositis
• active muscle and skin disease or being treated with medications
• age 18-75
• weight at least 40 kg, less than 130 kg and a BMI less than 40 kg/m2
• history of cancer in past 5 years
• dermatomyositis with irreversible muscle involvement
• active or recent infections
MT2019-38: Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)
The purpose of this study is to develop a questionnaire specifically designed for children and adolescents, which will help health care providers to better measure how bothersome symptoms of cGVHD are for children and adolescents living with cGVHD. Another purpose of this study is to design a caregiver companion questionnaire, to allow caregivers to measure how bothersome the symptoms of cGVHD are for their child/adolescent.
• children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
• clinical diagnosis of Graft vs Host Disease (cGVHD)
• currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months -eligible caregiver proxy who is willing to participate in the study
• see link to clinicaltrials.gov for complete criteria
• participant's cognitive ability would compromise their ability to participate in study related procedures
• study staff will review
LTx READY CF 2: A Multi-Site RCT: Lung Transplant Resources for Education And Decision-making for Your CF 2 Study: A Multi-Site Randomized Controlled Clinical Trial
The primary study objective is to determine whether “Take on Transplant” (ToT), a CF-specific Lung Transplant (LTx) educational website, improves patient-reported preparedness for LTx discussions, as measured by the Preparation for Decision Making (PrepDM) Scale at 3 months after randomization, compared to an attention control transplant website (unos.org, UNOS).
Global Patient Registry of Inherited Retinal Diseases
The purpose of this research study is to collect timely and relevant data that will support the evolving research needs of the Inherited Retinal Disease community (IRD), in order to provide insights that can be used to improve patient management, and to inform development of future treatments. No visits, assessments, or procedures are mandated, and follow-up will be captured as part of your standard of care. The planned length of registry is of 8 years with a potential to extend the duration as needs evolve.
• at least 3 years old
• documented genetic diagnosis of X-linked retinitis pigmentosa (XLRP) or Achromatopsia (ACHM) with any signs or symptoms of disease
• Caregiver participants must be at least 18 years old and identified by the participant as the primary care giver
• received a treatment in an Inherited Retinal Disease (IRD) related interventional trial, or is being screened for an IIRD-related interventional trial
• Caregiver participant has an IRD and has visual impairment
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON? (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)
The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.
• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)
The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.
• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection