Search Results
Neural Bases of Disgust Conditioning in Anorexia Nervosa
We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.
• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
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
MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.
• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets administered once daily in pediatric subjects aged 5 to 17 years with active, mild to moderate ulcerative colitis
The purpose of this research study is to test the safety and effectiveness of Budesonide in low and high dose extended- release tablets in pediatric participants with active, mild to moderate Ulcerative Colitis and to evaluate the level of budesonide that remains in the blood after taking it. Participants will be asked to take an oral (by mouth) form of Budesonide or a placebo once daily for 8 weeks. A placebo is a tablet that does not contain any active study drug (Budesonide).
• 5 to 17 years old
• diagnosis of Ulcerative Colitis (UC)
• weight is greater than 13.6 kg (30 pounds)
• active UC of mild or moderate severity
• see link to clinicaltrials.gov for complete inclusion criteria
• current or prior diagnosis of Crohn's disease or indeterminate colitis
• prior gastrointestinal surgery, except appendectomy or hernia
• 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
Technology Assisted Treatment for Binge Eating Disorder
This research is being done to study binge eating and potential treatment strategies. An app on a sensor logging device will log eating behavior data. The device will incorporate data and refine the performance of the HabitAware sensor logging model to recognize binge eating episodes. We hope this research will help inform novel treatments for targeting binge eating behavior.
• adults between the ages of 18 and 65 years
• diagnosis of bulimia nervosa, binge eating disorder, or other eating disorder
• women who are pregnant or breast feeding
• history of psychosis or bipolar disorder
• substance use disorder within the past six months
• BMI less than 18.5 kg/m2
• history of acute suicidality requiring hospitalization
• food allergies
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) (I CAN)
To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN
• Immunoglobulin A Nephropathy (IgAN) diagnosis established on kidney biopsy
• stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to starting the study
• if receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• diagnosis of rapid progressive glomerulonephritis
• clinically significant renal disease other than IgAN
• uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
• history of kidney transplant or planned kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
The purpose of this research is to compare the effects of nivolumab with vusolimogene oderparepvec (VO) against standard of care treatment drug(s) currently available for patients with advanced melanoma. We expect that taking part in this research will last up to 60 months.
• at least 12 years old
• confirmed metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma that cannot be surgically removed
• disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence for at least 8 weeks
• documented BRAF V600 mutation status
• see link to clinicaltrials.gov for complete inclusion criteria
• more than 2 lines of systemic therapy for advanced melanoma
• known acute or chronic hepatitis
• known human immunodeficiency virus (HIV) infection
• prior cancer in the previous 3 years, except for locally curable cancers that have apparently been cured
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-38: A Phase 1/2 Open-Label, Single-Ascending-Dose Study of EN-374, a Helper-Dependent Adenoviral-Based Gene Therapy, in Participants with X-Linked Chronic Granulomatous Disease
To evaluate the safety of the EN-374 treatment regimen (HSC mobilization, immune prophylaxis, EN-374 dose and administration, and enrichment of HSCs with O6BG/TMZ).
• at least 18 years old for initial phase of the study and then at least 3 months old for later phase
• diagnosis of X-CGD
• history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
• does not have a suitable, available and willing human related donor
• see link to clinicaltrials.gov for complete Inclusion criteria
• active infection
• history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• had investigational gene therapy
• see link to clinicaltrials.gov for complete Exclusion criteria
NRG-BN013: Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) versus Fractionated SRS (FSRS) for Intact Brain Metastases
We are doing this study to compare the effectiveness of Single Fraction Stereotactic Radiosurgery (SRS) to radiation treatment called fractionated SRS (or FSRS). SRS delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. FSRS that delivers a high dose of radiation given over 3 treatments. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue.
• diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: non-small cell lung cancer (NSLS), melanoma, breast cancer, renal cell cancer, gastrointestinal cancer
• no prior radiotherapy to the brain
• see link to clinicaltrials.gov for complete inclusion criteria
Tic Clips
This study is about learning more about the full range of what tics can look like. Participating includes filling out surveys and submitting two brief videos of yourself. We know tics can be really different across people. By getting a lot of videos of people doing tics, we hope to better understand the variety of tics that exist.
• Aged 4 years or older
• Self-report having tics
• Adult participant or parent is able to read in English
• Access to an internet connected device with video recording capability
MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders
The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.
• no more than 60 years old
• may be unable to work; able to live at home and care for self
• 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 inclusion and exclusion criteria (differ by diagnosis)
• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)
This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer
• locally advanced or metastatic solid tumor
• 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 specific requirements by type of tumor
• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
Standardized Microbiota Transplant Therapy in Crohn's Disease
The goal of this study is to determine if healthy donor microbes released in the small intestine act the same way as healthy donor microbes released in the large intestine for people with Crohn's Disease. We will see what good bacteria are present in intestinal biopsies at 8 weeks and look for improvement in inflammation with colonoscopy.
• 18 to 89 years old
• English speaking
• Diagnosis of Crohn's Disease (CD)
• currently experiencing a flare (Study will enroll people through 2027)
• Current CD therapies are in the maintenance phase of dosing
• Women who could become pregnant must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device)
• See link to clinicaltrials.gov for complete inclusion and exclusion criteria
• Extensive bowel resection or ileostomy or colostomy
• Diagnosis of ulcerative colitis
• Women who are pregnant or breastfeeding
• History of anaphylactic food allergies
Neuroplasticity in REM Sleep Behavior Disorder
REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).
HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma
This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.
• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals with Peripheral Neuropathy and Balance Problems - A Randomized Control Trial
The main purpose of this study is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. Walkasins have been developed to improve balance and walking by enhancing a person’s ability to feel the pressure beneath his/her feet as he/she walks.
• at least 55 years old
• able to complete all activities without the use of an assistive device
• diagnosis of peripheral neuropathy (if due to chemotherapy, must be 1 year after completion)
• experiencing problems with gait or balance
• able to stand on one leg for at least 30 seconds
• acute thrombophlebitis, including deep vein thrombosis, or severe peripheral vascular disease
• lymphedema
• swelling, infection, inflamed area of skin or eruptions on the lower leg
• weigh more than 300 pounds
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654) (INAVO123)
The purpose of this research is to test safety, efficacy and compare the effects of a combination therapy involving inavolisib plus a CDK4/6i (palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole on patients with HR+, HER2- advanced breast cancer (ABC). In this study, you will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole. A placebo looks like a drug but has no active ingredient.
• women or men with confirmed metastatic breast cancer
• ER-positive and/or progesterone receptor-positive and HER2-negative tumor and mutation in PI3K Gene
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Development of Tobacco Related Biomarkers
To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.
• formerly smoked cigarettes daily
• uses smokeless tobacco
• smokes cigars
• uses nicotine gum, lozenges, patches, nasal spray, pouches, or inhaler
• younger than 21 years old
• unstable health condition
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)
This study is looking at if we give ATG followed by either adalimumab or verapamil if those combinations will help in preserving insulin secretion 2 years after newly diagnosed type 1 diabetes.
• age 9 to <21 years
• recently diagnosed with T1D and can start the treatment phase within 6 months of diagnosis
• body weight more than 66 pounds
• fully vaccinated for age and willing to avoid certain live vaccines during the study
• able to read and understand English or Spanish
• use only insulin to control blood sugar (no other glucose-lowering medicines)
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of serious bacterial, viral, fungal, or other infections or current active infection
• history of underlying heart disease
• history of cancer other than of skin
• severe allergy to milk or adhesives
• see link to clinicaltrials.gov for complete Exclusion criteria
Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression
This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.
• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
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)
MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)
The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.
• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)
This study is for children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a study drug called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.
• 2 to 17 years old
• Chronic kidney disease (CKD) of any type
• on a stable dose of maximally tolerated standard therapy for at least 30 days
• see link to clinicaltrials.gov for complete Inclusion criteria
• Type 1 or Type 2 diabetes mellitus
• chronic dialysis or functioning kidney transplant or scheduled for transplantation
• Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age
• gastrointestinal disorders that might interfere withdrug absorption
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants (AGLOW)
To evaluate the efficacy, safety, and pharmacokinetics of VX-407 in participants with Autosomal Dominant Polycystic Kidney Disease with PKD1 gene variants
• Participants between the ages of 18 and 65 years, inclusive.
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
• participants with a pre-existing diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
• see link to clinicaltrials.gov for complete Inclusion criteria
• Kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD
• Solid organ or bone marrow transplantation, or nephrectomy
• Any condition possibly affecting drug absorption (e.g., gastrectomy, gastrointestinal tract surgery except appendectomy and cholecystectomy
• Clinically significant liver dysfunction
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.
• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or unable to do 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 clinical trials.gov for complete Inclusion criteria
• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)
The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
Characterizing Neuropathic Pain in Individuals Receiving Inpatient Treatment for an Alcohol Use Disorder
This study aims to learn more about neurological symptoms associated with alcohol use. The study team plans to characterize neuropathic pain in individuals receiving in-patient treatment for alcohol use compared with moderate drinkers of the same age.
• between 21 and 65 years of age
• must speak English
• Moderate drinkers group: Use alcohol at least 2-4 times per month
• Treatment group: patients in the Fairview Lodging Program primarily seeking treatment for alcohol - use of nicotine, cannabis, cocaine, and hallucinogens are permissible