[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Washington\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":611},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,200,0,25,[9,43,74,93,114,136,157,186,209,229,249,271,293,319,347,369,387,411,422,443,477,498,521,544,574],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054194","phase-2-igfbp-2-vaccine-to-prevent-ovarian-cancer-progression-in-patients-with-serologic-detection-of-recurrence-100054194",false,"NCT07495124","IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence","A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy\n* Have a cancer antigen 125 (CA-125) that normalized after first-line therapy\n* CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment\n* Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic\n* All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study (end of one year follow up). Note: Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal\n* Have estimated life expectancy of at least 3 months\n* Be willing and able to provide written informed consent\u002Fassent for the trial\n* Be ≥ 18 years of age on day of signing informed consent\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale\n* White blood cell (WBC) ≥ 3000\u002Fmm\\^3 (performed within 14 days of treatment initiation)\n* Hemoglobin (Hgb) ≥ 10 g\u002Fdl (performed within 14 days of treatment initiation)\n* Hematocrit (Hct) ≥ 28% (performed within 14 days of treatment initiation)\n* Serum creatinine ≤ 2.0 mg\u002Fdl or creatinine clearance \\> 60 mL\u002Fmin (performed within 14 days of treatment initiation)\n* Total bilirubin ≤ 2.5 mg\u002Fdl (performed within 14 days of treatment initiation)\n* Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN) (performed within 14 days of treatment initiation)\n* Blood glucose \\\u003C 1.5 ULN (performed within 14 days of treatment initiation)\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment (i.e., day 1)\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n\n  * Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events \\[irAEs\\]) is allowed\n* Has symptomatic ascites or pleural effusions\n* History of borderline or low malignant potential ovarian cancer\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier\n* Has had prior chemotherapy, biologic therapy, targeted small molecule therapy, hormonal therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study\n  * Note: If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\n* Clinically significant cardiovascular disease\n* Known severe hypersensitivity reactions to carboplatin ≥ grade 3, any history of anaphylaxis, or uncontrolled asthma\n* Patients with any contraindication to receiving recombinant human granulocyte macrophage-colony stimulating factor (rhuGM-CSF) based products\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies)\n* Has known active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis c virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed\n\n  * Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed","FEMALE","18 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial studies how well giving the insulin-like growth factor binding protein 2 \\[pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)\\] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.",[27,28,29],"Fallopian Tube Carcinoma","Ovarian Carcinoma","Primary Peritoneal Carcinoma","NOT_YET_RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":21},"2026-10-01",{"date":38,"type":21},"2028-09-30",{"name":40,"class":41},"University of Washington","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100054307","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100054307","NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","ALL","69 Years",{"count":53,"type":21},60,[24],"The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[57,58,59,60,61,62,63,64,65],"Type 1 Diabetes (T1D)","Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Autoimmune Diseases","Immune System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","RECRUITING",{"date":33,"type":34},{"date":69,"type":21},"2026-06",{"date":71,"type":21},"2029-12",{"name":40,"class":41},2,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":42},"100054222","a-home-based-exercise-intervention-carefit-bmt-in-improving-heart-function-among-patients-with-high-risk-acute-myeloid-leukemia-undergoing-stem-cell-transplant-100054222","NCT07616921","A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant","CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* New diagnosis of acute myeloid leukemia at Fred Hutch\n* High-risk patients as defined by one, or more, of the following criteria:\n\n  * Age 65 years or older and\u002For\n  * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and\u002For\n  * CARE-BMT score ≥ 5\n\n    * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff\n* Able to exercise at low to moderate intensity, as evaluated by study staff\n* Access to a mobile smart phone\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility\n* Recurrence of AML or diagnosis of other invasive cancer\n* Severe anemia (hemoglobin \\\u003C 7 gm\u002Fdl)\n* History of severe aortic stenosis\n* New York Heart Association (NYHA) class IV heart failure\n* Severe pain with basic movement\n* Pregnant persons\n* Unable to give consent",{"count":82,"type":21},30,[84],"NA","This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a \"prehabilitation\" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.",[87],"Acute Myeloid Leukemia",{"date":33,"type":34},{"date":36,"type":21},{"date":91,"type":21},"2028-04-03",{"name":40,"class":41},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":42},"100053814","phase-1-samuraciclib-for-the-treatment-of-patients-with-resectable-borderline-resectable-or-locally-advanced-basal-pancreatic-cancer-100053814","NCT07645651","Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer","Phase 1b Window-of-Opportunity Study Evaluating CDK7 Inhibition in Patients With Localized Basal Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.\n\n  * Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei\n* Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of positron emission tomography (PET)\u002FCT or PET\u002FMRI is NOT acceptable; CT or MRI with contrast as part PET\u002FCT or PET\u002FMRI is acceptable) of the chest, abdomen, and pelvis. The institutional radiologist must review the scans. Resectable, borderline resectable, and locally advanced will be defined by National Comprehensive Cancer Network (NCCN) guidelines version 2.2025.\n\n  * There must be no evidence of metastatic disease\n* Must be 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* Archival biopsy specimen collected within 3 months must be available. If not available, a diagnostic EUS\u002FFNB will be performed during screening\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (within 14 days prior to study drug)\n* Platelets ≥ 100,000\u002FmcL (within 14 days prior to study drug)\n* Hemoglobin ≥ 9 g\u002FdL (within 14 days prior to study drug)\n* Serum creatinine ≥ 1.5X upper limit of normal (ULN) or serum creatinine clearance ≥ 50 ml\u002Fmin by Cockcroft-Gault (within 14 days prior to study drug)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5X ULN (within 14 days prior to study drug)\n* Total bilirubin ≤ 1.5X ULN (within 14 days prior to study drug)\n* Participants must not be pregnant or nursing. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours of treatment initiation, where WOCBP are defined as all female participants between 18 - 55 years of age. Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception for up to 6 months after the final administered dose of investigational agent. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Prior radiation\n* Unable to tolerate oral medication, per assessment of the principal investigator (PI)\n* Participants who are receiving other investigational agents\n* Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that precluded adequate absorption of samuraciclib\n* Uncontrolled seizures\n* Active infection\n* Active bleeding diatheses\n* Known active hepatitis B or hepatitis C infection\n* Breastfeeding or pregnancy\n* Receipt of systemic corticosteroids within 14 days before the first dose of study medication\n* Receipt of St. John's Wort within 21 days before the first dose of study medication or of another concomitant medication, herbal supplement, or food that was a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein activity within 21 days before the first dose of samuraciclib\n* Known hypersensitivity to samuraciclib or any excipient of the product",{"count":101,"type":21},15,[103],"PHASE1","The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.",[106,107,108],"Resectable Pancreatic Ductal Adenocarcinoma","Borderline Resectable Pancreatic Ductal Adenocarcinoma","Locally Advanced Pancreatic Ductal Adenocarcinoma",{"date":33,"type":34},{"date":36,"type":21},{"date":112,"type":21},"2027-11-01",{"name":40,"class":41},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":42},"100054118","phase-2-measuring-circulating-tumor-deoxyribonucleic-acid-tumor-fraction-to-guide-early-177lu-psma-617-treatment-discontinuation-in-patients-with-metastatic-castration-resistant-prostate-cancer-dynamo-trial-100054118","NCT07698535","Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial","Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Adult males ≥ 18 years age\n* History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes)\n* Evidence of metastatic disease on bone scan or CT scan\n* Patient must have evidence of castration- resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \\[PCWG3\\] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg\u002FdL)\n\n  * Serum\u002Fplasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment and progression on at least one androgen receptor pathway inhibitor (ARPI), in either castration-sensitive or castration-resistant setting\n* Eligible for treatment with either 177Lu-PSMA-617 or docetaxel as per their respective Food and Drug Administration (FDA) labels\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance ≥ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome (direct bilirubin ≤ 1.5 x ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN. For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN\n* Able to comply with study requirements including provision of peripheral blood samples at specified time points for correlative studies\n\nExclusion Criteria:\n\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or provision of informed consent to participate in this study\n* Evidence of metastatic neuroendocrine\u002Fsmall cell prostate cancer (NEPC). Note: baseline biopsy is not required\n* Patients receiving any systemic therapy (aside from a luteinizing hormone-releasing hormone \\[LHRH\\] analogue) or radiotherapy within 2 weeks prior to study treatment\n* Persistent toxicities (CTCAE grade \\> 2) from prior cancer therapy, excluding alopecia and stable neuropathy\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent\n* Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \\\u003C 200\n* Patients with known active hepatitis (i.e. hepatitis B or C). Prior hepatitis C infection is allowed as long as polymerase chain reaction (PCR) is negative\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation \\> 500ms, or congenital long QT syndrome\n* Prior systemic chemotherapy with taxane chemotherapy, including in hormone sensitive setting (e.g. docetaxel or cabazitaxel)\n* Brain metastases or active epidural disease (treated epidural disease is permitted)\n\n  * Note: baseline brain imaging is not required\n* Contraindication to prednisone therapy including poorly controlled diabetes mellitus","MALE",{"count":123,"type":21},64,[24],"This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for the disease to grow, spread, or get worse or come back after a period of improvement. ctDNA TF is a type of ctDNA measurement. Research has shown ctDNA TF may be a promising way to predict which patients will respond to 177Lu-PSMA-617 treatment. Measuring ctDNA TF may help doctors identify which patients may benefit from changing treatments sooner, which may be an effective way to guide early 177Lu-PSMA-617 treatment discontinuation in patients with metastatic castration-resistant prostate cancer.",[127,128],"Metastatic Castration-Resistant Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","2026-07-06",{"date":33,"type":34},{"date":132,"type":21},"2026-12-01",{"date":134,"type":21},"2029-07-05",{"name":40,"class":41},{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":42},"100572830","phase-2-etoposide-prednisone-vincristine-cyclophosphamide-and-doxorubicin-da-epoch-with-or-without-rituximab-plus-recombinant-erwinia-asparaginase-jzp458-for-the-treatment-of-newly-diagnosed-ph-negative-b-acute-lymphoblastic-leukemia-or-t-acute-lymphoblastic-leukemia-100572830","NCT06738368","Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL\n* In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical\u002Flogistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen\n* Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL.)\n* Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN) (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and alanine aminotransferase \\[ALT\\]\u002Faspartate aminotransferase \\[AST\\] are ≤ 8.0 x ULN.)\n* AST (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002FALT (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT\u002FAST are ≤ 8.0 x ULN.)\n* Calculated creatinine clearance of ≥ 60 ml\u002Fmin\u002F1.73 m\\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible\n* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles\n* Ability to give informed consent and comply with the protocol\n* Anticipated survival of at least 3 months, independent of ALL\n* Female subjects of childbearing potential should use effective non-hormonal contraceptive methods during treatment with JZP458 and for 3 months after the last dose of study drug. Male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior systemic therapy for ALL except to control acute symptoms and\u002For leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg\u002Fm\\^2 per dose up to 2 doses and\u002For the equivalent of prednisone 50 mg\u002Fm\\^2\u002Fday for up to 2 days are permitted\n* Burkitt lymphoma\u002Fleukemia\n* Isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency\n* Known active chronic liver disease including, but not limited to, non-alcoholic steatohepatitis, cirrhosis, or non-alcoholic fatty liver disease\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* Pregnant or nursing\n\n  * Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \\[1\\] surgically sterilized, or \\[2\\] postmenopausal \\[i.e., a woman who is \\> 50 years old or who has not had menses for ≥ 1 year\\], or \\[3\\] not heterosexually active)",{"count":82,"type":21},[24],"This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, 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. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.",[147,148],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia","2026-06-30",{"date":151,"type":34},"2026-07-02",{"date":153,"type":34},"2026-05-08",{"date":155,"type":21},"2028-07-30",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":42},"100642967","kulindana-community-friendly-delivery-and-monitoring-of-tpt-to-improve-uptake-and-reduce-tb-transmission-100642967","NCT07628140","Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Inclusion Criteria:\n\n* Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).\n* People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.\n\nExclusion Criteria:\n\n* HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational\u002Finterventional HIV or TB study.\n* PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational\u002Finterventional HIV or TB study.",{"count":165,"type":21},1500,[84],"The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:\n\n* Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?\n* Does community-based and DSD TPT reduce household and community TB transmission?\n\nResearchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.\n\nParticipants will:\n\n* Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.\n* If eligible, receive DSD TPT service delivery or SoC TPT service delivery.\n* Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.\n* Have TPT completion assessed at 12 weeks following enrolment.\n* A subset of participants will be assess for TB incidence at 9 months following enrolment.",[169,170],"Tuberculosis Prevention","HIV",[172,173,174,175,170,176,177,178],"tuberculosis","household contact","TB preventive therapy","3HP","contact investigation","multi-month dispensing","differentiated service delivery","2026-06-25",{"date":149,"type":34},{"date":182,"type":21},"2026-07",{"date":184,"type":21},"2031-07",{"name":40,"class":41},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":195,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100610249","comparison-of-intravesical-therapy-and-surgery-as-treatment-options-for-bladder-cancer-2-100610249","NCT07225127","Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2","CISTO2","Inclusion Criteria:\n\n1. Adult 18 years of age or older; and\n2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:\n\n   1. Pathology documentation from any hospital\u002Fclinic\u002Fmedical center\n   2. More than 50% urothelial carcinoma component in the specimen; and\n3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and\n4. In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.\n\nExclusion Criteria:\n\n1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);\n2. Previous history of cystectomy or radiation therapy for bladder cancer;\n3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;\n4. Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;\n5. Incarcerated in a detention facility or in police custody at baseline\u002Fscreening (patients wearing a monitoring device can be enrolled);\n6. Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity);\n7. Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies);\n8. Unable to provide written informed consent in English;\n9. Unable to be contacted for research surveys;\n10. Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection.",{"count":194,"type":21},408,"OBSERVATIONAL","Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).",[198,199,200],"Bladder Cancer","Recurrent Bladder Cancer","Non-muscle Invasive Bladder Cancer (NMIBC)",{"date":202,"type":34},"2026-06-29",{"date":204,"type":34},"2025-11-03",{"date":206,"type":21},"2028-12",{"name":40,"class":41},6,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":216,"sex":50,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":42},"100644827","an-adapted-evidence-based-coaching-program-for-fathers-and-their-young-children-in-the-context-of-home-visiting-100644827","NCT07676240","An Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting","Randomized Controlled Trial of an Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting","Inclusion Criteria:\n\n* Identify as a father\n* Speak English or Spanish\n* Have a child between the ages of 12-36 months who lives with you\n* Be enrolled in Akin services\n\nExclusion Criteria:\n\n* No additional exclusion criteria",true,"12 Months",{"count":5,"type":21},[84],"Father-child pairs (N=200; children ages 12-36 months) will be randomized to FIND-F or a waitlist control group. Assessments comparing the two groups will occur at baseline, end of program, and 6 months post-program. Our aims include:\n\nAim 1: Evaluate the main impacts of FIND-F on the primary program target (fathers' supportive parenting) and related child and parent outcomes.\n\nAim 2. Identify mechanisms of FIND-F's intervention effects.\n\nAim 3. Examine variation by select child, father, and program measures.",[222],"Positive Parenting","2026-06-23",{"date":149,"type":34},{"date":226,"type":34},"2026-06-15",{"date":71,"type":21},{"name":40,"class":41},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":42},"100644764","phase-2-18fftt-positron-emission-tomographycomputed-tomography-to-predict-treatment-response-in-patients-scheduled-to-receive-gemcitabine-cisplatin-and-durvalumab-for-newly-diagnosed-cholangiocarcinoma-100644764","NCT07673341","[18F]FTT Positron Emission Tomography\u002FComputed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma","Imaging PARP Expression in Cholangiocarcinoma","Inclusion Criteria:\n\n* Patient must have histologically confirmed cholangiocarcinoma\n* Patient must be newly diagnosed and have not yet been treated\n* Patient planned to receive GCD per standard-of-care\n* Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1\n* Age ≥ 18 years\n* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \\[18F\\]FTT PET imaging\n* Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures\n* Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":237,"type":21},22,[24],"This phase II trial studies whether \\[18F\\]FTT can be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET\u002FCT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, \\[18F\\]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. \\[18F\\]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET\u002FCT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using \\[18F\\]FTT with PET\u002FCT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.",[241],"Cholangiocarcinoma","2026-06-22",{"date":202,"type":34},{"date":245,"type":21},"2026-11-01",{"date":247,"type":21},"2028-12-31",{"name":40,"class":41},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":42},"100644289","hepatitis-c-pharmacist-physician-patient-navigator-collaborative-care-model-in-permanent-supportive-housing-100644289","NCT07667101","Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing","A Hybrid Implementation-Effectiveness Study of the Pharmacist, Physician, and Patient Navigator Collaborative Care Model (PPP-CCM) to Cure Hepatitis C Among Persons Who Use Drugs With Housing Insecurity","HepP3","Inclusion Criteria:\n\n* Adult ≥18 years of age\n* Currently a resident at one of DESC's PSH buildings at the time of study enrollment\n* Positive HCV test documented (screening antibody test or viral load test)\n* Provides release of information (ROI) to access community pharmacy electronic medical records (EHR) and\u002For other HCV treatment providers for information on HCV care during the study period between baseline visit and 24-month visit\n\nExclusion Criteria:\n\n* Taking medications to treat HCV at the start of the study\n* Cognitive impairment (acute or chronic) resulting in inability to provide informed consent\n* Currently or impending incarceration\n* People who plan to leave the Seattle area within 24 months\n* Not English speaking\n* Behavioral risk posing safety concerns per discretion of research staff",{"count":258,"type":21},444,[84],"The objective of this study is to extend our prior research by conducting a pragmatic implementation trial using a parallel-group, cluster randomized design to evaluate the PPP-CCM's ability to improve access to DAAs for HCV within a network of permanent supportive housing (PSH) buildings in Seattle and King County. The study will implement PPP-CCM to 16 housing buildings, randomizing half to receive PPP-CCM (intervention) versus usual care (UC) for 12-months, after which all buildings will have access to PPP-CCM. All buildings will have access to point-of-care HCV screening for the first 6 months of the study. Study outcome data will be collected through a longitudinal cohort-study of persons who screened positive for HCV which will conduct surveys and review of medical records at baseline, 12- and 24-months.",[262],"HEPATITIS C (HCV)","2026-06-18",{"date":265,"type":34},"2026-06-24",{"date":267,"type":34},"2026-06-01",{"date":269,"type":21},"2029-06",{"name":40,"class":41},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":42},"100641890","phase-1-consolidative-therapy-after-ev--pembrolizumab-in-muscle-invasive-bladder-cancer-reinforce-trial-100641890","NCT07579195","Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial","Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Phase I\u002FII Pilot Feasibility Trial","Inclusion Criteria:\n\n* Age \\>= 18 at the time of screening\n* Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants\n* Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis\n* Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria and at the determination of treating physicians) after 3-9 cycles of induction EV + pembro\n* If M1 after completion of EV + pembro, patients need to have =\\\u003C 5 sites of metastasis and all sites of metastasis should be extracranial\n\n  * Note: when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastatic lesions, etc). Five or fewer sites of metastasis applies after the completion of EV + pembro, not at initial diagnosis\n* Be a candidate for consolidative radiation therapy (RT) to the pelvis (if indicated) or cystectomy (if indicated), and all sites of metastasis are amenable to RT\n* Life expectancy \\> 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Absolute neutrophil count (ANC) \\>= 1500 \u002FmcL (within 180 days of trial registration)\n* Platelets \\>= 100,000\u002FmcL (within 180 days of trial registration)\n* Hemoglobin \\> 9 g\u002FdL (within 180 days of trial registration)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR \\>= 60 mL\u002Fmin (within 180 days of trial registration)\n* Total bilirubin =\\\u003C 1.5 ULN OR direct bilirubin =\\\u003C ULN if total bilirubin \\> 1.5 x ULN (within 180 days of trial registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN OR \\\u003C 5 x ULN if patient has live metastasis (within 180 days of trial registration)\n* Albumin \\>= 2.5 g\u002FdL (within 180 days of trial registration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range (within 180 days of trial registration)\n* PTT =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range (within 180 days of trial registration)\n* Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception during, and for at least 90 days after the end of radiation therapy. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of treatment initiation\n* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial\n\nExclusion Criteria:\n\n* Prior radiation therapy with field overlapping with current proposed radiation field, precluding delivery of meaningful dose of radiation\n* Intracranial metastasis\n* Any small cell component, or predominant (\\> 50%) sarcomatoid or plasmacytoid histology\n* Other active malignancy or clinically relevant malignancy within past 2 years, per discussion with the principal investigator\n* Genetic conditions that increase sensitivity to radiation, such as Fanconi syndrome, ataxia telangiectasia, and Nijmegen breakage syndrome\n* Active human immunodeficiency virus (HIV) not adequately controlled, active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any other medical condition that may interfere with trial therapy delivery",{"count":279,"type":21},12,[103,24],"This phase I\u002FII clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and pembrolizumab. Although this combination has significantly improved outcomes compared to traditional chemotherapy, many patients are left with residual cancer in the bladder or other sites, and there is currently no established standard approach for managing this remaining disease or determining the optimal duration of systemic therapy. Prolonged treatment can lead to cumulative side effects and negatively impact quality of life.\n\nThis study investigates whether adding consolidative treatment-such as radiation therapy to the bladder and metastatic sites or surgical removal of the bladder (radical cystectomy)-can safely eliminate residual disease and delay cancer progression. Radiation therapy uses high-energy x-rays to precisely target and destroy cancer cells while minimizing exposure to surrounding normal tissues. In selected patients, surgery may be used to remove remaining tumor in the bladder. Targeted radiation techniques, such as stereotactic body radiation therapy (SBRT), may also be used to treat small metastatic sites. This approach may allow for safe discontinuation of systemic therapy, potentially reducing long-term treatment-related side effects.\n\nA key component of this trial is the integration of biomarker testing using circulating tumor DNA (ctDNA) from blood and urine tumor DNA (utDNA). These tests detect small amounts of tumor-derived genetic material and may help identify patients most likely to benefit from consolidative treatment, as well as guide decisions about ongoing therapy. By combining response to systemic therapy with personalized local treatment and biomarker-driven monitoring, this study aims to improve cancer control, reduce complications from untreated local disease, and inform future treatment strategies for patients with advanced bladder cancer.",[283,284,285],"Muscle Invasive Bladder Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","2026-06-17",{"date":242,"type":34},{"date":289,"type":21},"2026-07-01",{"date":291,"type":21},"2029-12-31",{"name":40,"class":41},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":216,"sex":50,"minAge":301,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":42},"100599859","hiv-testing-counselor-led-care-to-catalyze-integration-of-prep-delivery-in-family-planning-clinics-100599859","NCT07089966","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project","HTS PrEP","Inclusion Criteria:\n\n* ≥15 years of age\n* Accessing health services at participating public health facilities.\n* Not known to be living with HIV prior to the visit when their clinical data is first abstracted","15 Years",{"count":303,"type":21},30000,[84],"This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.",[307,308],"Human Immunodeficiency Virus (HIV)","HIV Pre-exposure Prophylaxis",[310,311],"PrEP","HIV Prevention","2026-06-16",{"date":263,"type":34},{"date":315,"type":34},"2025-12-01",{"date":317,"type":21},"2029-06-30",{"name":40,"class":41},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":216,"sex":50,"minAge":327,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":336,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":73},"100580855","a-trial-testing-a-two-way-sms-platform-to-recognize-and-prevent-wasting-among-hiv-infected-and-hiv-exposed-uninfected-children-in-kenya-100580855","NCT06842732","A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","A Mixed Methods Randomized Controlled Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","MAMMS IYCF R33","Inclusion Criteria (HIV-exposed caregiver-child pairs):\n\n* Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment\n* Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals\n* The child's caregiver is willing and able to provide informed consent\n* The child's caregiver can read or write or has someone to help them read or write\n* The child's caregiver is planning to remain in the catchment area with their child for \\> 6 months and willing to return to the health facility for 6-month follow up visits\n* The child's caregiver has access to a Safaricom phone line and provides a mobile phone number\n\nInclusion Criteria (healthcare workers):\n\n\\- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients\n\nExclusion Criteria:\n\n* Children with moderate or severe wasting (MUAC \\\u003C12.5cm, weight-for-height z-score \\\u003C-2, or nutritional edema) at the time of eligibility screening\n* Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding\n* Child is enrolled in another study that the PI judges to compromise the aims of this study\n* Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.\n* Child's caregiver is under the age of 18 years.","6 Months","24 Months",{"count":330,"type":21},776,[84],"The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring their child's nutritional status at home can improve nutritional outcomes for HIV-exposed children.\n\nThe aims include 1) to determine whether the MAMMS IYCF intervention lowers the incidence of malnutrition, leads to a shorter time to recover for those that become malnourished and results in a lower incidence of hospitalizations, severe malnutrition and death, 2) to determine the cost and cost-effectiveness of the MAMMS IYCF intervention, and 3) to determine the effect of the MAMMS IYCF intervention on the behavior and attitudes of participants through change in age-appropriate feeding, IYCF knowledge, trust in the healthcare system, and intention to seek care if the child becomes wasted.\n\nThe study team will enroll 776 caregiver-child pairs aged between 6 and 24 months in Migori and Homa Bay County, Kenya. Each caregiver-child pair will be randomly assigned to either the MAMMS IYCF intervention or standard of care (SOC) and followed for 180 days (about 6 months).\n\nCaregivers assigned to the intervention arm will be asked to respond to weekly messages with the color of the MUAC tape after measuring their child's arm after being trained on how to use the MUAC measuring tape. Weekly messages will include IYCF education and other age-appropriate child health related information. Caregivers in the SOC arm will receive clinic appointment and study visit reminders only. Caregivers in the intervention arm and the SOC arm will be asked to attend the study clinic for follow-up visits at Day 90 and Day 180. At enrollment and follow-up visits, the study team will administer a survey including a child's medical history, a standardized child clinical examination, and anthropometry.",[334,335],"Malnutrition in Children","Children Exposed to HIV",[337,338,339,340],"maternally administered malnutrition monitoring system (MAMMS)","infant and young child feeding practices","wasting","two-way SMS system",{"date":263,"type":34},{"date":343,"type":34},"2025-06-05",{"date":345,"type":21},"2027-07-15",{"name":40,"class":41},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":73},"100555897","phase-2-hippocampal-avoidance-in-craniospinal-irradiation-for-the-treatment-of-leptomeningeal-metastases-from-breast-cancer-or-non-small-cell-lung-cancer-100555897","NCT06518057","Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer","A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors","Inclusion Criteria:\n\n* Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and\u002For through CSF cytology\n* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases\n* Patients ≥ 18 years old\n* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2\n* The patient is able to provide informed consent\n* Hemoglobin \\> 8 g\u002FdL\n* Absolute neutrophil count \\> 1,000\u002Fmm\n* Platelet count \\> 100,000\u002Fmm\n* Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \\[≥ 60 years old, or with no menses for \\> 1 year without an alternative medical cause\\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum \u002Furine pregnancy test within 3 weeks prior to starting radiation therapy (RT)\n* Patients with reproductive potential must agree to practice two highly effective contraceptive methods\n\nExclusion Criteria:\n\n* Patients with multiple, serious major neurologic deficits per physician\u002Finvestigator assessment including encephalopathy\n* Patients with extensive systemic disease and without reasonable systemic treatment options\n* Patients who are unable to undergo MRI brain and spine with gadolinium contrast\n* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances\n* Gross ventricular disease\n* Brain metastases within 5 mm of the hippocampal contours not previously treated\n* Pregnant or lactating women",{"count":237,"type":21},[24],"This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.",[358,359,360,361,362],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Leptomeninges","Stage IV Lung Cancer AJCC v8",{"date":286,"type":34},{"date":365,"type":34},"2025-03-03",{"date":367,"type":21},"2028-07-01",{"name":40,"class":41},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":386,"locationsCount":42},"100483114","phase-2-sx-682-with-pembrolizumab-for-the-treatment-of-metastatic-or-recurrent-stage-iiic-or-iv-non-small-cell-lung-cancer-100483114","NCT05570825","SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer","A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Subjects aged 18 years and older\n* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK rearrangement, ROS1 rearrangement or RET rearrangement\n* Tumoral PD-L1 expression \\>=1% by any Clinical Laboratory Improvement Act (CLIA)-certified assay\n* Metastatic or recurrent non-small cell lung cancer (NSCLC). Stage IIIC per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment\n* At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Subjects must have ECOG PS 0 or 1 at the time of informed consent and at the time of treatment initiation\n* Must be willing to provide pre-treatment archived specimen or undergo a biopsy procedure if archived specimen is not available\n* Must be willing to provide an on-treatment biopsy, if deemed safe by the treating physician\n* Platelet count \\>= 100,000\u002FuL\n* Absolute neutrophil count \\>= 1,500\u002FuL\n* Hemoglobin \\>= 8g\u002FdL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 times upper limit of normal\n* Creatinine =\\\u003C 2.0 mg\u002FdL\n* Women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal or barrier method) prior to treatment initiation, during treatment and for three months after completing treatment\n* Negative beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential. Pregnant or breast feeding women are not eligible\n* Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment\n\nExclusion Criteria:\n\n* Participants must not have received prior chemotherapy or immune checkpoint inhibitor or immune-modulatory therapy (e.g. anti-PD\\[L\\]1, anti-CTLA4, anti-TIM3, anti-GITR, anti-TIGIT, anti-LAG3), for metastatic or recurrent NSCLC, with the following exceptions:\n\n  * Participants may have received prior chemotherapy, immune checkpoint inhibitor, and\u002For immune modulatory therapy in the curative setting if the last dose of treatment was more than (\\>) 24 weeks prior to consenting\n  * For patients with NSCLC harboring an oncogenic alteration other than listed may have received prior small molecule inhibitor therapy (e.g. MET inhibitor for MET exon 14 mutated NSCLC). A wash-out period of at least 5 half-lives is required prior to start of study treatment\n* Presence of other active cancers within the last 2 years. Patients with any prior early stage cancer who have received definitive local treatment at least 2 years previously and no evidence of recurrence are eligible. All patients with previously treated in situ carcinoma are eligible, as patients with history of non-melanoma skin cancer\n* Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no steroids or escalating doses of antiepileptics within 7 days prior to start of study treatment\n\n  * Patients with untreated CNS metastases may be enrolled as long as they meet the above criteria. Patients with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment\n* Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment\n* Participants must not have an active autoimmune disease that has required immune modulating treatment within (\\\u003C) 365 days prior to consenting (i.e., disease modifying agents, corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed\n* Inability to discontinue systemic corticosteroid therapy; systemic steroids must be tapered off 7 days prior to first dose of SX-682\n* Known history of primary immunodeficiency\n* History of organ transplant that requires use of immunosuppressives\n* Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history\n* History of non-infectious pneumonitis (e.g. radiation pneumonitis) that required steroids within 3 months of start of study treatment\n* Radiotherapy within 7 days of start of study treatment\n* Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment. Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed\n* Electrocardiogram (EKG) demonstrating a corrected QT (QTc) interval \\> 480 msec on three consecutive EKGs or patients with congenital long QT syndrome\n* Severe lung disease (e.g. chronic obstructive pulmonary disease \\[COPD\\]) who cannot stop steroids 7 days prior to start of study treatment\n* Serious cerebrovascular and cardiac disease defined as:\n\n  * Active unstable angina pectoris\n  * Congestive heart failure NYHA (New York Heart Association) \\> grade 3\n  * Acute myocardial infarction within 3 months of consenting\n  * Stroke or transient ischemic attack within 3 months of consenting\n* Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility. Active infection requiring IV antibiotics within 7 days of study treatment initiation\n\n  * Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay\n  * Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B virus surface antigen (HBsAg) per local assay\n* Known uncontrolled HIV (human immunodeficiency virus) infection\n\n  * Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count \\>= 350 cells\u002FuL within 6 months prior to study treatment initiation and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection\n* Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent",{"count":82,"type":21},[24],"This phase II trial tests whether CXCR1\u002F2 inhibitor SX-682 (SX-682) with pembrolizumab works to treat patients with stage IIIC or IV non-small cell lung cancer that has spread to other parts of the body (metastatic) or that has come back (recurrent). SX-682 is a drug that binds to receptors on some types of immune and cancer cells, inhibiting signaling pathways, reducing inflammation, and allowing other types of immune cells to kill and eliminate cancer cells. Pembrolizumab is a monoclonal antibody that binds to a receptor called PD-1 that is found on the surface of T-cells (a type of immune cell), activating an immune response against tumor cells. Giving SX-682 in combination with pembrolizumab may be more effective at treating patients with metastatic or recurrent non-small cell lung cancer than giving these treatments alone.",[360,380,381,362],"Recurrent Lung Non-Small Cell Carcinoma","Stage IIIC Lung Cancer AJCC v8",{"date":286,"type":34},{"date":384,"type":34},"2023-04-06",{"date":367,"type":21},{"name":40,"class":41},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":408,"leadSponsor":410,"locationsCount":73},"100643527","physical-activity-through-health-technology-in-axial-spondyloarthritis-100643527","NCT07642622","Physical Activity Through Health Technology in Axial Spondyloarthritis","Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach","Inclusion Criteria:\n\n* Diagnosis of axial spondyloarthritis by a rheumatologist\n* English speaking\n* Insufficiently active (less than 150 minutes of moderate intensity aerobic activity per week)\n* Willing to wear a Fitbit for the study duration\n* Willing to have or create a Google account and download the Google Health app (previously known as the Fitbit app)\n\nExclusion Criteria:\n\n* Currently pregnant\n* International travel or any circumstance causing lack of access to wi-fi\u002FInternet at any point during the study period\n* Recent or planned surgery that may affect ability to engage in physical activity\n* Unable to exercise for health reasons, or a provider has recommended against exercising for safety\u002Fhealth reasons\n* Unable to walk safely without difficulty, or is a fall risk (i.e., 3+ falls in past 6 months)\n* History of a fall resulting in a fracture or head injury in the past 6 months\n* Cardiovascular contraindicators for physical activity, or history of cardiovascular problems that may be exacerbated by physical activity, as defined by their rheumatologist\n* Diabetes causing hypoglycemia following physical activity",{"count":395,"type":21},40,[84],"The purpose of this study is to find out whether a mobile app called the ExerciseRx app is a practical and helpful way for people with axial spondyloarthritis (axSpA) to receive exercise recommendations as part of their regular rheumatology care.\n\nResearchers want to learn:\n\nWhether people with axSpA find the ExerciseRx app easy to use and helpful for supporting regular exercise.\n\nWhether using the ExerciseRx app leads to improvements in symptoms, physical function, and disease activity compared with usual care.\n\nParticipants assigned to the ExerciseRx group will use the app to complete guided exercises for 20-30 minutes, four times per week. They will also receive personalized weekly step-count goals to help increase their physical activity. Researchers will compare outcomes between participants using the app and those receiving usual care.",[399],"Axial Spondyloarthritis",[401,402,403],"digital health","exercise","mobile app","2026-06-09",{"date":406,"type":34},"2026-06-11",{"date":69,"type":21},{"date":409,"type":21},"2027-06",{"name":40,"class":41},{"id":412,"slug":4,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":104,"conditions":415,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":421,"locationsCount":42},"100643239",{"count":101,"type":21},[103],[106,107,108],"2026-06-08",{"date":418,"type":34},"2026-06-12",{"date":289,"type":21},{"date":112,"type":21},{"name":40,"class":41},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":42},"100518069","phase-1-a-phase-1-study-of-neoadjuvant-abemaciclib-in-combination-with-radiation-therapy-for-liposarcomas-100518069","NCT06025747","A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas","A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas","Inclusion Criteria:\n\n* Subjects, \\>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in situ hybridization (FISH), or other clinically appropriate methodology in the opinion of the reviewing pathologist. Histologic or imaging evidence of the presence of a dedifferentiated component must be present\n* Subjects must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT scan or MRI\n* At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable\n* Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for subjects receiving radiotherapy locally\u002Fat an outside institution must be reviewed and approved by a radiation oncologist investigator prior to initiation of radiotherapy\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (\\>= 1.5 GI\u002FL) without granulocyte colony-stimulating factor support in the last 14 days (subjects may not have received blood product transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] within 14 days prior to screening)\n* White blood cell count \\>= 2500\u002Fmm\\^3 (\\>= 2.5 GI\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Platelets \\>= 100,000\u002Fmm\\^3 (\\>= 100 GI\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Hemoglobin \\>= 8 g\u002FdL (\\>= 80 g\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (subjects with Gilbert's disease =\\\u003C 2 x ULN and direct bilirubin within normal limits are permitted) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Serum albumin \\>= 2.8 g\u002Fdl (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Serum creatinine =\\\u003C 2.0 x ULN or calculated creatinine clearance \\>= 30 mL\u002Fmin (\\>= 0.5 mL\u002Fsec) using the Cockcroft-Gault equation (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Urine protein\u002Fcreatinine ratio (UPCR) =\\\u003C 1 mg\u002Fmg (=\\\u003C 113.2 mg\u002Fmmol) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Male or non-pregnant and non-breast feeding female:\n\n  * Women of child-bearing potential (WOCBP) must agree to use highly effective contraception without interruption from initiation of therapy and continue until 4 months (120 days) after last dose of study therapy. WOCBP must have a negative serum pregnancy test (beta-human chorionic gonadotropin \\[hCG\\]) result at screening and agree to ongoing pregnancy testing during the study, and at the end of study treatment. A highly effective method of contraception is defined as one that results in a low failure rate (that is, \\\u003C 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner\n  * Male subjects must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study\n* Life expectancy of \\> 3 months, as determined by the investigator\n* Ability to understand and sign informed consent\n* Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis\n* Receipt of any prior radiation therapy for any reason to the affected area\n* Known central nervous system (CNS) metastases\n* Evidence of distant metastatic disease at time of treatment initiation\n* History of thromboembolic event within 1 year of treatment initiation. Thromboembolic events include, but are not limited to, deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis\n* History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* History of any major surgery within 14 days prior to enrollment\n* Receipt of ongoing anti-coagulation for treatment or prophylaxis of thromboembolic event in the setting of prior thromboembolic event\n* History of interstitial lung disease\n* Subjects with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* Pregnant or lactating females\n* Inability to swallow tablets\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations\n* Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized tumors deemed cured and not treated with systemic therapy\n* Concurrent use of medications (especially those interacting with CYP3A) that potentially interact unsafely with abemaciclib which cannot be discontinued or substituted\n* Recent infection requiring systemic anti-infective treatment that was completed =\\\u003C 14 days prior to enrollment (except for uncomplicated urinary tract infection or upper respiratory tract infection). Any active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening for human immunodeficiency virus (HIV)\u002Fhepatitis is not required for enrollment\n* Concurrent enrollment in any other type of medical research (for example: medical device) judged by the investigator not to be scientifically or medically compatible with this study",{"count":430,"type":21},18,[103],"This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.",[434,435,436],"Retroperitoneal Sarcoma","Liposarcoma","Dedifferentiated Liposarcoma",{"date":406,"type":34},{"date":439,"type":34},"2025-03-19",{"date":441,"type":21},"2029-03-03",{"name":40,"class":41},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":455,"conditions":456,"keywords":462,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":42},"100625608","phase-2-xylitol-and-the-prevention-of-periodontal-disease-and-preterm-birth-trial-100625608","NCT07424846","Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial","Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial","XaPPP","Inclusion Criteria:\n\n* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian\n* Less than 20 weeks' gestation (by best obstetric estimate)\n* At least 20 natural teeth\n* Planning to deliver at one of the health facilities within the XaPPP trial\n* Receiving antenatal obstetric care at one of the 8 health districts\n* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy\n* Willing to attend all study visits\n* Willing to provide biospecimens (oral, vaginal, placental, breast milk)\n* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \\\u003C20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth\n* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)\n* Speaks Chichewa or English\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy\n* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)\n* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy\n* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)\n* Known allergy to xylitol",{"count":452,"type":21},6000,[24,454],"PHASE3","The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.\n\nWhile PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams\u002Fday more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.\n\nThe investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \\\u003C20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams\u002Fday), (b) the PPaX trial xylitol dose (2.1 grams\u002Fday), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.",[457,458,459,460,461],"Preterm Birth","Low Birthweight Neonate","Periodontitis","Gingivitis","Developmental Delay",[463,464,465,466,467,468,469],"xylitol","preterm birth","prematurity","pregnancy","periodontitis","periodontal disease","chewing gum","2026-06-05",{"date":404,"type":34},{"date":473,"type":34},"2026-03-26",{"date":475,"type":21},"2030-09-30",{"name":40,"class":41},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":42},"100617724","phase-2-sx-682-and-atezolizumab-for-the-treatment-of-advanced-or-metastatic-recurrent-non-small-cell-lung-cancer-100617724","NCT07322341","SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer","A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy","Inclusion Criteria:\n\n* Age 18 years and older\n* Ability to understand and willingness to sign a written informed consent document\n* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK fusion, ROS1 fusion or RET fusions.\n\n  * For participants with NSCLC harboring an oncogenic alteration other than the above must have received prior targeted therapy (e.g. small molecule inhibitor therapy or antibody drug conjugates). A wash-out of at least 5 half-lives is required prior to start of study treatment\n* Metastatic or recurrent NSCLC. Stage 3C per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment\n* Participants must have received and progressed on at least 6 weeks of treatment with prior anti-PD-1 or anti-PD-L1 therapy for advanced disease. Also, participants must have received prior platinum doublet chemotherapy. Anti-PD1\u002FPD-L1 therapy may have been received concurrently with chemotherapy or as sequential therapy (e.g. anti-PD1 followed by chemotherapy).\n\n  * For participants who received neoadjuvant, adjuvant and\u002For consolidation anti-PD-1 or anti-PD-L1 therapy for stage 1 - 3 NSCLC: If they experienced disease progression ≤ 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy, this counts as the allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease.\n  * For participants who experienced disease progression more than 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy for advanced disease, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These patients must have received anti-PD-1 or anti-PD-L1 therapy for stage 4 or recurrent disease\n* Participants must have a minimum of 28 days after the last dose, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy prior to initiation of study treatment, including investigational agents\n* Participants must have at least one site of measurable disease as determined by the investigator, using RECIST v 1.1 criteria documented within 28 days prior to study treatment initiation\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at the time of informed consent and at the time of treatment initiation\n* Participants must be willing to provide pre-treatment archived specimen (taken within a year of trial entry) or undergo a biopsy procedure if archived specimen is not available.\n\n  * If biopsy is not deemed safe, it may be waived after discussion with principal investigator (PI)\n* Participants must be willing to provide an on-treatment biopsy, to be obtained at 6 - 9 weeks, if deemed safe by the treating physician\n* Platelet count \\> 100,000\u002FμL\n* Absolute neutrophil count \\> 1,500\u002FμL\n* Hemoglobin \\> 9.0 g\u002FdL. Participants may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) \\\u003C 2.5 times upper limit of normal\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease: serum bilirubin ≥ 3 x ULN\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Participants of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal methods must be supplemented by barrier method) prior to treatment initiation, during treatment, and for 5 months after the last dose of atezolizumab\n* Negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to initiation of study treatment for participants of childbearing potential. Pregnant or breast-feeding women or intention of becoming pregnant during study treatment or within 5 months of last dose of atezolizumab are not eligible\n\nExclusion Criteria:\n\n* Presence of other active cancers within the last 2 years. Participants with another cancer who have received definitive therapy at least 2 years previously and no evidence of recurrence are eligible. All participants with previously treated in situ carcinoma are eligible, as are participants with history of non-melanoma skin cancer\n* Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no ongoing requirement for steroids within 7 days prior to start of study treatment, no history of intracranial hemorrhage or spinal cord hemorrhage. If the patient is receiving anti-convulsant therapy, the dose is considered stable\n\n  * Participants with untreated CNS metastases may be enrolled as long as they meet the above criteria. Participants with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment\n* Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment\n* Participants must not have an active autoimmune disease that has required immune modulating treatment within 1 year prior to consenting (i.e., disease modifying agents, long term corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed. Short-term steroid therapy (≤ 2 weeks) is allowed\n* Inability to discontinue corticosteroid therapy; steroids must be tapered off 7 days prior to first dose of SX-682. Limited steroid use for allergic reactions is acceptable\n* Known history of primary immunodeficiency\n* History of organ transplant or prior allogenic stem cell transplantation that requires use of immunosuppressives\n* Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history\n* Prior history of grade 3 or higher immune checkpoint inhibitor (ICI)-induced immune-related adverse event (AE) (immune related adverse event \\[irAE\\]) except endocrine irAEs that are resolved or managed with replacement therapy\n* Radiotherapy within 7 days of start of study treatment\n* Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment.\n\n  * Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed\n* Electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) interval \\> 480 msec or patients with congenital long QT syndrome\n* Severe lung disease (e.g. chronic obstructive pulmonary disease \\[COPD\\]) who cannot stop steroids 7 days prior to start of study treatment\n* Serious cerebrovascular and cardiac disease defined as:\n\n  * Active unstable angina pectoris\n  * Congestive heart failure New York Heart Association (NYHA) \\> grade 3\n  * Acute myocardial infarction within 3 months of consenting\n  * Stroke or transient ischemic attack within 3 months of consenting\n* Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility per investigator judgment. Active infection requiring IV antibiotics within 7 days of study treatment initiation.\n\n  * Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay per investigator judgment.\n  * Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B surface antigen (HBsAg) per local assay per investigator judgment\n* Known uncontrolled HIV (human immunodeficiency virus) infection\n\n  * Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count \\> 350 cells\u002FµL within 6 months prior to study treatment initiation and no history of AIDS- defining opportunistic infection\n* Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* History of leptomeningeal disease\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the atezolizumab formulation",{"count":485,"type":21},32,[24],"This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. 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 SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.",[489,360,380,490,362],"Advanced Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","2026-06-04",{"date":416,"type":34},{"date":494,"type":21},"2026-09-01",{"date":496,"type":21},"2031-11-01",{"name":40,"class":41},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":514,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":42},"100618494","phase-2-neoadjuvant-intravesical-nadofaragene-firadenovec-with-gemcitabine-cisplatin-and-durvalumab-for-the-treatment-of-muscle-invasive-bladder-cancer-trifecta-trial-100618494","NCT07332351","Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial","Intravesical Nadofaragene Firadenovec With Neoadjuvant Chemotherapy and Durvalumab in Patients With Muscle Invasive Bladder Cancer (TRIFECTA)","TRIFECTA","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening\n* Ability to understand and willingness to sign the written informed consent document\n* Patients with confirmed muscle-invasive urothelial carcinoma of the bladder (cT2-4a, N0-1, M0 or cT1, N1, M0), who are planning to undergo RC\n* Pure urothelial or mixed histologic subtypes are allowed if urothelial is the primary histology (regardless of the % of conventional urothelial histology)\n* Eligible to receive neoadjuvant cisplatin\u002Fgemcitabine and durvalumab per the patient's medical oncologist's discretion\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Hemoglobin count ≥ 9 gm\u002FdL\n* Absolute neutrophil count of ≥ 1500 cells\u002FuL\n* Platelet count of ≥ 100,000\u002FuL\n* Alanine and aspartate aminotransferase levels ≤ 2.5 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN for Gilbert syndrome)\n* Creatinine clearance or estimated glomerular filtration rate (GFR) ≥ 40ml\u002Fmin (using Chronic Kidney Disease Epidemiology Collaboration Formula \\[CKD-EPI\\] 2021 equation)\n* For patients with evidence of, or history of HIV, chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the viral load must be undetectable, or the infection must have been treated and cured. Patients are not allowed to be on immunosuppressive agents for HIV, HBV or HCV. Routine testing for HIV, HBV and HCV is not required for patients without such history unless clinically indicated\n* Individuals with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are allowed to enroll\n\nExclusion Criteria:\n\n* cT4b, N2-3, or M1 stage at time of screening\n* Any known concurrent clinically relevant malignancies\n* Prior systemic therapy for muscle-invasive bladder carcinoma (MIBC) (prior intravenous pembrolizumab for non-muscle invasive bladder carcinoma \\[NMIBC\\] is allowed)\n* Current or prior use of systemic immunosuppressive medication within 14 days before first dose of investigational product. The following are allowed (not systemic route): intranasal, inhaled, intra-articular, topical steroids, local steroid injections\n* Pure non-urothelial histology subtype\u002Fvariant or any neuroendocrine (small or large cell) component\n* Prior treatment with adenovirus-based drugs\n* Known hypersensitivity or allergy to any components of rAd-interferon (IFN)a\u002FSyn3\n* Currently receiving other investigational agent\n* Pregnant or lactating women",{"count":507,"type":21},33,[24],"This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer.\n\nNadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.",[511,512,513],"Muscle Invasive Bladder Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8",[515],"Urinary Bladder",{"date":416,"type":34},{"date":494,"type":21},{"date":519,"type":21},"2027-02-01",{"name":40,"class":41},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":216,"sex":50,"minAge":528,"maxAge":18,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":42},"100508341","gait-adaptation-and-biofeedback-for-cerebral-palsy-100508341","NCT05899153","Gait Adaptation and Biofeedback for Cerebral Palsy","Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait","Inclusion Criteria:\n\n* Diagnosis of bilateral cerebral palsy that impacts both legs\n* Gross Motor Functional Classification System Level II\n* No surgery or lower-extremity injuries 12 months prior to enrollment\n* No botulinum toxin injections in prior 3 months\n* No prior selective dorsal rhizotomy surgery\n* No history of seizures or cardiac conditions that would preclude walking on a treadmill for 20 minutes\n* No current pain that hinders walking","7 Years",{"count":530,"type":21},36,[84],"This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and\u002For provide real-time feedback to evaluate how a child can alter their movement. The feedback will include a wearable exoskeleton that provides resistance to the ankle and audio and visual cues based on sensors that record muscle activity. This research will investigate three goals: first, to measure how children with CP adapt their walking; second, to see if either repeated training or orthopedic surgery can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after treatment. This research will help develop better treatments to enhance walking capacity and performance for children with CP.",[534],"Cerebral Palsy",[536,537],"Gait","Rehabilitation",{"date":416,"type":34},{"date":540,"type":34},"2023-11-28",{"date":542,"type":21},"2029-01-01",{"name":40,"class":41},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":559,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":571,"leadSponsor":573,"locationsCount":42},"100643525","dry-weight-reduction-intervention-via-extra-ultrafiltration-100643525","NCT07637110","Dry Weight Reduction Intervention Via Extra Ultrafiltration","DRIVE-UF","Inclusion Criteria:\n\n* Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:\n\n  1. Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.\n\n     OR\n  2. Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score \\\u003C75.\n\n     Exclusion Criteria:\n* Age \\\u003C18 years\n* Receiving hemodialysis treatments for acute kidney injury\n* Receiving hemodialysis treatments for less than four weeks\n* Planned switch to peritoneal or home dialysis within next three months\n* Current or planned incremental hemodialysis (less than 3 treatments per week)\n* Current or planned intensive hemodialysis (four or more treatments per week)\n* Scheduled kidney transplantation\n* Major cardiovascular or bleeding event within previous 90 days\n* Receiving chemotherapy or radiation treatment for cancer\n* History of cirrhosis with ascites\n* Inability to complete 24-hour ambulatory blood pressure measurement\n* Wheelchair dependance or other inability to complete six-minute walk test\n* Pre-dialysis systolic blood pressure \\\u003C100 mmHg\n* Scheduled use of midodrine with hemodialysis treatments\n* History of non-adherence with dialysis treatments\n* Pregnancy\n* Institutionalized\n* Current or pending enrollment in hospice care\n* Inappropriate for enrollment based on investigator or nephrologist discretion",{"count":552,"type":21},120,[84],"Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.\n\nThis trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.",[556,557,558],"Fluid Accumulation","Blood Pressure Management","End Stage Renal Disease (ESRD)",[560,561,562,563,564,565,566,567],"ESRD","Volume overload","Fluid accumulation","End stage renal disease","Congestion","Chronic dialysis","Blood Pressure (High)","Blood pressure management","2026-06-03",{"date":404,"type":34},{"date":69,"type":21},{"date":572,"type":21},"2030-11",{"name":40,"class":41},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":591,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":610,"locationsCount":42},"100643231","vocale-lbd-online-peer-support-for-caregivers-of-people-with-lewy-body-dementia-100643231","NCT07637097","VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia","Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.","VOCALE LBD","Inclusion Criteria:\n\n* Current family member or informal (unpaid) caregiver of a person with a confirmed diagnosis of Lewy Body Dementia (LBD) or LBD mixed pathology\n* Experiences depressive symptoms as defined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)\n* Able to read, write, and speak English\n* Has access to a device (computer, tablet, or smartphone) that can connect to the internet and be used for videoconferencing or phone calls, OR is interested in using a loaner device\n\nExclusion Criteria:\n\n* Active suicidal ideation as indicated by endorsement of PHQ-9 Item 9 (thoughts that you would be better off dead, or thoughts of hurting yourself)\n* Paid or professional caregiver (must be unpaid family\u002Finformal caregiver)\n* Unable to read, write, or speak English",{"count":583,"type":21},220,[84],"This study tests whether a tailored, fully asynchronous online group intervention (VOCALE LBD) reduces depression in family caregivers of people with Lewy Body Dementia (LBD), compared to standard educational materials. LBD is the second most common form of degenerative dementia and causes distinct challenges, including visual hallucinations, REM sleep disorder, and severe motor symptoms, that are not addressed by generic caregiver interventions. Depression rates in LBD caregivers reach 40-50%, double the rate seen in Alzheimer's disease caregivers, yet no rigorous digital interventions exist specifically for this population. VOCALE LBD is a text-based, low-bandwidth platform (Discourse) that brings groups of 10-15 caregivers together in an 8-week moderated online community. Weekly topics address LBD-specific challenges (sleep problems, hallucinations, self-care) and problem-solving skills using the ADAPT method. A pilot study (n=54) showed strong effects on depressive symptoms (Cohen's d=0.54 at 1-month follow-up), near-perfect engagement, and high participant satisfaction. This RCT (N=220) will test efficacy, examine mechanisms of action (self-efficacy and problem-solving), and explore analytics approaches for pragmatic monitoring, laying groundwork for future implementation in clinics and community organizations.",[587,588,589,590],"Lewy Bodies Disease","Depression Disorder","Caregiver Burden","Caregivers",[592,593,594,595,596,597,598,599,600,601,602,603,604,605],"Lewy body disease","LBD","Family caregivers","Caregiver Depression","Online Intervention","Asynchronous","Digital Health","Peer Support","Problem-solving therapy","VOCALE","Telehealth","Dementia caregiver","ADAPT method","Discourse Platform",{"date":404,"type":34},{"date":132,"type":21},{"date":609,"type":21},"2030-11-30",{"name":40,"class":41},""]