[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Northwell Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":622},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,41,69,90,116,147,168,189,215,236,256,276,295,317,351,371,401,430,454,473,499,524,552,575,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100645154","phase-2-nimble-crc-neoimmunomodulation-before-leveraging-excision-in-colorectal-rectal-cancer-100645154",false,"NCT07677579","NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer","NIMBLE","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A signed informed consent must be obtained prior to conducting any study-specific procedures.\n* Male or female adult 18 to 80 years of age on day of signing informed consent.\n* Histological-confirmed adenocarcinoma of the colon that is amenable to curative intent resection.\n* Only participants with pMMR\u002FMSS CRC are eligible. Microsatellite status should be performed per local standard of practice. (e.g., IHC and\u002For PCR, next-generation sequencing). Subjects with unknown or indeterminate results for either test at the time of enrollment are not eligible.\n* Adequate organ and marrow function as defined below:\n* Absolute neutrophil count: ≥ 1,500\u002Fmcl\n* Platelets: ≥ 100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). This may be up to 3x ULN if Gilbert's syndrome is documented.\n* AST and ALT ≤ 3 x institutional ULN.\n* Serum creatinine ≤ 1.5 x ULN and EGFR ≥ 40\n* ECOG performance status (PS) 0 or 1.\n* Urine protein-to-creatinine ratio ≤ 1mg\u002Fmg creatinine.\n* INR ≤ 1.5 and aPTT ≤ 1.2 x ULN\n* Measurable disease as determined by RECIST v1.1.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (listed in addendum), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n* Through 186 days after the last dose of zanzalintinib or 120 days from retifanlimab (whichever is latest) for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib or retifanlimab (whichever is latest) for men\n* At least T3 disease or with pathologically enlarged local lymph nodes by pre-surgical imaging.\n\nExclusion Criteria:\n\n* Symptoms of clinical obstruction or impending clinical obstruction including severe constipation, nausea and vomiting, or other as deemed by the principal investigator.\n* Tumor invading GI-tract from external viscera\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n* Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment\n* Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy within the last two years.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within 2 years prior to study treatment initiation unless NED for greater than 2 years or deemed to have no possibility of interference with the current study (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n* Receipt of any organ transplantation, including allogeneic stem cell transplantation\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, such as rheumatoid arthritis, which in the opinion of the Investigator might impair the subject's tolerance or ability to participate in the trial\n* Known severe hypersensitivity reactions to monoclonal antibodies or drug formulation components of retifanlimab or Zanalintinib\n* Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final end of treatment visit\n* Congestive heart failure ≥ New York Heart Association (NYHA) class III.\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before start of study drug.\n* Uncontrolled cardiac arrhythmias.\n* Poorly controlled hypertension, defined as a blood pressure consistently above 140\u002F90 mmHg despite optimal medical management.\n* Persistent proteinuria of NCI-CTCAE Grade 3 or higher. Urine dipstick result of 3+ or abnormal, based on type of urine test strip used, is allowed if protein excretion (estimated by urine protein\u002Fcreatinine ratio on a random urine sample) is \\\u003C 3.5 g\u002F24 hr.\n* Non-healing wound, non-healing ulcer, or non-healing bone fracture.\n* Significant acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or NCI CTCAE Grade ≥ 2 diarrhea of any etiology other then secondary to colon cancer.\n* Participants with an active, known or suspected autoimmune disease. -Participants with type I diabetes mellitus (T1DM), hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n* Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n* Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n* Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n* Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 7 days before first dose of study treatment\n* Has received a live vaccine within 28 days before the planned start of study treatment (mRNA vaccines not considered live vaccines).\n\nNote: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed\n\n* Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 180 days after the last dose of retifanlimab.\n* Participants with laboratory values at screening defined in Table 1.\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\n* Concomitant anticoagulation with oral anticoagulants and platelets inhibitors including the following Warfarin, Clopidogrel Acceptable anticoagulants include wow molecular weight heparin, aspirin, rivaroxaban, apixaban, edoxaban\n* Subjects must have discontinued non-accepted anticoagulant within 3 days or 5 half-lives prior to first dose of treatment (whichever is longer)\n* Any medical condition, patient characteristic or past medical history that in the opinion of the principal investigator that would interfere with the patient's safety or compliance while on trial\n* Any prior treatment with zanzalitinib or retifanlimab\n* Stroke or including TIA, MI, or other ischemic event within 6 months before first dose of study treatment\n* Known gastric or esophageal varices\n* Ascites, pleural effusions, or pericardial fluid requiring drainage in the last 4 weeks.\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 tsp (2.5ml) of red blood, or other history of significant bleeding within 12 weeks before first dose of study treatment\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)\n* Lesions invading or encasing any major blood vessels\n* Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness with the exception of subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) CD4+ T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: In order to be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.\n* Requirement for hemodialysis or peritoneal dialysis.\n* Major surgery within 8 weeks, prior laparoscopic nephrectomy within 4 weeks, minor surgery within 5 days. Endoscopy with or without biopsy is not considered minor surgery. Subjects must have complete wound healing before first dose of study treatment.\n* Inability to swallow tablets or ingest a suspension either orally or by a NG or PEG tube.\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* Free T4 outside of the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after principal investigator approval.","ALL","18 Years","80 Years",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase II, single-arm, open-label trial evaluating the feasibility, safety, and preliminary activity of neoadjuvant Zanzalintinib (a VEGFR-targeting TKI) and Retifanlimab (an anti-PD-1 antibody) in patients with resectable stage II-III mismatch repair-proficient (pMMR) colon cancer. The study's primary objective is to determine the proportion of patients able to undergo curative-intent surgery within 14-35 days after completing two cycles (6 weeks) of neoadjuvant therapy. Secondary objectives include assessment of safety\u002Ftolerability and rates of pathologic response, including tumor regression grade (TRG). Two-year relapse-free survival (RFS) will also be evaluated.\n\nThis trial builds on emerging evidence from neoadjuvant immunotherapy studies-including in pMMR tumors-and the recently positive readout of STELLAR-303, which evaluated Zanzalintinib plus a PD-(L)1 inhibitor in refractory metastatic colorectal cancer. With a favorable safety profile, short treatment window, and rapid post-treatment pathologic readout, this study provides a low-risk opportunity to test whether immunotherapy-based neoadjuvant strategies can improve outcomes and potentially redefine management in early-stage, pMMR colon cancer.",[28],"Colon Cancer Metastatic","NOT_YET_RECRUITING","2026-06-24",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2026-08-30",{"date":37,"type":22},"2028-12-30",{"name":39,"class":40},"Northwell Health","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100644940","phase-1-phase-i-ii-ptcy-bortezomib-and-sitagliptin-for-prevention-of-gvhd-following-allogeneic-hsct-100644940","NCT07675174","Phase I-II PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT","A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-versus-Host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n1. Patients with any of the following hematologic malignancies:\n\n   1. AML in first remission (CR1) if they have intermediate- or high-risk cytogenetic and\u002For molecular features, or patients in second or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \\\u003C5% blasts in the bone marrow with no morphological evidence of leukemia. Patients in CR with incomplete count recovery may be included.\n   2. ALL with any of the following in CR1 or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \\\u003C5% blasts in the bone marrow with no morphological evidence of leukemia. Patients in CR with incomplete count recovery may be included.\n   3. MDS with a revised International Prognostic System Score (IPSS-R) of greater than 3 at diagnosis. Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\*\n   4. Therapy-related myelodysplastic disorder (t-MDS). Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\*\n   5. CMML type 1 or 2. Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\* \\*Patients with MDS, t-MDS, and CMML will be included only in the phase I portion of the study.\n2. Patient age ≥ 18 years\n3. KPS ≥70%\n4. Patients must also be suitable to receive an RIC regimen at the discretion of the treating physician. While there are not universally accepted or validated cut-off criteria of age, performance status, or HCT-CI for suitability for RIC, RIC transplants should be considered for patients 60 years and older and for patients \\\u003C60 years who are \"less fit\" (e.g., KPS \\\u003C90% and\u002For HCT-CI ≥3 due to lower non-relapse mortality associated with RIC).\n5. Patients receiving allogeneic PBSC grafts from HLA-matched (5\u002F6 and 6\u002F6 matches) siblings or matched unrelated donors (7\u002F8 or 8\u002F8 matches at HLA-A, B, C, DRB1 by high resolution typing) are included. All grafts will be unmanipulated (i.e., no T cell depleted or CD34 selected grafts). In addition, donors should meet institutional criteria for donation of PBSC, as well as the screening and eligibility criteria of the (NMDP) for unrelated donors, and the requirements of the United States Food and Drug Administration for HCT\u002FP (21 CFR Part 1271).\n6. Required baseline laboratory values within 16 days prior to admission:\n\n   1. Estimated creatinine clearance \\>60 mL\u002Fmin\u002F1.72 m2\n   2. Serum total bilirubin ≤2 x upper limit of normal value (except for Gilbert's disease)\n   3. AST and ALT ≤3 x upper limit of normal value\n   4. ALP ≤250 IU\u002Fl\n7. Required baseline values within 60 days prior to admission:\n\n   1. LVEF \\>40%\n   2. Adjusted carbon monoxide diffusing capacity (DLCO) \\>50%\n8. No evidence of HIV infection (patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies)\n9. Non-pregnant and non-nursing\n10. Signed written informed consent (patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)\n11. Patients must otherwise fulfill institutional criteria for eligibility to undergo reduced-intensity allogeneic stem cell transplantation\n\nExclusion Criteria:\n\n1. Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice effective methods of contraception from start of conditioning through a minimum of 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 consecutive months.\n2. Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post- vasectomy).\n3. Inability to provide informed consent.\n4. Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.\n5. Patients with active central nervous system leukemia\n6. Prior allogeneic HSCT or an autologous HSCT in past 12 months\n7. Patients with diabetes mellitus requiring insulin secretagogues and\u002For insulin at time of enrollment\n8. Patients with a history of pancreatitis\n9. Patients with symptomatic cholelithiasis\n10. Known hypersensitivity to any of the components of the investigational treatment regimen\n11. Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n12. Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy\n13. Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial, and throughout the duration of this trial\n14. Prisoners",{"count":49,"type":22},72,[51,25],"PHASE1","Phase I-II studying post transplant cyclophosphamide, bortezomib and sitagliptin for GvHD prevention in allogeneic HSCT. Adults with hematologic malignancies undergoing an RIC allogeneic PBSC transplant from a 5\u002F6 or 6\u002F6 sibling or 7\u002F8 or 8\u002F8 matched unrelated donor.",[54],"GVHD - Graft-Versus-Host Disease",[56,57,58,59,60],"GvHD","Allogeneic Transplant","Post transplant cyclophosphamide","Sitagliptin","Bortezomib","2026-06-23",{"date":63,"type":33},"2026-06-30",{"date":32,"type":22},{"date":66,"type":22},"2032-07-01",{"name":39,"class":40},1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100607846","early-phase-1-pilot-study-of-an-implantable-microdevice-for-in-situ-evaluation-of-drug-response-in-patients-with-colorectal-liver-metastasis-100607846","NCT07193862","Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis","Inclusion Criteria:\n\n* Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age\n\nNormal organ and marrow function, defined as follows:\n\n* Leukocytes ≥3,000\u002FmcL\n* Absolute neutrophil count ≥1500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* PT≤ 14, PTT≤ 38, INR ≤ 1.\n* Creatinine within normal institutional limits OR clearance ≥60mL\u002Fmin\u002F1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures\n\nMales and females of childbearing potential must agree to use effective contraception starting before the first day of treatment and continuing for at least 3 months (men) or 6 months (women) after implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents of the study, mothers must agree to discontinue breastfeeding for a total of 14 days after the insertion of the microdevice.\n\nExclusion Criteria:\n\nTumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications involved.\n\nPrior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the CLM Extra-hepatic disease or unresectable liver metastasis on baseline imaging",{"count":76,"type":22},10,[78],"EARLY_PHASE1","Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +\u002F- immune-modulating drugs has an impact on the surrounding tissue.",[81],"Colorectal Cancer Metastatic","RECRUITING",{"date":30,"type":33},{"date":85,"type":33},"2025-12-10",{"date":87,"type":22},"2028-04-15",{"name":39,"class":40},2,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100590618","phase-4-biomarkers-to-enhance-early-schizophrenia-treatment-100590618","NCT06969755","Biomarkers to Enhance Early Schizophrenia Treatment","BEEST","Inclusion Criteria:\n\n1. Aged 18 to 35.\n2. DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder.\n3. Current positive symptoms rated ≥4 (moderate) on one or more of the following BPRS positive subscale items: unusual thought content, conceptual disorganization, hallucinatory behavior, suspiciousness.\n4. Preserved striatal connectivity, as determined by screening MRI scan\n5. Absence of the MC4R high-risk genotype, as determined by genetic testing\n6. Absence of the HLA-DQB1 high-risk genotype, as determined by genetic testing\n7. In an early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 4 weeks or less (with exceptions of very low doses for other off-label indications, e.g. sleep)\n8. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. The patient reports or medical records state a serious neurological or endocrine disorder at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements\n2. An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements\n3. Any medical condition which requires treatment with a medication with psychotropic effects.\n4. Significant risk of suicidal or homicidal behavior (i.e. 'severe' risk on the Columbia Suicide Scale, a 'hostility' score of 7 on the BPRS, or an answer of 'yes' on questions 4,5 or 6 on the CDSS).\n5. Cognitive limitations, or any other factor that would preclude potential participants providing informed consent\n6. Contraindications to MRI (e.g. pacemaker).\n7. Meeting SCID-5 substance use disorder moderate or severe for any substance, other than nicotine within 3 months of screening visit. Meeting SCID5 substance use disorder mild for any substance other than cannabis, alcohol, or nicotine for less than 3 months prior to screening visit, or a positive urine baseline drug screen with a substance other than nicotine, alcohol, or cannabis\n8. Suspected DSM5 intellectual disability based upon clinical interview and psychosocial history, as well as screening with the Weschler Test for Adult Reading (IQ score \\\u003C71)\n9. Prior psychosurgery\n10. Pregnancy (self-report)\n11. Seizure disorder (self-report)\n\n    \\-","35 Years",{"count":99,"type":22},180,[101],"PHASE4","This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.",[104],"Schizophenia Disorder",[106],"Schizophrenia","2026-06-11",{"date":109,"type":33},"2026-06-12",{"date":111,"type":33},"2025-09-30",{"date":113,"type":22},"2030-07-30",{"name":39,"class":40},5,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100482428","enteral-anastomosis-for-the-treatment-of-gastric-outlet-obstruction-a-randomized-controlled-study-comparing-endoscopic-versus-surgical-gastrojejunostomy-100482428","NCT05561907","Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy","EAT-GO","Inclusion Criteria:\n\n1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer\n2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):\n\n   1. post prandial vomiting,\n   2. abdominal pain,\n   3. inability to tolerate PO,\n   4. imaging consistent with GOO\n3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)\n4. Age \\>18 years old\n5. Life expectancy greater than 2 months or failed duodenal stenting\n6. Surgical Candidate\u002FTolerate General Anesthesia\n7. Unresectable or metastatic disease\n\nExclusion Criteria:\n\n1. Age\\\u003C 18 years old\n2. Pregnancy\n3. Intestinal obstruction distal to the Ligament of Treitz\n4. Evidence of other luminal strictures of the GI tract\n5. Previous gastric or periampullary surgery\n6. Inability to complete quality of life surveys (QOLS)\n7. Presence of abdominal ascites",{"count":124,"type":22},32,[126],"NA","Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment",[129],"Gastric Outlet Obstruction",[131,132,133,134,135,136,137,138],"Gastric outlet obstruction","GOO","Periampullary malignancy","Periampullary cancer","Surgical gastrojejunostomy","Endoscopic gastrojejunostomy","Gastrojejunostomy","Enteral anastamosis",{"date":140,"type":33},"2026-06-15",{"date":142,"type":33},"2022-10-28",{"date":144,"type":22},"2027-06",{"name":39,"class":40},4,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":68},"100449578","examining-the-use-of-three-dimensional-ultrasound-in-the-assessment-of-vascular-pathologies-100449578","NCT05134311","Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies","3D-US","Inclusion Criteria:\n\n* Age 18 years of age or older\n* Suspected vascular insufficiency that requires ultrasound evaluation\n* Subject is able to sign a consent form\n* Scheduled ultrasound testing at the wound center to evaluate vasculature\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Subject is not scheduled to have ultrasound testing at the wound center\n* Subject is unable to or refuses to consent to participate",{"count":155,"type":22},270,[126],"The ability to have a visual aid to depict areas of vascular disease that are affecting the patient's health can help in patient comprehension of the problem. This comprehension can lead to better understanding of the issue and increase patient compliance to treatment. The hand drawn sketch produced by the ultrasound technologist provides an inadequate visualization of the vascular insufficiency that is causing the patient's symptoms.\n\nPIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging. This system will provide a low cost and reproducible imaging solution that will be an effective educational tool for people with vascular disease.",[159,160,161],"PAD - Peripheral Arterial Disease","Vascular Diseases","Wounds",{"date":140,"type":33},{"date":164,"type":33},"2025-07-01",{"date":166,"type":22},"2028-09-01",{"name":39,"class":40},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":175,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":89},"100446229","a-pilot-study-to-evaluate-purewick-for-nocturia-100446229","NCT05090722","A Pilot Study to Evaluate PureWick for Nocturia","Inclusion Criteria:\n\n* Women aged 50 years or older.\n* Experiences 2 or more voids per night as assessed on a 3-day bladder diary.\n\nExclusion Criteria:\n\n* Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.).\n* Neurological impairment or psychiatric disorder preventing proper understanding of consent.\n* Unable to operate the PureWick system.\n* Unable to complete required questionnaires and diaries.\n* Investigator deems subject as unsuitable for enrollment.",true,"FEMALE","50 Years",{"count":178,"type":22},40,[126],"This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.",[182],"Nocturia",{"date":140,"type":33},{"date":185,"type":33},"2021-12-16",{"date":187,"type":22},"2027-10",{"name":39,"class":40},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":68},"100327492","phase-4-trial-of-belimumab-in-early-lupus-100327492","NCT03543839","Trial of Belimumab in Early Lupus","Pilot Trial of Belimumab in Early Lupus","Inclusion Criteria:\n\n* Diagnosis of SLE per current ACR classification criteria\n* Date of SLE diagnosis within 2 years of screening\n* ANA positive (with a titer ≥ 80)\n* anti-ds DNA antibody positive\n* Mild to moderate disease activity define by a SLEDAI-2K ≥4\n* Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg\u002Fday.\n* If on methotrexate, dose must be stable for 4 weeks\n* Concomitant treatment with hydroxychloroquine unless documented inability to tolerate\n* Able and willing to give written informed consent and comply with the requirements of the study protocol\n* Negative serum pregnancy test (for women of child bearing potential)\n* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment\n\nExclusion Criteria:\n\n* Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.\n* Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.\n* Active renal or nervous system disease or disease activity fulfilling BILAG A criteria\n* Use of high dose steroids (\\>0.5 mg\u002Fkg\u002F day) within the 4 weeks prior to screening\n* Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study\n* Hemoglobin: \\\u003C 8.0 gm\u002FdL\n* Platelets: \\\u003C 50,000\u002Fmm\n* ANC \\\u003C 1.0 x 103\u002Fmm\n* AST or ALT \\>2.5 x Upper Limit of Normal unless related to primary disease.\n* Creatinine clearance ≤ 25ml\u002Fmin per 1.73 m2\n* Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)\n* History of positive HIV (HIV conducted during screening if applicable)\n* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)\n* Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab\n* Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies\n* Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)\n* Hospitalization for treatment of infection within 60 days of Day 0.\n* Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0\n* History of serious recurrent or chronic infection\n* Lack of peripheral venous access\n* History of drug, alcohol, or chemical abuse within 365 days prior to Day 0\n* Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative \\\u003C 7 days prior to first dose and monthly)\n* Lactation\n* History of psychiatric disorder that would interfere with normal participation in this protocol\n* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk\n* History of a primary immunodeficiency\n* Have a significant IgG deficiency (IgG level \\\u003C 400 mg\u002FdL)\n* Have an IgA deficiency (IgA level \\\u003C 10 mg\u002FdL)\n* Have any other clinically significant abnormal laboratory value in the opinion of the investigator\n* Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months\n* Inability to comply with study and follow-up procedures",{"count":197,"type":22},30,[101],"This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.",[201,202],"Lupus Erythematosus, Systemic","Lupus Erythematosus",[204,205,206,207],"lupus","early lupus","belimumab","autoreactivity","2026-06-10",{"date":109,"type":33},{"date":211,"type":33},"2020-09-15",{"date":213,"type":22},"2029-03",{"name":39,"class":40},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":68},"100642910","exclusion-of-left-atrial-appendage-thrombus-in-emergency-department-patients-with-atrial-fibrillation-undergoing-ct-to-assess-for-pulmonary-embolus-a-feasibility-study-100642910","NCT07647939","Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study","ELATE-AF","Inclusion Criteria:\n\n* Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.\n* Room air oxygen saturation above 92%\n* Systolic blood pressure above 100 mm Hg\n* Respiratory rate less than 24 breaths\u002Fmin\n\nExclusion Criteria:\n\n* Inability to personally give informed consent\n* Pregnant or breastfeeding individuals\n* Stroke like symptoms\n* ECG criteria for ischemia or infarction\n* Heart rate \\\u003C40 or \\> 120 bpm (inclusive) or 3rd degree heart block\n* Unable to lie flat for at least 10 minutes\n* Unable to follow simple commands\n* Northwell Health Employees.\n* Non-English-speaking patients",{"count":223,"type":22},60,[126],"This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an \"ungated\" CT scan and the other half a \"gated\" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.",[227,228,229],"Atrial Fibrillation (AF)","Pulmonary Embolism (PE)","Left Atrial Appendage Thrombosis","2026-06-09",{"date":140,"type":33},{"date":233,"type":22},"2026-07",{"date":144,"type":22},{"name":39,"class":40},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":244,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100643452","single-chamber-atrial-leadless-pacing-for-isolated-sinus-node-dysfunction-100643452","NCT07638995","Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction","Inclusion Criteria:\n\n1. Symptomatic sinus bradycardia\n2. Sino-atrial exit block\n3. Symptomatic sinus arrest with sinus pauses \\> 2 sec during waking hours\n4. Symptomatic sinus bradycardia \\\u003C 40 bpm for \\> 1 min during waking hours\n5. PR interval ≤ 0.22 sec if aged \\\u003C 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years\n6. QRS width ≤ 0.12 sec\n7. No prior PM implantation\n8. Patients willing to receive an Assert-IQ loop recorder for research purposes\n\nExclusion Criteria:\n\n1. Atrioventricular block\n2. Bundle branch block\n3. History of atrial fibrillation\n4. Carotid sinus hypersensitivity\n5. Planned cardiac surgery\n6. Estimated life expectancy \\\u003C 1 year\n7. Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator\n8. Known acute deep vein thrombosis of either lower extremity\n9. Unable to read or write\n10. Patient with Limited English Proficiency (LEP)\n11. Cognitively impaired individuals\n12. Pregnant",{"count":243,"type":22},50,"OBSERVATIONAL","The study aims to evaluate the following: 1) the incidence of new onset atrial fibrillation in patients with an atrial leadless pacemaker, 2) the need for upgrade from a standalone atrial leadless pacemaker to a dual chamber leadless pacemaker system, and 3) to compare the battery longevity of the Aveir AR at two years with the battery longevity of subjects implanted with dual chamber leadless pacemakers in the Aveir DR i2i study.",[247],"Atrial Fibrillation","2026-06-05",{"date":208,"type":33},{"date":251,"type":33},"2026-05-18",{"date":253,"type":22},"2029-12-31",{"name":39,"class":40},6,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":174,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":68},"100522805","convivo-endomicroscopy-100522805","NCT06087393","CONVIVO Endomicroscopy","A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.","Inclusion Criteria:\n\n* . The patient is suffering from an intracranial lesion requiring surgery:\n* Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors.\n* Patients undergoing neurosurgical resection for other brain tumors,.\n* All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use\n\nExclusion Criteria:\n\n* History of hypersensitivity to fluorescein\n* History of allergy or bronchial asthma\n* Renal failure - Children (patients less than 18 years of age)\n* Pregnant women\n* Breast feeding women\n* Patients with inability to give informed consent",{"count":197,"type":22},[126],"Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image (\"optical biopsy\") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.",[267],"Brain Tumor","2026-06-03",{"date":270,"type":33},"2026-06-04",{"date":272,"type":33},"2024-01-08",{"date":274,"type":22},"2026-10-12",{"name":39,"class":40},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":68},"100612444","phase-1-pressurized-intraperitoneal-aerosolized-chemotherapy-pipac-in-patients-with-peritoneal-metastasis-from-pancreatic-adenocarcinoma-100612444","NCT07253662","Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma","Phase I Trial of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Ability to understand and sign informed consent form\n* Age ≥18 years\n* Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis on cross sectional imaging\n* ECOG performance status ≤ 2\n* Pre-treatment Laboratory Parameters:\n* Absolute neutrophil count (ANC) \\> 1500\u002Fmm3\n* Platelets \\> 100,000\u002Fmm3\n* Hemoglobin \\> 9 g\u002Fdl\n* Serum total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 x ULN, unless patient is known to have chronic liver disease (hepatitis) in which case AST and ALT must be ≤ 5 x ULN.\n* Creatinine clearance (Ccr) \\> 40 ml\u002Fmin\n\n  * No contraindications for a laparoscopy.\n* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to visible on cross sectional imaging or diagnostic laparoscopy.\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the PIPAC or last dose of chemotherapy in such a manner that the risk of pregnancy is minimized .-WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:\n\nAmenorrhea ≥ 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered of childbearing potential.\n\nInclusion to proceed with PIPAC :\n\nLaparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:\n\n* PIPAC access is feasible\n* There is room for aerosol therapy\n* There is no evidence of impending bowel obstruction\n* \\\u003C 5 L of ascites\n* Not a candidate for cytoreduction and HIPEC\n\nExclusion Criteria:\n\n* Confirmed or suspected extra-peritoneal metastasis\n* Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.\n* Life expectancy of less than 4 months.\n* Prior intra-abdominal aerosol chemotherapy\n* Previous anaphylactic reaction to the nab-paclitaxel drug used.\n* Intra-abdominal Ascites \\>5L\n* Patients may not be receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment.\n* Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.\n* New York Heart Association (NYHA) Class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months.\n* Exclusive total parenteral nutrition.\n* Pregnancy. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":76,"type":22},[51],"Palliative systemic therapy is the standard treatment option for patients with pancreatic ductal adenocarcinoma (PDAC) and peritoneal metastasis (PM), who have a median overall survival of only 6-11 months and a serious adverse event (SAE) rate of \\>5%. Patients with peritoneal-only metastasis may demonstrate unique tumor biology with less potential for hematogenous and lymphatic spread, making them potential candidates for a regional approach directed at the peritoneum. PIPAC is a drug- delivery system that combines the pharmacokinetic advantages of low- dose intraperitoneal chemotherapy (high tumor tissue penetration with low systemic absorption\u002Ftoxicity) with the principles of aerosolization (homogenous intraperitoneal distribution and deeper tissue penetration). PIPAC may offer a complimentary approach to maximize drug delivery to tumor implants, potentially improving quality of life and survival without significant additional morbidity. Several non-randomized studies have evaluated safety, feasibility, and efficacy of PIPAC with various intraperitoneal agents in a variety of tumor types. Very few patients with pancreatic cancer PM have been included in these studies and most have been treated with either PIPAC-oxaliplatin or doxorubicin\u002Fcisplatin. A recent phase 1 dose-escalation study included patients with ovarian, gastric, breast, and hepatopancreatobiliary malignancies. One patient with\n\npancreatic cancer was included in this study. The recommended phase 2 dose was 140 mg\u002Fm2, with guidance to decrease the dose to 112.5 mg\u002Fm2 in patients with hepatic impairment. Therefore, the dose utilized in this study is 112.5 mg\u002Fm2. This recommendation was based on concern for nab-paclitaxel hepatotoxicity, but there was no data presented to support this expert recommendation.\n\nThis study sets out to explore the role of PIPAC with nab-paclitaxel in combination with medical oncology choice standard of care therapy in this patient population.",[287],"Adenocarcinoma Pancreas","2026-06-02",{"date":268,"type":33},{"date":291,"type":33},"2026-01-11",{"date":293,"type":22},"2027-12-30",{"name":39,"class":40},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":68},"100523478","phase-1-dbs-for-depression-100523478","NCT06096207","DBS for Depression","Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression","Inclusion Criteria:\n\n1. Major Depression Disorder (MDD) or Bipolar Disorder (I \u002FII) diagnosed by Structured Clinical Interview for DSM-V (SCID I\u002FDSM-V)\n2. Age 18 - 65 years.\n3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and\u002For Montgomery-Asburg Depression Rating Scale (MADRS) score of at least 21.\n4. World Health Organization Disability Assessment Scale 2.0(WHODAS2.0) score of 19 or more\n5. A recurrent (equal or \\>4 episodes) or chronic (episode duration equal or higher \\>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior) over lifetime history as determined by an investigator\n6. As determined by the study psychiatrist\u002Finvestigator, has treatment resistant depression defined as failure to respond to: 6.1. Adequate trials (equal or \\>6 weeks at an adequate dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials (equal\\>4 weeks at an adequate dose) of augmentation\u002Fcombination of a primary antidepressant using at least 2 different augmenting\u002Fcombination agents (lithium, T3, stimulants,neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\\>20 sessions with an experienced psychotherapist).\n7. Able to comply with the operational and administrative requirements of participation in the study.\n8. Able to give written informed consent\n9. Major Depressive Disorder (MDD) or Bipolar Disorder (I\u002FII) is the primary psychiatric diagnosis in the medical opinion of an investigator.\n10. On a stable psychiatric medication regimen beginning at least 6 weeks prior to enrollment and continuing through the first 6 months of the study, as determined by the investigator. Psychiatric medication changes can be made during the entirety of the subject's study participation but would be limited to the clinical judgment of the PI\u002Fstudy psychiatrist.\n11. At enrollment, provides the following information from at least two (2) verifiable contacts who reside within a 10-mile radius of the patient: name, relationship to patient, address (email mail); and telephone (mobile, home, work as applicable).\n12. Agrees to allow medical records requests and communications of any type to any and all health care providers who have seen the patient within five years of screening or enrollment.\n13. For the duration of study participation, agrees to be followed by a licensed psychiatrist and\u002For other licensed mental health practitioner on a regularly scheduled basis.\n14. FOR AGES 18-21: An average of at least 3 in the following subdomains on the Psychological Maturity Scale (PMS): questions 1-6, \"Ego Resilience\"; questions 7-13, \"Self-Awareness\"; questions 14-17, \"Autonomy\"; questions 18-21, Flexibility\".\n15. FOR AGES 18-21: Residing with a caretaker or having oversight of a caretaker.\n\nExclusion Criteria\n\n1. Patients with any lifetime history of psychosis or psychotic disorder, according to DSM-V diagnostic criteria, or in the medical opinion of the PI\u002Fstudy psychiatrist.\n2. Any finding on the preoperative magnetic resonance imaging (MRI) scan that, in the opinion of the principal investigator and after consultation with the neuroradiologist, is, or might be, considered clinically significant such that participation in the study: (a) seems likely to increase the medical risk to the subject sufficient to outweigh the potential benefit to study participation; (b) seems likely to jeopardize the subject's ability to complete the study or fulfill all study requirements per protocol; or (c) may impact he integrity of the data or the validity of the results.\n3. Any previous surgery to destroy the treatment target (superolateral MFB) rendering it either unilaterally or bilaterally damaged such that it cannot be effectively stimulated, as visualized by pre-operative MRI scans, in the medical opinion of the PI\n4. Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and\u002Forinability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantablestimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. DBS contraindications include patients who are unable to properly operate the neurostimulator, and patientswho will be exposed to MRI or diathermy. MRI and diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) are contraindicated because the energy can be transferred through the implanted System (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.\n5. Refusal of an adequate trial of ECT in the medical opinion of the study psychiatrist or PI following consultation with a study psychiatrist.\n6. History of stimulation intolerance in any area of the body.\n7. Within six (6) months of the enrollment date, has been diagnosed with, or has met the diagnostic criteria for, a substance abuse disorder (SUD) according to DSM-V criteria.\n8. Women of childbearing potential who, at enrollment or during the study: (a)have a positive urine pregnancy test; (b) are heterosexually active without the usage of a medically acceptable, highly effect contraceptive method\\* (≤1% pregnancy rate); or (c) are planning to become pregnant during the 60-month course of this study, as determined by the PI. \\*Examples include tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), and long-acting reversible contraceptives (LARC).\n9. Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists.\n10. Participation in another drug, device, or biologics trial within the preceding 30 days\n11. Presence of a condition requiring routine MRIs.\n12. Presence of a condition requiring diathermy.\n13. Subject is on anticoagulant medication.\n14. Prior to enrollment or during the course of the study and in the opinion of the PI, has a history of an medical, psychiatric, physical or non-physical disease, disorder, condition, injury, or disability; or has a non-medical reason (e.g., financial, logistical, personal, other) that: (a) may pose a significant risk to the patient; (b) may increase the possibility that the subject is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) may adversely impact the integrity of the data or the validity of the study results.\n15. Subjects without a fixed home address or stable living situation, in the opinion of the Principal Investigator.\n16. Subjects involved in activities involving significant radiation exposure in the past year.\n17. Receiving TMS after DBS implantation\n18. Any mania or manic episodes within 5 years of enrollment according to DSM-V diagnostic criteria, or in the medical opinion of the PI\u002Fstudy psychiatrist","65 Years",{"count":304,"type":22},20,[51],"The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are:\n\n* Is deep brain stimulation effective in treating treatment resistant depression?\n* Does deep brain stimulation improve overall clinical well-being and functioning?\n\nParticipants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year.\n\nResearchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.",[308],"Treatment Resistant Depression",[310],"TRD",{"date":270,"type":33},{"date":313,"type":33},"2023-10-18",{"date":315,"type":22},"2038-10-18",{"name":39,"class":40},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100639725","coordinated-communication-education-and-care-transitions-after-acute-kidney-injury-connect-aki--a-pilot-randomized-controlled-trial-100639725","NCT07626268","COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial","CONNECT-AKI: COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury - A Pilot Randomized Controlled Trial","CONNECT-AKI","Inclusion Criteria:\n\n* Age 18 years or older\n* Hospitalized with Stage 2 or Stage 3 acute kidney injury\n* Kidney function has not returned to baseline at the time of hospital discharge\n* Able to communicate in English\n* Able to provide informed consent\n* Willing and able to participate in study procedures independently or with assistance from a patient-designated care partner\n\nExclusion Criteria:\n\n* Acute kidney injury requiring ongoing dialysis at the time of hospital discharge\n* End-stage kidney disease\n* Kidney transplant recipient\n* Currently pregnant\n* Documented cognitive impairment that precludes informed consent\n* Receiving hospice or comfort-focused end-of-life care",{"count":326,"type":22},160,[126],"The goal of this clinical trial is to learn whether different ways of providing information and follow-up support after acute kidney injury, also called AKI, can improve care transitions for adults being discharged from the hospital. AKI is a sudden decrease in kidney function that can occur during a hospital stay.\n\nThe main questions this study aims to answer are:\n\n* Does an AKI discharge summary template improve communication about AKI after hospital discharge?\n* Does a chat-based educational messaging program improve patient understanding of AKI and support follow-up care after hospital discharge?\n* Researchers will compare usual care, an AKI discharge summary template, a chat-based educational messaging program, and the combination of the discharge summary template plus chat-based messaging.\n\nResearchers will compare four groups:\n\n* Usual care\n* An AKI discharge summary template\n* A chat-based educational messaging program\n* Both the AKI discharge summary template and the chat-based educational messaging program\n\nParticipants will complete questionnaires at the start of the study and about 4 weeks after hospital discharge. Participants will also receive a brief phone call about 3 months after discharge, and the research team will review their medical record for information about follow-up care, lab testing, emergency department visits, and hospital readmissions.",[330,331],"Acute Kidney Injury","Acute Kidney Injury (AKI)",[333,334,335,336,337,338,339,340,341,342,343],"Acute kidney injury","AKI","Hospital discharge","Care transitions","Post-discharge care","Patient education","Discharge communication","Discharge summary","Hospital readmission","Chat-based education","Digital health","2026-05-29",{"date":270,"type":33},{"date":347,"type":22},"2026-06-01",{"date":349,"type":22},"2027-10-30",{"name":39,"class":40},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":68},"100637649","early-phase-1-impact-of-rtms-on-abnormal-cortical-fmri-in-patients-with-dystonia-100637649","NCT07626216","Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia","The Effect of Repetitive Trans-cranial Magnetic (rTMS) Stimulation on Abnormal Cortical Hubs Identified by Functional Magnetic Resonance in Subjects With Dystonia.","Inclusion Criteria:\n\n* Male or female\n* 18 and 80 years of age.\n* Patients who manifest dystonia - sustained involuntary movement of the head, neck, trunk or limbs.\n* The dystonia may be spontaneous or genetic, specifically DYT1 or DYT6 and then only those patients who are demonstrating dystonia. The patient\u002Fsubject will have a normal neurological exam except for dystonia.\n\nExclusion Criteria:\n\n* Heredodegenrative dystonia of the type DYT8,9 or 10.\n* Past history of head trauma, stroke, epilepsy, demyelinating disease\n* Hypertension in excess of 160mmHg systolic and 90mmHg diastolic\n* Congestive heart failure\n* Diabetes\n* Past psychiatric conditions: e.g., depression\n* Systemic metabolic disease: e.g., Wilson's disease, progressive neurodegenerative disease (like supranuclear palsy or corticobasal ganglionic degeneration)\n* Magnetizable incorporated metal parts - like pacemakers\n* History or diagnosis of Parkinson's disease\n* Presence of myoclonus\n* No previous surgery for dystonia\n* Long term exposure to benzodiazepines, neuroleptics or anticonvulsants\n* No botulinum toxin within 12 weeks of baseline assessment and fMRI.\n* Moderate to severe cognitive impairment (judged by a minimental status of \\\u003C24.)",{"count":76,"type":22},[78],"By tracking resting-state fMRI scans, we aim to discover how repetitive transcranial magnetic stimulation (rTMS) changes brain connectivity in individuals with dystonia.",[362],"Dystonia Disorder",[364],"Transcranial Magnetic Stimulation, Heperkinetic Movement Disorder,Truncal (Axial) Dystonia, Abnormal Posture,Contractions of the chest, back,abdominal muscles",{"date":270,"type":33},{"date":367,"type":33},"2026-03-04",{"date":369,"type":22},"2029-05",{"name":39,"class":40},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":378,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":383,"conditions":384,"keywords":389,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100638318","phase-2-pilot-study-of-galantamine-to-treat-metabolic-syndrome-in-people-with-chronic-traumatic-spinal-cord-injury-sci-100638318","NCT07625332","Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Inclusion Criteria:\n\n* Adults aged 21-75 years (male or female)\n* Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)\n* Wheelchair user for community mobility\n* Injury level of tetraplegia (cervical level) or paraplegia (all levels)\n* SCI-specific obesity indicated by waist circumference ≥94 cm\n* Resting heart rate \\>45 bpm based on 10 measurements over 10 minutes\n* Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG\n* Tolerable bowel routine indicated by a score of \\\u003C10 on the International SCI Bowel Function Data Set (ISCI-BDS)\n* Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg\u002FdL, (3) dyslipidemia: high triglycerides ≥150 mg\u002FdL or low HDL cholesterol \\\u003C40 mg\u002FdL for men and \\\u003C50 mg\u002FdL for women, (4) C-reactive protein (CRP) levels \\>1 mg\u002FdL\n* Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures\n* Willingness to comply with all study procedures and availability for the duration of the study\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Diagnosis of neurological injury or condition other than SCI\n* Progressive condition that would be expected to change neurological status\n* Signs and symptoms of cardiovascular disease or cardiac arrhythmias\n* Resting heart rate \\\u003C45 bpm\n* Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction\n* Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician\n* Psychopathology documented in the medical record or history that may conflict with study objectives\n* Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study\n* Active cancer or currently in treatment for cancer\n* Triglyceride levels ≥400 mg\u002FdL\n* Chronic use of medications with known or probable interactions with galantamine\n* Enrolled in another research study that is likely to interfere with conduct or results of the current study\n* Any other reason the site physician feels that participation is contraindicated","21 Years","75 Years",{"count":223,"type":22},[25,382],"PHASE3","The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.",[385,386,387,388],"Spinal Cord Injury","Traumatic Spinal Cord Injury","Paraplegia and Tetraplegia","Metabolic Syndrome",[390,391,392,393],"spinal cord injury","tetraplegia","paraplegia","metabolic syndrome","2026-05-28",{"date":270,"type":33},{"date":140,"type":22},{"date":398,"type":22},"2027-12",{"name":39,"class":40},3,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":419,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":68},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":124,"type":22},[126],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[412,413,414,415,416,417,418],"Glioma, Malignant","Glioblastoma","Glioblastoma Multiforme","Glioblastoma Multiforme, Adult","High Grade Glioma","GBM","Brain Cancer",[420,421,422,423],"tissue autograft","blood brain barrier","pedicled temporoparietal fascial","pericranial flap",{"date":347,"type":33},{"date":426,"type":33},"2023-06-29",{"date":428,"type":22},"2029-06-30",{"name":39,"class":40},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":439,"conditions":440,"keywords":443,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":68},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":76,"type":22},[126],"This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[441,412,413,414,442,417,418,416],"Glioma","Glioblastoma Multiforme of Brain",[421,444,445,446,447],"omentum autograft","omental autograft","omentum","omental",{"date":347,"type":33},{"date":450,"type":33},"2023-04-04",{"date":452,"type":22},"2028-04",{"name":39,"class":40},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":68},"100460101","phase-3-repeated-superselective-intraarterial-cerebral-infusion-siaci-of-bevacizumab-with-temozolomide-and-radiation-compared-to-temozolomide-and-radiation-alone-in-newly-diagnosed-gbm-100460101","NCT05271240","Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM","A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Subject must be able to undergo MRI evaluation.\n6. Subject meets the following laboratory criteria:\n\n   i. White blood count ≥ 3,000\u002FμL ii. Absolute neutrophil count ≥ 1,500\u002FμL iii. Platelets ≥ 100,000\u002FμL iv. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).\n\nExclusion Criteria:\n\n1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.\n3. Subject intends to participate in another clinical trial\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject, if female, is pregnant or is breast feeding.",{"count":462,"type":22},432,[382],"Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology.\n\nThe investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg\u002Fkg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I\u002FII clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.",[413,414,412,417,418,466,415],"Glioblastoma, IDH-wildtype",{"date":347,"type":33},{"date":469,"type":33},"2022-04-27",{"date":471,"type":22},"2028-04-01",{"name":39,"class":40},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":481,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":68},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121","NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","74 Years",{"count":483,"type":22},67,[51,25],"The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[487,413,488,489,267,490,491,492,418],"Glioblastoma Multiforme (GBM)","Glioma of Brain","Glioblastoma, Adult","Brain Tumor, Primary","Brain Tumor Adult","Cancer",{"date":347,"type":33},{"date":495,"type":33},"2017-06-13",{"date":497,"type":22},"2029-06",{"name":39,"class":40},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":514,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":68},"100275179","phase-1-super-selective-intra-arterial-repeated-infusion-of-cetuximab-for-the-treatment-of-newly-diagnosed-glioblastoma-100275179","NCT02861898","Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Phase I\u002FII Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age.\n* Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.\n* Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL.\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease.\n* Patients with history of allergic reaction to CTX\n* Patients who initiated or completed chemo\u002FRT",{"count":507,"type":22},33,[51,25],"Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).\n\nThis trial will be a non-randomized open label Phase I\u002FII clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.",[413,418,511,267,512,513,417],"Brain Neoplasm","Brain Neoplasm, Malignant","EGFR Gene Overexpression",[515,516,517],"EGFR","Epidermal Growth Factor Receptor","EGFRvIII",{"date":347,"type":33},{"date":520,"type":4},"2016-06",{"date":522,"type":22},"2029-12",{"name":39,"class":40},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":68},"100153487","phase-1-repeated-super-selective-intraarterial-cerebral-infusion-of-bevacizumab-avastin-for-treatment-of-relapsed-gbm-and-aa-100153487","NCT01269853","Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA","Phase I\u002FII Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed\u002FRefractory Glioblastoma Multiforme and Anaplastic Astrocytoma.","Inclusion Criteria:\n\n* 18 years of age or older.\n* Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).\n* Patients must have at least one confirmed and evaluable tumor site. A confirmed tumor site is one in which is biopsy-proven.\n* Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of 0-2).\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period.\n\nExclusion Criteria:\n\n* Previous treatment with greater than 2 cycles of Bevacizumab at 10mg\u002Fkg (2 IV Infusions).\n* Women who are pregnant or lactating.\n* Patients with significant inter-current medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.",{"count":532,"type":22},54,[51,25],"The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg\u002Fkg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I\u002FII clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the patients in the near future.",[414,536],"Anaplastic Astrocytoma",[417,538,539,540,541,542,413,543,544,545],"AA","AO","Brain","Tumors","Malignant","Multiforme","Anaplastic","Astrocytoma",{"date":347,"type":33},{"date":548,"type":4},"2010-10",{"date":550,"type":22},"2029-10",{"name":39,"class":40},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":68},"100640712","prospective-remapping-with-concomitant-left-atrial-appendage-occlusion-to-ensure-durable-electroporation-study-100640712","NCT07620262","Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study","PRECLUDE","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age, or older if specified by local law\n* Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause\n* Participant has AF-related symptoms, and\u002For presence of CHF or LV dysfunction\n* Participant has a CHADSVASc\\>=3\n* There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection\n* Participant is willing and capable of providing informed consent\n* Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n* Participant has had prior AF ablation (including surgical ablation)\n* Participant has had prior left atrial appendage occlusion or closure\n* Participant has an intracardiac mass or thrombus\n* Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation\n* Participant has a life expectancy \\\u003C 1 year\n* Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days\n* Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits Participant has an active systemic infection\n* Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis\n* Participant has a vena cava embolic protection filter devices and\u002For known femoral thrombus who require catheter insertion from the femoral approach\n* Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)\n* Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period",{"count":243,"type":22},[126],"This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.",[227],[564,565,566,567],"Ablation","Atrial Fibrilation","Re-mapping","LAAO Device","2026-05-27",{"date":288,"type":33},{"date":571,"type":33},"2026-05-01",{"date":573,"type":22},"2028-07",{"name":39,"class":40},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":582,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":68},"100461477","phase-1-post-transplant-cyclophosphamide-bortezomib-and-abatacept-for-the-prevention-of-graft-versus-host-disease-gvhd-100461477","NCT05289167","Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)","A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n* Age ≥14 years\n* Karnofsky score ≥70%\n* No evidence of progressive bacterial, viral, or fungal infection\n* Creatinine clearance \\>50 mL\u002Fmin\u002F1.72m2\n* ALT and AST \\\u003C3 x the upper limit of normal\n* Total bilirubin \\\u003C2 x the upper limit of normal (except for Gilbert's syndrome)\n* Alkaline phosphatase ≤250 IU\u002FL\n* Left Ventricular Ejection Fraction (LVEF) \\>45%\n* Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \\>50%\n* Negative HIV serology\n* Negative pregnancy test: Confirmation per negative serum β-human chorionic gonadotropin (β-hCG)\n* Willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.\n* Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).\n* Inability to provide informed consent.\n* Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.\n* Known allergies to any of the components of the investigational treatment regimen.\n* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.\n* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.\n* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.\n* Prisoners\n* Pregnant women","14 Years","100 Years",{"count":585,"type":22},74,[51,25],"This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or ≥7 out of 8 allele level HLA matched unrelated donor are eligible for the study if they meet the criteria defined in our standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Subjects will receive a standard of care conditioning regimen. Subjects will receive investigational PTCy, investigational bortezomib and investigational abatacept as GvHD prophylaxis.",[589],"Graft-versus-host Disease",[591],"GvHD, post transplant cyclophosphamide, abatacept","2026-05-26",{"date":344,"type":33},{"date":595,"type":33},"2022-03-13",{"date":597,"type":22},"2028-08",{"name":39,"class":40},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":607,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":68},"100630101","phase-4-cerebellum-based-imaging-neural-markers-for-antipsychotic-response-100630101","NCT07483294","Cerebellum-based Imaging Neural Markers for Antipsychotic Response","Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis","CINEMA","Inclusion Criteria:\n\n* Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder Not Otherwise Specified (NOS), bipolar disorder with psychosis, and major depressive disorder with psychosis;\n* Current positive symptoms rated \\> 3 (moderate) on one or more of the Brief Psychiatric Rating Scale (BPRS) psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;\n* At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less;\n* Age 15 to 40;\n* Competent to sign informed consent.\n\nExclusion Criteria:\n\n* Serious neurological or endocrine disorder or brain trauma;\n* Any medical condition which requires treatment with a medication with psychotropic effects;\n* Significant risk of suicidal or homicidal behavior;\n* Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;\n* Contraindications to antipsychotic monotherapy;\n* Contraindications to MR imaging (e.g. pacemaker);\n* Pregnancy by self report.","15 Years","40 Years",{"count":610,"type":22},120,[101],"This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.",[614],"Psychosis; Acute","2026-05-21",{"date":592,"type":33},{"date":618,"type":33},"2025-11-01",{"date":620,"type":22},"2030-06-01",{"name":39,"class":40},""]