[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shaare Zedek Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":369},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,45,65,91,122,148,170,196,221,253,275,296,318,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641211","early-phase-1-senna-vs-polyethylene-glycol-3350-for-the-treatment-of-retentive-encopresis-in-children-100641211",false,"NCT07604025","Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children","Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children: a Randomized, Double-blinded, Study","Inclusion Criteria:\n\n* Children aged 4 to 18 years.\n* Diagnosis of functional constipation according to Rome IV criteria.\n* Fecal incontinence occurring ≥4 times per week.\n* Treatment-naïve or treatment-experienced (i.e., any of the following treatments in the past: PEG, senna, bisacodyl and rectal disimpaction) patients.\n\nExclusion Criteria:\n\n* Presence of organic disease that causes or contributes to fecal incontinence (e.g., Hirschsprung disease, spinal cord anomalies, anorectal malformations).","ALL","4 Years","17 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The goal of this clinical trial is to learn which treatment is more effective for children with functional constipation (FC) and fecal incontinence (FI), also called retentive encopresis.\n\nFunctional constipation is common in children and can cause pain, embarrassment, social stress, and repeated medical visits. One of the hardest symptoms to treat is fecal incontinence. Two common treatments are polyethylene glycol 3350 (PEG), an osmotic laxative, and Senna, a plant-based stimulant laxative. PEG is often used as standard maintenance therapy, while Senna is increasingly used, especially in children with difficult or refractory constipation. However, there is not enough high-quality evidence comparing these two treatments directly in children with fecal incontinence.\n\nThe main question this study aims to answer is:\n\nDoes Senna reduce the number of fecal incontinence episodes more than PEG after 3 months of treatment? The study will also assess safety, tolerability, abdominal pain or cramping, use of rescue enemas, treatment satisfaction, and treatment compliance.\n\nThis is a prospective, randomized, double-blinded clinical trial. Children will be randomly assigned to receive either daily Senna or daily PEG for 3 months. Neither the families nor the treating medical team will know which treatment the child is receiving. Both medications will be prepared as identical-looking white powder in identical packages.\n\nParticipants will be children aged 4 to 18 years who have functional constipation according to Rome IV criteria and have fecal incontinence at least 4 times per week. Children with an organic disease that may cause fecal incontinence, such as Hirschsprung disease, spinal cord abnormalities, or anorectal malformations, will not be included.\n\nBefore starting the study medication, all participants will complete a 3-day bowel clean-out using high-dose PEG, with Pico-Salax added on the third day. After this clean-out, children will start their assigned daily treatment, either Senna or PEG. The dose will be based on age and may be adjusted by the physician according to stool consistency, stool frequency, cramping, and the child's clinical response. All families will also receive behavioral advice, including regular toilet sitting twice daily, correct toilet position using a footstool, and going to the toilet when the child feels the need.\n\nParticipants will:\n\n* Take daily Senna or daily PEG for 3 months\n* Visit the clinic at baseline, 1 month, 2 months, and 3 months\n* Complete a 7-day stool and fecal incontinence diary before each visit\n* Report abdominal pain, cramping, diarrhea, perianal irritation, or any other adverse events\n* Return medication containers so compliance can be checked by weighing the remaining medication\n* Complete satisfaction and improvement questionnaires at the 3-month visit\n\nOutcome Measurements:\n\nThe primary outcome is the mean number of fecal incontinence episodes per week after 3 months of treatment. This will be measured using a prospective 7-day diary completed by the family before the 3-month clinic visit.\n\nThe secondary outcomes, assessed at 3 months, include:\n\n* Change in patient-initiated toilet sitting, meaning times when the child independently says they need to defecate\n* The proportion of children who reach 0-1 fecal incontinence episodes per week\n* The proportion of children with any improvement, defined as at least 1 fewer fecal incontinence episode per week\n* Number of rescue enemas used during the 3-month study period\n* Frequency and severity of abdominal pain or cramping\n* Parent-reported satisfaction with treatment using a 5-point Likert scale\n* Family impression of overall improvement using a 5-point Likert scale\n* The proportion of children still meeting Rome IV criteria for functional constipation\n* Treatment compliance, defined as good compliance if more than 80% of doses were taken\n\nThe study plans to enroll 80 children total, with 40 children in the Senna group and 40 children in the PEG group.",[27],"Encopresis With Constipation and Overflow Incontinence",[29,30,31],"Functional constipation","Retentive encoperesis","Encoperesis","NOT_YET_RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":21},"2026-07-01",{"date":40,"type":21},"2028-01-01",{"name":42,"class":43},"Shaare Zedek Medical Center","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100576480","early-phase-1-intra-rectal-botulinum-toxin-injection-for-intractable-non-retentive-fecal-incontinence-in-children---an-open-label-pilot-study-100576480","NCT06785844","Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study","Inclusion Criteria:\n\n* Children 4-18 years old with fecal incontinence for a period greater than 6 months.\n* FI frequency of ≥ 3 episodes\u002Fweek.\n* After appropriate medical evaluation, FI cannot be explained by another medical condition.\n* Normal colonic transit study, defined as passage of 80% of markers on day\n* Normal RAIR on anorectal manometry\n\nExclusion Criteria:\n\n* Patients currently fulfilling rome IV criteria for functional constipation.\n* Patients with evidence of fecal retention.\n* Patients who had had good response to treatment for overflow incontinence.\n* Absent RAIR on anorectal manometry.\n* Any radiologic evidence of dochylosigmoid or distended colon.\n* Any known organic condition that may affect bowel transit.","18 Years",{"count":5,"type":21},[24],"Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.\n\nObjectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.\n\nMethods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.\n\nSignificance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.",[56],"Fecal Incontinence","RECRUITING",{"date":35,"type":36},{"date":60,"type":36},"2025-07-01",{"date":62,"type":21},"2030-09",{"name":42,"class":43},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":64},"100636036","budesonide-following-endoscopic-dilatation-of-esophageal-strictures-in-children-100636036","NCT07560462","Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.","Single-blinded, Randomized Controlled Trial of Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.","Inclusion Criteria:\n\n* Infants and children \\\u003C 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia \u002F tracheoesophageal fistula\n* Dysphagia score ≥1\n* Parental consent\n\nExclusion Criteria:\n\n* Additional stricture\u002Fs besides anastomotic stricture eg. Congenital stricture\n* Complicated stricture - including length \\>2cm, significant angulation or irregularity\n* Neurological impairment or other cause of expected limitation to oral intake\n* Previous anastomotic dilatations\n* Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak\n* Suspected or verified thoracic vascular anomaly affecting esophageal patency or function\n* Verified co-diagnosis of eosinophilic esophagitis\n* Any contraindication to EBD according to treating physician's planned treatment course","12 Years",{"count":74,"type":21},32,[76],"NA","Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and trachea-esophageal fistula repairs is reported as the most frequent cause in children.\n\nStricture dilatation is usually performed under direct endoscopic vision, with graduated balloon dilatation, utilizing increasing balloon diameters deployed until reaching a pre-determined, age-based, dilatation target. Balloon dilatation is repeated every 2-4 weeks until the target is reached. Success is defined as prolonged restoration of effective swallow with no dysphagia or dietary restrictions. Dilatation is repeated if clinical resolution is not obtained, or if symptoms return after initial resolution.\n\nIn children, a stricture is considered refractory when the age-appropriate esophageal lumen is not achieved with five dilatations within 5 months, or if despite ≥7 dilatations overall an age-appropriate esophageal lumen was not maintained.\n\nSeveral interventions have been studied to improve the efficacy of balloon dilatation, including injecting corticosteroids at the dilatation site, topical Mitomycin C following dilatation, or pre-dilatation endoscopic incisions of the anastomotic scar tissue. All these interventions are performed endoscopically at the time of the dilatation, require advanced endoscopic skills and may potentially have associated additional risk.\n\nIn this study the investigators aim to test the efficacy and safety of topical budesonide gel following EBD for anastomotic esophageal strictures in a single-blinded, randomized controlled study of children.",[79],"Esophageal Stricture",[81,82,83],"EBD","esophageal stricture","Oral viscous budesonide","2026-04-27",{"date":86,"type":36},"2026-05-01",{"date":86,"type":21},{"date":89,"type":21},"2029-05-01",{"name":42,"class":43},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":64},"100554563","acupuncture-as-add-on-to-g-csf-for-febrile-neutropenia-related-hospitalization-in-doxorubicin-treated-patients-with-sarcoma-100554563","NCT06500715","Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma","Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study","Inclusion Criteria:\n\n* age 18-65 years\n* diagnosed with sarcoma of any stage\n* scheduled for doxorubicin-based chemotherapy\n* function ECOG status score of 0-1\n\nExclusion Criteria:\n\n* not fulfilling all inclusion criteria\n* unwilling or unable to provide written informed consent for study participation","65 Years",{"count":100,"type":21},60,[76],"Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.",[104,105,106,107],"Febrile Neutropenia","Sarcoma","Doxorubicin Adverse Reaction","Hospitalization-Associated Infection",[109,110,111,112,113],"febrile neutropenia","acupuncture","sarcoma","doxorubicin","hospitalization","2026-04-23",{"date":116,"type":36},"2026-04-29",{"date":118,"type":21},"2026-12-01",{"date":120,"type":21},"2028-12-31",{"name":42,"class":43},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":130,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":147,"locationsCount":64},"100464708","acupuncture-withwithout-self-acupressure-for-post-oophorectomy-hot-flashes-in-brca-carriers-100464708","NCT05331209","Acupuncture With\u002FWithout Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers","Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial","BRCA","Inclusion Criteria:\n\n* Female carriers of the BRCA 1 and 2 genes\n* age ≥ 25 years\n* after risk-reducing salpingo-oophorectomy\n* reporting ≥ 5 hot flashes per day\n\nExclusion Criteria:\n\n* Patients not fulfilling the study inclusion criteria will be excluded from participation","FEMALE","25 Years",{"count":133,"type":21},200,[76],"Risk-reducing surgery with salpingo-oophorectomy (RRSO) is the standard recommended treatment for all female carriers of BRCA genes 1 and 2. The post-surgical menopause induced is invariably accompanied by hot flashes and other symptoms, which can severely impair quality of life and function. Hormone-replacement therapy (HRT) is the standard conventional treatment for these symptoms, though these drugs do not always provide adequate relief and many patients either cannot receive them due to a diagnosis of breast cancer or hypercoagulable state; or are unwilling to take them due to their concern about the associated increased risk for developing hormone-induced breast cancer.\n\nAcupuncture and acupressure have been researched extensively and shown to be both safe and effective in reducing hot flashes in post-menopausal patients and in those with breast cancer receiving anti-hormonal drugs.\n\nThe present study will examine the effectiveness of acupuncture, with\u002Fwithout self-acupressure, on 200 post- RRSO patients who suffer from at least 5 hot flashes per day, including those treated with HRT. All participants will receive 8 weekly treatments with acupuncture, and then randomly assigned to receive (or not) self-administered acupressure, to be performed daily at home. The response to the study interventions will be assessed using daily Hot Flash Scores, the Menopause Specific Quality of Life (MenQoL) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaires (at baseline; at the end of the 8-week intervention; and at 16 weeks). The safety of the study treatments will be assessed throughout.",[137,138],"Hot Flashes","Menopause Surgical",[110,140,141,142,143],"acupressure","hot flashes","surgical menopause","quality of life",{"date":116,"type":36},{"date":118,"type":21},{"date":120,"type":21},{"name":42,"class":43},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":16,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":64},"100458741","prodromal-parkinsonian-features-in-gba1-mutation-carriers-100458741","NCT05253560","Prodromal Parkinsonian Features in GBA1 Mutation Carriers","Inclusion Criteria:\n\n* Willing to participate\n\nExclusion Criteria:\n\n* PD patients\n* Dementia",true,"40 Years","75 Years",{"count":158,"type":21},600,"OBSERVATIONAL","Objective of the trial. To define a sub-population which is at increased risk of developing Parkinson, beyond the fact of carrying Gaucher; in this sub-population the investigators shall conduct a comprehensive evaluation that includes a variety of non-invasive tests, whose purpose is to evaluate the state of the pre- Parkinson's disease signs, signs which can appear, even twenty years before the appearance of the disease, and also to compare them to a group of diagnosed Gaucher patients and a group of healthy people who are not carriers of Gaucher disease.\n\nA group of those carriers will be available for trial or for treatment, if there will be a medicine for the prevention of the development of Parkinson, obtainable.",[162,163],"Gaucher Disease, Type 1","Healthy",{"date":116,"type":36},{"date":166,"type":36},"2017-05-16",{"date":168,"type":21},"2030-12-31",{"name":42,"class":43},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":64},"100434715","integrative-oncology-for-patient-symptoms-100434715","NCT04940780","Integrative Oncology for Patient Symptoms","Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study","Inclusion Criteria:\n\n* age ≥ 18 years\n* undergoing active oncology treatment\n* fully understand the study plan\n* agree to sign the study informed consent form.\n\nExclusion Criteria:\n\n* not fulfilling all of the study criteria\n* not interested in attending all 8 weekly CIM treatments sessions",{"count":178,"type":21},750,[76],"The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.\n\nA total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the \"Patient-Preference Arm\", for patients who specify their preference for either acupuncture or touch therapy; and the \"Randomized Treatment Arm\", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status \u002F Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent\u002Fchild, sibling, friend, etc.).",[182,183],"Oncologic Complications","Symptoms and Signs",[185,186,187,188,189],"Integrative medicine","Integrative oncology","Acupuncture","Touch therapy","Wellbeing",{"date":116,"type":36},{"date":192,"type":36},"2021-11-01",{"date":194,"type":21},"2027-12-31",{"name":42,"class":43},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100392359","world-data-on-ambroxol-for-patients-with-gd-and-gba-related-pd-100392359","NCT04388969","World Data on Ambroxol for Patients With GD and GBA Related PD","IIR REGISTRY for the Collection of Real World Data on the Safety and Efficacy of Ambroxol for Patients With Gaucher Disease or GBA Carriers With Parkinson Disease","Inclusion Criteria:\n\n* patients with Gaucher disease type 1,2 or 3(a,b,c).\n* patients with GBA-related Parkinson disease.\n\nExclusion Criteria:\n\n* None.","100 Years",{"count":205,"type":21},300,"Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. In 2009 it was found to also act as a pharmacological chaperone (PC) for mutant glucocerebrosidase, albeit in a several-fold higher dose. Unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. Thus, data are needed on the safety and efficacy of ambroxol for patients with Gaucher disease (GD).",[208,209,210],"Gaucher Disease","Parkinson Disease","GBA Gene Mutation",[212,208,213],"Ambroxol","GBA carriers with Parkinson disease",{"date":116,"type":36},{"date":216,"type":36},"2020-05-06",{"date":218,"type":21},"2030-11-30",{"name":42,"class":43},3,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":64},"100634262","phase-2-patients-between-the-ages-of-12-months-to-21-years-with-newly-diagnosed-high-risk-neuroblastoma-will-receive-childrens-oncology-group-cog-type-recommended-therapy-with-the-addition-of-naxitamab-and-granulocyte-macrophage-colony-stimulating-factor-gm-csf-to-induction-cycles-1-5-100634262","NCT07537400","Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5","Phase II Trial of Naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Combination With Induction Chemotherapy for Patients With Newly-Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Age - 12 months to 21 years at protocol enrollment\n* Clinical eligibility criteria:\n\n  1. Newly diagnosed high risk neuroblastoma.\n  2. BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days.\n  3. Patients ≥ 547 days of age who were initially diagnosed with INRG L1 or L2 disease but progress to Stage M without chemotherapy\n  4. Patients \\\u003C 547 days of age with INRG Stage M or MS disease and patients of any age with INRG L2 with MYCN amplification (v-myc avian myelocytomatosis viral related oncogene)\n* Pathology:\n\n  1. Neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis, or\n  2. demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n* Molecular testing:\n\n  1. MYCN testing will be done by FISH (Fluorescence In Situ Hybridization) assessment of the FFPE (Formalin-Fixed Paraffin-Embedded) material submitted from the tumor mass. \\> 4-fold increase in MYCN signals as compared to reference signals will qualify as MYCN amplified.\n  2. ONCOMINE testing will evaluate ALK (Anaplastic Lymphoma Kinase) mutation\n* Timing of patient enrollment\n\n  1. Patients will be enrolled up to 6 weeks from primary diagnosis\n  2. Pre-study imaging tests are acceptable up to 3 weeks prior to study enrollment and only if done after any pre-protocol chemotherapy.\n* Pre-treatment functional status:\n\n  1. No active bacterial infection without adequate antibiotic therapy\n  2. No uncontrolled viral infection - decision will be made after infectious disease consultation\n  3. No uncontrolled organ dysfunction:\n\n  i. Renal function based on the Schwartz formula (Schwartz et al. J. Peds, 106:522, 1985). If creatinine level is abnormal chemotherapy treatment will be planned in consultation with Nephrology service. Naxitamab will be initiated if creatinine level is up to 1.2 of normal.\n\nii. Adequate liver function defined as: -\n\n1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age,\n2. and SGPT (Serum Glutamic Pyruvic Transaminase - ALT) ≤ 10 x ULN\\* iii. Adequate cardiac function defined as: -\n\n1\\. Shortening fraction of ≥ 27% by echocardiogram, 2. or Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram.\n\nExclusion Criteria:\n\n* Subjects who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and\u002For no more than 1 cycle of chemotherapy.\n* This will not restrict the emergency regimen at initial diagnosis.\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.\n* Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.\n* Patients with known bone marrow failure syndromes.\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable.\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.","12 Months","21 Years",{"count":231,"type":21},10,[233],"PHASE2","This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.",[236],"High-Risk Neuroblastoma",[238,239,240,241,242,243,244],"Neuroblastoma","High-risk","Resistant to treatment","Newly-diagnosed","Naxitamab","Anti-GD2 antibody","Chemotherapy","2026-04-16",{"date":247,"type":36},"2026-04-17",{"date":249,"type":21},"2026-05",{"date":251,"type":21},"2032-04",{"name":42,"class":43},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":64},"100453134","tolerability-of-goat-milk-protein-in-eosinophilic-esophagitis-patients-with-cow-milk-protein-trigger-100453134","NCT05180578","Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger","Inclusion Criteria:\n\n* All patients diagnosed with EoE age ≤ 17.5 years at inclusion who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction.\n* Verified histologic remission on milk-free diet on endoscopy prior to intervention\n* Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food.\n* Ability to consent to enrollment in the trial - legal guardians with joint consent for patients \\>10 years.\n\nExclusion Criteria:\n\n* Patients with clinical IgE-mediated milk allergy.\n* Provisional exclusion: patients without a known IgE-mediated allergic reaction to milk who have a positive RAST (as per local reference range) or positive skin-prick test for cow milk or goat milk must be assessed by a certified allergist\u002Fimmunologist and cleared for the trial by a supervised goat milk challenge.\n* Use of inhaled corticosteroids for more than 5 days per month during the trial period.",{"count":260,"type":21},20,[76],"Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction.\n\nWhile the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease.\n\nThe most frequent dietary trigger for EoE is milk, but there is limited data on the cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE.\n\nRestrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species.\n\nThe aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.",[264],"Eosinophilic Esophagitis",[264,266],"EOE","2025-05-19",{"date":269,"type":36},"2025-05-22",{"date":271,"type":36},"2020-11-12",{"date":273,"type":21},"2025-10",{"name":42,"class":43},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":64},"100424209","pre-stenotic-inflammation-following-endoscopic-balloon-dilatation-in-crohns-disease-a-prospective-study-100424209","NCT04803916","Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study","Inclusion criteria:\n\n* Patients diagnosed with CD as per most recent international guidelines.\n* Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation \\>2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US))\n* Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.\n* Planned EBD as per clinical management.\n* Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN).\n* No planned treatment changes or additions over the 3 months following recruitment. The treating physician can change treatment at any time should the clinical need arise however the patient will be excluded from primary analysis\n\nExclusion criteria:\n\n* Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included\n* Change in therapy (dose or type) in the 3 months prior to planned EBD",{"count":282,"type":21},24,"As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stricturing of the bowel lumen, and even complete bowel obstruction. Stricturing CD is thought to be a major contributor to penetrating complications including abscesses and fistulae.\n\nDepending on the severity and clinical significance of fixed strictures, treatment options include either endoscopic balloon dilatation (EBD), or surgery with either resection or stricturoplasty recommended on a case-by-case basis.\n\nEBD has been shown to be a safe alternative to surgery in management of CD strictures.\n\nWhile the short- and medium-term clinical outcomes of EBD have been well described, less well studied is the impact of relieving Crohn's strictures on the inflammatory load proximal to the stricture. The restricted flow of fecal contents through a stricture creates a region of relative stasis in the bowel loops immediately proximal to the stricture, appreciated at times by pre-stenotic dilatation on cross-sectional imaging. This stasis fosters localized bacterial overgrowth and worsening dysbiosis in these bowel loops.\n\nThe investigators hypothesize that improvement of fecal flow by way of successful balloon dilatation of a CD stricture, could independently reduce the inflammatory burden, not only in the stenotic segment but also in the proximal loop of bowel.",[285],"Crohn Disease",[287,288,289],"Crohn","Stricture","Endoscopic Balloon Dilatation",{"date":269,"type":36},{"date":292,"type":36},"2020-11-01",{"date":294,"type":21},"2028-10",{"name":42,"class":43},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":130,"minAge":51,"maxAge":155,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100582972","early-phase-1-comparison-of-pregnancy-rates-in-modified-natural-frozen-embryo-transfer-fet-cycle-after-luteal-support-with-gnrh-agonist-versus-progesterone-100582972","NCT06870266","Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone","Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone: Prospective Randomized Study","Inclusion Criteria:\n\n1. Women treated at the Shaare Zedek IVF clinic scheduled for frozen embryo transfer\n2. Normo-ovulatory women\n3. Women undergoing frozen embryo transfer in a modified natural cycle\n4. BMI 18-35\n5. Age 18-40\n\nExclusion Criteria:\n\n1. Women undergoing medicated FET cycles\n2. BMI \\>35 or \\\u003C18\n3. Women with hydrosalpinx\n4. Women with congenital or acquired uterine anomalies (e.g., myomas)\n5. Egg donation or surrogacy\n6. Women with endometriosis\n7. Intolerance to GnRH agonists\n8. Nasal congestion or respiratory conditions affecting nasal absorption",{"count":304,"type":21},150,[24],"Background:\n\nThe capability to transfer frozen embryos reduces embryo loss following in vitro fertilization (IVF) and results in higher pregnancy rates compared to a single IVF cycle.\n\nEndogenous progesterone from the corpus luteum, following frozen embryo transfer in natural or modified natural cycles, is expected to provide sufficient luteal support, as observed in spontaneous pregnancies. Nevertheless, research has demonstrated higher pregnancy success rates with additional luteal support. The current standard for luteal phase support involves vaginal progesterone administration.\n\nSeveral case reports have indicated that administering a gonadotropin-releasing hormone (GnRH) agonist during the luteal phase does not compromise pregnancy continuation achieved through IVF and may, in fact, enhance implantation success.\n\nStudies have shown that the luteal phase can be maintained with a GnRH agonist alone, without the need for progesterone supplementation.\n\nA recent prospective randomized controlled trial compared standard progesterone support with GnRH agonist support in fresh embryo transfers. The group receiving GnRH agonist support demonstrated a significantly higher pregnancy rate.\n\nGiven the studies proving the positive impact of GnRH agonist, there is a need for a prospective randomized controlled trial to evaluate the use of GnRH agonist support in frozen embryo transfers.\n\nAims and Significance:\n\nThis study aims to compare pregnancy rates between women receiving GnRH agonist treatment and those receiving standard progesterone-based luteal support during frozen embryo transfers in natural cycles as part of IVF treatments.\n\nConducting a prospective comparative study will enable us to assess the effectiveness of GnRH agonist treatment relative to standard luteal phase support. Based on the results, the investigators may consider treatment with intranasal GnRH agonist, which improves quality of life and may also enhance pregnancy and live birth rates.\n\nMethods:\n\nThe study will be conducted on patients scheduled to undergo modified natural cycles. Participants will be randomly allocated into two groups:\n\n1. Study Group: Luteal phase support will begin on the day of ovulation with Nafarelin nasal spray (200 mcg twice daily) for two weeks, until pregnancy blood test (hCG).\n2. Control Group: Luteal phase support will be provided through vaginal progesterone. Endometrin 100 mg twice daily. If the hCG test is positive, the supportive treatment will continue until the 8th week of pregnancy, as per the attending physician's instructions.\n\nClinical follow-up will include monitoring for clinical pregnancy outcomes, miscarriage rates, and live births.",[308,309],"Ivf","Frozen Embryo Transfer (FET)","2025-03-05",{"date":312,"type":36},"2025-03-11",{"date":314,"type":21},"2025-03",{"date":316,"type":21},"2027-06",{"name":42,"class":43},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":51,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":64},"100539003","risankizumab-in-children-with-crohns-disease-risakids-100539003","NCT06298188","Risankizumab in Children With Crohn's Disease (RisaKids)","Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study","Inclusion Criteria:\n\n* Children under the age of 18 years,\n* Patients diagnosed with CD.\n* Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.\n\nExclusion Criteria:\n\n\\* There will be no exclusion criteria to this study.","6 Years",{"count":327,"type":21},90,[76],"The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.\n\nThis is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.",[285],"2024-11-27",{"date":333,"type":36},"2024-12-03",{"date":335,"type":36},"2024-10-31",{"date":337,"type":21},"2026-10",{"name":42,"class":43},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":130,"minAge":51,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":64},"100331132","phase-1-phase-1b-study-of-pegylated-liposomal-doxorubicin-and-pembrolizumab-in-endocrine-resistant-breast-cancer-100331132","NCT03591276","Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer","A Phase 1b Study of Combination Chemo-immunotherapy With Pegylated Liposomal Doxorubicin (Doxil\u002FCaelyx) and Pembrolizumab (Keytruda) in Metastatic Endocrine-resistant Breast Cancer","KEYDOX","Inclusion Criteria:\n\n1. Have pathological diagnosis of breast cancer, ER positive (%ER+ cells≥1%, Allred score ≥3), Her2 negative subtype, locally advanced (stage III non-operable), or metastatic (stage IV) disease.\n2. Have measurable disease on computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) scan.\n\n2\\. Be 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1. 4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 5. Have an estimated life expectancy of at least 3 months. 6. Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days of treatment initiation.\n\n7\\. Have received at least two lines of hormonal therapy, one of which had included aromatase inhibitors.\n\n8\\. May have received none or up to 2 lines of chemotherapy (excluding any chemotherapy given in adjuvant or pre-operative-neoadjuvant settings).\n\n9\\. Have a ≥21-day treatment-free interval from chemotherapeutic treatment. 10. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n11\\. Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2, for the course of the study through 120 days after the last dose of study medication.\n\nNote: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n12\\. Understanding of study procedures and willingness to comply throughout the entire course of the study and to provide written informed consent.\n\nExclusion Criteria:\n\n1. Has known hypersensitivity to the study drugs or to any of their excipients.\n2. Has congestive heart failure (New York Heart Association \\[NYHA\\] Class IV) or left ventricular ejection fraction (LVEF) ≤40%.\n3. Has chronic obstructive pulmonary disease (COPD) \\>Stage 3 (forced expiratory volume in 1 second \\[FEV1\\] \\\u003C50%, forced expiratory volume 1\u002Fforced vital capacity \\[FEV1\u002FFVC\\] \\\u003C70%).\n4. Has cirrhosis (Child-Pugh Class C score).\n5. Has serum albumin level \\\u003C 2.5 g\u002Fdl.\n6. Has a known history of HIV (HIV 1\u002F2 antibodies).\n7. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n8. Has evidence of active bleeding or bleeding diathesis.\n9. Concomitant use of any other chemotherapy (except for PLD) or hormonal therapy during the study\n10. Uncontrolled ascites (defined as 2 or more palliative taps within 30 days of screening).\n11. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n12. Continuous steroid treatment for other than brain metastases requiring daily corticosteroid dose ≥ 10 mg prednisone or corticosteroid-equivalent per day.\n13. Anthracycline treatment (doxorubicin, epirubicin, mitoxantrone, PLD) in metastatic setting.\n14. Less than 6 months from last treatment with anthracyclines in adjuvant or neo-adjuvant setting.\n15. Use of any investigational drug within 28 days prior to study entry.\n16. Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix.\n17. Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, or uncontrolled diarrhea in the last 4 weeks prior to enrollment.\n18. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n19. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy (except for prednisone ≤10 mg\u002Fday or equivalent) within 7 days prior to the first dose of trial treatment.\n20. Has a known history of active Bacillus Tuberculosis.\n21. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.\n22. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent.\n\n    Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n\n    Note: If the subject underwent major surgery, she must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n23. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or melanoma that have undergone potentially curative therapy or in situ cervical or bladder cancer.\n24. Has known active central nervous system metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases are eligible for recruitment provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and may be receiving dexamethasone at a dose ≤4 mg\u002Fday prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n25. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n26. Has a known history of, or any evidence of active, non-infectious pneumonitis.\n27. Has an active serious infection or an active infection requiring systemic therapy.\n28. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n29. Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n30. Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n31. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.",{"count":348,"type":21},15,[350,233],"PHASE1","Very few patients with endocrine-resistant, hormone-receptor positive metastatic breast cancer respond to single agent immunotherapy. Responses to chemotherapy are usually of short duration. Combining immunotherapy with chemotherapy that has minimal immunosuppressive effect, it may be possible to achieve higher response rates while keeping the immune-associated pattern of long durations of response.\n\nThis will be a single-center phase 1b study to evaluate the tumor response and appropriate dose of a chemo-immunotherapy regime consisting of treatment with pegylated liposomal doxorubicin (PLD) and pembrolizumab-based in endocrine-resistant breast cancer (ERBC) patients.\n\nUp to 15 female patients, ages 18 and above, with pathological diagnosis of breast cancer, estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2-) negative subtype, stage III non-operable, or stage IV disease, who have received at least two lines of hormonal therapy, one of which included aromatase inhibitors will be eligible for enrollment to this single arm study.",[353],"Metastatic Breast Cancer",[355,356,357,358,359,360],"metastatic breast cancer","immune check point inhibitors","chemotherapy","liposomal doxorubicin","pharmacokinetics","Anti-PD1 antibodies","2020-10-22",{"date":363,"type":36},"2020-10-23",{"date":365,"type":36},"2019-04-18",{"date":367,"type":21},"2021-06-15",{"name":42,"class":43},""]