[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laboratorio Elea Phoenix S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100564454","phase-2-clinical-trial-with-cannabidiol-kanbis-for-parkinson-disease-symptoms-100564454",false,"NCT06629389","Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms","Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson's Disease Symptoms","CBD-EP-2","Inclusion Criteria:\n\n1. Participants between 40 and 80 years old.\n2. Participants diagnosed with PD according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson\\'s disease (72), and to the Brain Bank Criteria for Parkinson\\'s disease, with mild to moderate disease as measured by the modified Hoehn and Yahr scale. (Both clinical criteria are included since many of the study participants were diagnosed with previous criteria and others with current criteria, both of which are very similar and do not change or raise any doubt about the diagnosis of the disease).\n3. Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.\n4. Acceptance by the participant by signing the ICF.\n5. Subjects capable of giving consent to participate in the study\n\nExclusion Criteria:\n\n1. Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .\n2. Severe psychiatric pathology: severe depression, treatment-refractory psychosis. Evaluation by psychiatrist who confirms the pathology. History of hospitalization in a psychiatric center or mental health center is an exclusion criterion regardless of the time spent since hospitalization or the reason for which the patient was hospitalized.\n3. Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.\n4. History of drug or alcohol dependence.\n5. Use of dopamine blockers within 180 days prior to study entry.\n6. Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.\n7. Patients who have received within 90 days prior to study entry the following drugs due to drug interactions: valproic acid, felbamate, niacin (nicotinic acid) at doses ≥2000mg\u002Fday or nicotinamide (nicotinic acid amide or nicotinamide) at doses ≥3000mg\u002Fday, isoniazid, ketoconazole and\u002For clobazam.\n8. Unstable medical condition detected by the following laboratory alterations: Hemoglobin\\<10g\u002FdL, Leukocytes\\<4000 u\u002Fml, Neutrophils\\<1500 u\u002Fml, Lymphocytes\\<500u\u002Fml, Platelets\\<100000 u\u002Fml, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\\> 3 times the upper limit of normal.\n9. Moderate-severe liver disease. (Child Pugh B-C)\n10. Pregnant or breastfeeding.\n11. Women of reproductive age who do not agree to use at least one contraceptive method of proven efficacy (diaphragm or partner using condom, oral or implanted hormonal contraceptive; intrauterine device, stable partner with vasectomy), until at least four weeks after completion of study treatment. Pregnancy blood test will be performed before starting the study.\n12. Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.\n13. Patients de novo or with recent diagnosis of PD (less than 5 years).","ALL","40 Years","80 Years",{"count":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.",[28],"Parkinson Disease",[30,31,32,33],"parkinson disease","Cannabidiol","oil","cannabis","RECRUITING","2024-12-03",{"date":37,"type":38},"2024-12-05","ACTUAL",{"date":40,"type":38},"2024-11-28",{"date":42,"type":22},"2026-11",{"name":44,"class":45},"Laboratorio Elea Phoenix S.A.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100490632","phase-3-double-blind-study-to-evaluate-the-pk-efficacy-safety-and-immunogenicity-of-mb12-versus-keytruda-in-stage-iv-nsclc-100490632","NCT05668650","Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC","Randomized, Multicenter, Multinational, Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV NSCLC","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be included in the study:\n\n1. Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.\n2. Greater than or equal to 18 years of age at the time of signing the ICF.\n3. Body weight ≥50 kg at Screening.\n4. Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n5. At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.\n6. Programmed death-ligand 1 (PD-L1) expression ≥50%, locally determined by immunohistochemistry, as determined by a Food and Drug Administration (FDA) validated method.\n7. Life expectancy of at least 3 months.\n8. ECOG performance status of 0 to 1.\n9. Adequate hepatic, renal, hematologic, endocrine, and coagulation function, defined as:\n\n   1. Liver function: bilirubin level ≤1.5 × the upper limit of normal (ULN) (≤3 × ULN for subjects with Gilbert's syndrome), albumin level ≥ lower limit of normal (LLN), aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤2.5 × ULN in subjects without liver metastases or ≤5 × ULN in subjects with liver metastases.\n   2. Renal function: serum creatinine level ≤1.5 × ULN, calculated creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n   3. Hematologic function: absolute neutrophil count ≥1.5 × 109\u002FL; platelet count ≥100 × 109\u002FL, hemoglobin ≥9 g\u002FdL.\n   4. Endocrine function: thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.\n   5. Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days before the first dose of the study drug.\n10. Subjects with a negative COVID-19 test (done at the discretion of investigator or per local regulation) within previous 24 hours before randomization. In case of confirmed COVID-19 infection before Screening, documentation of resolution of infection by appropriate laboratory test is required.\n11. No history of prior malignancy, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, or has undergone potentially curative therapy without evidence of disease recurrence for 3 years from the start of that therapy.\n12. Women of childbearing potential (WOCBP) must either abstain from sexual intercourse or employ highly effective contraception measures during the study and for at least 6 months after the last dose of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range for women under 50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 6 months after the last dose of the study drug.\n13. Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 6 months after the last dose of the study drug. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above mentioned duration.\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.\n2. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.\n3. Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.\n4. Known actionable mutations for which there is an approved and available therapy.\n5. Known central nervous system metastases and\u002For carcinomatous meningitis.\n6. Previous systemic steroid therapy (prednisone at a dose of 10 mg or equivalent) within 3 days before the first dose of the study drug or receiving any other form of immunosuppressive medication. Subjects receiving daily steroid replacement therapy (daily prednisone at a dose of 5 to 7.5 mg or equivalent) could be included in the study.\n7. Subject who requires any other form of localized or systemic antineoplastic therapy during the study.\n8. Prior anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, anti programmed death-ligand 2 (anti-PD-L2), anti-CD137, or anti cytotoxic T lymphocyte antigen (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co stimulation of T cells or immune checkpoints).\n9. Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose of the study drug; have received thoracic radiation therapy of \\>30 gray (Gy) within 6 months before the first dose of the study drug. Palliative radiotherapy is allowed if completed \\>14 days before the first dose of the study drug.\n10. Known history of severe hypersensitivity to another monoclonal antibody.\n11. Active autoimmune disease which has required systemic treatment in the last 2 years before the first dose of the study drug (eg, disease modifying agents, corticosteroids, or immunosuppressive treatment). Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency) is not considered a form of systemic treatment.\n12. Interstitial lung disease or pneumonitis requiring oral or intravenous steroids.\n13. Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.\n14. Subject who has received or is about to receive a live virus vaccination within 30 days before the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n15. Known history of human immunodeficiency virus (HIV)-1 or HIV-2.\n16. Known active tuberculosis or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C (hepatitis C antibody positive and hepatitis C virus \\[HCV\\] RNA positive).\n17. Subject who has received a solid organ\u002Ftissue allogeneic transplant.\n18. Known psychiatric disorders that could interfere with cooperation with study requirements.\n19. At the time of signing the ICF, the subject is a regular user (including \"recreational use\") of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol).\n20. Subject is pregnant or lactating or expecting to conceive during the study or up to 120 days after the last dose of the study drug.\n21. Immediate family member who is at the research site or sponsoring staff who is directly involved in this study","18 Years",{"count":56,"type":22},174,[58],"PHASE3","This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled.\n\nEligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent.\n\nThe study will consist of 2 periods defined as follows:\n\n* Main Study Period from Screening up to Cycle 6 included.\n* Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response \\[CR\\], partial response \\[PR\\], and stable disease \\[SD\\]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.\n\nA Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.",[61],"Non Small Cell Lung Cancer Metastatic","2024-07-14",{"date":64,"type":38},"2024-07-16",{"date":66,"type":38},"2023-08-15",{"date":68,"type":22},"2024-12",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100431394","phase-3-shorter-benznidazole-regimens-compared-to-the-standard-regimen-for-chagas-disease-100431394","NCT04897516","Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease","Phase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease","NuestroBen","Inclusion criteria (Subjects must meet ALL the inclusion requirements listed below to enter the study):\n\n* Signed informed consent form;\n* Between ≥18 and ≤60 years of age;\n* Weight ≥ 50 kg to ≤ 95 kg;\n* Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two tests must be reactive);\n* Serial qualitative PCR (one blood sample divided in three DNA extractions, at least one of which must be positive);\n* Women of childbearing potential must have a negative pregnancy result at the time of inclusion, must not be breast-feeding, and must use a highly effective method of contraception during study treatment and until 30 days after the last dose of study treatment or demonstrate permanent sterilization;\n* Ability to comply with all exams and specific protocol visits;\n* Having a permanent address;\n* ECG criteria: (Heart rate: 50 -100 bpm or isolate sinus bradycardia from 41 to 59 beats\u002Fmin; QRS ≤120 msec, and QTc ≥ 350 msec and ≤ 450 msec) at screening) or following findings belonging to non-severe chagasic cardiomyopathy: uncomplete right bundle branch block, Left anterior fascicular block, First-degree atrioventricular block, Low voltage. The abnormalities included are not exclusionary;\n* Normal or minimal structural changes in echocardiogram (left ventricular diastolic diameter (LVDD) \\\u003C= 55 mm, diastolic dysfunction, absence of Microaneurysm or tip aneurysm, absence of hypo or generalized akinesia, absence of Systolic dysfunction (low fractional shortening and ejection fraction), and\u002For absence of mural thrombus);\n* Not presenting signs or symptoms of moderate- severe chronic cardiac and\u002For digestive forms of Chagas disease (criteria detailed in Study Manual and specific SOP);\n* No prior history of mental disorders or suicidal tendencies;\n* Not suffering from known acute or chronic illnesses at the moment of selection for the study that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infections, immunosuppressive conditions, or liver or kidney diseases that have required treatment);\n* Not having received a formal indication not to take BZN (contraindication, according to the Summary of Product Characteristics - SmPC);\n* No prior history of hypersensitivity, allergy, or serious adverse reactions to any of the nitroimidazole compounds (including BNZ) and\u002For its components\u002Fexcipients;\n* Have not previously undergone antiparasitic treatment for T. cruzi infection;\n* No prior history of drug abuse or alcoholism;\n* Not suffering from any disease or condition that prevents subjects from consuming oral medication.\n\nExclusion criteria (The presence of any of the items below will exclude subjects from inclusion in the study):\n\n* Subject pregnant or intending to become pregnant during treatment and within 30 days of the last dose of study treatment;\n* Signs or symptoms of the established (moderate- severe) chronic cardiac and\u002For digestive form of Chagas disease, or any ECG\u002F echocardiographic findings not included at Inclusion criteria;\n* History of cardiomyopathy, heart failure, or severe ventricular arrhythmia;\n* History of digestive surgery potentially related to Chagas Disease or megacolon \u002F mega-esophagus;\n* Acute or chronic disease that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infection, history of immunosuppressive conditions, or liver or kidney disease that has required treatment);\n* Laboratory test values that are considered clinically significant or outside the allowable values, per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1;\n* Disease or clinical condition that prevents subjects from consuming oral medication;\n* Subjects with a contraindication (known hypersensitivity) to any of the nitroimidazole compounds, e.g. metronidazole;\n* Subjects with a history of allergy (serious or not), allergic rash, asthma, intolerance, sensitivity or photosensitivity;\n* Concomitant use and\u002For consumption of allopurinol, antimicrobial and antiparasitic agents, herbal medicines, dietary supplements and energy drinks;\n* Scheduled surgery that may interfere with the conduct of the trial and\u002For with the treatment evaluation;\n* Inability to attend study visits, comply with treatment, and cooperate with study procedures;\n* Previous participation in a trial for the evaluation of the treatment of T. cruzi infection;\n* Simultaneous participation in another trial or within 3 months prior to screening for this trial (in accordance with national regulations).\n* Subjects suffering from a serious medical or psychiatric illness that increases the risk associated with study participation or that interferes with the interpretation of study results should not be included.","60 Years",{"count":80,"type":22},300,[58],"Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.",[84],"Chagas Disease",[86,87,88,89,90],"Chagas disease","Benznidazole","Trypanosoma Cruzi","Standar treatment","Short treatment","2023-11-27",{"date":93,"type":38},"2023-11-30",{"date":95,"type":38},"2021-07-28",{"date":97,"type":22},"2026-12-01",{"name":44,"class":45},6,""]