[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abdelrahman Mahmoud\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100618836","phase-2-effect-of-empagliflozin-on-metabolic-outcomes-in-adults-living-with-hiv-receiving-dolutegravir-based-therapy-100618836",false,"NCT07336797","Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy","Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus","Inclusion Criteria:\n\n* Age \\>18 years up to 65 years old.\n* Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2.\n* Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).\n* Sustained virologic suppression, defined as HIV-1 RNA \\\u003C 200 copies\u002FmL for at least 6 months.\n* Current CD4 count \\> 250 cells\u002FmL.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \\> 126 mg\u002FdL or glycated hemoglobin (HbA1c) \\> 6.5% (or per ADA definition).\n* Renal impairment (e.g., eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m\\^2).\n* Active viral hepatitis B or C.\n* Hypersensitivity to empagliflozin or any of its excipients.\n* Pregnancy or breastfeeding.\n* Current use of other SGLT-2 inhibitors.\n* Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).\n* Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).\n* Known thyroid disease, defined as TSH \\> 6.0 mIU\u002FL or \\\u003C 0.35 mIU\u002FL","ALL","18 Years","65 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","We investigate the role of empagliflozin in the treatment of obesity in PLWH.",[27,28,29],"Metabolic Syndrome","Obesity & Overweight","HIV (Human Immunodeficiency Virus)",[31,32,33,34,35,27,36],"Obesity","Empagliflozin","PLWH","HIV","SGLT-2 inhibitor","Weight","RECRUITING","2026-01-02",{"date":40,"type":41},"2026-01-13","ACTUAL",{"date":43,"type":41},"2025-09-01",{"date":45,"type":21},"2027-12-30",{"name":47,"class":48},"Abdelrahman Mahmoud","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100561896","phase-2-vitamin-d-supplementation-in-breast-cancer-patients-100561896","NCT06596122","Vitamin D Supplementation in Breast Cancer Patients","The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy","Inclusion Criteria:\n\n1. Female aged 18 to 65 years old.\n2. Histologically confirmed breast cancer.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 \\[21\\] \\[22\\].\n4. All patients should fulfill the criteria of the initiation of taxane-based chemotherapy such as absolute neutrophil count (ANC) \\> 1,500\u002FmcL, platelets \\> 100,000\u002FmcL, hemoglobin ≥ 9 g\u002FmL, Aspartate Aminotransferase (AST) (Serum Glutamic-Oxaloacetic Transaminase) (SGOT) to Alanine Aminotransferase (ALT), (Serum Glutamic-Pyruvic Transaminase) (SGPY) ratio (AST (SGOT)\u002FALT (SGPT)) \\< 2.5 x institutional upper limit of normal (ULN), total bilirubin less than or equal to 1.5 x institutional ULN, serum creatinine \\< 1.5 x institutional ULN.\n5. Stage I-III breast cancer scheduled to undergo adjuvant or neoadjuvant paclitaxel-based chemotherapy for breast cancer using doxorubicin 60 mg\u002Fm² and cyclophosphamide 600 mg\u002Fm² followed by paclitaxel 80 mg\u002Fm² weekly for 12 weeks protocol code BRAJACTW \\[23\\].\n6. Vitamin D insufficiency defined as serum level \\< 30 ng\u002Fml.\n7. Ability to give informed consent as per the legal requirement.\n\nExclusion Criteria:\n\n1. Prior neurotoxic chemotherapy including paclitaxel.\n2. Metastatic carcinoma.\n3. History of any other malignancy except malignancy that was treated with curative intent and for which there has been no known active disease for more than 3 years prior to randomization, curatively treated non-melanoma skin malignancy, cervical cancer in situ, in situ ductal carcinoma, or breast in situ lobular carcinoma.\n4. Grade II neuropathy or higher based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. neurosensory or neuromotor neuropathy, regardless of causality.\n5. Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone.\n6. Diabetes mellitus\n7. Psychiatric disorders that limit ability to comply with study protocol i.e., history of regular exacerbation of major psychosis (schizophrenia, bipolar disorder) in last 2 years.\n8. Known Fibromyalgia\n9. Gastric bypass surgery.\n10. Patients with chronic granuloma forming disorders (sarcoidosis or tuberculosis TB).\n11. Known hyperparathyroidism.\n12. Known thyroid dysfunction.\n13. Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.\n14. Pregnancy and lactation.\n15. Hypercalcemia (corrected blood calcium \\> 10.5 mg\u002Fdl or \\> 2.6 mmol\u002FL)\\[24\\]\n16. Hyperphosphatemia, serum phosphate concentration \\> 4.5 mg\u002FdL \\[25\\]\n17. History of symptomatic genitourinary stones within the past year.\n18. Allergy to any cholecalciferol dosage form component.\n19. Alcohol consumption.\n20. Regular use of vitamin D \\> 2000 IU daily over the past year.\n21. Inability to swallow pills.\n22. Medications that may interfere with vitamin D metabolism, including enzyme inducing anticonvulsants, lithium, phenytoin, verapamil, orlistat, tuberculosis medications as isoniazid, and\u002For rifampin and estrogen-containing medications.\n23. Patients receiving any of the following medications used to prevent CIPN: vitamin E, glutamine, nortriptyline, amitriptyline, tricyclic antidepressants, pregabalin, and duloxetine and other nutritional supplements as vitamin B during taxane administration.","FEMALE",{"count":59,"type":21},132,[24],"It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.",[63],"Peripheral Neuropathic Pain",[65,66,67,68,69,70],"Cholecalciferol","Breast cancer","Neuropathic pain","Taxane","Paclitaxel","Vitamin D3","NOT_YET_RECRUITING","2024-09-11",{"date":74,"type":41},"2024-09-19",{"date":76,"type":21},"2024-10-15",{"date":78,"type":21},"2026-12-30",{"name":47,"class":48},""]