[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Saskatchewan Health Authority - Regina Area\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100458582","phase-3-ferric-derisomaltose-iron-isomaltoside-versus-iron-sucrose-for-treatment-of-iron-deficiency-in-pregnancy-100458582",false,"NCT05251493","Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy","Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial","Inclusion Criteria:\n\n* 18 years of age and over\n* Pregnancy with Gestational age ≥13 weeks\n* Iron deficiency anemia defined as:\n* Hemoglobin less than or equal to 110g\u002FL and\n* Serum ferritin less than 30ng\u002FmL or\n* Iron Saturation (Iron\u002FTIBC) less than 20%\n* Willing to participate and attend all planned follow up visits\n* Willing to sign informed consent form\n* Willing to attend appointments for iron infusion and follow up visits\n* Willing to attend all planned bloodwork appointments\n\nExclusion Criteria:\n\n* Pregnancy GA less than 13 weeks\n* History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,\n* Known serious hypersensitivity to other parental iron products\n* Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)\n* Decompensated liver cirrhosis or active hepatitis\n* History of multiple allergies\n* Active acute or chronic infections\n* Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion\n* Current participation in any other interventional trial\n* Multiple gestation pregnancy\n* Significant comorbidities (asthma requiring daily therapy or other lung diseases)\n* Heart disease\n* Kidney disease\n* Rheumatologic disease\n* Cancer\n* Known hypersensitivity to iron sucrose or any excipients\n* Known hypersensitivity to iron isomaltoside or any excipients.",true,"FEMALE","18 Years","50 Years",{"count":21,"type":22},280,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion.\n\nThe goal of this clinical trial:\n\n* Correct IDA with fewer visits and less impact on the healthcare system\n* Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.",[28],"Iron Deficiency Anaemia in Childbirth",[30,31],"quality of life","anemia","RECRUITING","2025-05-12",{"date":35,"type":36},"2025-05-15","ACTUAL",{"date":38,"type":36},"2022-06-06",{"date":40,"type":22},"2027-02-28",{"name":42,"class":43},"Saskatchewan Health Authority - Regina Area","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100560724","phase-4-evaluation-of-switch-to-dolutegravirlamivudine-dtg3tc-from-current-suppressive-antiretroviral-therapy-in-people-living-with-hiv-plwh-receiving-opioid-agonist-therapy-oat-100560724","NCT06580873","Evaluation of Switch to Dolutegravir\u002FLamivudine (DTG\u002F3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)","Inclusion Criteria:\n\n* Male and females, 18 years or older\n* HIV-1 infected\n* Prescribed a combination antiretroviral therapy (cART) regimen that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers is appropriate for their patient, except Dolutegravir\u002FLamivudine (DTG\u002F3TC), or with DTG and 3TC as separate components of a single ART regimen at any point previously\n* HIV-1 RNA \\\u003C 200 c\u002FmL at screening and at least 3 months prior to screening\n* CD4 ≥ 200 cells\u002FmL at screening\n* Prescribed opioid agonist therapy (OAT) with oral methadone, sublingual buprenorphine, subcutaneous buprenorphine, slow-release oral morphine, or any combination thereof for at least 3 months prior to screening and deemed stable on OAT by the investigator\n* Ability to remain adherent to medications and study protocol as per investigator opinion\n* Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening\n\nExclusion Criteria:\n\n* Co-infection with hepatitis B (HBsAg positive). Individuals who are negative for HBsAg and anti-HBs but positive for hepatitis B core antibody (anti-HBc) will be excluded if they have detectable HBV DNA (i.e. greater than 10 IU\u002FmL).\n* History or presence of allergy to any component of DTG\u002F3TC\n* Documented or suspected resistance to any component of DTG\u002F3TC\n* Tuberculosis infection requiring treatment\n* Concomitant use of drugs with contraindication or unmanageable drug interactions with any component of DTG\u002F3TC\n* Alanine transferase (ALT) greater than 5 times the upper limit of normal (ULN), or ALT greater than 3 times the ULN and bilirubin greater than 1.5 times the ULN (with \\>35% direct bilirubin)\n* Has an estimated glomerular filtration rate (eGFR; by MDRD equation) \\\u003C 30 mL\u002Fmin\u002F1.73m2\n* Severe hepatic impairment (Class C or greater) by Child-Pugh classification\n* Is pregnant, planning to get pregnant, or lactating\n* Involved in any other interventional HIV study during the study period\n* Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications","ALL",{"count":53,"type":22},40,[55],"PHASE4","The goal of this clinical trial is to determine the efficacy of Dolutegravir\u002FLamivudine (DTG\u002F3TC), or \"Dovato\", in virally-suppressed (HIV-1 RNA \\\u003C 200 copies\u002FmL) individuals receiving opioid agonist therapy such as methadone, buprenorphine, slow-release morphine, after switching from their current suppressive antiretroviral therapy (ART).\n\nThe main questions this trial seeks to answer are:\n\n1. whether people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) remain virally suppressed after switching to DTG\u002F3TC from their current suppressive ART 48 weeks post-switch;\n2. the number and type of adverse events (AEs) and serious adverse events (SAEs) attributable to DTG\u002F3TC as documented per standard process at each study visit, and any discontinuations of DTG\u002F3TC due to AEs and SAEs as determined by the study investigator;\n3. the number of dosing changes in OAT attributable to DTG\u002F3TC as determined by the study investigator and documented as per standard progress at each study visit;\n4. the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed (HIV-1 RNA \\\u003C 200 copies\u002FmL) at 48 weeks post-switch from current suppressive ART to DTG\u002F3TC;\n5. any change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG\u002F3TC of serum creatinine and non-fasting lipid parameters;\n6. any change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG\u002F3TC in HIV Treatment Satisfaction Questionnaire (Status) (HIVTSQs) scores;\n7. the number of persons who remain virally suppressed (HIV RNA \\\u003C 200 copies\u002FmL) at 48 weeks post-switch from current suppressive ART to DTG\u002F3TC in conjunction with differing levels of adherence to DTG\u002F3TC, and;\n8. the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events)\n\nDuring the course of the study, participants will complete:\n\n* A set of questionnaires\n* Blood draws\n* A review of adverse events and concomitant medications\n* ECG scans at screening and 48 weeks\n* Urine drug screening\n* Physical exams\n* Review of alcohol consumption",[58,59],"HIV-1-infection","Opioid Use Disorder",[61],"Antiretroviral Therapy","NOT_YET_RECRUITING","2024-08-29",{"date":65,"type":36},"2024-08-30",{"date":67,"type":22},"2024-09-30",{"date":69,"type":22},"2027-10-31",{"name":42,"class":43},""]