[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Sfax\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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},"100645632","pilot-trial-of-oral-sodium-bicarbonate-versus-higher-dialysate-bicarbonate-in-hemodialysis-patients-with-metabolic-acidosis-100645632",false,"NCT07688434","Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis","Comparative Pilot Trial of Oral Sodium Bicarbonate Versus Increased Dialysate Bicarbonate in Chronic Hemodialysis Patients With Metabolic Acidosis","Bicarbonate-HD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Stable hemodialysis prescription: 3 times a week, high-flux dialyzers, no major change in dialysis prescription in the previous weeks.\n* Predialysis low \"alkaline reserves\" (serum bicarbonate concentration) according to the operational threshold used in the unit (e.g., \"alkaline reserves\" \\\u003C 22 mmol\u002FL), consistent with KDIGO 2017 definition of metabolic acidosis.\n* Ability to give written informed consent.\n\nFor the observational group:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Hemodialysis 3 times a week, high-flux dialyzers.\n* Predialysis \"alkaline reserves\" considered stable and within the locally defined normal range (≥ 22mmol\u002FL).\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Recent hemodynamic instability (e.g., repeated intradialytic hypotension or unstable blood pressure in the previous weeks).\n* Recent hospitalization for an acute condition.\n* Acute infection or major intercurrent acute event at the time of screening.\n* Major change in dialysis prescription in the 2 weeks prior to inclusion (e.g., change in dialysis schedule, duration, or dialysate composition outside the study protocol).\n* Severe digestive disorders limiting oral intake (e.g., persistent vomiting, severe malabsorption, or any condition preventing safe oral Bicardis administration).\n* Known hypernatremia or high risk of uncontrolled sodium and fluid overload (as judged by the investigator).\n* Severe uncontrolled hypercalcemia or hypocalcemia.\n* Any condition that, in the investigator's judgment, would preclude safe participation or interfere with study procedures (e.g., very limited life expectancy, inability to attend scheduled visits).\n* Refusal to participate or inability to provide written informed consent.","ALL","18 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24],"NA","Metabolic acidosis is frequent in chronic hemodialysis patients and is associated with adverse clinical outcomes. Two commonly used strategies to correct acidosis are oral sodium bicarbonate supplementation and increasing the bicarbonate concentration of the dialysate, but their comparative effectiveness and tolerance in routine care remain uncertain. This pilot, prospective, randomized, open-label, single-center trial will compare oral sodium bicarbonate versus higher dialysate bicarbonate in chronic hemodialysis patients with metabolic acidosis, using predialysis plasma bicarbonate concentrations, so-called \"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports, as a pragmatic marker of acid-base status.\n\nApproximately 30 acidotic patients (serum bicarbonate \\\u003C 22 mmol\u002FL) will be randomized 1:1 to receive either oral sodium bicarbonate or an increase in dialysate bicarbonate for 6 weeks. An additional non-acidotic observational group will provide descriptive reference data. The primary outcome is the change in predialysis serum bicarbonate from baseline (Day 0) to Day 42 between the two randomized arms. Secondary outcomes include the proportion of patients reaching target serum bicarbonate levels, the weekly kinetics of correction, dialysis adequacy (Kt\u002FV and online clearance monitoring), intradialytic tolerance (blood pressure, cramps, hypotension, symptoms), sodium-related safety (natremia, interdialytic weight gain), and the effects of acidosis correction on nutritional and bone-mineral metabolism, including changes in serum albumin, calcium, phosphorus, and parathyroid hormone (PTH). Feasibility indicators such as recruitment, retention, adherence to treatment and dialysate adjustment, and data completeness will also be described to inform the design of a larger definitive trial.",[27,28,29],"End-stage Renal Disease (ESRD)","Chronic Hemodialysis","Metabolic Acidosis",[31,32,29,33,34,35,36],"Hemodialysis","End-Stage Renal Disease","Oral sodium Bicarbonate","Dialysate Bicarbonate","Pilot Trial","Bicarbonate Supplementation","NOT_YET_RECRUITING","2026-07-18",{"date":40,"type":41},"2026-07-21","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2026-09",{"name":47,"class":48},"University of Sfax","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":49},"100603720","impact-of-a-physical-activity-intervention-on-sleep-quality-mental-and-physical-well-being-in-health-sciences-students-100603720","NCT07140185","Impact of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students","Evaluation of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students: A Randomized Controlled Trial Comparing Regular Weekly Activity With a \"Weekend Warrior\" Pattern","Inclusion Criteria:\n\n* Aged 18 to 25 years.\n* Low level of physical activity, determined using the validated International Physical Activity Questionnaire (IPAQ) according to its scoring thresholds.\n* Provided written informed consent.\n* Available to participate in the entire intervention program and all planned assessments.\n\nExclusion Criteria:\n\n* Current use of medications that may affect sleep quality or alertness (e.g., sedative hypnotics, sedative antidepressants, psychostimulants).\n* History of serious medical conditions or any contraindication to moderate physical activity.\n* Morbid obesity.\n* Current pregnancy during the study period.\n* Participation in another intervention program simultaneously.",true,"25 Years",{"count":60,"type":21},100,[24],"This randomized controlled trial aims to compare the effects of a regular weekly physical activity program versus a \"Weekend Warrior\" activity pattern on sleep quality, physical well-being, and mental well-being in sedentary university students. Participants will be randomly assigned to one of the intervention groups or to a control group and assessed at baseline and after the intervention.",[64,65,66,67],"Sleep Quality","Sedentary Lifestlye","Physical Activity","Well-being",[69,70,71,72,73,74,75,76,77,78],"Sedentary lifestyle","University students","Physical activity","Exercise intervention","Weekend Warrior","Sleep quality","well-being","Mental health","Fatigue","Randomized controlled trial","2025-08-21",{"date":81,"type":41},"2025-08-24",{"date":83,"type":21},"2025-09-15",{"date":85,"type":21},"2025-12-20",{"name":47,"class":48},""]