[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical University of Lodz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":180},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,67,96,120,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100623079","evaluation-of-saco-vlma-for-general-anesthesia-for-laparoscopic-procedures-100623079",false,"NCT07391969","Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures","Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures","Inclusion Criteria:\n\n* Patients undergoing elective surgery under general anesthesia for laparoscopic surgery of predicting lasting no longer than about 1 hour.\n* Age \\>18 years.\n* ASA I-III.\n* Present ordinary airway\n\nExclusion Criteria:\n\n* Not meeting the above criteria\n* Presenting 3 predictors of a difficult airway (Mallampatti class III or IV; thyromental distance \\\u003C6 cm, sternomental distance \\\u003C12.5 cm, distance between incisors \\\u003C4.0 cm, bite test II or III, cervical mobility \\\u003C90o).\n* Gestation\n* Allergy to any drug included in the protocol.\n* Present risk factors for bronchial aspiration\n\n  \\- Presenting with preoperative sore throat\n* Present severe respiratory, coronary or cerebral vascular pathology.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison with other airway management methods including other supraglottic devices. The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.",[26,27,28],"Laparoscopic Surgical Procedures","Airway Control","Anesthesia","NOT_YET_RECRUITING","2026-02-02",{"date":32,"type":33},"2026-02-06","ACTUAL",{"date":35,"type":20},"2026-02-01",{"date":37,"type":20},"2027-03-01",{"name":39,"class":40},"Medical University of Lodz","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100564653","conservative-treatment-in-patients-with-supraspinatus-tendon-injury-100564653","NCT06631976","Conservative Treatment in Patients With Supraspinatus Tendon Injury.","Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.","Inclusion Criteria:\n\n1. Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination.\n2. Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score \\> 5.\n3. Shoulder pain disrupting the quality of sleep.\n4. BMI \\\u003C 30.\n5. Age 40-75.\n\nExclusion Criteria:\n\n1. Other accompanying pain symptoms.\n2. History of shoulder surgery.\n3. Coexistence of psychiatric or neurological disorders.\n4. Presence of comorbidities that may disrupt sleep.\n5. Presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia.\n6. Alcohol dependence, nicotine addiction, passive smoking.\n7. Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.\n8. Lack of patient consent, lack of cooperation, or impaired verbal-logical communication.","40 Years","75 Years",{"count":51,"type":20},40,[23],"Rotator cuff injuries are a major cause of severe pain, often significantly impacting patients\\' sleep quality. For patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. In cases of minor injuries, physiotherapy is as effective as surgical intervention.\n\nThe aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (BDNF) and proBDNF (precursor) at the mRNA protein level before the planned intervention (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after intervention.\n\nThe study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients\\' quality of life.",[55,56],"Supraspinatus Injury","Sleep Disturbance","RECRUITING","2025-12-03",{"date":60,"type":33},"2025-12-10",{"date":62,"type":33},"2024-06-04",{"date":64,"type":20},"2026-09",{"name":39,"class":40},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":66},"100550917","phase-2-comparison-of-ustekinumab-infliximab-and-combination-therapy-in-moderately-to-severely-active-ulcerative-colitis-100550917","NCT06453317","Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis","Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)","COMBO-UC","Inclusion Criteria:\n\n1. Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.\n2. Age ≥ 18 years and ≤65 at the time of screening.\n3. In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.\n4. For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15 weeks if using UST (patients in arms B and C) or 6 months if using IFX (patients in arm A).\n5. Negative serum or urine pregnancy test in women of childbearing age.\n6. Diagnosis of UC a minimum of. 3 months prior to screening documented by:\n\n   (a) medical source documentation of the patient with the result of an endoscopic examination that diagnosed features typical of UC.\n\n   (b) a histopathological examination result consistent with UC. In the absence of a histopathological result, it is possible to take sections during the endoscopic examination for histopathological evaluation at the time of eligibility for the study with subsequent sending of the material to the local pathomorphology laboratory to confirm the diagnosis of UC before randomization.\n7. UC with moderate or severe activity defined as a Mayo scale score (Appendix 2) of 7 to 12 including the following sub-item values (each sub-item 0-3 points depending on the severity of the lesions):\n\n   \\- Frequency of bowel movements\n   * Bowel bleeding\n   * Endoscopic image of the colonic mucosa\n   * General medical evaluation and:\n   * with inadequate response to standard treatment, including corticosteroids and 6-mercaptopurine or azathioprine, or.\n   * intolerant of treatment with corticosteroids and 6-mercaptopurine or azathioprine, or\n   * having contraindications to treatment with corticosteroids and 6-mercaptopurine or azathioprine, or\n   * with loss of response to standard treatment, including to treatment with corticosteroids and 6-mercaptopurine or azathioprine, including patients:\n   * Steroid-resistant - in whom there is no clinical improvement despite the use of a daily steroid up to 0.75 mg\u002Fkg prednisolone for 4 weeks;\n   * Steroid-dependent - in whom failure to reduce the steroid dose below 10 mg\u002Fday, converted to prednisolone, within 3 months of starting steroid therapy or relapse of complaints within 3 months of steroid withdrawal.\n   * Refractory patients\u002Fabout inadequate response to immunosuppressive treatment, defined as lack of remission or recurrence of complaints despite immunosuppressive treatment for at least 3 months at appropriate doses (azathioprine 2-2.5 mg\u002Fkg\u002Fday or 6-mercaptopurine 1-1.5 mg\u002Fkg\u002Fday).\n8. Patients taking 5-ASA derivatives, corticosteroids, immunosuppressants may be included in the study if they are taking a fixed and specified dose of the above drugs 14 days before the day of randomization.\n\nExclusion Criteria:\n\n1. Previous use of the study drug IFX or UST.\n2. Hypersensitivity to the active substance or excipients.\n3. Moderate or severe myocardial insufficiency (NYHA III or IV).\n4. Unstable coronary artery disease.\n5. History of serious cerebrovascular disease (stroke, intracranial hemorrhage, transient cerebral ischemia) within the last 24 weeks prior to screening.\n6. Chronic respiratory failure.\n7. Severe chronic renal failure.\n8. Severe chronic liver failure.\n9. Demyelinating syndrome or symptoms resembling the syndrome.\n10. Alcoholic disease, post-alcoholic liver damage.\n11. Diagnosis of malignant neoplasms, including within 5 years preceding the time of eligibility for the program (except for carcinoma in situ of the cervix, and non-melanoma skin cancers).\n\n12 Complications requiring other management (e.g., surgery). 13. Current or recent (defined as an incident within 12 weeks prior to randomization) documented episode of fulminant colitis, or intra-abdominal abscess, or acute colonic distension, or bowel perforation.\n\n14\\. Status after extensive colorectal resection, subtotal or total colectomy with or without colostomy, or J-pouch reservoir.\n\n15\\. Indication of surgical intervention due to underlying disease or when there is a suspicion of need for such intervention during the course of the study.\n\n16\\. History of current or previously documented unclassified colitis or ischemic colitis.\n\n17\\. History of colonic diverticulitis within the last 60 days prior to the randomization visit.\n\n18\\. Current adenomatous polyps of the colon, small- or large-grade dysplasia in colon specimens, or previously diagnosed foci of large-grade dysplasia that have not been treated.\n\n19\\. Enteral nutrition or total parenteral nutrition. 20. Pregnancy or breastfeeding. 21. Taking medications on the prohibited drugs list (Section 7.4.6). 22. daily dose of prednisone\\> 40 mg (or equivalent other corticosteroid) or budesonide MMX \\> 9 mg.\n\n23\\. Status after bone marrow transplantation. 24. Condition after apheresis 12 months prior to the randomization visit. 25. Period after administration of allowed biologic drugs shorter than the drug's washout period from the body (Section 7.2).\n\n26\\. Period after intestinal microbiota transplantation less than 8 weeks before signing informed consent to participate in the study.\n\n27\\. Active or latent form of tuberculosis. 28. HIV infection. 29. Treatment period for active lesions of chronic infections (including pneumocystodosis, CMV, HPV, HSV infection, atypical mycobacteriosis, invasive bacterial or fungal infections).\n\n30 History of HSV, HPV, influenza virus, SARS-CoV2 infection within 12 weeks prior to randomization or history of disseminated or complicated HSV infection.\n\n31\\. History of congenital or acquired immunodeficiency. 32. receipt of live vaccine within 30 days prior to randomization. 33. infection with HBV or HCV. 34. Clinically significant changes on chest X-ray or ECG. 35 Clinically significant changes observed in laboratory test results:\n\n1. ALT activity \\>3x the upper limit of normal (GGN)\n2. AST activity \\>3x GGN\n3. Total bilirubin level \\>2x GGN (exception is Gilbert syndrome when other causes of isolated hyperbilirubinemia are excluded).\n4. ALP or GGTP activity \\>3x GGN\n5. Creatinine level \\>2x GGN or impaired renal function (eGFR) \\\u003C45mL\u002Fmin calculated by MDRD formula.\n6. Hemoglobin level \\\u003C9g\u002FdL\n7. Absolute leukocyte count \\\u003C3000\u002Fmm3\n8. Absolute lymphocyte count \\\u003C750\u002Fmm3\n9. Neutrophil level \\\u003C1000\u002Fmm3\n10. Platelet level \\\u003C100000\u002Fmm3. 36. Positive stool culture for bacteria\u002Ffungus (if clinically relevant in the opinion of the investigator).\n\n    37.Positive stool culture for Clostridioides difficile. 38. Use of treatment not permitted under this protocol.","64 Years",{"count":77,"type":20},172,[79],"PHASE2","The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are:\n\nDoes the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy?\n\nParticipants:\n\nPatients diagnosed with UC will be qualified to biologic therapy (infliximab\u002Fustekinumab\u002Finfliximab + ustekinumab).\n\nVisit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.",[82,83],"Ulcerative Colitis","Inflammatory Bowel Diseases",[85,86,87,83,82],"dual biological therapy","infliximab","ustekinumab","2025-05-12",{"date":90,"type":33},"2025-05-15",{"date":92,"type":33},"2025-02-17",{"date":94,"type":20},"2028-06-30",{"name":39,"class":40},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":66},"100586586","virtual-reality-as-a-digital-premed-to-alleviate-pain-and-anxiety-preoperatively-in-patients-undergoing-spine-surgery-100586586","NCT06917300","Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery","Inclusion Criteria:\n\n* Adult patients between 25-70 years old, undergoing an elective spinal surgery.\n* Patient's admission prior to surgery day (at least 1 day).\n* Expected hospital stay - 2 days.\n* Capable of providing informed consent and participate in the study follow-up questionnaire.\n* Patients speak Polish.\n\nExclusion Criteria:\n\n* Congestive heart failure, hypertension and anti-hypertensive medications\n* Adrenal insufficiency\n* Alcohol addiction (evaluated by CAGE\u002FAUDIT) and substance addiction (evaluated by DUDIT)\n* Cognitive impairment (evaluated by MMSE, MoCA)\n* Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire\n* Auditory impairment\n* Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)\n* Patients with neuropathic pain\n* Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs\n* Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)\n* Patient with high risk due to major and emergency operations\n* Claustrophobia\n* GCS \\\u003C 15","25 Years","70 Years",{"count":105,"type":20},150,[23],"The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.",[109,110,111],"Anxiety and Fear","Pain, Postoperative","Stress","2025-03-31",{"date":114,"type":33},"2025-04-08",{"date":116,"type":33},"2024-08-16",{"date":118,"type":20},"2026-09-30",{"name":39,"class":40},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":16,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":66},"100581460","phase-2-efficacy-and-safety-of-dimethyl-fumarate-among-patients-with-mild-cognitive-impairment-and-dementia-due-to-alzheimers-disease-100581460","NCT06850597","Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease","Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease","Inclusion Criteria:\n\n1. Men and women aged 55-90 years.\n2. Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate Alzheimer's dementia (MMSE \\>16) diagnosed based on NIA-AA criteria.\n3. MMSE score from 17 to 30 points.\n4. CDR score from 0.5 to 2.\n5. The patient signs an informed, voluntary consent to participate in the study.\n6. The patient has a close person\u002Fde facto guardian who agrees to help the patient during participation in the study.\n7. At least 6 years of education.\n8. In the case of anti-Alzheimer's drugs, the use of cholinesterase inhibitors is permitted provided that they are included at least 3 months before entering the study and used at a stable dose for at least 60 days before entering the study. In the case of memantine, its use is permitted provided that it is included at least 4 months before entering the study and used at a stable dose for at least 3 months before entering the study.\n\nExclusion Criteria:\n\n1. Lack of informed voluntary consent to participate in the study.\n2. Patients who cannot read or write.\n3. Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).\n4. Participation in another clinical trial, currently or within 3 months prior to the screening visit.\n5. Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.\n6. Chronic kidney disease with GFR below \\\u003C 60 ml\u002Fmin\u002Fm2\n7. Abnormal liver parameters: ALAT exceeding \\> 2 times the upper limit of normal\n8. Leukopenia (\\\u003C4000\u002Fmm3), granulocytopenia (\\\u003C1500\u002Fmm3) or lymphopenia (\\\u003C1000\u002Fmm3) regardless of the cause.\n9. Severe agitation.\n10. Mental retardation.\n11. Delirium diagnosed according to DSM-5 criteria.\n12. Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke).\n13. Presence of hemorrhagic foci in magnetic resonance imaging with a diameter of ≥ 2 cm3, more than three (3) ischemic stroke foci with a diameter of ≥ 1.5 cm3 or a single ischemic foci with a diameter of ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normal pressure hydrocephalus, final decision at the discretion of the investigator.\n14. Severe or uncontrolled somatic disease that could affect the course of the study (e.g. neoplastic, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant hypertension).\n15. Use of benzodiazepines or barbiturates within 1 week prior to screening.\n16. Pharmacological immunosuppression.\n17. Patients with bipolar disorder or psychotic disorders or any other psychiatric condition (current or past) that the Investigator believes interferes with the study.\n18. Alcoholism or drug addiction as defined by DSM-5 within the past 5 years (dependent for more than 1 year and or in remission for less than 3 years).\n19. Patients with any medical condition that, in the Investigator's judgment, is an exclusion criterion.\n20. Thyroid hormone therapy initiated, discontinued, or modified within 3 months prior to screening visit.\n21. Menopausal hormone replacement therapy initiated, discontinued, or modified within 3 months prior to screening visit.\n22. Use of prohibited drugs in the study: Antineoplastic drugs (no studies). Immunosuppressive drugs (no studies). Corticosteroids (impact on project results). Live attenuated vaccines (no studies). Inactivated vaccines may be used. Benzodiazepines (impact on assessed endpoints). Other ethyl esters used orally or topically.",true,"55 Years","90 Years",{"count":131,"type":20},30,[79],"The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.",[135,136,137],"MCI","MCI-AD, Early Stage Alzheimer's Disease","Alzheimer's Disease","2025-02-24",{"date":140,"type":33},"2025-02-27",{"date":142,"type":33},"2024-10-28",{"date":144,"type":20},"2027-12-31",{"name":39,"class":40},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":66},"100512792","phase-2-lisdexamphetamine-vs-methylphenidate-for-pediatric-patients-with-adhd-and-type-1-diabetes-100512792","NCT05957055","Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes","LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial","LAMAinDiab","Principal inclusion criteria:\n\n* Age 8-16.5 years at study entry;\n* T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-glutamate decarboxylase, islet cell antibody, insulin autoantibody\u002Fislet antigen 2 autoantibody, zinc transporter 8 antibody) and\u002For low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies:\n\n  * an incidental glycemia ≥200mg\u002Fdl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or\n  * two times a fasting blood glucose ≥125mg\u002Fdl or\n  * a blood glucose ≥200mg\u002FdL in the 120th minute of an oral glucose load test or\n  * HbA1c ≥6.5%.\n* T1D diagnosed at least 12 months before recruitment;\n* T1D treated with functional intensive insulin therapy\n* a diagnosis of ADHD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by an authorized person as consistent with DSM-5\n* Polish citizenship and Polish health insurance\n\nPrincipal exclusion criteria:\n\n* Daily insulin dose\\\u003C0.3 j\u002Fkg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);\n* Severely unsatisfactory glycemic control - mean HbA1c over the past year ≥12% (not including HbA1c measurement at diagnosis of T1D);\n* Diagnosed intellectual or other disability that prevents participation in the trial or adherence to its therapeutic regimen;\n* Clinically apparent cardiovascular disease: recognized hemodynamically significant heart defect, advanced vascular atherosclerosis;\n* Diagnosis of other mental illness or disorder preventing participation in the trial, e.g. bipolar affective disorder, schizophrenia, other psychotic disorders, psychoactive substance abuse;\n* Diagnosed allergy or hypersensitivity to drugs used in pharmacological intervention -methylphenidate and\u002For lisdexamphetamine;\n* Language barrier making it impossible to conduct a full psychological consultation in Polish;\n* Lack of permanent residence in Poland;\n* Contraindications as reported for investigated drugs: documented hypertension (at least stage 2), positive family history for sudden cardiac deaths and atrial arrythmias in relatives below 40 y.o., clinically evident glaucoma or abnormally elevated intraocular pressure, history of suicide attempts or present suicide intentions, oppositional defiant disorder, chronic motor tics or Tourette syndrome, pregnancy or breastfeeding, short stature, underweight (≤ 3rd percentile for reference percentile charts), epilepsy, pheochromocytoma, substance abuse or positive drug test results, prolonged treatment with sedative drugs (e.g., 1st generation antihistamines);\n* Declared by the parents\u002Flegal guardians' inability or unwillingness to come to the Center at the time specified by the protocol, in particular - to pick up the Trial drugs at the dose adjustment stage (the need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receiving the recommendations);\n* Other reasons that, in the opinion of the attending physician, are more likely to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health in case of participation in the trial.","8 Years","198 Months",{"count":105,"type":20},[79],"This clinical trial aims to evaluate the safety and effectiveness of an intervention involving parental training in behaviour management and medication in children with both Type 1 Diabetes (T1D) and Attention Deficit Disorder with Hyperactivity (ADHD). ADHD is a neurodevelopmental disorder that affects around 5% of school-age children and adolescents, while T1D is a chronic disease requiring strict management.\n\nAfter initial parental training provided for parents\u002Flegal guardians, the children will be randomized to one of two cross-over groups, and treated with either lisdexamfetamine or methylphenidate first. After dose optimization for first 5-7 weeks, patients will be treated for 6 months total, after which they will be switched to the other drug.\n\nResearchers will then compare the ADHD symptom severity as measured by Conners 3 questionnaire, and compare the frequency of any adverse events associated with the therapy. As secondary outcomes, patient's T1D control and quality of life will be compared between the two drugs.",[160,161],"Attention Deficit Disorder with Hyperactivity","Diabetes Mellitus, Type 1",[163,164,165,166,167,168,169,170,171],"attention deficit disorder with hyperactivity","diabetes mellitus, type 1","methylphenidate","lisdexamfetamine dimesylate","adolescent","child","glycemic variability","randomized cross-over trial","continuous glucose monitoring","2024-11-26",{"date":174,"type":33},"2024-11-29",{"date":176,"type":33},"2024-02-05",{"date":178,"type":20},"2027-12-01",{"name":39,"class":40},""]