[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":152},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,72,95,116],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644826","early-phase-1-evaluation-of-the-effectiveness-and-safety-of-mesotherapy-in-the-treatment-of-chronic-low-back-pain-syndrome-100644826",false,"NCT07675304","Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome","Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study","Inclusion Criteria:\n\nAge between 18 and 65 years Chronic localized pain in the lumbosacral spine without radicular symptoms or radiation to the lower limbs Recent spinal imaging (X-ray, computed tomography (CT), or magnetic resonance imaging (MRI)) performed within the last 6 months confirming the diagnosis\n\nExclusion Criteria:\n\nKnown allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent","ALL","18 Years","65 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The aim of this study is to evaluate the effectiveness of collagen mesotherapy in the treatment of chronic low back pain (CLBP) in the lumbosacral spine.\n\nMesotherapy is expected to reduce pain in the lumbosacral region, decrease soft tissue tension (including muscles, fascia, and ligaments), improve spinal mobility, and support subsequent physiotherapy.\n\nA total of five treatment sessions will be performed at weekly intervals.\n\nDuring each session, approximately 20 intradermal microinjections will be administered into the paraspinal soft tissues of the lumbosacral region. Participants will receive injections of either type I tropocollagen, 1% lignocaine (lidocaine), or a combination of both, with a volume of 0.1 mL per injection.",[27],"Chronic Low Back Pain (Non-specific, Uncomplicated)","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2026-05-06",{"date":36,"type":21},"2027-03",{"name":38,"class":39},"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","NETWORK",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":40},"100538919","phase-3-study-of-the-efficacy-of-nintedanibtocilizumab-in-patients-with-systemic-sclerosis-and-interstitial-lung-disease-100538919","NCT06297096","Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease","Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach","NINTOC-TU","Inclusion Criteria:\n\n1. Men or women aged 18-74 at the date of signing the informed consent.\n2. Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed before any study procedure.\n3. Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against Rheumatism) - EULAR, meeting the criteria of active disease \\[patients with limited and diffused SSc)\\] and with an overall disease duration of less than or equal to (≤ 72 months).\n4. Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).\n5. Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive.\n6. Patients treated with conventional drugs such as mycophenolate mofetil, methotrexate; should be on stable doses for ≥ 8 weeks before and including the screening visit (W0).\n7. Patients may be treated with standard therapy, but no new therapy or withdrawal of therapy within 8 weeks before the first screening visit (W0).\n8. Patients taking oral glucocorticosteroids (GCS) should be on a stable dose of ≤ 10 mg\u002Fday prednisone or equivalent for at least 8 weeks before the baseline visit.\n9. Patients of childbearing potential should agree to abstain from sexual activity or use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of medicinal products.\n\nExclusion Criteria:\n\n1. Patients not fully capable of giving informed consent.\n2. Pregnant or breastfeeding women.\n3. Major surgery within 8 weeks before screening (W0A).\n4. Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of secondary Sjögren's syndrome is acceptable.\n5. Active diverticulitis and severe enteritis.\n6. Untreated lipid disorders (Initiation of treatment and modification of the lipid profile enable re-screening for examination after 8 weeks from the start of hypolipidemic treatment).\n7. Immunization with a live or attenuated vaccine within 4 weeks before scheduled treatment.\n8. Known hypersensitivity to human, humanized or murine monoclonal antibodies and hypersensitivity to peanut, soya.\n9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels greater than 1.5 times the upper limit of normal (ULN). If normalized, the patient may be considered for re-screening.\n10. Bilirubin \\>1.5 x ULN.\n11. Creatinine clearance \\\u003C30 ml\u002Fmin.\n12. Significant pulmonary hypertension (PH).\n13. Airway obstruction (forced expiratory volume before bronchodilation in 1 second (FEV1)\u002FFVC \\\u003C0.7) and other clinically significant pulmonary abnormalities.\n14. Cardiovascular diseases with heart failure NYHA III\u002FIV.\n15. More than 4 digital ulcers or a history of severe digital necrosis requiring hospitalization or severe other digital ulcers.\n16. Bleeding risk (such as bleeding tendency, fibrinolysis, full dose of anticoagulants, high dose of antiplatelet therapy, history of central nervous system (CNS) bleeding events in the last year. (INR) \\>2, prothrombin time (PT) and partial thromboplastin (PTT) \\> 1.5 x ULN) and history of a thrombotic event within the last year, history of thrombosis still requiring full therapeutic anticoagulant therapy, fibrinolysis or high-dose antiplatelet therapy \\> 150 mg ASA per day.\n17. History of stroke, or myocardial infarction within 6 months before screening.\n18. Prior treatment with pirfenidone or nintedanib if a minimum of 6 months had not been completed before enrolling the patient in the NINTOC-TU study.\n19. Plasmapheresis and\u002For plasma exchange within the last 12 weeks before screening and use of immunoglobulins within the last 12 weeks and treatment with tocilizumab, treatments targeting B cell depletion, biologics (e.g. tumor necrosis factor antagonists), tyrosine kinase inhibitors, current treatment with alkylating agents (chlorambucil), autologous bone marrow transplantation, thalidomide, antithymocyte globulin, extracorporeal photopheresis.\n20. Treatment with prednisone \\>10 mg\u002Fday, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine if within 8 weeks before W0. Cyclophosphamide within \\\u003C 8 weeks of randomization visit (W 1). Rituximab within 6 months of visit (randomization W1).\n21. Unstable (fluctuating) background therapy with mycophenolate mofetil or methotrexate in the last 8 weeks.\n22. Patients with chronic liver disease (Child-Pugh A, B, C hepatic impairment).\n23. Active or significant history of infection, including treatment with intravenous antibiotics within the last 4 weeks or oral antibiotics within 2 weeks before screening. Including active confirmed tuberculosis or latent tuberculosis without chemoprophylaxis following applicable local recommendations. Active infection with HBV, HCV, Herpes-Zoster virus in the last 12 months. Human Immunodeficiency Virus (HIV) infection.\n24. A positive result of the SARS-CoV-2 PCR test during the \"0\" visit is an exclusion criterion, while a history of infection more than 4 weeks before the screening tests and confirmed by a negative SARS-CoV-2 PCR test is not an exclusion criterion.\n25. Active or history of malignancy, except for excised\u002Fcured local basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n26. Active or past drug or alcohol abuse.\n27. The inability to understand and comply with the requirements of the protocol (lack of compliance) excludes from participation in the study.","74 Years",{"count":51,"type":21},86,[53],"PHASE3","The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.",[56,57],"Systemic Sclerosis","Interstitial Lung Disease",[59,60,61,62,63],"systemic sclerosis","ILD","tocilizumab","nintedanib","combination therapy","2026-04-07",{"date":66,"type":32},"2026-04-08",{"date":68,"type":32},"2025-07-01",{"date":70,"type":21},"2028-03-30",{"name":38,"class":39},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100514416","phase-2-study-of-the-effectiveness-of-treatment-of-sarcopenia-with-the-use-of-a-medicinal-product-nandrolone-comprehensive-physiotherapy-and-diet-100514416","NCT05978206","Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet","Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Nandrolone Decanoate Therapy and Therapy With Complex Physiotherapy and Diet in the Treatment of Sarcopenia","SARKOPENIA","Inclusion Criteria:\n\n1. individuals aged 60 years or older through 99 years of age.\n2. Patients meeting the following criteria diagnosed with sarcopenia based on EWGSOP 2 criteria from 2019:\n\n   * weakness of muscle strength measured by hand dynamometer ( \\\u003C 27 kg for men and 16 kg for women) and\n   * reduction in densitometry:\n\n     * upper and lower limb muscle mass (ASMM)(below 7.0 kg\u002Fm2 height in men and 5.5 kg\u002Fm2 in women) or\n     * total muscle mass of the arms and legs in men less than 20 kg and less than 15 kg in women).\n\nExclusion Criteria:\n\n1. Mini-Mental State Examination (MMSE) score less than 24;\n2. malignant neoplasm, lymphoproliferative or myeloproliferative disorders requiring oncologic or palliative treatment and the period before: 5 years in the case of: malignant melanoma, leukemia, Hodgkin's disease, malignant lymphomas, kidney tumors, 12 months in the case of other malignant neoplasms after the completion of surgery, chemotherapy or radiotherapy;\n3. history of oncologic diagnosis of focal lesions in the prostate gland;\n4. acute and chronic inflammatory diseases of the gastrointestinal tract that present with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.);\n5. uncompensated hyper- or hypothyroidism;\n6. recent history of myocardial infarction or stroke (up to 4 weeks prior to study entry); history of thromboembolism (up to 6 months prior to study entry) or recurrent thromboembolism;\n7. poorly controlled hypertension;\n8. liver impairment (AST and\u002For ALT \\> 3x normal: AST\\> 111 U\u002Fl and ALT\\> 123 U\u002Fl); 9 Acute kidney injury and\u002For chronic kidney disease (stage G4 and G5);\n\n10\\. nephrotic syndrome, acute or chronic glomerulonephritis; 11. advanced circulatory failure (NYHA stages III and IV); 12. Acute and chronic respiratory failure requiring oxygen therapy; 13. Amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, dystrophies, spinal muscular atrophy type IV, primary muscular disorders (ICD-10 G71), toxic-field myopathies, myopathies in the course of infectious and parasitic diseases. Epilepsy; 14. need for treatment during the study period:\n\n* systemic corticosteroids for more than 3 weeks at a dose equivalent to greater than or equal to 5 mg prednisone;\n* hormone replacement therapy,\n* 5-alpha reductase inhibitors,\n* aromatase inhibitors,\n* anti-estrogenic hormonal drugs with anabolic effects other than nandrolone decanoate,\n* megestrol. 15. Lack of informed consent for participation in the study.","60 Years","99 Years",{"count":83,"type":21},168,[85],"PHASE2","This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia).\n\nPatients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention.\n\nThere will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule.\n\nIt is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (\\\u003C 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg\u002Fm2 height in men and 5.5 kg\u002Fm2 in women) or total muscle mass of the upper and lower extremities (\\\u003C 20 kg in men and \\\u003C 15 kg in women) by densitometry.",[88],"Sarcopenia",{"date":66,"type":32},{"date":91,"type":32},"2023-08-10",{"date":93,"type":21},"2026-12-30",{"name":38,"class":39},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":40},"100517003","phase-2-study-of-the-efficacy-and-safety-of-etanercept-treatment-in-patients-with-sapho-syndrome-100517003","NCT06011889","Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome","A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome","SAPHO","Inclusion Criteria:\n\n1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.\n2. Age over 18.\n3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.\n4. Expressing informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. According to the Summary of Product Characteristics (SmPC) for Enbrel.\n2. Pregnancy, breastfeeding, inability to use effective contraception during the examination.\n3. Change in the dose of NSAIDs treatment in the last 4 weeks.\n4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.\n5. Use of biological drugs \u002F synthetic targeted drugs in the last 12 weeks.\n6. Use of corticosteroids (orally or local injections), bisphosphonates and\u002For antibiotics in the last 4 weeks.\n7. Any medical condition that the investigator judges to contraindicate etanercept treatment.",{"count":104,"type":21},60,[85,53],"The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and\u002For classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.",[108],"SAPHO Syndrome",{"date":110,"type":32},"2026-04-13",{"date":112,"type":32},"2024-09-04",{"date":114,"type":21},"2028-10-18",{"name":38,"class":39},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":40},"100611591","effect-of-physical-exercise-and-neuromodulation-on-pain-sleep-and-fatigue-in-patients-with-fibromyalgia-100611591","NCT07242573","Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia","Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 20 and 80 years\n* Confirmed diagnosis of fibromyalgia\n* Presence of chronic fatigue symptoms\n* Stable health condition\n* Presence of sleep disturbances\n* Ability to provide written informed consent and cooperate during the study\n\nExclusion Criteria:\n\n* Lack of informed consent or cooperation\n* Refusal to undergo procedures beyond standard NFZ physiotherapy\n* Cancer\n* Neurological disorders (e.g., neuralgia, multiple sclerosis, diabetic polyneuropathy, stroke)\n* Diagnosed dementia or cognitive impairment\n* Implanted electronic devices (e.g., pacemaker)\n* Internal bleeding or acute febrile illness\n* Acute thrombophlebitis\n* Hysteria or electric phobia\n* Neurotic addiction to stimulation\n* Infectious skin diseases (e.g., mycosis, purulent dermatitis)\n* Inability to communicate in Polish sufficiently to complete questionnaires or follow instructions","20 Years","80 Years",{"count":126,"type":21},75,[128],"NA","Fibromyalgia (FMS) is a chronic, multifactorial syndrome characterized by widespread pain, fatigue, and cognitive disturbances. This interventional study evaluates the impact of structured physical training using diagnostic-training devices (Zebris treadmill and Alfa balance platform) and transcutaneous neuromodulation (NESA X-Signal) on pain, sleep quality, and overall health status in patients with fibromyalgia and chronic fatigue symptom.\n\nParticipants are allocated into three groups:\n\n1. Physical training + conventional physiotherapy,\n2. Transcutaneous neuromodulation + conventional physiotherapy,\n3. Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.",[131,132],"Fibromyalgia","Chronic Fatigue Syndrome (CFS)",[131,134,135,136,137,138,139,140,141,142,143],"Rehabilitation","Sleep Quality","Pain Management","Exercise Therapy","NESA X-Signal","Transcutaneous Electrical Stimulation","Neuromodulation","Physiotherapy","Physical Training","Chronic Fatigue Syndrome","2026-02-20",{"date":146,"type":32},"2026-02-24",{"date":148,"type":32},"2025-11-01",{"date":150,"type":21},"2027-12-15",{"name":38,"class":39},""]