[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arthralgia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arthralgia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,57,85,111,141,164,197],{"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":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100624462","multicomponent-care-for-aromatase-inhibitor-related-musculoskeletal-symptoms-100624462",false,"NCT07409948","Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms","Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial","AIMSS-CARE","Inclusion Criteria:\n\n1. Pathologically confirmed hormone receptor-positive (HR+) breast cancer.\n2. Aged 18 years or older.\n3. Currently receiving aromatase inhibitor therapy (e.g., anastrozole, letrozole, or exemestane) for at least 2 months.\n4. Experiencing aromatase inhibitor-induced musculoskeletal symptoms, defined as a worst joint pain score ≥ 2\u002F10 on the Brief Pain Inventory (BPI) during the past 7 days.\n5. Capable of understanding the study and willing to sign informed consent.\n\nExclusion Criteria:\n\n1. History of fracture or major surgery within the past 6 months.\n2. Patients diagnosed with arthritis (e.g., rheumatoid arthritis).\n3. Patients diagnosed with osteoporosis according to WHO criteria (T-score -2.5).\n4. Recurrent or metastatic breast cancer, or receipt of chemotherapy or radiotherapy during the study period.\n5. Presence of other primary malignancies.\n6. Patients with severe heart, brain, liver, or kidney dysfunction, or infectious diseases.\n7. Patients with severe mental, cognitive, or behavioral disorders that hinder understanding or participation in the study.","FEMALE","18 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24],"NA","Breast cancer patients who receive endocrine therapy particularly aromatase inhibitors often experience aromatase inhibitors associated symptoms (AIMSS) such as joint and muscle pain along with stiffness and fatigue that can disrupt with daily activities and lead some patients to stop treatment early. A structured intervention program named AIMSS-CARE (Aromatase Inhibitor-associated Musculoskeletal Symptoms-Comprehensive Adapted Rehabilitation Evaluation) developed in China that combines exercise, education, symptom monitoring, and follow-up has been shown to reduce these symptoms and improve treatment adherence.\n\nThis study will adapt this program for use in Ethiopia while testing its effectiveness to enhance pain management, treatment adherence and quality of life among Ethiopian breast cancer patients receiving endocrine therapy. The study will be conducted at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia.\n\nEighty-eight patients will be randomly assigned to either the adapted intervention program or usual care. The research will also examine the feasibility and acceptability of the intervention to patients and healthcare providers, and what factors influence its successful implementation. Results will help determine whether this program can be used more widely in Ethiopia and other African cancer centers.",[27,28,29,30,31,32],"Breast Neoplasms","Musculoskeletal Pain","Arthralgia","Musculoskeletal Diseases","Pain","Fatigue Syndrome, Chronic",[34,35,36,37,38,39,40,41,42,43,44],"Breast neoplasms","Aromatase inhibitors","endocrine therapy","Randomized controlled trial","pain","quality of life","fatigue","treatment adherence","musculoskeletal symptoms","symptom monitoring","exercise and rehabilitation","NOT_YET_RECRUITING","2026-02-07",{"date":48,"type":49},"2026-02-13","ACTUAL",{"date":51,"type":21},"2026-03-15",{"date":53,"type":21},"2026-11",{"name":55,"class":56},"Addis Ababa University","OTHER",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100493286","phase-3-web-based-pain-coping-skills-training-for-breast-cancer-survivors-with-ai-associated-arthralgia-100493286","NCT05703178","Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia","Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female sex\n* Aged 18 years old or older\n* Diagnosed with Stage 0-III hormone receptor positive breast cancer\n* Completed primary cancer treatment (surgery, chemotherapy, and\u002For radiation therapy)\n* Postmenopausal\n* Currently taking AI therapy (letrozole, exemestane, or anastrozole)\n* Reporting musculoskeletal pain that developed or worsened since starting AI therapy\n* Reporting at least 15 days of pain in the past 30 days\n* A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week\n* Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol\n* ECOG performance status of 0-2\n* English proficient\n* If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic)\n* Comfortable using a tablet computer, a computer, or a smartphone to access online training\n\nExclusion Criteria:\n\n* Evidence of metastatic disease\n* Other active cancer (with the exception of non-melanoma skin cancer)\n* Completed chemotherapy or radiation therapy less than four weeks prior to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously)\n* Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team\n* Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing\u002Fvision)",{"count":65,"type":21},452,[67],"PHASE3","The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are:\n\n1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives.\n2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications.\n3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain.\n4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats.\n\nParticipants can complete all parts of the study at home. They will:\n\n1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months.\n2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference.\n3. Use an electronic pill bottle to track their use of their AI medication.\n4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program.\n\nResearch will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.",[70,29,71],"Breast Cancer","Pain, Chronic",[73],"Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments","RECRUITING","2025-07-22",{"date":77,"type":49},"2025-07-25",{"date":79,"type":49},"2023-01-19",{"date":81,"type":21},"2026-11-30",{"name":83,"class":56},"Northwestern University",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100389728","phase-2-immune-mediated-pathophysiology-and-clinical-triage-program-100389728","NCT04354649","Immune-Mediated Pathophysiology And Clinical Triage Program","A Study to Evaluate the Efficacy and Safety Hydroxychloroquine in Immune Related Arthritis or Arthralgias","IMPACT 2","Inclusion Criteria:\n\n1. Patients must be 18 years of age, or older;\n2. Patients must be capable of providing consent to enrolment and treatment.\n3. Patients with a performance status of ECOG 0-2 will be eligible for enrolment (see appendix A).\n4. Patients with histologically confirmed cancer receiving anti-PD1 or anti-PDL1 monoclonal antibody ICI therapy, either alone or in combination with anti-CTLA4 monoclonal antibody ICI therapy who develop CTCAEv5.0 grade ≥2 arthritis or arthralgia that has developed on, or after, ICI therapy and is felt to be treatment related (irAA).\n5. Adequate hepatic and renal function defined by the following laboratory parameters:\n\n   * AST and ALT and alkaline phosphatase ≤ 2.5x ULN,\n   * Total bilirubin ≤ 1.5x ULN,\n   * Serum creatinine ≤ upper limit of institutional normal OR calculated creatinine clearance of ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula.\n6. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n7. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, during the study treatment period and for a period of 3 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. These may include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation. Double-barrier methods may be acceptable in circumstances when highly effective methods cannot be implemented (e.g. male condom with diaphragm, male condom with cervical cap). Note: Contraceptive requirements for the oncology regiments will apply, if they are more stringent than those for this trial. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n8. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last dose of study drug.\n9. Male patients should agree to not donate sperm during the study and for a period of at least 3 months after last dose of study drug.\n10. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion Criteria:\n\n1. History of inflammatory arthritis, including, but not limited to: Rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, Ankylosing spondylitis or other chronic inflammatory arthritis. Note: Patients with a known history of stable osteoarthritis will not be excluded.\n2. Patients with an indication for systemic immunosuppressive medications or corticosteroids. Patients with CTCAEv5.0 grade ≥2 irAE's other than irIAA (ie. colitis, pneumonitis, rash, etc) are not eligible for trial, with the exception of endocrinopathies that are being treated with hormone replacement alone and not systemic immunosuppressive medications or corticosteroids.\n3. Patients weighing \\\u003C 40 kg.\n4. Patients with G6PD deficiency, porphyria or psoriasis.\n5. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n6. Prolonged corrected QT interval or concurrent medications that prolong QT interval.\n7. Diagnosis of immunodeficiency.\n8. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n9. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAEv5.0 Grade ≥ 3).\n10. Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.","ALL",{"count":95,"type":21},46,[97],"PHASE2","Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment.\n\nThe usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment.\n\nHydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition.\n\nThe purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.\n\nThis is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.",[100,29],"Arthritis","2025-06-16",{"date":103,"type":49},"2025-06-18",{"date":105,"type":49},"2021-09-16",{"date":107,"type":21},"2029-07",{"name":109,"class":56},"AHS Cancer Control Alberta",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":93,"minAge":4,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100400452","phase-2-an-intravenous-iv-zanamivir-pharmacokinetics-pk-study-in-hospitalized-neonates-and-infants-with-influenza-infection-100400452","NCT04494412","An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection","An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection","Inclusion Criteria:\n\n* Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. Preterm neonates and infants will be eligible for inclusion but must have reached PMA of at least 28 weeks.\n* Participants who are hospitalized with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative Reverse transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential for improvement Participants with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR.\n* Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). (applicable only for Netherlands)\n* Body weight \\>=1 kilograms (kg).\n* No gender restriction.\n* LAR of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, Independent Ethics Committees \\[IECs\\] or local laws).\n\nExclusion criteria:\n\n* Participants who are known or suspected to be hypersensitive to any component of the study medication.\n* Participants with a disease process which is likely to be irreversible.\n* Liver function:\n\n  * Participants who meet the following criteria at Baseline:\n\n    1. Alanine transaminase (ALT) \\>=3 times upper limit of normal (ULN) with bilirubin \\>=2 times ULN\n    2. or isolated bilirubin \\>=2 times ULN and \\>50 percent (%) direct bilirubin\n    3. or ALT \\>=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor.\n  * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain).\n* Participants who require concurrent therapy with another anti influenza drug.\n* Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.\n* Child in care (CiC), as defined below:\n\n  * A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.\n  * The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.\n* Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration.\n* Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening","6 Months",{"count":120,"type":21},12,[97],"Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.",[124,29],"Influenza, Human",[126,127,128,129],"Human influenza","Zanamivir","Pediatric","Hospitalized neonates and infants","2025-03-14",{"date":132,"type":49},"2025-03-17",{"date":134,"type":49},"2022-11-21",{"date":136,"type":21},"2026-04-30",{"name":138,"class":139},"GlaxoSmithKline","INDUSTRY",9,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":110},"100573445","effect-of-a-specific-hand-intervention-in-women-with-arthralgia-secondary-to-hormone-therapy-following-breast-cancer-100573445","NCT06746376","Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.","Effect of a Specific Hand Intervention Program With Strength and Manipulative Dexterity Exercises in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.","Inclusion Criteria\n\nExperiencing hand arthralgia as a result of hormone therapy (aromatase inhibitors or tamoxifen) following breast cancer.\n\nAbility to communicate pain levels effectively. Ability to follow simple instructions to participate in the intervention and assessments.\n\nExclusion Criteria Participants requiring any medication changes during the study period that could influence pain levels (increase or decrease).\n\nConcurrent physiotherapy or occupational therapy specifically targeting the hand during the study.\n\nPre-existing diagnosis of arthritis or osteoarthritis in the hand before starting hormone therapy.\n\nPresence of systemic diseases associated with hand arthralgia. Neurological conditions affecting hand movement.",true,"65 Years",{"count":151,"type":21},32,[24],"This study aims to evaluate the impact of a 12-week hand exercise program on pain, manual dexterity, and hand function in women experiencing hand joint pain (arthralgia) due to hormone therapy after breast cancer. Participants will be randomly assigned to either an intervention group, where they will perform specific hand exercises, or a control group, which will not receive any exercise program. Pain levels, hand function, and manual dexterity will be assessed before and after the intervention using questionnaires and functional tests. The goal is to determine whether targeted hand exercises can improve pain and daily hand use in this population.",[29],"2024-12-17",{"date":157,"type":49},"2024-12-24",{"date":159,"type":21},"2025-04-01",{"date":161,"type":21},"2025-11-01",{"name":163,"class":56},"Universidad Europea de Madrid",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":148,"sex":17,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":183,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":110},"100556849","phase-2-the-muse-study-for-menopausal-arthralgia-100556849","NCT06530459","The MUSE Study for Menopausal Arthralgia","The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia","MUSE","INCLUSION CRITERIA:\n\n1. Patients with muscle stiffness and joint discomfort in various sites, including hands, knees, back, hips, and\u002For shoulders. Patients with pain in only one isolated joint would not be accepted.\n2. Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause).\n3. Women should be at the menopause transition, less than or equal to 59 years old at the time of enrollment, or within 5 years of menopause whichever is earlier.\n\n   .\n4. Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)\n5. Community-dwelling and able to ambulate independently.\n\nEXCLUSION CRITERIA:\n\n1. History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions.\n2. Pregnancy\n3. Non-adherence to national guidelines for breast cancer screening\n4. High risk for breast cancer\n5. Any joint surgery within the last 6 months\n6. Severe obesity: BMI\\>35\n7. Migraine with aura\n8. Poorly controlled diabetes\n9. Use of any form of female hormone supplementation within the past 12 weeks.\n10. High venous thromboembolism risk\n11. Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding.\n12. Current smoker.\n13. History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers.\n14. Receiving treatment for any form of cancer.\n15. History of fragility bone fractures within the 2 years.\n16. Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.","30 Years","59 Years",{"count":175,"type":21},100,[97,67],"The investigators plan to conduct a pilot 4-arm, randomized study comprising the following interventions: muscle strengthening exercises (MSE) alone, estrogen therapy (ET) alone, and a combination of MSE and ET, compared to usual care in women with menopausal arthralgia. The aim of this pilot study is to assess the feasibility, patient acceptability, and patient perspectives and logistics of delivering interventions, and practicability of outcome assessment tools in this 4-arm study over a 12-week period.",[29,179,180,181,182],"Menopause","Perimenopausal Disorder","Joint Pain","Postmenopausal Disorder",[184,185,186,37,187],"Menopausal hormone therapy","Muscle strength","Exercise","Midlife women","2024-07-26",{"date":190,"type":49},"2024-07-31",{"date":192,"type":21},"2024-08-01",{"date":194,"type":21},"2028-04",{"name":196,"class":56},"National University Hospital, Singapore",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":93,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100526385","finding-the-optimal-aim-of-correction-in-opening-wedge-high-tibial-osteotomy-100526385","NCT06134050","Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy","Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy Using 3D Printed Patient-specific Instrumentation (PSI). An RCT Comparing Correction Aimed at 62% Versus 55%.","Inclusion Criteria:\n\n* Patients having accepted and signed the informed consent form before surgery\n* Patients aged 30-60 years\n* Patients with an indication for primary HTO based on anamnestic, clinical and radiological findings leading to the diagnosis of major medial knee compartment overload symptoms\n* Mechanical varus axis of 3-9 deg. (calculated on full length weightbearing X-ray (FLWB))\n* Correctable angular deformity on the tibia only (medial proximal tibial angle (MPTA) + planned correction \\\u003C 95 deg. Lateral distal femoral angle (LDFA) \\\u003C92 deg.)\n* Maximal calculated gap height 14 mm\n* Only the first knee will be included if later contralateral HTO\n\nExclusion Criteria:\n\n* Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)\n* Patients using Prednisolone perorally\n* Smokers (need to quit preoperatively)\n* Significant overweight (Body Mass Index \\> 35)\n* Earlier fractures in affected leg with fracture malalignment \\>5 deg.\n* Extension deficit \\>10 deg. in the affected knee\n* Earlier septic arthritis\u002Fosteomyelitis in the affected leg\n* Previous major surgery affecting leg function. Earlier knee arthroscopic procedures like ACL-reconstruction are not excluded\n* Planned combined procedures involving HTO + ACL\u002FPCL-reconstruction, meniscal transplantation or meniscal root fixation is excluded\n* Neurologic disease with symptoms affecting the leg\n* Serious illness or other factors that make communication, follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease, non-Norwegian speakers).","20 Years","60 Years",{"count":207,"type":21},70,[24],"The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55% correction is non-inferior to aiming at 62%.",[211,212,29],"Osteoarthritis, Knee","Knee Pain Chronic",[214,215,216,217,218,219,220,221,222,223,224,225],"osteotomy","knee","osteoarthritis","3D print","PSI","High tibial osteotomy","Knee overload","Inertial measurement units","IMU","wearable sensors","gait analysis","accelerometer","2023-11-10",{"date":228,"type":49},"2023-11-18",{"date":230,"type":21},"2023-11",{"date":232,"type":21},"2028-10",{"name":234,"class":56},"Vestre Viken Hospital Trust"]