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1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial. primaryPurpose: PREVENTION masking: NONE count: 1028 type: ESTIMATED name: Trelegy Ellipta 100/62.5/25Mcg Inh 30D name: Brimica name: Duaklir name: Ultibro name: Ulunar name: Xoterna name: Anoro name: Laventair name: Spiolto Respimat name: Yanimo name: Foradil name: Broncoral name: Formoterol stada name: Oxis name: Formatris name: Formoterol Aldo name: Onbrez name: Oslif name: Hirobriz name: Striverdi name: Beglan name: Betamican name: Inaspir name: Serevent name: Soltel name: Eklira name: Bretaris name: Seebri name: Tovanor name: Enurev name: Spiriva name: Tavulus name: Sirkava name: Braltus name: Gregal name: Incruse name: Rolufta measure: Clinical Control (CC) measure: Clinical Important Deterioration (CID) measure: Patients persistently controlled measure: Time to deterioration measure: Time to no control event of CC - Stability Domain measure: Time to no control event of CC - Impact Domain measure: Time to deterioration event of CID-CAT Exacerbations measure: Time to deterioration event of CID-CAT Spirometry measure: Exacerbation rate measure: Time to first Exacerbation measure: Spirometry changes measure: Independent predictors sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic Barcelona status: RECRUITING city: Barcelona state: Catalunya zip: 08036 country: Spain name: Àlvar Agustí role: CONTACT phone: 93 227 57 79 email: aagusti@clinic.cat name: Nestor Soler role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06282848 id: HongKongPU_Optometry4 briefTitle: Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate overallStatus: RECRUITING date: 2024-01-01 date: 2026-12 date: 2026-12 date: 2024-02-28 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER name: The University of Hong Kong briefSummary: The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:
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* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
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* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.
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Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.
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Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double-blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Atropine 0.05% name: DIMS lens measure: Subjective refraction measure: Axial length measure: mfERG responses measure: Retinal and choroidal thickness sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD facility: School of Optometry, Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 00000 country: Hong Kong name: Henry HL Chan, PhD role: CONTACT phone: 85227667937 email: henryhl.chan@polyu.edu.hk name: Kaiyip Choi, PhD role: CONTACT phone: 85234002934 email: kaiyip.choi@polyu.edu.hk lat: 22.27832 lon: 114.17469 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-02 uploadDate: 2024-02-21T22:59 filename: ICF_000.pdf size: 234773 hasResults: False
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<|newrecord|> nctId: NCT06282835 id: 2023KY242 briefTitle: Eravacycline Combination Therapy for MRAB overallStatus: RECRUITING date: 2024-01-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Fujian Medical University Union Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.
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Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time conditions: Pulmonary Infection conditions: Pneumonia, Bacterial conditions: Acinetobacter Baumannii studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Eravacycline Injection measure: Clinical Responded Rate measure: The microbiological clearance rate measure: The all-cause mortality rate within 28 days measure: "Incidence Rate of Adverse Event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350000 country: China name: Hui Zhang, Phd role: CONTACT phone: 13015723860 email: xhzh@fjmu.edu.cn lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06282822 id: HFpEF-SWE briefTitle: Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2025-03-01 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF. conditions: Shear Wave Elastography conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Transthoracic echocardiography measure: Shear wave velocity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282809 id: CSP3325 briefTitle: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy acronym: GANNON overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-01 date: 2024-02-28 date: 2024-04-11 name: HistoSonics, Inc. class: INDUSTRY briefSummary: The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy. conditions: Pancreas Cancer conditions: Adenocarcinoma of the Pancreas conditions: Pancreatic Cancer conditions: Tumor of Pancreas studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multi-center, single-arm, feasibility trial. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy measure: Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de la Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06282796 id: EPW-CABC-01 briefTitle: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Echocardiography measure: Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. measure: Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Weiqin Huang role: CONTACT lat: 26.06139 lon: 119.30611 facility: Dalian Friendship Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Bo Zhang role: CONTACT lat: 38.91222 lon: 121.60222 facility: Dalian Municipal Central Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Qingxiong Yue role: CONTACT lat: 38.91222 lon: 121.60222 facility: Liaoning Cancer Hospital & Institute status: RECRUITING city: Shenyang state: Liaoning country: China name: Xiaoxue Zhang role: CONTACT lat: 41.79222 lon: 123.43278 facility: The Third People's Hospital Of Chengdu status: RECRUITING city: Chengdu state: Sichuan country: China name: Min Xu role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06282783 id: 2024-511532-27-00 briefTitle: Studying Topiramate for Re-Activating the HIV-1 Reservoir acronym: STAR overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-04 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.
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So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.
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Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone. conditions: HIV-1-infection conditions: Hiv conditions: HIV Infections conditions: HIV I Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Topiramate measure: Effect of topiramate as measured by cell-associated HIV RNA measure: Number of treatment-related adverse events as assessed by CTCAE v4.0 measure: Influence of sex on the primary outcome measures measure: The effect of topiramate on the size of the HIV reservoir measured by relevant assays sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Centre city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06282770 id: IRB#23-000444 briefTitle: Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery overallStatus: RECRUITING date: 2023-07-01 date: 2024-07-01 date: 2025-07-01 date: 2024-02-28 date: 2024-02-28 name: University of California, Los Angeles class: OTHER briefSummary: After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.
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Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace. conditions: Spinal Fusion conditions: Chronic Lower Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Laser Diode Brace name: Sham Laser Diode Brace measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI measure: Stony Brook Scar Evaluation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semel Institute of Neuroscience at UCLA status: RECRUITING city: Los Angeles state: California zip: 90024 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Mark Yamamoto, BS role: CONTACT phone: 424-535-9634 email: MTYamamoto@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: UCLA Clinical and Translational Research Center status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Adreanne Rivera, BS role: CONTACT phone: 424-946-5712 email: adreannerivera@mednet.ucla.edu lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06282757 id: 202302 briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-02-28 date: 2024-03-07 name: HAN University of Applied Sciences class: OTHER briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.
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Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP
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Study design: Web-based randomized controlled trial.
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Study population: 100 participants
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Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.
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Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). conditions: Communication conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Video placebo communication name: Video nocebo communication measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in openness to VR measured using a single question measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HAN University of Applied Sciences city: Nijmegen state: Overijssel zip: 6525EN country: Netherlands name: Syl Slatman, MSc role: CONTACT phone: +31629684200 email: syl.slatman@han.nl lat: 51.8425 lon: 5.85278 hasResults: False
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<|newrecord|> nctId: NCT06282744 id: OPTIMAL Arabic version briefTitle: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log acronym: OPTIMAL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03 date: 2024-04 date: 2024-02-28 date: 2024-02-28 name: Cairo University class: OTHER briefSummary: Purpose of the study:
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To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language. conditions: Physical Performance conditions: Outpatients studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 880 type: ESTIMATED name: Outpatient physical therapy improvement in movement assessment log measure: validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282731 id: ECKIRB1020407 briefTitle: The Changes of Urine Growth Factors Level overallStatus: COMPLETED date: 2013-05-31 date: 2016-09-01 date: 2017-04-27 date: 2024-02-28 date: 2024-02-28 name: En Chu Kong Hospital class: OTHER briefSummary: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 74 type: ACTUAL name: Silodosin measure: Urine growth factors level measure: Urine growth factors level measure: Urine growth factors level sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: En Chu Kong Hospital city: New Taipei City zip: 23702 country: Taiwan lat: 25.01111 lon: 121.44583 hasResults: False
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<|newrecord|> nctId: NCT06282718 id: POS-ARI-PC CORE and AUDIT id: 965313 type: OTHER_GRANT domain: European Union id: 10204126 type: REGISTRY domain: ISRCTN id: 55487 type: OTHER domain: NIHR CPMS id: 324504 type: OTHER domain: IRAS briefTitle: A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe acronym: POS-ARI-PC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-03 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: European Clinical Research Alliance for Infectious Diseases (ECRAID) class: OTHER name: UMC Utrecht name: University of Oxford name: Universiteit Antwerpen briefSummary: Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC. conditions: Acute Respiratory Tract Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Age Bands measure: The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI) measure: Overall illness severity rating measure: Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens. measure: Proportion undergoing POC (with results) and lab-based investigations measure: Details of prescriptions given on presentation of ARI measure: Details of tests ordered on presentation of ARI measure: Return to usual daily activities measure: Feeling recovered from RTI measure: Use of prescription medication measure: Use of over the counter medications measure: Complications reported associated to ARI presentation measure: Variation in practice and advice from national guidelines, to be fed back to national teams measure: Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients. measure: An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings. measure: An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials measure: Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282705 id: 306347 briefTitle: Dose Response Effect of Drop Jumps on Bone Characteristics overallStatus: COMPLETED date: 2023-01-06 date: 2023-12-13 date: 2023-12-13 date: 2024-02-28 date: 2024-02-28 name: Nottingham Trent University class: OTHER briefSummary: The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.
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The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals? conditions: Healthy Participants conditions: Low Activity Level studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Semi-randomised, matched model. primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ACTUAL name: Diagonal Drop Jumps 0cm name: Diagonal Drop Jumps 40cm name: Diagonal Drop Jumps 60cm measure: BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Peak impact load as assessed by force plates. measure: Impulse as assessed by force plates. measure: Load rate as assessed by force plates. measure: Jump height as assessed by force plates. measure: Centre of Mass (CoM) velocity as assessed by force plates. measure: Peak acceleration as assessed by Inertial measurement units (IMU). measure: Stiffness as assessed by motion capture. measure: Moments as assessed by motion capture. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Nottingham Trent University city: Nottingham state: Nottinghamshire zip: Ng11 8NS country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06282692 id: UNAIR-MP-INAKTIF-R-005 briefTitle: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old overallStatus: RECRUITING date: 2023-06-19 date: 2024-05-19 date: 2024-07-19 date: 2024-02-28 date: 2024-02-28 name: Dr. Soetomo General Hospital class: OTHER_GOV name: Indonesia-MoH name: Universitas Airlangga name: PT Biotis Pharmaceuticals, Indonesia briefSummary: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.
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INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents. conditions: COVID-19 Pandemic conditions: COVID-19 Vaccines studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.
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The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. count: 400 type: ESTIMATED name: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg measure: Vaccine Neutralizing Antibody Profile measure: Incidence of Adverse Events measure: Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum measure: Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA measure: Cellular Immunogenicity Profile measure: Persistence of Antibody Level measure: Whole Genome Sequencing (WGS) of SARS-CoV-2 sex: FEMALE minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Dr. Soetomo General Hospital status: RECRUITING city: Surabaya state: Jawa Timur zip: 67161 country: Indonesia name: Dominicus Husada, MD role: CONTACT phone: +6281232266377 email: dominicushusada@yahoo.com name: Damayanti Tinduh, MD role: CONTACT phone: +6281703293335 email: damayanti.tinduh@fk.unair.ac.id name: Dominicus Husada, MD role: PRINCIPAL_INVESTIGATOR name: Damayanti Tinduh, MD role: SUB_INVESTIGATOR name: Gatot Soegiarto, MD role: SUB_INVESTIGATOR name: Leny Kartina, MD role: SUB_INVESTIGATOR name: Laksmi Wulandari, MD role: SUB_INVESTIGATOR name: Deasy Fetarayani, MD role: SUB_INVESTIGATOR name: Novira Widajanti, MD role: SUB_INVESTIGATOR name: Yudi H Oktaviano, MD role: SUB_INVESTIGATOR name: Aryati Aryati, MD role: SUB_INVESTIGATOR name: Fitriah Munawaroh, MD role: SUB_INVESTIGATOR name: Neneng D Kurniati, MD role: SUB_INVESTIGATOR name: Budi Utomo, MD role: SUB_INVESTIGATOR name: Eko B Khoendori, MD role: SUB_INVESTIGATOR name: Jusak Nugroho, MD role: SUB_INVESTIGATOR name: Maria I Lusida, MD role: SUB_INVESTIGATOR lat: -7.24917 lon: 112.75083 hasResults: False
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<|newrecord|> nctId: NCT06282679 id: KY20220701-03 briefTitle: Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea overallStatus: RECRUITING date: 2022-04-01 date: 2024-03-01 date: 2024-06-28 date: 2024-02-28 date: 2024-02-28 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea. conditions: Rosacea conditions: Botulinum Toxin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Botulinum Toxin Type A Injection [Botox] measure: CEA score measure: GAIS score measure: VISIA red zone score measure: Dermatology Quality of Life Score (DLQI) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jie Dai status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: jie dai role: CONTACT phone: 02552271117 email: karry_dj@126.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06282666 id: KE-0254/150/2019 briefTitle: Lumbar ESPB in Hip Replacement Surgery acronym: ESPB_HIP overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02-01 date: 2025-08-01 date: 2024-02-28 date: 2024-02-28 name: Medical University of Lublin class: OTHER briefSummary: In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed. conditions: Coxarthrosis conditions: Pain, Postoperative conditions: Pain, Acute conditions: Pain, Chronic conditions: Postoperative Pain, Chronic conditions: Analgesia conditions: Quality of Life conditions: Anesthesia conditions: Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups will be randomly allocated to Epidural and ESPB (1:1) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.
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Physiotherapists assessing outcomes will not be aware of patient allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Spinal anesthesia name: lumbar erector spinae plane block name: Epidural analgesia name: patient-controlled analgesia name: Timed Up and Go test name: neuropathic pain symptom inventory name: Lovett test name: Visual analog scale name: Quality of Recovery 40 name: Ability to sit, stand upright, and walk measure: Opiod consumtion with PCA measure: Pain at rest measure: Pain upon activity measure: Lovett test measure: TUG measure: QoR-40 measure: NPSI sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: II Department of Anesthesia and Intensive Care city: Lublin zip: 20-081 country: Poland name: Michał A Borys, M.D. Ph.D role: CONTACT phone: 506350569 phoneExt: +48 email: michalborys1@gmail.com name: Paweł Kutnik, M.D. role: CONTACT phone: 608769410 phoneExt: +48 email: pe.kutnik@gmail.com lat: 51.25 lon: 22.56667 hasResults: False
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<|newrecord|> nctId: NCT06282653 id: Endo-ergonomics briefTitle: Postural and Muscle Fatigue Analysis of Endodontic Residents overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-11-01 date: 2024-02-28 date: 2024-02-28 name: Universidad Europea de Madrid class: OTHER briefSummary: Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA). conditions: Musculoskeletal System Disease conditions: Position Sense Disorders conditions: Symptoms and Signs conditions: Postural; Defect conditions: Endodontic Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 10 type: ESTIMATED measure: Symptom Perception sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Europea de Madrid status: RECRUITING city: Villaviciosa De Odón state: Madrid country: Spain name: Antonio Conde, PhD role: CONTACT lat: 40.35692 lon: -3.90011 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-20 uploadDate: 2024-02-20T05:22 filename: Prot_000.pdf size: 96217 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-20 uploadDate: 2024-02-20T05:30 filename: ICF_001.pdf size: 77805 hasResults: False
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<|newrecord|> nctId: NCT06282640 id: 567 briefTitle: Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome overallStatus: COMPLETED date: 2021-12-30 date: 2022-06-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: Dr. Ayşe Güç class: OTHER_GOV name: Kayseri City Hospital briefSummary: Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. conditions: Carpal Tunnel Syndrome conditions: Vitamin D Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 87 type: ACTUAL name: Vitamin D measure: electrophysiological scale. measure: monofilament test measure: Boston symptom severity scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kayseri City Hospital city: Kayseri country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06282627 id: 10430012010023 briefTitle: The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients acronym: COVID-HOME overallStatus: COMPLETED date: 2020-03-20 date: 2022-07-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: University Medical Center Groningen class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.
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The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.
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Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status. conditions: COVID-19 conditions: Post-COVID-19 Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ACTUAL name: Observational study measure: SARS-CoV-2 infection measure: Long-term sequelae sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06282614 id: MUCO245 id: 2023-A02081-44 type: OTHER domain: ID-RCB briefTitle: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer acronym: MOVHYDA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-01 date: 2024-02-28 date: 2024-02-28 name: Biocodex class: INDUSTRY name: Voisin Consulting Life Science (VCLS) briefSummary: The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness. conditions: Vaginal Dryness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, multicenter (France), open label without comparator study primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Mucogyne Ovule measure: Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness measure: Assessment of the patient's sexual function measure: Assessment of the patient's satisfaction measure: Assessment of changes in patient's clinical status measure: Assessment by investigator of changes in patient's clinical status measure: Assessment of the safety of MUCOGYNE® Ovule measure: Assessment of the device deficiencies of MUCOGYNE® Ovule measure: Assessment of the usability of MUCOGYNE® Ovule sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JEAN Christian's medical office city: Nogent-sur-Marne zip: 94130 country: France lat: 48.83333 lon: 2.48333 facility: Dr Ramez GHADRI's medical office city: Orléans zip: 45100 country: France name: Ramez GHADRI, MD role: CONTACT name: Ramez GHADRI, MD role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Dr Raïssa APERANO-MAS's medical office city: Rennes zip: 35000 country: France name: Raïssa APERANO-MAS, MD role: CONTACT name: Raïssa APERANO-MAS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 hasResults: False
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<|newrecord|> nctId: NCT06282601 id: GUIGOU - Defaye 2023 briefTitle: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS acronym: AMORCAGE MUSIC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.
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However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.
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In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.
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This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children. conditions: Presbyacousie studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 27 type: ESTIMATED name: Audiogram name: Musical priming for the syntax test name: Test MMSE name: Barcelona Music Reward Questionnaire measure: linguistic performance test focusing on syntax. sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282588 id: CTO21042GZA briefTitle: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers acronym: THUNDER overallStatus: RECRUITING date: 2023-12-13 date: 2030-07-31 date: 2030-12-31 date: 2024-02-28 date: 2024-02-28 name: Cancer Research Antwerp class: OTHER name: Bayer name: Veracyte, Inc. briefSummary: This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.
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The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.
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The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 2: non randomised, 1 treatment arm, open label Phase 3: randomized 1:1 between two treatment arms, blinded primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Phase 3 trial: blinded Phase 2 trial: open label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 493 type: ESTIMATED name: Darolutamide name: Darolutamide matched placebo name: Radiotherapy name: Zoladex 3.6Mg Implant name: Zoladex LA name: Decapeptyl sustained release 22.5 mg name: Decapeptyl sustained release 11.25 mg name: Depo-Eligard 45 mg name: Depo-Eligard 22.5 mg name: Depo-Eligard 7.5 mg name: Firmagon 120 MG Injection name: Firmagon 80 MG Injection name: Docetaxel measure: Phase 3: PSMA PET metastasis free survival (ppMFS) measure: Phase 2: quality of life (sexual subdomain) measure: Phase 2: quality of life (hormonal subdomain) measure: Overall survival measure: Prostate-cancer specific survival measure: Biochemical progression-free survival measure: Time to next systemic therapy measure: Frequency and severity of adverse events sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GZA Sint-Augustinus status: RECRUITING city: Wilrijk state: Antwerp zip: 2610 country: Belgium name: Piet Ost, MD, PhD role: CONTACT email: cancertrials@gza.be name: Piet Ost role: PRINCIPAL_INVESTIGATOR lat: 51.16734 lon: 4.39513 facility: OLVZ Aalst status: NOT_YET_RECRUITING city: Aalst zip: 9300 country: Belgium name: Samuel Br role: CONTACT name: Samuel Bral role: PRINCIPAL_INVESTIGATOR lat: 50.93604 lon: 4.0355 facility: AZ Sint-Jan status: NOT_YET_RECRUITING city: Brugge zip: 8000 country: Belgium name: Sabine Meersschout role: CONTACT name: Sabine Meersschout role: PRINCIPAL_INVESTIGATOR lat: 51.20892 lon: 3.22424 facility: Saint Luc status: NOT_YET_RECRUITING city: Bruxelles zip: 1200 country: Belgium name: Ad Vanderm role: CONTACT name: Ad Vandermeulen role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: UZA status: NOT_YET_RECRUITING city: Edegem zip: 2600 country: Belgium name: Karen Fransis role: CONTACT name: Karen Fran role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: UZ Gent status: NOT_YET_RECRUITING city: Gent zip: 9000 country: Belgium name: Valérie Fonteyne role: CONTACT name: Valérie Fonteyne role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Sint-Lucas status: NOT_YET_RECRUITING city: Gent zip: 900 country: Belgium name: Lien Van De Voorde role: CONTACT name: Lien Van De Voor role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Groeninge status: NOT_YET_RECRUITING city: Kortrijk zip: 8500 country: Belgium name: Nick Liefhooghe role: CONTACT name: Nick Liefhooghe role: PRINCIPAL_INVESTIGATOR lat: 50.82803 lon: 3.26487 facility: CHU Liège status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Brieuc Suatois role: CONTACT name: Brieuc Sautois role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AZ Delta status: NOT_YET_RECRUITING city: Roeselare zip: 8800 country: Belgium name: Benedikt Engels role: CONTACT name: Benedikt Enge role: PRINCIPAL_INVESTIGATOR lat: 50.94653 lon: 3.12269 facility: VITAZ status: NOT_YET_RECRUITING city: Sint-Niklaas zip: 9100 country: Belgium name: Bart De Troyer role: CONTACT name: Bart De Troyer role: PRINCIPAL_INVESTIGATOR lat: 51.16509 lon: 4.1437 hasResults: False
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<|newrecord|> nctId: NCT06282575 id: JZP598-302 id: 2023-508219-21-00 type: OTHER domain: CTIS briefTitle: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer overallStatus: RECRUITING date: 2024-04-30 date: 2028-07-01 date: 2029-11-01 date: 2024-02-28 date: 2024-04-08 name: Jazz Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. conditions: Biliary Tract Cancer conditions: HER2 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 286 type: ESTIMATED name: Zanidatamab name: Cisplatin name: Gemcitabine name: Pembrolizumab name: Durvalumab measure: Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors measure: Overall survival (OS) in participants with IHC 3+ tumors measure: Progression Free Survival for all participants measure: OS for all participants measure: Number of participants achieving Confirmed objective response rate (cORR) measure: Duration of response (DOR) measure: Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) measure: Maximum serum concentration of Zanidatamab measure: Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab measure: Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30 measure: TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 measure: TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis) measure: TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Cancer Centers, LLP status: RECRUITING city: Lone Tree state: Colorado zip: 80124 country: United States lat: 39.55171 lon: -104.8863 facility: Norton Cancer Institute - Audubon status: NOT_YET_RECRUITING city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 facility: Minnesota Oncology Hematology, P.A. status: RECRUITING city: Maple Grove state: Minnesota zip: 55369 country: United States lat: 45.07246 lon: -93.45579 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Texas Oncology - DFW status: RECRUITING city: Dallas state: Texas zip: 75246 country: United States lat: 32.78306 lon: -96.80667 facility: Hospital Oncologico, Puerto Rico Medical Center status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False
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<|newrecord|> nctId: NCT06282562 id: NL84223.018.23 briefTitle: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients acronym: FeelFit overallStatus: RECRUITING date: 2024-03 date: 2026-08-15 date: 2026-08-15 date: 2024-02-28 date: 2024-03-06 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients. conditions: Brain Tumor, Primary conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: High-Intensity Interval Training (HIIT) measure: Self-reported physical fitness measure: Self-reported fitness measure: VO2max measure: Daily physical activity measure: Health-related quality of life questionnaire measure: Perceived functional impairments measure: Self-efficacy measure: Mastery measure: Brain tumor specific quality of life questionnaire measure: Subjective Happiness measure: Subjective cognitive functioning measure: Subjective cognitive failure measure: Fatigue questionnaire measure: Sleep questionnaire measure: Anxiety questionnaire measure: Self-reported depression questionnaire measure: Depression questionnaire measure: Muscle strength measure: Subjective physical fitness measure: Objective neurocognitive functioning measure: Objective neurological functioning measure: Brain imaging (optional) measure: Brain activity (optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VU University Medical Centers, location VUmc status: RECRUITING city: Amsterdam zip: 1081 HV country: Netherlands name: Marieke Blom, Msc role: CONTACT phone: +31621522442 email: gripopfitheid@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06282549 id: YMC046 briefTitle: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension overallStatus: RECRUITING date: 2022-06-08 date: 2027-03-31 date: 2027-03-31 date: 2024-02-28 date: 2024-02-28 name: Yuhan Corporation class: INDUSTRY briefSummary: This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination. conditions: Essential Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1210 type: ESTIMATED name: Telmisartan/Amlodipine/Chlorthalidone(Truset) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage measure: Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) measure: Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP) measure: Percentage of patients who terminated the treatment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Busan Veterans Hospital status: RECRUITING city: Busan zip: 46996 country: Korea, Republic of name: Jonghyun Choi role: CONTACT lat: 35.10278 lon: 129.04028 facility: Daegu Veterans Hospital status: RECRUITING city: Daegu zip: 42835 country: Korea, Republic of name: Sangwook Kang role: CONTACT lat: 35.87028 lon: 128.59111 facility: Gwangju Veterans Hospital status: RECRUITING city: Gwangju zip: 62284 country: Korea, Republic of name: Seowon Choi role: CONTACT lat: 35.15472 lon: 126.91556 facility: Konkuk University Medical Center status: RECRUITING city: Seoul zip: 05030 country: Korea, Republic of name: Chanhee Kwon role: CONTACT lat: 37.566 lon: 126.9784 facility: Veterans Health Service Medical Center status: RECRUITING city: Seoul zip: 05368 country: Korea, Republic of name: Changhoon Lee role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06282536 id: LungMate-018 briefTitle: Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2029-12 date: 2024-02-28 date: 2024-02-28 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer. conditions: Potentially Resectable ALK Positive Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All enrolled patients received Iruplinalkib neoadjuvant therapy. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Iruplinalkib name: surgery measure: Objective response rate (ORR) measure: Pathologic complete response (PCR) rate measure: Major pathologic response (MPR) rate measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Treatment-related adverse event (TRAE) measure: 5-year overall survival (OS) measure: 1-year event-free survival (EFS) rate measure: Health related quality of life (HRQol) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282523 id: 2023-1773 id: A171600 type: OTHER domain: UW- Madison id: EDUC/COUNSELING PSYCH type: OTHER domain: UW- Madison id: Protocol Version 12/27/23 type: OTHER domain: UW- Madison briefTitle: Healthy Minds Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-04-25 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.
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Participants will complete a four-week well-being program and complete surveys via an app on their phone. Participants can expect to participate in the study for four months. conditions: Depression conditions: Anxiety conditions: Depression/Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: HMP app name: HMRP web app measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety measure: HMP App Utilization: Days measure: HMP App Utilization: Number of Activities measure: HMP App Utilization: Minutes measure: Change in Healthy Minds Index (HM Index): Awareness measure: Change in Healthy Minds Index (HM Index): Connection measure: Change in Healthy Minds Index (HM Index): Purpose measure: Change in Healthy Minds Index (HM Index): Insight measure: Change in Subjective Happiness Scale measure: Change in Satisfaction with Life Scale (SWLS) measure: Change in Perceived Stress Scale (PSS-10) measure: Change in Flourishing Measure measure: Change in Digital Working Alliance Inventory (DWAI) measure: Change in Experiences Questionnaire (EQ) Decentering Subscale measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale measure: Change in NIH Toolbox Loneliness measure: Change in Wellbeing Growth Mindset measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Simon Goldberg, PhD role: CONTACT phone: 608-265-8986 email: sbgoldberg@wisc.edu name: Simon Goldberg, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06282510 id: 23053003 briefTitle: Nasal Antisepsis for C. Auris Prevention overallStatus: RECRUITING date: 2024-01-29 date: 2026-12 date: 2028-12 date: 2024-02-28 date: 2024-02-28 name: Mary K Hayden class: OTHER name: Rush University Medical Center name: RML Specialty Hospital briefSummary: This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris. conditions: Candida Auris Infection conditions: Colonization, Asymptomatic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Povidone Iodine Topical measure: Detection of C. auris from the anterior nares measure: Detection of C. auris from body sites other than anterior nares measure: Detection of C. auris from environmental surfaces measure: Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares measure: Detection of MRSA from environmental surfaces measure: Non-susceptibility of C. auris to povidone iodine measure: Change in microbiome community sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Sarah E Sansom, DO role: CONTACT phone: 312-563-6201 email: sarah_e_sansom@rush.edu name: Mary K Hayden, MD role: CONTACT phone: 312-942-8727 email: mhayden@rush.edu lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Chicago state: Illinois zip: 60624 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: 630-286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Hinsdale state: Illinois zip: 60521 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: (630) 286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.80086 lon: -87.93701 hasResults: False
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<|newrecord|> nctId: NCT06282497 id: ZSCPH-003 briefTitle: Xerostomia-optimised IMRT Versus Standard IMRT in NPC overallStatus: RECRUITING date: 2023-10-23 date: 2026-10-23 date: 2029-10-23 date: 2024-02-28 date: 2024-02-28 name: Zhongshan People's Hospital, Guangdong, China class: OTHER briefSummary: This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 524 type: ESTIMATED name: Optimised neck CTV name: standard neck CTV measure: Regional recurrence free survival measure: Overall survival measure: Local recurrence free survival measure: Distant metastasis-free survival measure: Progression free survival measure: Acute toxicities measure: Late toxicities sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan City People's Hospital status: RECRUITING city: Zhongshan state: Guangdong zip: 528403 country: China name: Gui-qiong Xu, MD role: CONTACT phone: +8613528109888 email: donna_shee@163.com lat: 21.31992 lon: 110.5723 hasResults: False
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<|newrecord|> nctId: NCT06282484 id: KY20232348-C-1 briefTitle: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions overallStatus: COMPLETED date: 2022-09-01 date: 2023-06-01 date: 2023-09-29 date: 2024-02-28 date: 2024-02-28 name: Xijing Hospital of Digestive Diseases class: OTHER briefSummary: To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer. conditions: Gastric Xanthoma conditions: Helicobacter Pylori Infection conditions: Gastric Cancer conditions: Intestinal Metaplasia conditions: Precancerous Lesions studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1260 type: ACTUAL measure: corelation between the gastric xanthoma and gastric mucosa diseases sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hosipital of Digestive Disease city: Xi'an state: Shaanxi zip: 710032 country: China lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06282471 id: MCC-23-20794 id: HM20028614 type: OTHER domain: Virginia Commonwealth University briefTitle: EW and Self-Guided PST in Cancer Survivors and Caregivers overallStatus: RECRUITING date: 2024-02-21 date: 2026-03-31 date: 2026-03-31 date: 2024-02-28 date: 2024-02-29 name: Virginia Commonwealth University class: OTHER briefSummary: To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers conditions: Cancer Survivors conditions: Informal Caregivers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Expressive Writing and Problem-Solving Therapy (EW+PST) measure: Consent Rate measure: Study Retention measure: Completed Journal Entries measure: Patient Satisfaction Questionnaire measure: Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks measure: Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks measure: Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks measure: Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks measure: Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks measure: Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks measure: Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks measure: Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks measure: Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Kendra Rowe role: CONTACT phone: 804-828-1965 email: rowek2@vcu.edu name: Massey CPC Team role: CONTACT phone: 804-828-1965 email: MasseyCPC@vcu.edu name: Susan Hong, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False
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<|newrecord|> nctId: NCT06282458 id: V2000101 briefTitle: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-20 date: 2025-04-30 date: 2024-02-28 date: 2024-04-24 name: Veru Inc. class: INDUSTRY briefSummary: The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists. conditions: Muscle Loss conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study.
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The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Enobosarm name: Semaglutide measure: The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. measure: The percent change from baseline in total fat mass sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinnacle Trials city: Anniston state: Alabama zip: 36207 country: United States name: April Bolt role: CONTACT phone: 256-460-6379 email: Abolt@Pinnacletrials.com name: Almena Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: Cullman Clinical Trials city: Cullman state: Alabama zip: 35055 country: United States name: Cheryl Hargrove role: CONTACT phone: 256-708-2826 email: cheryl@cullmanclinicaltrials.com name: Randall Quinn role: PRINCIPAL_INVESTIGATOR lat: 34.17482 lon: -86.84361 facility: Velocity Clinical Research, CA city: Los Angeles state: California zip: 90057 country: United States name: Jenny Francisco role: CONTACT phone: 213-413-2500 email: JFrancisco@velocityclinical.com name: David Guzman role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Artemis Institute for Clinical Research city: San Diego state: California zip: 92103 country: United States name: Analicia Murillo role: CONTACT phone: 858-867-3557 email: analicia.murillo@artemis-research.com name: Stacy Layle role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Universal Axom Clinical Research city: Doral state: Florida zip: 33122 country: United States name: Diana Marinez role: CONTACT phone: 305-677-9267 phoneExt: 24 email: Dmarinez@uaclinical.com name: Luis Martinez role: PRINCIPAL_INVESTIGATOR lat: 25.81954 lon: -80.35533 facility: Altus Research city: Lake Worth state: Florida zip: 33461 country: United States name: Junieth Leyes role: CONTACT phone: 561-641-0404 email: jleyes@altusresearch.com name: Samuel Lederman role: PRINCIPAL_INVESTIGATOR lat: 26.61708 lon: -80.07231 facility: MARC Research Center city: Louisville state: Kentucky zip: 40213 country: United States name: Laken Heitz role: CONTACT phone: 502-214-3925 email: lheitz@lmarc.com name: Harold Bays role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: Pennington Biomedical city: Baton Rouge state: Louisiana zip: 70810 country: United States name: Aubrey Windham role: CONTACT phone: 225-763-2618 email: aubrey.windham@pbrc.edu name: Steven Heysmfield role: PRINCIPAL_INVESTIGATOR lat: 30.45075 lon: -91.15455 facility: DelRicht Research - New Orleans city: New Orleans state: Louisiana zip: 70115 country: United States name: Emily Krambeck role: CONTACT phone: 504-336-2667 email: ekrambeck@delricht.com name: Patrick Dennis role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Centennial Medical Group (CMG) city: Elkridge state: Maryland zip: 21075 country: United States name: Tyler Stine role: CONTACT phone: 443-698-8678 email: TSTINE@centennialmedical.com name: Steven Geller role: PRINCIPAL_INVESTIGATOR lat: 39.21261 lon: -76.71358 facility: SKY Integrative Medical Center city: Ridgeland state: Mississippi zip: 39157 country: United States name: Bob Hutchins role: PRINCIPAL_INVESTIGATOR lat: 32.42848 lon: -90.13231 facility: Clinvest Headlands LLC city: Springfield state: Missouri zip: 65807 country: United States name: Kealon Cox role: CONTACT phone: 417-883-7889 email: kealon.cox@clinvest.com name: David True role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Palm Research Center city: Las Vegas state: Nevada zip: 89119 country: United States name: Sasha Sandry role: CONTACT phone: 702-736-5161 email: sasha@palmresearchcenter.com name: Samer Nakhle role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: Lillestol Research LLC city: Fargo state: North Dakota zip: 58104 country: United States name: Michael Lillestol role: CONTACT phone: 701-232-7705 email: lillestolmd@lillestolresearch.com name: Michael Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 hasResults: False
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<|newrecord|> nctId: NCT06282445 id: K2024035 briefTitle: Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-31 date: 2024-02-28 date: 2024-02-28 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Adebrelimab name: Oxaliplatin name: Capecitabine name: Bevacizumab measure: Progression-free survival measure: Organ retention rate measure: Overall survival measure: Disease Control Rate measure: Surgical conversion rate measure: TRAEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine status: RECRUITING city: Jinhua state: Zhejiang zip: 322000 country: China name: Qijia Xuan, MD&Phd role: CONTACT lat: 29.10678 lon: 119.64421 hasResults: False
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<|newrecord|> nctId: NCT06282432 id: RP-L201-0121-LTFU briefTitle: Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) overallStatus: ENROLLING_BY_INVITATION date: 2022-03-09 date: 2037-03 date: 2037-03 date: 2024-02-28 date: 2024-02-28 name: Rocket Pharmaceuticals Inc. class: INDUSTRY briefSummary: This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene conditions: Leukocyte Adhesion Deficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ESTIMATED measure: Hematopoietic stem cell transplant (HSCT) free survival measure: Incidence of hospitalizations measure: Incidence of significant infections measure: Resolution of LAD-I-related skin rash measure: Resolution of LAD-I-related periodontal abnormalities measure: Event free survival measure: Overall Survival measure: Long-term genetic correction in peripheral blood mononuclear cells (PBMCs) measure: Long-term genetic correction in PB CD15+ granulocytes measure: Long-term CD18 neutrophil expression by flow cytometry measure: Long-term CD11 neutrophil expression by flow cytometry measure: Improvement or resolution of LAD-I related neutrophilia measure: Improvement or resolution of LAD-I-related leukocytosis. measure: Incidence of Investigational Product (IP) related serious adverse events (SAEs) measure: Incidence of hematologic malignancy sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles (UCLA) city: Los Angeles state: California zip: 90095-1489 country: United States lat: 34.05223 lon: -118.24368 facility: Hospital Infantil Universitario Niño Jesús city: Madrid zip: 28009 country: Spain lat: 40.4165 lon: -3.70256 facility: University College London Great Ormond Street Institute of Child Health (GOSH) city: London zip: WC1N 1EH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06282419 id: B.30.2.ATA.0.01.00/542 briefTitle: The Effect of Visual and Audio Stimulus Offered to Father-to-be overallStatus: RECRUITING date: 2023-08-21 date: 2024-03-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-01 name: Ataturk University class: OTHER briefSummary: It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program. conditions: Ultrasonography Prenatal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 132 type: ESTIMATED name: USE OF MOBILE ULTRASOUND name: ultrasound image taken from the internet measure: Introductory Information Form (For Women) measure: Spouse Support Scale Perceived by Women During Early Postpartum Period measure: Breastfeeding Self-Efficacy Scale-Short Form measure: Breastfeeding Adaptation Scale measure: Edinburgh Postpartum Depression Scale measure: Introductory Information Form (For Men) measure: Fathers' Breastfeeding Attitude and Participation Scale measure: Edinburgh Postpartum Depression Scale for Men sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Merve Çakıl role: CONTACT phone: +905310854245 email: mervecakil92@gmail.com name: Ayla KANBUR role: CONTACT email: aylakanbur28@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06282406 id: N4532-R id: I0X1RX004532 type: OTHER_GRANT domain: U.S. Department of Veterans Affairs briefTitle: Pupil-Indexed Noninvasive Neuromodulation overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-04-03 date: 2028-08-05 date: 2024-02-28 date: 2024-02-28 name: VA Office of Research and Development class: FED briefSummary: Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning. conditions: Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning. primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Transcutaneous Electrical Stimulation name: Sham measure: Force Control Change sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA city: Pittsburgh state: Pennsylvania zip: 15240 country: United States name: Elizabeth B Toth, BA role: CONTACT phone: 412-954-5382 email: elizabeth.toth2@va.gov name: Kimberly A Toland role: CONTACT phone: (412) 215-5084 email: Kimberly.Toland@va.gov name: Michael A. Urbin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06282393 id: Z-2023072 briefTitle: FibriCheck Data Registry acronym: FDR overallStatus: RECRUITING date: 2024-01-31 date: 2026-02 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders. conditions: Cardiac Arrhythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: FibriCheck recordings measure: Alignment PPG measurement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost Limburg status: RECRUITING city: Genk state: Limburg zip: 3600 country: Belgium name: Pieter Vandervoort, MD role: CONTACT phone: 089/325050 email: pieter.vandervoort@zol.be lat: 50.965 lon: 5.50082 hasResults: False
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<|newrecord|> nctId: NCT06282380 id: FDA-AF study briefTitle: Fibricheck Detection cApabilities for Atrial Fibrillation acronym: FDA-AF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: FibriCheck Mobile Application measure: Accuracy of the FibriCheck Mobile Application measure: Sensitivity of the FibriCheck Mobile Application measure: Specificity of the FibriCheck Mobile Application sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282367 id: JOSE AGURTO TELLO HOSPITAL briefTitle: Bowel Preparation for Colonoscopy With Oral Lactulose overallStatus: COMPLETED date: 2021-07-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-28 date: 2024-02-28 name: Josue Aliaga class: OTHER_GOV briefSummary: Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.
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Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects. conditions: Colonoscopy conditions: Colonoscopy Preparation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: Degree of bowel cleansing using the Boston score measure: adenomas detection rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jose Agurto Tello Hospital city: Lima zip: 05001 country: Peru lat: -12.04318 lon: -77.02824 hasResults: False
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<|newrecord|> nctId: NCT06282354 id: NP4035/2023 briefTitle: Telemedicine for Postoperative Follow-up After Oncological Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-15 date: 2025-02-15 date: 2024-02-28 date: 2024-02-28 name: Instituto do Cancer do Estado de São Paulo class: OTHER briefSummary: The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form. conditions: Urologic Cancer conditions: Satisfaction, Patient conditions: Surgery conditions: Postoperative Adhesion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Type of post-operative appointment measure: Patient satisfaction in the post-operative return measure: unattended arrivals at the institution measure: Postoperative complications measure: Appointment's time measure: Number of exams requested measure: Total cost involved per service measure: Environmental impact sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282341 id: 23CH132 briefTitle: Fatigue and Recovery: a Comparison Between Trail and Marathon acronym: MARA-TRAIL overallStatus: RECRUITING date: 2023-12-28 date: 2025-08 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines primaryPurpose: SCREENING masking: NONE count: 90 type: ESTIMATED name: Race: Simulated marathon name: Race: Simulated trail name: Race: Trail in nature measure: Change in knee extensors maximal isometric torque output measure: Change in plantar flexor maximal isometric torque output measure: Recovery of quadriceps maximal isometric torque output the month after the race measure: Voluntary activation level measure: Force assessed in dynamic measure: Velocity assessed in dynamic measure: Power assessed in dynamic measure: Muscular power and stretch-shortening cycle assessed through squat jumps measure: Muscular power and stretch-shortening cycle assessed through countermovement jump measure: Muscular power and stretch-shortening cycle assessed through drop jump measure: Muscle electrical activity measure: The kinetics of energy cost measure: Racing kinematics measure: Ground reaction force (in Newton) measure: Center of pressure (in Newton) measure: Muscle damage blood markers measure: Resting heart rate variability parameters measure: Effort perception measure: fatigue assessment measure: Muscular pain sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Unités de Myologie et de Médecine du Sport status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Léonard FEASSON, Phd role: CONTACT phone: 04 77 12 03 83 email: leonard.feasson@chu-st-etienne.fr name: Diana RIMAUD role: CONTACT email: diana.rimaud@chu-st-etienne.fr name: Clément FOSCHIA, Dr role: SUB_INVESTIGATOR name: Pascal EDOUARD, Dr role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06282328 id: CET 26-2024 briefTitle: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting acronym: HIV-HOTE overallStatus: RECRUITING date: 2024-02-14 date: 2025-11-01 date: 2026-03-01 date: 2024-02-28 date: 2024-03-18 name: Castagna Antonella class: OTHER briefSummary: This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors.
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This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.
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