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After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline. conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Volagidemab measure: Change in Time to glucagon treatment success at Week 6. measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia. measure: Treatment emergent adverse events (AEs) measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale measure: Hypoglycemia symptoms - Clarke Survey measure: Hypoglycemia symptoms - Gold Questionnaire measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6. sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altman Clinical and Translational Research Institute status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States name: Schafer Boeder, MD role: CONTACT name: Schafer Baoder, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Diablo Clinical Research status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States name: Mark Christiansen, MD role: CONTACT email: mchristiansen@diabloclinical.com name: Mark Christiansen, MD role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 hasResults: False
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<|newrecord|> nctId: NCT06272682 id: 6669 briefTitle: Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study overallStatus: RECRUITING date: 2023-07-17 date: 2024-08-11 date: 2025-10-11 date: 2024-02-22 date: 2024-02-22 name: Hospital Italiano de Buenos Aires class: OTHER briefSummary: The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.
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The main questions it aims to answer are:
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* What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?
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* What are the adverse effects and application site pain associated with each route of administration?
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Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.
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The Redcap randomizer will be used to assign the patient to one of the branches.
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Researchers will compare
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* Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound
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* Branch B: patients treated with intramuscular corticosteroid injection.
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Researchers will:
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* Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.
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* Describe adverse reactions associated with the route of administration.
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* Compare the pain at the site of application associated with the route of administration. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomised, controlled, non-inferiority analytical study primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: Systemic bethametasone injection name: Local bethametasone injection measure: Compare the Boston Carpal Tunnel Syndrome Questionnaire measure: Adverse reactions measure: Pain at the site of application sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Italiano de Buenos Aires status: RECRUITING city: Buenos Aires zip: C1199 country: Argentina name: Jorge Boretto, MD role: CONTACT phone: +541169026969 email: jorge.boretto@hospitalitaliano.org.ar name: Rocio Avanzi, MD role: CONTACT phone: +541157727055 email: rocio.avanzi@hospitalitaliano.org.ar lat: -34.61315 lon: -58.37723 hasResults: False
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<|newrecord|> nctId: NCT06272669 id: HSEARS20220216004 briefTitle: Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD overallStatus: RECRUITING date: 2022-06-02 date: 2025-09 date: 2025-12 date: 2024-02-22 date: 2024-02-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD. conditions: Transcranial Direct Current Stimulation conditions: Autistic Spectrum Disorder conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study comprises 3 phases: Phase 1 will be a randomized controlled trial in which 90 participants will be randomly assigned to receive either active or sham-tDCS combined with computerized executive function training for 10 consecutive working days over 2 weeks period. The other 2 phases will be an open-label, crossover phase, in which for Phase 2, participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session. Whereas bimonthly booster tDCS sessions will be provided to all tDCS responders for the first 3 months and monthly booster tDCS in the subsequent 3 months (Total 9 sessions in phase 3), and with assessments performed every month in Phase 3. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active-tDCS name: Sham-tDCS measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) measure: Clinical response in tDCS outcome measure: Change in neuropsychological measures - CANTAB® cognitive tests sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon zip: Hong Kong country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 27667578 email: yvonne.han@polyu.edu.hk lat: 22.30715 lon: 114.18532 hasResults: False
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<|newrecord|> nctId: NCT06272656 id: AKR-TACE-001 briefTitle: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-04-03 name: Hebei Medical University Third Hospital class: OTHER briefSummary: Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE measure: long-term survival (1-year, 3-year, 5-year) measure: progression- free - time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HebeiMUTH status: RECRUITING city: Shijia Zhuang state: Hebei zip: 050000 country: China name: Yuemin Nan role: CONTACT phone: +8633188602489 email: Hb20231221@163.com name: Pei Guo role: CONTACT phone: 17835683894 email: G545632518@163.com lat: 34.17775 lon: 109.84894 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-12-25 uploadDate: 2024-02-02T21:48 filename: Prot_ICF_000.pdf size: 258859 hasResults: False
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<|newrecord|> nctId: NCT06272643 id: EPIC36-EMPERATRIZ briefTitle: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions acronym: EMPERATRIZ overallStatus: RECRUITING date: 2024-04-04 date: 2025-01-20 date: 2026-01-20 date: 2024-02-22 date: 2024-04-09 name: Fundación EPIC class: OTHER briefSummary: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT. conditions: Coronary Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 129 type: ESTIMATED name: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) measure: To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions measure: Cardiac Death measure: Cardiovascular Death measure: Acute myocardial infarction of treated/functionally assessed lesion measure: Acute myocardial infarction of any lesion measure: Need for revascularisation of lesion treated/functionally assessed measure: Need for revascularisation of any lesion measure: Secondary efficacy endpoint: Clear Image Length measure: Extend of detectable EEL in LM measure: Correlation between contrast volume used and results, as well as the average contrast volume used in the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Juan Ramon Jimenez status: RECRUITING city: Huelva zip: 21005 country: Spain lat: 37.26638 lon: -6.94004 facility: Hospital Universitario de Leon status: RECRUITING city: León zip: 24071 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False
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<|newrecord|> nctId: NCT06272630 id: DW_DWJ1464401 briefTitle: Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease overallStatus: ENROLLING_BY_INVITATION date: 2023-02-06 date: 2024-05-31 date: 2024-08-31 date: 2024-02-22 date: 2024-04-26 name: Daewoong Pharmaceutical Co. LTD. class: INDUSTRY briefSummary: This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 258 type: ESTIMATED name: DWJ1464 name: Placebo of DWJ1464 measure: At 8 weeks, the change of ALT level compared to baseline measure: At 4 weeks, the change of ALT level compared to baseline measure: At 4, 8 weeks, the change of AST level compared to baseline measure: At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline measure: At 8 weeks, the change of liver function comparator Fibrotest compared to baseline measure: At 8 weeks, the change of liver function comparator Fibroscan compared to baseline measure: At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SoonChunHyang University Seoul Hospital city: Seoul zip: 04401 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06272617 id: 2023-960 briefTitle: Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer overallStatus: RECRUITING date: 2023-07-25 date: 2024-07-24 date: 2025-07-24 date: 2024-02-22 date: 2024-02-22 name: West China Hospital class: OTHER name: West China Fourth Hospital, Sichuan University briefSummary: A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors conditions: Malignant Tumor of Head and/or Neck conditions: Radiotherapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: verum acupuncture name: sham acupuncture measure: Xerostomia questionnaire scores measure: Salivary flow rate measure: Taste function assessed by patients measure: Taste function assessed by electrogustometer test measure: Taste function assessed by taste strips test measure: Oral mucositis measure: Dysphagia measure: Quality of Life assessed by EORTC QLQ-C30 measure: Quality of Life assessed by QLQ-H&N35 measure: Adverse effects measure: Changes of oral flora measure: Tongue range of motion measure: Neck Fibrosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Xingchen Peng role: CONTACT phone: 0086-18980606753 email: pxx2014@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06272604 id: 2024-IRB-0015-P-01 briefTitle: Exercise Rehabilitation for Children With Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-10-01 date: 2024-02-22 date: 2024-02-22 name: The Children's Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients. conditions: Asthma in Children conditions: Rehabilitation conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Personalized Exercise Rehabilitation measure: Lung Function measure: Daily Physical Activity Level measure: Asthma Control Status measure: Fractional Exhaled Nitric Oxide (FeNO) measure: Body Composition measure: Sleep measure: Health Related Quality of Life measure: Anxiety and Depression measure: Inflammatory Mediators sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272591 id: IRBN1192023/CHUSTE briefTitle: Comparison of Patient Satisfaction With Home Induction and In-patient Induction. overallStatus: RECRUITING date: 2023-11-20 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.
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Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.
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Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital. conditions: Induced; Birth conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Preliminary search in the patient's file name: A posteriori research in the patient's file name: First questionnaire : choice of induction method reason for choice name: Second questionnaire : experience of induction measure: Questionnaire on patients' experience of induction in hospital and at home. measure: Questionnaire on patients' satisfaction of induction in hospital and at home. measure: Questionnaire on patients' choice of induction method measure: Questionnaire on reasons for choosing home induction. measure: Maternal morbidity measure: Maternal mortality measure: Neonatal morbidity measure: Neonatal mortality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint Etienne status: RECRUITING city: St Etienne zip: 42100 country: France name: Tiphaine BARJAT, MD PhD role: CONTACT phone: (0)477828609 phoneExt: +33 email: tiphaine.barjat@chu-st-etienne.fr name: Clara CHIARADONNA, resident role: CONTACT phone: (0)634100341 phoneExt: +33 email: clara.chiaradonna@etu.univ-st-etienne.fr name: Tiphaine BARJAT, MD PhD role: PRINCIPAL_INVESTIGATOR name: Clara CHIARADONNA, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06272578 id: 20021405 briefTitle: Screen CardRen - A Cross-sectional Observational Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-27 date: 2025-06-30 date: 2024-02-22 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: AstraZeneca briefSummary: In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure. conditions: Heart Failure conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Echocardiography measure: prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction measure: Proteomic analysis measure: Duration of echocardiographic examination measure: Time saved by portable echocardiography and automated image analysis measure: Image quality of cart-based vs. portable echo images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272565 id: 2023KYPJ292 briefTitle: Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage acronym: DR overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-12-30 date: 2026-12-30 date: 2024-02-22 date: 2024-02-22 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER briefSummary: Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group. conditions: Diabetic Retinopathy conditions: Diabetic Macular Edema conditions: Anti-vascular Endothelial Growth Factor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Untargeted metabolomics for metabolic profile using UHPLC/MS measure: Best-corrected visual acuity measure: Central subfield thickness sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Ophthalmic Center of Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510623 country: China name: Zhongshan Ophthalmic Center of Sun Yat-sen University role: CONTACT phone: 86+13560323773 email: chh5413@126.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06272552 id: PI21-00026 id: 2021/10182/I type: OTHER domain: CEIm Parc de Salut Mar briefTitle: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact acronym: PROMs & PREMs overallStatus: RECRUITING date: 2023-10-25 date: 2027-10 date: 2027-10 date: 2024-02-22 date: 2024-02-22 name: Parc de Salut Mar class: OTHER name: Instituto de Salud Carlos III briefSummary: There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.
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Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.
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Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.
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Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.
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Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).
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Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).
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Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health. conditions: PROMs conditions: PREMs conditions: Implementation Research conditions: Impact Evaluation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1440 type: ESTIMATED name: PROMs and PREMs name: PREMs name: Control name: Healthcare professionals measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital del Mar Reseach Institute status: RECRUITING city: Barcelona state: Catalonia zip: 08003 country: Spain name: Olatz Garin role: CONTACT phone: +34 636210255 email: ogarin@research.net name: Olatz Garin role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06272539 id: 2023 101435 briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-22 date: 2024-02-28 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER name: Instituto de Investigación Biomédica de Salamanca briefSummary: Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception. conditions: Failed Back Surgery Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: By doing so, we will aim to eliminate or reduce potential biases due to the order of patients and any transference effects that might occur if one profile clinical patients will influence the performance in several evaluations. Specifically, each patient will complete a sequence of allocation in the order of A, B, B, A, where 'A' represents SCS treatment isolated and 'B' denotes combined treatment. Subsequently, the average of the two 'A' conditions was calculated, and the same process was applied for the 'B' conditions whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Exercise name: Spinal Cord Stimulation measure: Disability (Oswestry Disability Index) measure: Perception Pain (Visual analogue scale) measure: Quality of life (Short Form 36 Health Survey, SF36) measure: Patient's satisfaction measure: Strength (Sorensen Test) measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK) measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale) measure: Catastrophic thinking (Pain Catastrophizing Scale) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Vicente-Mampel city: Torrent state: Valencia zip: 46900 country: Spain lat: 39.43705 lon: -0.46546 hasResults: False
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<|newrecord|> nctId: NCT06272526 id: SOCIALANX_1 briefTitle: Internet-Based Self-Help Intervention for Social Anxiety Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Anadolu University class: OTHER briefSummary: This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.
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The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Internet Based Intervention - GUIDED measure: Liebowitz Social Anxiety Scale (LSAS) Turkish Form measure: Social Appearance Anxiety Scale (SAAS) Turkish Form measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form measure: Sociodemographic Information Form measure: System Usability Scale (SUS-10) Turkish Form measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form measure: Adherence to Intervention measure: Guide Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272513 id: ProAct-HNC-02 briefTitle: Influencing Factors for Physical Activity in People With Head and Neck Cancer acronym: ProAct-HNC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03-31 date: 2025-06-30 date: 2024-02-22 date: 2024-02-26 name: Kantonsspital Winterthur KSW class: OTHER name: Eastern Switzerland University of Applied Sciences name: University of Applied Sciences of Western Switzerland name: UMC Utrecht name: University of Lausanne name: Zurich University of Applied Sciences briefSummary: The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.
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Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:
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* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
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* What motivates people with advanced head and neck cancer to be physically active?
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* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?
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The interviews will be transcribed verbatim and analysed with a structuring content analysis approach. conditions: Advanced Head and Neck Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: interview transcripts measure: personal information of participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-09 uploadDate: 2024-02-15T04:21 filename: Prot_000.pdf size: 1702659 hasResults: False
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<|newrecord|> nctId: NCT06272500 id: 2024-KY-0146-001 briefTitle: Exploring Methods for Treating Hypergastrinemia in Patients With Autoimmune Gastritis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Jianning Yao class: OTHER briefSummary: Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+/K+-ATPase. CD4+ T lymphocytes target the parietal cells' H+/K+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).
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Gastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.
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Due to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of oral apple cider vinegar on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients. conditions: Autoimmune Gastritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: oral administration of a compound digestive enzyme capsule name: oral administration of apple cider vinegar name: oral administration of both the compound digestive enzyme capsule and apple cider vinegar measure: serum gastrin levels measure: serum gastrin levels measure: the adverse reaction rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: Prot_SAP_000.pdf size: 152941 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: ICF_001.pdf size: 156619 hasResults: False
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<|newrecord|> nctId: NCT06272487 id: ALN-AGT01-007 briefTitle: Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) acronym: KARDIA-3 overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-20 date: 2025-12-19 date: 2024-02-22 date: 2024-04-18 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications. conditions: High Cardiovascular Risk conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: Zilebesiran name: Placebo measure: Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) measure: Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) measure: Change from Baseline at Month 6 in Mean Seated Office SBP measure: Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM measure: Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM measure: Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP measure: Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM measure: Change from Baseline Over Time in Serum Angiotensinogen (AGT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trial Site status: RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 hasResults: False
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<|newrecord|> nctId: NCT06272474 id: 0266-07/2021 - 18/07/2021 briefTitle: Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments overallStatus: COMPLETED date: 2022-09-11 date: 2023-12-09 date: 2023-12-09 date: 2024-02-22 date: 2024-02-22 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.
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The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.
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Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained. conditions: Dental Occlusion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Single group is receiving the two interventional arms primaryPurpose: DIAGNOSTIC masking: NONE count: 26 type: ACTUAL name: CAD-CAM zirconia crowns using buccal interocclusal record. name: CAD-CAM zirconia crowns using lateral interocclusal records. measure: Static occlusal interference measure: Dynamic occlusal interference sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06272461 id: UTEM ELKI briefTitle: Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-30 date: 2024-06-30 date: 2024-02-22 date: 2024-04-16 name: University Tunis El Manar class: OTHER briefSummary: Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).
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For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.
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For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.
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Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. conditions: Colorectal (Colon or Rectal) Cancer conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intravenous Lidocaine vs intravenous ketamine primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Lidocaine IV name: Ketamine Injectable Solution measure: The variation of Interleukin-6 levels measure: Pain assessed by Numerical Rating Scale (NRS) measure: Post-operative nausea and vomiting measure: Bowel function. measure: Hospital length of stay. measure: Post-operative complications. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunisia status: RECRUITING city: Nabeul zip: 8000 country: Tunisia name: BEN ALI MECHAAL role: CONTACT phone: 53890987 phoneExt: 00216 email: mechaal_benali@yahoo.fr lat: 36.45606 lon: 10.73763 hasResults: False
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<|newrecord|> nctId: NCT06272448 id: CERM2022-27 21042022 briefTitle: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment acronym: RAPIDO overallStatus: RECRUITING date: 2022-11-15 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Università Politecnica delle Marche class: OTHER name: Universita di Verona briefSummary: The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-after study with one follow-up at 3 months of treatment end primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Telerehabilitation measure: Compliance with the telerehabilitation system measure: Perceived usability of system measure: Incidence of treatment-emergent adverse events measure: User satisfaction measure: Compliance with the monitoring system measure: Feasibility of telemonitoring approach measure: Motor symptom and disability progression measure: Non motor symptom progression measure: Patients' Quality of life measure: Caregiver's burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurorehabilitation Clinic status: RECRUITING city: Ancona zip: 60126 country: Italy name: Elisa Andrenelli, Dr role: CONTACT phone: 0715965794 email: e.andrenelli@univpm.it lat: 43.5942 lon: 13.50337 facility: Università di Verona status: RECRUITING city: Verona zip: 37100 country: Italy name: Marialuisa Gandolfi, Prof role: CONTACT phone: +39 045 812 4943 email: marialuisa.gandolfi@univr.it lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06272435 id: PRO-FY2024-64 briefTitle: Beverage Hydration Index: Assessment of Four Rehydration Solutions overallStatus: RECRUITING date: 2023-12-23 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: University of Memphis class: OTHER briefSummary: No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine. conditions: Hydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Semi-blinded, placebo controlled, crossover design primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup. whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Multiplier name: Sugar Free name: Sugar Free with Amino Acids name: Water measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Body Mass measure: Body Mass measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Nutraceutical and Dietary Supplement Research status: RECRUITING city: Memphis state: Tennessee zip: 38152 country: United States name: Jackie Pence, Ph.D. role: CONTACT phone: 901-678-1547 email: jpence1@memphis.edu name: Richard J Bloomer, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06272422 id: 2022/0472 id: 2023-A00358-37 type: OTHER domain: IDRCB - ANSM ID briefTitle: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning acronym: HIP3D overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Lille class: OTHER briefSummary: The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.
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To this end, two types of examination are carried out, both of which are used in current practice:
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* Pre-operatively: EOS radiography
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* Post-operatively: EOS radiograph and CT scan
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Inclusion (m-3; m-1) :
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* Patient information at pre-operative visit
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* Non-opposition of patient, family member or legal guardian, if applicable
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* Questionnaires and clinical examination (standard management)
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* EOS during anesthetic consultation
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Follow-up visit (m+3):
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- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination
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