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* Identifying links between the severity of ASD and difficulties in written production.
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The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).
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The secondary evaluation criteria are:
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* Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).
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* Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).
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* Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC). conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is part of category 2 of research involving humans and which corresponds to an interventional study with minimal risks and constraints. The patient is asked to return to carry out this study. primaryPurpose: DIAGNOSTIC masking: NONE count: 38 type: ESTIMATED name: Cognitive and writing tests measure: Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd) measure: Identifying links between specific deficits of ASD and difficulties in written production measure: Identifying links between the severity of ASD and difficulties in written production sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Niort status: RECRUITING city: Niort zip: 79000 country: France name: Diane D Chuillet-Moreau, Mrs role: CONTACT phone: +33549782049 email: diane.chuillet-moreau@ch-niort.fr lat: 46.32313 lon: -0.45877 hasResults: False
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<|newrecord|> nctId: NCT06304688 id: University of Jaén_24 briefTitle: Yoga and Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults overallStatus: COMPLETED date: 2023-11-13 date: 2024-02-05 date: 2024-02-12 date: 2024-03-12 date: 2024-04-04 name: University of Jaén class: OTHER briefSummary: Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted. Also, Nutrition plays a fundamental role in the health and well-being of individuals at all stages of life, but it is especially crucial in old age due to the physiological and metabolic changes that occur during the aging process. Maintaining a healthy and balanced diet is essential for providing the necessary nutrients for proper body function, strengthening the immune system, and maintaining the health of bone and cardiovascular structures. Specifically, the Mediterranean diet is a traditional dietary pattern based on foods commonly consumed in Mediterranean regions such as Greece, Italy, and Spain. It is characterized by high consumption of fruits, vegetables, legumes, nuts, whole grains, fish, and olive oil, along with moderate intake of dairy and red wine, and limited con-sumption of red meat and processed products. This eating style has been the subject of numerous scientific studies highlighting its multiple health benefits. Apart from the physical health benefits for older adults, the Mediterranean diet has consistently been associated with positive effects such as reduced risk of cardiovascular pathologies, de-creased chronic diseases and pro-inflammatory factors, as well as contributing to the prevention of obesity and cognitive decline. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 125 type: ACTUAL name: Yoga and Mediterranean Diet intervention measure: TMT (Trail Making Test) measure: SFT (Senior Fitness Test) measure: Handgrip Strength measure: Mindful Attention Awareness Scale (MAAS) measure: Digit symbol substitution test (DSST) measure: D2 test measure: Isaac test measure: Anxiety and Depression measure: Sleep quality measure: Balance measure: Nutritional status sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Agustín Aibar Almazán city: Jaén zip: 23007 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False
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<|newrecord|> nctId: NCT06304675 id: 905055423985 briefTitle: Manageable Environmental Factors in Migraine overallStatus: COMPLETED date: 2023-09-30 date: 2024-02-15 date: 2024-03-04 date: 2024-03-12 date: 2024-03-12 name: Samsun University class: OTHER briefSummary: There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups. conditions: Migraine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: no intervention measure: 1. Environmental factors/triggers affecting the chronicity of migraine measure: 2.Environmental factors/triggers and migraine treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun University city: Samsun zip: 55100 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06304662 id: *University of Jaén briefTitle: Yoga for Physical and Mental Health overallStatus: COMPLETED date: 2023-11-13 date: 2024-02-09 date: 2024-02-19 date: 2024-03-12 date: 2024-03-26 name: University of Jaén class: OTHER briefSummary: In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future. conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 142 type: ACTUAL name: Yoga intervention measure: D2 test measure: Mindful Attention Awareness Scale (MAAS) measure: Handgrip Strength measure: Anxiety and Depression measure: Sleep quality measure: Stress level measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: State Anxiety Inventory (STAI) measure: Attentional Control: Shifting and Distraction (AC-S and AC-D) measure: Positive and Negative Affect Schedule measure: Difficulties in Emotion Regulation Scale (DERS) sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Agustín Aibar Almazán city: Jaén zip: 23007 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False
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<|newrecord|> nctId: NCT06304649 id: Cast21CHLA2023Study1SAP briefTitle: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures acronym: Cast21 SAP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: Cast21 class: INDUSTRY briefSummary: The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.
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A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product. conditions: Fractures, Closed conditions: Fractures Bone conditions: Fracture conditions: Fractures conditions: Radius; Fracture, Lower or Distal End conditions: Ulna Fractures conditions: Radius Distal Fracture studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Cast or brace alternative measure: Clinical determination of healing (standard of care) measure: Range of Motion (standard of care) measure: Patient Reported Outcomes - Pain measure: Patient Reported Outcomes - Satisfaction measure: Physical Therapy Referral sex: ALL minimumAge: 3 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304636 id: DC15-MM-01 briefTitle: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma acronym: DC15-MM-01 overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-01 date: 2027-10-01 date: 2024-03-12 date: 2024-03-12 name: Cartesian Therapeutics class: INDUSTRY briefSummary: This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15 conditions: Refractory Multiple Myeloma conditions: Relapsed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms. primaryPurpose: TREATMENT masking: NONE count: 41 type: ESTIMATED name: Descartes-15 measure: Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM) measure: To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Cancer and Blood Disorders (AON) status: RECRUITING city: Bethesda state: Maryland zip: 20817 country: United States lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06304623 id: CIRE.112 briefTitle: SVF for Treating Pulmonary Fibrosis Post COVID-19 acronym: SVFCOVID-19 overallStatus: COMPLETED date: 2020-05-05 date: 2024-03-01 date: 2024-03-01 date: 2024-03-12 date: 2024-03-12 name: Michael H Carstens class: OTHER name: Ministerio de Salud de Nicaragua name: Wake Forest University name: National Autonomous University of Nicaragua briefSummary: General description of the study
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This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.
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Primary objective
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The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.
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Secondary objective
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To evaluate the efficacy of the initial treatment with SVF IV. conditions: Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Autologous adipose-derived SVF IV administration measure: Safety of treatment with SVF IV measure: Efficacy of the initial treatment with SVF IV measure: Effectiveness of the initial treatment with SVF IV sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA) city: León state: Leon zip: 21000 country: Nicaragua lat: 12.43787 lon: -86.87804 facility: Hospital Escuela Cesar Amador Molina city: Matagalpa zip: 61000 country: Nicaragua lat: 12.92559 lon: -85.91747 hasResults: False
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<|newrecord|> nctId: NCT06304610 id: ONZ-2024-0044 briefTitle: Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador acronym: ELEVATE-Pilot overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-28 name: University Hospital, Ghent class: OTHER name: Horizon 2020 - European Commission name: Universidad de Cuenca briefSummary: ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.
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In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.
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At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.
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Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):
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* AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test
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* ELISA protein detection: only available comparison test
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In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):
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• HPV DNA Mole Bioscience test
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Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes. conditions: Cervical Cancer conditions: HPV Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: all participants receive the same tests primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Questionnaire name: HPV self-sample name: Endocervical sample measure: Clinical validation measure: Concordance measure: HPV DNA test validation measure: Protein test validation sex: FEMALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University Hospital city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Steven Weyers, MD,PhD,Prof role: CONTACT phone: 09 332 37 83 email: steven.weyers@uzgent.be name: Philippe Tummers, MD,PhD,Prof role: CONTACT phone: 09 332 37 83 email: philippe.tummers@uzgent.be name: Philippe Tummers, MD,PhD,Prof role: PRINCIPAL_INVESTIGATOR name: Heleen Vermandere, PhD role: SUB_INVESTIGATOR name: Marie Hendrickx, MSC role: SUB_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: SOLCA University Hospital city: Cuenca country: Ecuador name: Bernardo José Vega Crespo role: CONTACT phone: 0998276441 email: bernardo.vegac@ucuenca.edu.ec name: Bernardo José Vega Crespo role: PRINCIPAL_INVESTIGATOR name: Dayanara Delgado role: SUB_INVESTIGATOR name: Vivian Alejandra Neira Molina role: SUB_INVESTIGATOR lat: -2.90055 lon: -79.00453 hasResults: False
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<|newrecord|> nctId: NCT06304597 id: 17651 briefTitle: Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy acronym: PREDICT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-12 date: 2024-03-12 name: University Medical Center Groningen class: OTHER briefSummary: Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 18 type: ESTIMATED name: Imfinzi name: Opdivo measure: Safety of nivolumab-800CW in combination with durvalumab-680LT measure: To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect nivolumab-800CW and durvalumab-680LT signals indicating PD1 and PD-L1 expression. measure: Heart rate measure: Blood pressure systolic and diastolic measure: Temperature measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression measure: Perform real-time polymerase chain reaction (qPCR) and western blot on biopsies to determine whether there is genetic downregulation or protein degradation of PD-1 and PD-L1 after chemoradiotherapy measure: Compare immune cell composition between the radiated and non-radiated area of the bowel. measure: Evaluate targeted detection with nivolumab-800CW and durvalumab-680LT of the tumor by ex vivo visualization of the resection specimen with PEARL Trilogy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands name: Wouter B Nagengast, Prof. role: CONTACT email: w.b.nagengast@umcg.nl name: Lisanne E van Heijst, Bsc. role: SUB_INVESTIGATOR name: Pia Volkmer, Drs. role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06304584 id: P-2023-143 briefTitle: Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture overallStatus: RECRUITING date: 2023-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-03-12 date: 2024-03-12 name: University Hospital Bispebjerg and Frederiksberg class: OTHER name: Frederiksberg Municipality briefSummary: The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.
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The main questions aim to answer:
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* how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered
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* what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture
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Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation. conditions: Hip Fractures conditions: Rehabilitation conditions: Recovery of Function studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Recovery of pre-fracture function measure: Basic mobility measure: 30 second chair stand test (CST) measure: Timed Up & Go test (TUG) measure: Hip related pain measure: Hand Grip Strength (HGS) measure: Health questionnaire measure: Physical activity (weekly) measure: Physical activity / upright time (time standing and walking) measure: Frailty measure: Fear of falling measure: Comorbidity measure: Cognitive status measure: Number of falls measure: Residential status / discharge destination measure: Length of stay in acute hospital measure: Number of weekly exercise sessions with therapist in all settings measure: Number of rehab weeks measure: Type of training in Municipality measure: Training after discharge from 24-hour setting measure: Home care, nurse/other health assistance, times pr week measure: Data 30 days post-discharge measure: Data 3 months post-discharge measure: Data 1 year post-discharge sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg status: RECRUITING city: Copenhagen zip: 2400 country: Denmark name: Morten T Kristensen, Professor role: CONTACT email: morten.tange.kristensen@regionh.dk name: Camilla K Zilmer, MSc, PT role: CONTACT email: camilla.kampp.zilmer@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06304571 id: HC006-001 briefTitle: A Study of HC006 in Subjects With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-27 date: 2026-03-15 date: 2026-07-16 date: 2024-03-12 date: 2024-03-12 name: HC Biopharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: HC006 measure: Incidence of Dose Limiting Toxicities(DLTs) measure: Incidence of adverse events(AEs) measure: Incidence of Serious adverse events(SAEs) measure: Clinically Significant changes in safety assessments measure: Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) measure: PK Parameter:Time to reach Cmax (Tmax) measure: PK Parameter:Area Under the Concentration-time Curve (AUC) measure: Immunogenicity measure: Objective Response Rate (ORR) per RECIST 1.1 measure: progression-Free Survival (PFS) per RECIST 1.1 measure: Overall Survival (OS) measure: Disease Control Rate (DCR) per RECIST 1.1 measure: Duration of response (DOR) per RECIST 1.1 measure: Time to progression (TTP) per RECIST 1.1 measure: Time To Response (TTR) per RECIST 1.1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Ye Guo, MD role: CONTACT email: pattrickguo@gmail.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06304558 id: CI 240228, 2024-480 briefTitle: "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects. overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04 date: 2024-06 date: 2024-03-12 date: 2024-03-12 name: Universidad Europea de Madrid class: OTHER briefSummary: The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.
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As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results. conditions: Sexual Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Non-Invasive Neuromodulation (NESA) measure: Sexual satisfaction measure: Stress levels measure: Blood Pressure (Sistolic and diastolic) measure: Heartbeats per minute measure: Sleep Quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304545 id: SHR-1210-HLJ-081 briefTitle: Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-08-16 date: 2027-03-15 date: 2024-03-12 date: 2024-03-12 name: Harbin Medical University class: OTHER briefSummary: This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Camrelizumab name: Chemotherapy name: Radiotherapy measure: Pathological Complete Response rate measure: Objective Response Rate measure: Disease Control Rate measure: Anal preservation rate measure: Disease-free Survival measure: Overall Survival measure: AEs measure: 3-years Overall Survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304532 id: HU123 briefTitle: Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection overallStatus: COMPLETED date: 2023-08-15 date: 2024-03-05 date: 2024-03-06 date: 2024-03-12 date: 2024-03-13 name: Hamdard University class: OTHER briefSummary: Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.
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In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy. conditions: H. Pylori Infection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 69 type: ACTUAL measure: H. pylori stool for antigen test will screened before and after treatment. sex: ALL minimumAge: 15 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Shifa Ul Memorial Hospital-Hamdard University city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06304519 id: 1986626-1 briefTitle: Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke overallStatus: RECRUITING date: 2023-03-01 date: 2026-02-28 date: 2026-02-28 date: 2024-03-12 date: 2024-03-12 name: University of Delaware class: OTHER briefSummary: Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Dynamic ankle-foot orthosis measure: Mechanical Cost of Transport of the Lower Extremities measure: Sagittal plane ankle moment during stance measure: Sagittal plane ankle angle during stance measure: Self-selected walking speed measure: a candidate set of clinical outcome measures sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Delaware STAR Campus status: RECRUITING city: Newark state: Delaware zip: 19713 country: United States name: Elisa Arch, Ph.D. role: CONTACT phone: 302-831-7268 email: schranke@udel.edu lat: 39.68372 lon: -75.74966 hasResults: False
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<|newrecord|> nctId: NCT06304506 id: 514-0894/23-3000 briefTitle: Effect of Obesity on Extracellular Matrix Composition acronym: EOBECM overallStatus: RECRUITING date: 2024-03-15 date: 2024-11-15 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: University of Copenhagen class: OTHER briefSummary: The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.
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The main questions to answer,
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- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men conditions: Adipose Tissue studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross sectional study with three groups primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Cross sectional study measure: The effect of obesity and age on adipose tissue extracellular matrix composition sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen status: RECRUITING city: Copenhagen zip: 2200 country: Denmark name: Jørn M Helge, PhD role: CONTACT phone: +4528757506 email: jhelge@sund.ku.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06304493 id: 23-2470 briefTitle: REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-12 date: 2024-03-12 name: University of Colorado, Denver class: OTHER briefSummary: The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders. conditions: Postoperative Atelectasis conditions: Postoperative Hypoxemia conditions: Postoperative Pneumonia conditions: Postoperative Pulmonary Complications conditions: Patient Adherence conditions: Incentive Spirometry conditions: Respiratory Therapy conditions: Respiratory Insufficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF"). whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Alarms measure: Rate of adequate IS breaths achieved in PACU measure: Rate of IS breaths attempted in PACU measure: Time to first adequate IS breath measure: Duration of postoperative O2 therapy measure: Presence of postoperative pulmonary complications measure: Individual postoperative pulmonary complications measure: Need for ICU Admission after PACU measure: PACU Length of Stay sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CU Anschutz city: Aurora state: Colorado zip: 80045 country: United States name: Emily G Helmer role: CONTACT phone: 303-724-2938 email: emily.helmer@cuanschutz.edu name: Carolyn Gronowski role: CONTACT email: carolyn.gronowski@cuanschutz.edu name: Ana Fernandez-Bustamante, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06304480 id: AFCRO-179 briefTitle: Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-07-31 date: 2024-07-31 date: 2024-03-12 date: 2024-03-12 name: University College Cork class: OTHER name: AIT Austrian Institute of Technology GmbH briefSummary: There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.
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As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens. conditions: Gut Microbiome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised, open label, controlled, parallel study in healthy males and females. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Randomised, open label, controlled, parallel study in healthy males and females. count: 50 type: ESTIMATED name: 100g fermented Tofu measure: To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition. measure: To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement. measure: To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement. measure: To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype. measure: To measure the effect of the meat substitution on cholesterol and serum triglycerides. measure: To measure the effect of the meat substitution on blood pressure. measure: To measure the effect of the meat substitution on body mass index (BMI). sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304467 id: IRB#23-001133 briefTitle: CM for Patients With ALD After Liver Transplant overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: Arpan A. Patel, MD class: OTHER briefSummary: Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use.
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The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility. conditions: Alcohol Use Disorder conditions: Alcohol; Liver conditions: Post Liver Transplant conditions: Contingency Management conditions: Alcohol Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Contingency Management measure: Number of Non-Drinking Days measure: Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr)) measure: Client Satisfaction Questionnaire-8. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304454 id: P5_BG briefTitle: Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-02-29 date: 2024-03-15 date: 2024-03-12 date: 2024-03-12 name: Brain In Game scientific-technical service class: OTHER briefSummary: Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.
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The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group. conditions: Kindergarten Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster RCT primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double (outcomes assessor and participants) whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 26 type: ACTUAL name: Board game intervention measure: Visual Memory measure: Processing speed and inhibition measure: Affect recognition measure: Hollingshead Index (Hollingshead, 1975) measure: CHEXI (Giménez et al. 2022) sex: ALL minimumAge: 5 Years maximumAge: 6 Years stdAges: CHILD facility: Faculty of Education, Psychology and Social Work; University of Lleida city: Lleida zip: 25001 country: Spain lat: 41.61674 lon: 0.62218 hasResults: False
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<|newrecord|> nctId: NCT06304441 id: IPVO briefTitle: Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-12 date: 2024-03-12 name: Guangzhou Medical University class: OTHER briefSummary: Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined. conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Osimertinib name: Pemetrexed measure: Clinical response rate measure: Overall survival measure: Incidence of treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University) status: RECRUITING city: Huizhou state: Guangdong country: China name: Zhenyu Pan role: CONTACT phone: +8615804302753 email: dr-zypan@163.com name: Guozi Yang role: CONTACT phone: +8615804302755 email: guoziyang_1982@163.com lat: 23.11147 lon: 114.41523 hasResults: False
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<|newrecord|> nctId: NCT06304428 id: Pro00114580 briefTitle: Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-07-01 date: 2028-07-01 date: 2024-03-12 date: 2024-03-12 name: Duke University class: OTHER name: Patient-Centered Outcomes Research Institute name: Hebrew SeniorLife name: Brown University name: The American Health Care Association name: University of North Carolina, Chapel Hill briefSummary: The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.
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The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.
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The main questions this study aims to answer are:
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* Which of the three models is more effective in preventing falls with fractures?
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* What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.
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* What are the differences in osteoporosis treatment and medication burden?
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The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.
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42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.
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This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol. conditions: Accidental Falls/Prevention and Control conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 3780 type: ESTIMATED name: Deprescribing Care Model name: Bone Health Service Model name: Injury Prevention Service Model measure: Injurious falls measure: Number of patients who initiate treatment for osteoporosis measure: Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims measure: Number of patients who had deprescribing ordered measure: Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims measure: Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3). measure: Patient falls self-efficacy (i.e. fear of falling), measured via Falls Efficacy Scale measure: Patient pain, measured via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form measure: Patient depression, measured via Patient Health Questionnaire survey (PHQ-8) measure: Patient anxiety, measured via PROMIS anxiety short form survey measure: Patient sleep, measured via PROMIS sleep disturbance short form sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304415 id: CIRB2023/2651 briefTitle: Elevated Lipoprotein(a) in Hospital Staff acronym: LPACO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2035-12-01 date: 2036-12-31 date: 2024-03-12 date: 2024-03-13 name: Changi General Hospital class: OTHER briefSummary: The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population. conditions: Hypercholesterolemia conditions: Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2800 type: ESTIMATED measure: Distribution and prevalence of elevated Lipoprotein(a) measure: Correlation of lipoprotein(a) with cardiovascular outcomes measure: Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trials & Research Unit city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06304402 id: 7978-GOA briefTitle: Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players overallStatus: RECRUITING date: 2024-03-10 date: 2024-05-01 date: 2024-06-01 date: 2024-03-12 date: 2024-04-22 name: Dokuz Eylul University class: OTHER briefSummary: This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications. conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: The Percussive Massage Treatment name: The Proprioceptive Neuromuscular Facilitation Stretching measure: Shoulder internal rotation range of motion measure: Attack Speed sex: FEMALE minimumAge: 14 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation status: RECRUITING city: İzmir state: Balçova zip: 35340 country: Turkey name: Gonca Sahiner, PhD role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06304389 id: BLUELIGHT-VNS briefTitle: Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy acronym: BLUELIGHTVNS overallStatus: RECRUITING date: 2023-07-01 date: 2023-07-01 date: 2026-04 date: 2024-03-12 date: 2024-03-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS. conditions: Refractory Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration name: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration measure: Effect of blue light on VNS biomarkers measure: Effect of blue light on VNS biomarkers measure: Effect of blue light on VNS biomarkers sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cliniques Universitaires Saint Luc status: RECRUITING city: Woluwe-Saint-Lambert zip: 1200 country: Belgium name: Inci Cakiroglu, Phd student role: CONTACT phone: +32470612917 email: inci.cakiroglu@uclouvain.be name: Inci Cakiroglu, Phd student role: SUB_INVESTIGATOR lat: 50.84389 lon: 4.42912 hasResults: False
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<|newrecord|> nctId: NCT06304376 id: OMFS/FSDC002 briefTitle: Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting acronym: Alveolar cleft overallStatus: COMPLETED date: 2022-03-12 date: 2023-11-30 date: 2024-02-22 date: 2024-03-12 date: 2024-03-12 name: October 6 University class: OTHER name: Ministry of Health, Kuwait briefSummary: This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT. conditions: Alveolar Cleft conditions: Alveolar Ridge Cleft studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Alveolar ridge grafting measure: Volumetric bone gain measure: Eruption of the tooth in the cleft sex: ALL minimumAge: 7 Years maximumAge: 14 Years stdAges: CHILD facility: Ministry of Health, Farwaniya Hospital city: Al Farwānīyah zip: 81004 country: Kuwait lat: 29.2775 lon: 47.95861 hasResults: False
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<|newrecord|> nctId: NCT06304363 id: Braining booster briefTitle: Braining - Evaluation of Acute Effects of Physical Exercise overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: "Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.
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The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes. conditions: Psychiatric Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Braining measure: Anxiety Visual Analogue Scale (VAS) measure: Beck Anxiety Inventory BAI measure: Montgomery-Åsberg Depression Rating Scale MADRS measure: High sensitivity C-reactive protein hsCRP measure: Brain-derived neurotrophic factor BDNF measure: Telomerase activity measure: Motivational factors of continued exercise sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) city: Stockholm zip: 14186 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06304350 id: SGHDOT-24-20 briefTitle: Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-02-17 date: 2026-02-25 date: 2026-12-31 date: 2024-03-12 date: 2024-03-13 name: Tongji University class: OTHER briefSummary: This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Combination of pembrolizumab and platinum containing dual drugs measure: Pathological complete remission (pCR) measure: Major pathological remission (MPR) measure: R0 resection rate measure: Progression free survival (PFS) measure: Total survival time (OS) measure: Safety (incidence of adverse drug reactions) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200080 country: China name: Jiang Fan, MD role: CONTACT phone: 02163240090 email: fan_jiang@tongji.edu.cn name: Jiang Fan, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06304337 id: YXLL-KY-2023(162) briefTitle: Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-10-10 date: 2025-03-03 date: 2024-03-12 date: 2024-03-12 name: Qianfoshan Hospital class: OTHER briefSummary: The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2\<90%, t\>10s) and severe hypoxia (Spo2\<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients. conditions: Airway Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 228 type: ESTIMATED name: New oropharyngeal airway group measure: Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation measure: The incidence of choking, reflux aspiration and laryngeal spasm were recorded measure: The dose of additional drugs during the operation measure: Endoscopist satisfaction measure: Record adverse events that occur throughout the process sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304324 id: 18/2023 briefTitle: Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-04-30 date: 2024-03-12 date: 2024-03-12 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery. conditions: Ankle Disease conditions: Ankle Injuries and Disorders conditions: Foot Injury conditions: Foot Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: 0.9% Sodium chloride name: 0.1mg/kg Dexamethasone name: 0.05ug/kg Dexmedetomidine measure: time to the first need of opiate following the procedure measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale measure: Neutrophil-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Time to mobilization sex: ALL minimumAge: 3 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland city: Poznań state: Wielkopolska zip: 61-545 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
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<|newrecord|> nctId: NCT06304311 id: MAHSA/PHD/SON/2024/01 briefTitle: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida overallStatus: COMPLETED date: 2022-10-02 date: 2023-10-02 date: 2024-01-04 date: 2024-03-12 date: 2024-03-12 name: University of Lahore class: OTHER name: Mahsa University briefSummary: The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes. conditions: Labor Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 90 type: ACTUAL name: Routine Obstetrics care & Lamaze breathing techniques and backside massage measure: Labour pain intensity measure: Anxiety level measure: Duration of Labour measure: Maternal self-efficacy sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Lady Wallingdon Hospital city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06304298 id: 10/2023 briefTitle: NLR and PLR Levels Following iPACK Block in Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-01 date: 2025-08-01 date: 2024-03-12 date: 2024-03-12 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of iPACK block on NLR and PLR following knee arthroplasty conditions: Knee Arthropathy conditions: Knee Osteoarthritis conditions: Knee Pain Chronic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 0.9% Sodium Chloride Injection name: Ropivacaine 0.2% Injectable Solution measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: PLR measure: PLR measure: PLR measure: first need of opiate measure: Opioid Consumption measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score measure: Pain score sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304285 id: 2023-ky421 briefTitle: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: The First Affiliated Hospital of University of Science and Technology of China class: OTHER briefSummary: The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD conditions: Parkinson's Disease conditions: Chronic Appendicitis conditions: Acupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Acupuncture treatment name: Sham acupuncture treatment measure: Score of MDS Unified-Parkinson Disease Rating Scale III sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of University of Science and Technology of China status: RECRUITING city: Hefei state: Anhui zip: 230001 country: China name: Yuhua Chen, M.M.S. role: CONTACT phone: +8615955236270 email: yh1215@mail.ustc.edu.cn name: Chao Han, M.D. role: CONTACT phone: +8615255629713 email: chaohan@ustc.edu.cn lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06304272 id: Irrigation briefTitle: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-09 date: 2027-12 date: 2024-03-12 date: 2024-03-12 name: Patan Academy of Health Sciences class: OTHER briefSummary: There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference. conditions: Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double blinded, parallel, non-inferiority trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 440 type: ESTIMATED name: Irrigating Traumatic Wound with Drinking Water measure: Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304259 id: 24428 briefTitle: Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10-01 date: 2024-03-12 date: 2024-03-26 name: October 6 University class: OTHER briefSummary: Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. conditions: Endodontic Disease conditions: Endodontically Treated Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Saline name: Saline measure: postoperative pain measure: postoperative pain measure: postoperative pain measure: Substance P level measure: Substance P level measure: Substance P level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, Ain shams University city: Cairo zip: 4543070 country: Egypt name: Yara Adel, BDs role: CONTACT phone: 00201000099191 email: yara.adel170496@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06304246 id: FU-S.OZCAN 001 briefTitle: The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-30 date: 2024-10-30 date: 2024-03-12 date: 2024-03-12 name: Firat University class: OTHER briefSummary: Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures.
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It is known that one of the most important factors affecting mothers\&#39; approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients\&#39; perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors.
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We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels.
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In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use. conditions: Obstetric Pain conditions: Cesarean Section conditions: Postoperative Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Measurement Pain Threshold name: Measurement of Serum Asprosin measure: Preoperative Asprosin Level measure: Postoperative Pain measure: Postoperative analgesic consumption sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304233 id: 606103 briefTitle: The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease overallStatus: RECRUITING date: 2023-12-13 date: 2024-12 date: 2038-06 date: 2024-03-12 date: 2024-03-12 name: Norwegian University of Science and Technology class: OTHER name: St. Olavs Hospital briefSummary: To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia. conditions: Heart Diseases conditions: Heart; Functional Disturbance conditions: Schizophrenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Echocardiography name: Cardiac Magnetic Resonance Imaging name: Electrocardiography name: Blood sampling measure: Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography measure: Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography measure: DISC1 mRNA quantification measure: Levels of high sensitive-CRP measure: Levels of CK-MB measure: Levels of Troponin T measure: Levels of Troponin I measure: Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter measure: Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter measure: Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter measure: Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter measure: Left ventricular mass measured by echocardiography measure: Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography measure: Fractional shortening measured by echocardiography measure: Global longitudinal strain (GLS), echocardiographic parameter measure: TAPSE echocardiographic parameter of right ventricular longitudinal systolic function measure: Echocardiographic parameter MPI, Myocardial performance index measure: Echocardiographic parameter Mitral E/A ratio measure: Echocardiography parameter of peak E velocity measure: Echocardiography parameter of E wave deceleration time measure: Echocardiography parameter of ratio of E/e' measure: Echocardiographic parameters septal e' and lateral e' velocities measure: Echocardiographic parameter LAVI, left atrial volume indexed measure: Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity measure: Echocardiographic parameter, S wave velocity measure: Echocardiographic parameter, Indexed LV and RV stroke volumes measure: Levels of NT-proBNP measure: Levels of IGF1 measure: Levels of ANP measure: Levels of BDNF, brain derived neurotrophic factor measure: Levels of Tumor Necrosis Factor alpha measure: Levels of Transforming Growth Factor Beta measure: Levels of cardiac Myosin-Binding Protein C measure: Interleukin levels measure: native T1 time, cardiac MRI measure: Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI measure: Indexed LV mass, cardiac MRI measure: LV Ejection Fraction, cardiac MRI measure: ECG corrected QT interval measure: Number of participants with and abnormal ECG measure: Number of participants with abnormal liver function measure: Number of participants with abnormal kidney function measure: Number of participants with abnormal thyroid function measure: Number of participants with low Vitamin D levels measure: Incidence of cardiovascular disease or mortality as registered in a health registry on follow up measure: Triglyceride levels measure: High-density lipoprotein, HDL-cholesterol levels measure: Low-density lipoprotein, LDL-cholesterol levels measure: Fasting glucose levels measure: Glycated Hemoglobin (HbA1c) levels measure: Heart rate measured on ECG measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Lipoprotein a measure: Magnesium levels measure: Calcium levels measure: Sodium levels measure: Potassium levels measure: Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire measure: Average length of inpatient stay for schizophrenia related admissions measure: Need of Care based on number of total hospital admission for schizophrenia measure: Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity measure: Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS) measure: Duration of schizophrenia measure: Length of treatment with an antipsychotic medication measure: Antipsychotic dosage in daily equivalent dosage of chlorpromazine measure: Smoking status measure: Waist Hip Ratio measure: Body Mass Index measure: Body fat percent measure: Physical Activity measure: Body muscle composition measure: Smoking history measure: Age of participant measure: Gender of participant sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian University of Science and Technology status: RECRUITING city: Trondheim country: Norway name: Morten A Høydal, PhD role: CONTACT phone: +47 48134843 email: morten.hoydal@ntnu.no name: Rita Brekke, MD, MSc role: CONTACT phone: +47 45111574 email: rita.brekke@ntnu.no lat: 63.43049 lon: 10.39506 facility: St Olavs Hospital, Trondheim University Hospital status: RECRUITING city: Trondheim country: Norway name: Mette E Tunset, MD role: CONTACT email: mette.elise.tunset@stolav.no name: Morten B Schou, PhD role: CONTACT email: morten.brix.schou@stolav.no lat: 63.43049 lon: 10.39506 hasResults: False
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<|newrecord|> nctId: NCT06304220 id: MedroGestrel briefTitle: Comparison of Two PPOS Models for Pituitary Suppression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: NextFertility class: INDUSTRY name: SINAE SL briefSummary: The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients. conditions: Infertility, Female conditions: Fertility Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 210 type: ESTIMATED name: Cerazet measure: Total number of oocytes retrieved from follicular puncture measure: Number of mature oocytes (MII) retrieved from follicular puncture measure: Oocyte quality variables measure: Ovarian sensitivity index (OSI measure: Follicles sex: FEMALE minimumAge: 18 Years maximumAge: 34 Years stdAges: ADULT facility: NextFertility city: Valencia state: Comunidad Valenciana zip: 46009 country: Spain name: Luis Quintero role: CONTACT phone: +34 963160240 email: luis.quintero@next-clinics.com lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06304207 id: 300423 briefTitle: Telehealth and Onsite Maintenance Exercise in COPD acronym: COPD overallStatus: RECRUITING date: 2023-09-01 date: 2025-12-30 date: 2026-03-01 date: 2024-03-12 date: 2024-03-12 name: MGH Institute of Health Professions class: OTHER briefSummary: The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD.
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The specific aims of the study are:
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* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.
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* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation.
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Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention. conditions: Copd conditions: COPD Exacerbation conditions: COPD Bronchitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be a pilot randomized controlled, assessor-blinded trial with three groups: 1) Tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) Onsite outpatient physical therapy, 3) Control group. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Onsite Maintenance Exercise Training name: Telehealth Maintenance Exercise measure: Exercise Capacity measure: Exercise Capacity measure: Exercise Capacity measure: Dyspnea measure: Dyspnea measure: Dyspnea measure: Physical Function measure: Physical Function measure: Physical Function measure: Quality of life measure measure: Quality of life measure measure: Quality of life measure measure: Inspiratory muscle strength measure: Inspiratory muscle strength measure: Inspiratory muscle strength measure: Physical activity measure: Physical activity measure: Physical activity measure: Participants adherence to the program measure: Healthcare utilization measure: Adverse events measure: PROMIS Global 10 score measure: PROMIS Global 10 score measure: PROMIS Global 10 score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MGH Institute of Health Professions status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Shweta Gore, PhD role: CONTACT phone: 617-643-6326 email: sgore@mghihp.edu name: Jane Bladwin, DPT role: CONTACT email: jbaldwin@mghihp.edu lat: 42.37787 lon: -71.062 hasResults: False
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<|newrecord|> nctId: NCT06304194 id: BIOMARC_ONCO briefTitle: Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology overallStatus: RECRUITING date: 2023-07-05 date: 2027-07-05 date: 2028-07-05 date: 2024-03-12 date: 2024-03-12 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.
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In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.
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This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection. conditions: Oncologic Disease conditions: Hematologic Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 340 type: ESTIMATED name: Analysis of biological samples measure: Average sample delivery time and % of accepted sample measure: Appropriateness sample labelling measure: Percentage of sample suitable for RNA extraction measure: Quantity and quality of extracted material. measure: Research report production time measure: Genetic variants measure: Completed patient cards sex: ALL minimumAge: 0 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Marinella Veltroni role: CONTACT email: marinella.veltroni@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero-Universitaria Pisana status: RECRUITING city: Pisa country: Italy name: Gabriella Casazza role: CONTACT lat: 43.70853 lon: 10.4036 facility: Azienda Ospedaliero-Universitaria Senese status: RECRUITING city: Siena country: Italy name: Salvatore Grosso role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False
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<|newrecord|> nctId: NCT06304181 id: KY-2023-195 briefTitle: Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-01 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group. conditions: Postoperative Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ESTIMATED name: Paracetamol and Mannitol Injection name: Parecoxib measure: NRS scores measure: RASS score measure: Time of first use of remedial analgesics or analgesic pump measure: Total analgesic pump drug use measure: Postoperative liver enzyme level measure: Postoperative bilirubin level measure: Postoperative creatinine level measure: Postoperative cortisol level measure: Postoperative IL-6 level measure: Postoperative IL-8 level sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304168 id: 19-000890 id: NCI-2024-00954 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-000890 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study overallStatus: RECRUITING date: 2019-05-13 date: 2028-05-15 date: 2028-05-15 date: 2024-03-12 date: 2024-03-12 name: Mayo Clinic class: OTHER briefSummary: This study explores the potential value of a new blood test approach for early detection of cancer. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5850 type: ESTIMATED name: Non-Interventional Study measure: Overall cancer (Y/N) - blood test measure: Overall cancer (Y/N) - urine test measure: Cancer specific site prediction - blood samples/MDM measure: Cancer specific site prediction - urine samples/MDM measure: Cancer specific site prediction - blood samples/RNA measure: Cancer specific site prediction - urine samples/RNA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: John B. Kisiel, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06304155 id: 202437 briefTitle: Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-12 date: 2024-03-15 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Diagnostic efficacy,SUV measure: Diagnostic efficacy measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06304142 id: SGB-reflux briefTitle: Effect of Lidocaine Block on Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:
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• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom. conditions: Gastroesophageal Reflux Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Injection name: Lidocaine hydrochloride measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold measure: Modified Mayo Clinic Dysphagia-30 questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304129 id: 2023-A00709-36 briefTitle: Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers acronym: PLASM-ALZ overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-01-02 date: 2026-09-02 date: 2024-03-12 date: 2024-03-12 name: Central Hospital, Nancy, France class: OTHER name: Thérèse Jonveaux name: Laure Joly name: Lucie Hopes name: Maia Simon name: Franck Schreiner briefSummary: .The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:
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* to define a threshold value for each of the plasma,
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* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
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* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
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* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital. conditions: Alzheimer Blood Biomarkers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 189 type: ESTIMATED name: Blood ponction measure: Aβ40 and Aβ42, P-Tau, Tau and NFL measure: Sensitivity/specificity measure: Co-mobidity measure: Final diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU De Nancy city: Nancy state: Grand Est zip: 54500 country: France lat: 48.68439 lon: 6.18496 hasResults: False
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<|newrecord|> nctId: NCT06304116 id: SGB-TBI briefTitle: Effect of Lidocaine Block in Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:
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Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.
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