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The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.
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International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.
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To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.
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New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment. conditions: HER2-positive Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Pre-treatment biopsy measure: Transcriptomic profile change of HER2+ primary breast tumours before any treatment measure: Transcriptomic profile change on circulating tumour DNA (ctDNA) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358612 id: DALNSHA2024ABR001 briefTitle: Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-20 date: 2025-08-31 date: 2024-04-10 date: 2024-04-10 name: Nova Scotia Health Authority class: OTHER briefSummary: Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool. conditions: Anxiety State studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Stress Balls name: No Stress Balls measure: Change in anxiety level of greater than 20% based on Visual Analog Score (VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358599 id: TUO-UR-21-01 briefTitle: The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy overallStatus: COMPLETED date: 2021-01-07 date: 2023-10-20 date: 2024-01-15 date: 2024-04-10 date: 2024-04-10 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen. conditions: Bladder Cancer conditions: Bladder Cancer Stage I conditions: Bladder Cancer Stage II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 221 type: ACTUAL name: Cisplatin measure: Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy. measure: Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy. sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital city: Ankara zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06358586 id: 044(H)MD21176 id: CRO-PK-21-356 type: OTHER domain: CRO code briefTitle: New Paediatric Formulation of Tachipirina® overallStatus: COMPLETED date: 2022-04-09 date: 2022-04-25 date: 2022-04-25 date: 2024-04-10 date: 2024-04-10 name: Aziende Chimiche Riunite Angelini Francesco S.p.A class: INDUSTRY name: Cross S.A. briefSummary: This is a single centre, single dose, single-arm, open-label, palatability study.
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The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single centre, single dose, single-arm, open-label, palatability study primaryPurpose: OTHER masking: NONE count: 20 type: ACTUAL name: Tachipirina® 120 mg/5 mL oral suspension, new flavour measure: Palatability of new flavour - Taste (1) measure: Palatability of new flavour - Taste (2) measure: Palatability of new flavour - Smell measure: Palatability of new flavour - Aftertaste (1) measure: Palatability of new flavour - Aftertaste (2) measure: Palatability of new flavour - Aftertaste (3) measure: Palatability of new flavour - Texture (mouthfeel) measure: Palatability of new flavour - Overall measure: Treatment emergent adverse events (TEAEs) sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: CROSS Research S.A. - Phase I Unit, city: Arzo zip: CH-6864 country: Switzerland lat: 45.87606 lon: 8.94103 hasResults: False
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<|newrecord|> nctId: NCT06358573 id: SAKK 66/22 briefTitle: Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-03 date: 2029-12 date: 2024-04-10 date: 2024-04-10 name: Swiss Group for Clinical Cancer Research class: OTHER briefSummary: About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined. conditions: Triple-negative Breast Cancer conditions: TNBC - Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, open-label multicenter phase 2 clinical study to determine the clinical activity, safety and tolerability of INT230-6 in patients with early stage, operable TNBC who undergo neoadjuvant systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: INT230-6 name: neoadjuvant immuno-chemotherapy measure: Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). measure: pCR (invasive and in-situ, only invasive, respectively) in the breast measure: pCR in lymph nodes measure: Pattern of non pCR measure: Overall response according to RECIST v1.1 measure: Radiological tumor response using two perpendicular diameters measure: Event free survival (EFS) measure: Rate of breast conserving surgery (BCS) at the time of definitive surgery measure: Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tumor Zentrum Aarau city: Aarau zip: 5000 country: Switzerland name: Razvan Popescu, MD role: CONTACT phone: +41 62 836 78 33 email: [email protected] name: Razvan Popescu, MD role: PRINCIPAL_INVESTIGATOR lat: 47.39254 lon: 8.04422 facility: St. Claraspital city: Basel zip: 4058 country: Switzerland name: Thomas Schmid, MD role: CONTACT phone: +41 61 685 88 65 email: [email protected] name: Thomas Schmid, MD role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: Istituto Oncologico della Svizzera Italiana (IOSI) city: Bellinzona zip: 6500 country: Switzerland name: Lorenzo Rossi, MD role: CONTACT phone: +41 91 811 85 77 email: [email protected] name: Lorenzo Rossi, MD role: PRINCIPAL_INVESTIGATOR lat: 46.19278 lon: 9.01703 facility: Kantonsspital Graubünden city: Chur zip: 7000 country: Switzerland name: Michael Schwitter, MD role: CONTACT phone: +41 81 256 75 68 email: [email protected] name: Michael Schwitter, MD role: PRINCIPAL_INVESTIGATOR lat: 46.84986 lon: 9.53287 facility: Kantonsspital Baselland city: Liestal zip: 4410 country: Switzerland name: Marcus Vetter, MD role: CONTACT phone: +41 61 925 2715 email: [email protected] name: Marcus Vetter, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48455 lon: 7.73446 facility: Kantonsspital St. Gallen city: St. Gallen zip: 9007 country: Switzerland name: Markus Jörger, MD role: CONTACT phone: +41 76 559 10 70 email: [email protected] name: Markus Jörger, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: TBZO - Tumor- & Brustzentrum Ostschweiz city: St. Gallen zip: 9016 country: Switzerland name: Markus Niemeyer, MD role: CONTACT phone: +41 71 243 02 57 email: [email protected] name: Markus Niemeyer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: Kantonsspital Winterthur city: Winterthur zip: 8401 country: Switzerland name: Ursina Zürrer, MD role: CONTACT phone: +41 52 266 25 83 email: [email protected] name: Ursina Zürrer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.50564 lon: 8.72413 facility: Universitätsspital Zürich - Klinik für Gynäkologie city: Zürich zip: 8091 country: Switzerland name: Isabell Witzel, Prof role: CONTACT phone: +41 43 253 64 05 email: [email protected] name: Isabell Witzel, Prof role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06358560 id: BrainHealthClinics briefTitle: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers overallStatus: RECRUITING date: 2024-03-04 date: 2024-12-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-10 name: Dylan Saulsbery class: OTHER briefSummary: The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study. conditions: Stress studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Therapeutic exercises measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Brain Health Clinics status: RECRUITING city: Nashville state: Tennessee zip: 37217 country: United States name: Tyler Hurst, DC role: CONTACT phone: 615-922-0977 email: [email protected] name: Dylan Saulsbery, DC role: PRINCIPAL_INVESTIGATOR name: Tyler Hurst, DC role: SUB_INVESTIGATOR name: Dominic Fetterly, DC role: SUB_INVESTIGATOR lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06358547 id: H-23072469 briefTitle: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2029-04-01 date: 2024-04-10 date: 2024-04-10 name: Rigshospitalet, Denmark class: OTHER briefSummary: A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 590 type: ESTIMATED name: PGT-A measure: Live birth rate per first embryo transfer measure: Cumulative live birth rate after one complete ART treatment sex: FEMALE minimumAge: 18 Years maximumAge: 41 Years stdAges: ADULT facility: Rigshospitalet city: København Ø zip: 2100 country: Denmark name: Nathalie F Wang, MD role: CONTACT phone: +4535454071 email: [email protected] name: Kristine Løssl, MD role: CONTACT email: [email protected] lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06358534 id: RTEU-SBF-KB-01 briefTitle: The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2023-11-30 date: 2024-07-30 date: 2024-04-10 date: 2024-04-26 name: Recep Tayyip Erdogan University class: OTHER briefSummary: Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease. conditions: Kidney Failure, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest-posttest, control and intervention groups primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 32 type: ACTUAL name: psychoeducation based on acceptance and commitment therapy measure: Chronic Disease Adaptation Scale (CHAS): measure: Acceptance and Action Questionnaire-II Scale (AAQ-II) measure: Life Satisfaction Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Recep Tayyip Erdoğan University Faculty of Health Sciences city: Rize state: Güneysu zip: 53100 country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False
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<|newrecord|> nctId: NCT06358521 id: 6040471 briefTitle: Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial overallStatus: RECRUITING date: 2023-10-02 date: 2025-11-01 date: 2025-11-01 date: 2024-04-10 date: 2024-04-10 name: Queen's University class: OTHER name: Canadian Institutes of Health Research (CIHR) name: The Arthritis Society, Canada briefSummary: This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada. conditions: Hip Osteoarthritis conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model primaryPurpose: TREATMENT masking: NONE maskingDescription: Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention. count: 728 type: ESTIMATED name: Physiotherapist-led primary care model for hip and knee pain name: Usual physician-led primary care model for hip and knee pain measure: Self-Reported Functioning measure: Self-Reported Pain Intensity measure: Health-Related Quality of Life measure: Pain Self Efficacy measure: Catastrophic Thinking measure: Fear of Movement measure: Depression Subscale measure: Global Rating of Change measure: Satisfaction with Health Care measure: Adverse Events measure: Health-Care Utilization - Consultations in Electronic Medical Record (EMR) measure: Health-Care Utilization Survey - Visits to health professionals measure: Health-Care Utilization Survey - Medications measure: Health-Care Utilization Survey - Walk-In Clinic Visits measure: Health-Care Utilization Survey - Emergency Department Visits measure: Health-Care Utilization Survey - Inpatient Hospital Stays measure: Health-Care Utilization Survey - Surgeries, Procedures, Injections measure: Health-Care Utilization Survey - Specialist Visits measure: Health-Care Utilization Survey - Diagnostic Imaging measure: Process Outcome - Medications prescribed measure: Process Outcome - Diagnostic Imaging Ordered measure: Process Outcome - Exercises Prescribed measure: Process Outcome - Education Provided measure: Process Outcome - Referrals to other health care providers (HCPs) measure: Process Outcome - Primary Care Visits measure: Process Outcome - Notes to Employers or Insurers measure: Self-Report Time Lost measure: Assistance Needed measure: Extra Expenses measure: Cost outcomes measure: Health Care Accessibility measure: Baseline Characteristics measure: Comorbidities measure: Chronicity of Pain measure: Participant Treatment Fidelity sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen's University status: RECRUITING city: Kingston state: Ontario zip: K7L3N6 country: Canada name: Jordan Miller role: CONTACT lat: 44.22976 lon: -76.48101 hasResults: False
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<|newrecord|> nctId: NCT06358508 id: VP-0786 briefTitle: Sapphire 3 CTO Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2025-07 date: 2024-04-10 date: 2024-04-15 name: OrbusNeich class: INDUSTRY name: Avania briefSummary: A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.
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One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first. conditions: Coronary Artery Disease conditions: Coronary Disease conditions: Myocardial Ischemia conditions: Heart Diseases conditions: Arteriosclerosis conditions: Cardiovascular Diseases conditions: Chronic Total Occlusion conditions: Chronic Total Occlusion of Coronary Artery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Sapphire 3 Coronary Dilatation Catheter measure: Number of Participants With Device Procedural Success measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) measure: Number of Deaths (Cardiac and Non-Cardiac) measure: Number of Participants With Myocardial Infarctions (MI) measure: Number of Participants With Target Lesion Revascularization (TLR) measure: Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) measure: Number of Participants With Absence of Sapphire 3 Study Balloon Rupture measure: Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA) measure: Number of Participants With Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358495 id: REB24-0253 briefTitle: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-07-30 date: 2024-04-10 date: 2024-04-15 name: University of Calgary class: OTHER name: Hotchkiss Brain Institute, University of Calgary briefSummary: Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders). conditions: Insomnia conditions: Sleep Disturbance conditions: Depressive Symptoms conditions: Anxiety Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes assessor will be blinded to participants' assigned condition. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia name: Active Control measure: Insomnia Severity Index measure: Pittsburgh Sleep Quality Index measure: Internalizing Symptoms Subscale of the Youth Self-Report measure: Sleep Logs - Total sleep time measure: Sleep Logs - Onset latency measure: Sleep Logs - Wake after sleep onset measure: Sleep Logs - Sleep efficiency sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06358482 id: ORAL1 briefTitle: Electric Toothbrush Efficacy in Preventing Dental Plaque Development acronym: E-TOOTH overallStatus: RECRUITING date: 2023-01-30 date: 2024-04-30 date: 2024-07-30 date: 2024-04-10 date: 2024-04-15 name: Riccardo Polosa class: OTHER briefSummary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology. conditions: Dental Plaque conditions: Calculus, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: oscillating toothbrush name: standard manual toothbrush measure: fluorescence intensity of at least 30% (ΔR30) measure: the fluorescence intensity of at least 120% (ΔR120) measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: ADDENDO status: RECRUITING city: Catania zip: 95100 country: Italy lat: 37.49223 lon: 15.07041 hasResults: False
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<|newrecord|> nctId: NCT06358469 id: VU2 briefTitle: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision acronym: STRIVE overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2030-06-30 date: 2031-11-30 date: 2024-04-10 date: 2024-04-10 name: Canadian Cancer Trials Group class: NETWORK name: Australia New Zealand Gynaecological Oncology Group briefSummary: This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach? conditions: Vulvar Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 249 type: ESTIMATED name: Surgery name: Active Surveillance measure: Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival measure: HPV-I and HPV-A VSCC cohorts: Overall-survival measure: HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358456 id: 20-928 briefTitle: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices overallStatus: COMPLETED date: 2020-11-20 date: 2022-04-22 date: 2022-04-22 date: 2024-04-10 date: 2024-04-10 name: University Clinic Frankfurt class: OTHER briefSummary: The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
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* Do artificial tears alter the measurements of the corneal surface
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* Is there a difference between the devices used in this study
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This is relevant because high quality measurements improve the postoperative outcome after cataract surgery. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one arm for each diagnostic device (three in total) primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The investigator and patient knew which device they were tested on count: 145 type: ACTUAL name: Artificial tear name: No artificial tears measure: Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? measure: Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Goethe University Hospital city: Frankfurt state: Hesse zip: 60590 country: Germany lat: 50.11552 lon: 8.68417 hasResults: False
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<|newrecord|> nctId: NCT06358443 id: PF-Jarlsberg/IIIB briefTitle: The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia acronym: PF-JB3 overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-18 date: 2025-02-23 date: 2024-04-10 date: 2024-04-10 name: Meddoc class: OTHER name: Tine briefSummary: Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).
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Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.
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Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.
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Sample size: At least 16 patients will be included conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One armed observational study primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Jarlsberg cheese measure: Bone Mineral Density measure: Bone Turnover Markers measure: Osteocalcin measure: Vitamin K2 sex: ALL maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358430 id: 2023-1017 id: NCI-2024-03107 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-01-18 date: 2029-01-18 date: 2024-04-10 date: 2024-04-10 name: M.D. Anderson Cancer Center class: OTHER name: Bellicum Pharmaceuticals, Inc. briefSummary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC. conditions: Colorectal Cancer conditions: Minimal Residual Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Fludarabine Phosphate name: Cyclophosphamide name: Cetuximab name: TROP2-CAR-NK Cells name: Rimiducid (AP1903) name: Lymphodepleting Chemotherapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Maria Pia Morelli, MD, PhD role: CONTACT phone: 713-745-1297 name: Maria Pia Morelli, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06358417 id: 2024P000873 briefTitle: CHW Intervention to Improve Nutrition Security of Patients With Hypertension acronym: HeartWell overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-01-31 date: 2027-05-01 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER briefSummary: The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. conditions: Hypertension conditions: Nutrition, Healthy conditions: Food Insecurity conditions: Community Health Worker studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Nutrition-enhanced CHW name: Basic CHW measure: Feasiblity measure: Feasibility of CHW nutrition intervention (intervention arm only) measure: Acceptability (intervention arm only) measure: Diet quality measure: Blood pressure sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358404 id: 2024P000615 briefTitle: Developing a Peer Support Intervention for Depression in SCD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER name: National Institutes of Health (NIH) briefSummary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline. conditions: Subjective Cognitive Decline conditions: Depression in Old Age studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: PeersCOG measure: Feasibility of Intervention measure: Acceptability of Intervention measure: Fidelity of Intervention sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358391 id: TS-RF system briefTitle: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-10 date: 2024-04-16 name: Starmed class: INDUSTRY name: Helptrial briefSummary: The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device. conditions: Arrhythmias, Cardiac conditions: Atrial Fibrillation conditions: Heart Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: TS-RF Transseptal Needle name: BRK Transseptal Needle measure: First-pass TSP Success Rate (percent) measure: TSP Time (Second) measure: Fluoroscopy Time (Second) for TSP measure: Needle cross-over between the study and control groups measure: Intra-TSP procedural device-associated complications measure: Changes in patient's quality of life measure: Complications measure: Intra-TSP procedural Adverse Events measure: Overall Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358378 id: 995 briefTitle: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Sligo General Hospital class: OTHER briefSummary: Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.
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Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.
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There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Aktiia SA Bracelet measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state measure: Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis measure: Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices measure: User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices measure: Proportion of recruited patients who provide at least 5 daytime cuffless blood pressure readings per day measure: Proportion of total measurements taken which can be paired (i.e. taken within 1-hour of a measurement from the other device) measure: Proportion of missing data from activity diaries measure: Proportion of recruited patients who provide at least 3 paired blood pressure readings for 3 consecutive days sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358365 id: AQP-DCL-026 briefTitle: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients overallStatus: COMPLETED date: 2023-03-29 date: 2023-11-02 date: 2023-11-07 date: 2024-04-10 date: 2024-04-10 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin. conditions: Acute Kidney Failure conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: The AquaPass System measure: Differences in weight gain over the long interdialytic period measure: Device related Adverse Events measure: Changes in NT-proBNP measure: Changes in Blood Urea Nitrogen measure: Effect on Quality of Life measure: Affect on Ultrafiltration Rates after the long inter dialytic gap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nazareth Hospital EMMS city: Nazareth state: Al Wadi Al Jawani 1611 zip: 16100 country: Israel lat: 32.69925 lon: 35.30483 hasResults: False
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<|newrecord|> nctId: NCT06358352 id: M18080921 briefTitle: Clinical and Radiographic Assessment of PRF Versus Lutein Placement overallStatus: COMPLETED date: 2021-10-01 date: 2022-02-01 date: 2023-05-01 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
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Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
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Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.
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7
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Patients grouping: Patients will be randomly divided into three groups:
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Group A: Immediate implant placement with leaving the gap distance empty
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Group B: Immediate implant placement then placement of PRF around the implant in the gap distance
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Group C: Immediate implant placement then placement of lutein around the implant in the gap distance
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Clinical evaluation:
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Patients will be evaluated clinically for:
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1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.
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3. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.
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4. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.
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Radiographic evaluation:
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conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months conditions: Osteogenesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Lutein / Zeaxanthin name: Platelet rich fibrin measure: bone formation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: faculty of dentistry,Mansoura university city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06358339 id: 72374095 briefTitle: TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-08-31 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Shenzhen Kangning Hospital class: OTHER briefSummary: Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, feasibility, and sustainability of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: After recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program. The allocation ratio in randomization will be 1:1. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 640 type: ESTIMATED name: TEEM measure: Suicide ideation at three months after discharge measure: The rate of re-visits to outpatient clinic at three months after discharge measure: Self-determination at at three months after discharge measure: Social connectedness at three month after discharge measure: Social support at three months after discharge measure: Times of re-hospitalization for mental disorders measure: Attitudes towards the acceptability of the intervention measure: Attitudes towards the adoption of the intervention measure: The adoption rate of the intervention in patients measure: Attitudes towards the equity of the intervention measure: Attitudes towards the feasibility of the intervention measure: Attitudes towards the patient-centeredness of the intervention measure: Cost for implementing the TEEM-GIFTS measure: Fidelity of the study measure: Efficiency of the intervention measure: Attitudes towards the safety of the intervention measure: The timeliness of the intervention measure: Patients' perceived stigma from baseline to three months after discharge measure: Patients' self-efficacy from baseline to three months after discharge measure: Patients' compliance to treatment from baseline to three months after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shenzhen Kangning Hospital city: Shenzhen state: Guangdong zip: 518020 country: China lat: 22.54554 lon: 114.0683 hasResults: False
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<|newrecord|> nctId: NCT06358326 id: Karabuk-1 briefTitle: Dry Needling and Rehabilitatin Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-04-05 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Karabuk University class: OTHER briefSummary: Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS. conditions: Dry Needling conditions: Carpal Tunnel Syndrome conditions: Myofacial Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dry needling name: Control group measure: Pain severity measure: Wrist range of motion measure: Position sense measure: Severity of symptoms measure: Functional status measure: Hands activity level measure: neuropathic pain severity measure: Nerve cross-sectional area sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pursaklar State Hospital status: RECRUITING city: Ankara country: Turkey name: Fidan Yılmaz, Msc role: CONTACT phone: 0551 207 2954 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06358313 id: 0023098816 briefTitle: Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-10 date: 2024-04-10 name: Kafrelsheikh University class: OTHER briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 3 months and an open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40mg name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: [email protected] lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06358300 id: Usakpcos2 briefTitle: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2022-01-01 date: 2022-09-01 date: 2023-07-20 date: 2024-04-10 date: 2024-04-10 name: Uşak University class: OTHER briefSummary: We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls. conditions: Visceral Adiposity Index conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ACTUAL measure: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Usak Training and Research Hospital city: Usak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
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<|newrecord|> nctId: NCT06358287 id: STUDY19030375 briefTitle: Neural Correlates of Auriculotherapy overallStatus: COMPLETED date: 2021-07-15 date: 2022-11-07 date: 2022-11-07 date: 2024-04-10 date: 2024-04-10 name: Keith M. Vogt, MD, PhD class: OTHER briefSummary: Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: cryogenic auriculotherapy measure: Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity measure: Brief Pain Inventory (BPI) Severity Scores MRI #1 measure: BPI Pain Severity Scores MRI #2 measure: General Anxiety Disorder-7 (GAD-7) Scoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Montefiore city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06358274 id: MED-2024-32848 briefTitle: Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-10 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.
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The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities. conditions: Thru-hiking studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Thru-hiking measure: blood lipid panel: total cholesterol measure: blood lipid panel: high-density lipoprotein (HDL) measure: blood lipid panel: low-density lipoprotein (LDL) measure: blood lipid panel: triglycerides sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358261 id: IRB00433279 id: R03DK135898 type: NIH link: https://reporter.nih.gov/quickSearch/R03DK135898 briefTitle: Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2025-09 date: 2024-04-10 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation. conditions: PreDiabetes conditions: Lifestyle, Healthy conditions: Activation, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pilot group-randomized controlled trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Diabetes Prevention Patient Activation Clinical Decision Support Tool measure: patient activation as assessed by the Patient Activation Measure Survey (PAM) measure: number of participants referred to Diabetes Prevention Program measure: number of participants prescribed metformin measure: percent of participants who make diet changes measure: change in amount and frequency of physical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358248 id: SPHERE briefTitle: Standardized Physician-modified Fenestrated Endograft Registry acronym: SPHERE overallStatus: RECRUITING date: 2023-10-01 date: 2028-10-01 date: 2033-10-01 date: 2024-04-10 date: 2024-04-16 name: University Hospital Padova class: OTHER briefSummary: Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA). conditions: Aortic Aneurysm, Thoracoabdominal conditions: Aortic Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA). measure: Technical success measure: Freedom from target vessel instability measure: Freedom from endograft instability measure: Early (30-days) Major Adverse Event (MAE) measure: Aneurysm sac dynamics sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vascular and Endovascular Clinic - Padova University status: RECRUITING city: Padova zip: 35020 country: Italy name: Michele Piazza, Pr role: CONTACT phone: 3498644688 email: [email protected] lat: 45.40797 lon: 11.88586 hasResults: False
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<|newrecord|> nctId: NCT06358235 id: SDU-IH-HA-01 briefTitle: The Effect of Music Therapy on Dyspnea Severity and Vital Signs overallStatus: RECRUITING date: 2024-01-07 date: 2024-05-30 date: 2024-06-30 date: 2024-04-10 date: 2024-04-10 name: Suleyman Demirel University class: OTHER briefSummary: This study aims to investigate the effect of music therapy on dyspnea severity and quality of life indicators in patients with Chronic Obstructive Pulmonary Disease (COPD) admitted to the intensive care unit. The study will be conducted at Isparta City Hospital and Kumluca State Hospital in Antalya, Turkey, using an experimental design. Patients will be divided into experimental and control groups, selected using randomization.
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Patients in the experimental group will receive music therapy in the Hüseyni maqam, while those in the control group will not receive any music therapy. Life indicators and Modified Borg Scale (MBS) values of patients in the experimental group will be recorded before, immediately after, and 30 minutes post-application. Music therapy will be administered to patients for only one day, once in the morning. Data for patients in the control group will be collected at the same time intervals. The results of this study aim to contribute to the literature on the impact of music therapy on dyspnea severity and quality of life indicators in COPD patients. conditions: Dyspnea conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Music Therapy name: No Music therapy measure: Patient Identification Form measure: Modified Borg Scale measure: Vital Signs Record Chart measure: Blood Test Results Record Chart sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suleyman Demırel University status: RECRUITING city: Isparta zip: 32200 country: Turkey name: Hafize Aydemir role: CONTACT phone: +905078380979 email: [email protected] lat: 37.76444 lon: 30.55222 hasResults: False
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<|newrecord|> nctId: NCT06358222 id: LUNon-invasive briefTitle: Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan overallStatus: RECRUITING date: 2023-12-15 date: 2027-12-31 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Shanghai Chest Hospital class: OTHER briefSummary: This is a single center, prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNA/specific methylation molecular features combined with PET-CT imaging features and intervention study. conditions: Carcinoma conditions: Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood ctDNA + methylation + PET-CT and Postoperative pathology name: MRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA name: Intraoperative lymph node dissection measure: Negative prediction value (NPV) of lymph node metastasis rates measure: Disease-free survival (DFS) measure: ctDNA-free interval (CFI) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: ShangHai country: China name: Feng Yao, PhD role: CONTACT phone: 021-22200000 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06358209 id: LY2024-045-B briefTitle: Safety and Efficacy of Ventricular Irrigation for Ventriculitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-30 date: 2026-05-30 date: 2024-04-10 date: 2024-04-10 name: RenJi Hospital class: OTHER name: Southern Medical University, China name: First Affiliated Hospital of Zhejiang University name: 904 Hospital of the People's Liberation Army Joint Logistic Support Force name: Shenzhen Second People's Hospital name: First Affiliated Hospital of Wannan Medical College name: Huashan Hospital briefSummary: Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.
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Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.
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This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis. conditions: Central Nervous System Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Ventricular irrigation measure: Mortality rate measure: GOSE measure: CRS-R measure: DRS measure: mRS measure: Microbial culture measure: CSF glucose measure: CSF protein measure: CSF WBC count measure: Length of stay measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Wannan Medical College city: Wuhu state: Anhui country: China name: Xuefei Shao, Dr role: CONTACT lat: 31.33728 lon: 118.37351 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China name: Qinghua Wang, Dr role: CONTACT lat: 23.11667 lon: 113.25 facility: Shenzhen Second People's Hospital city: Shenzhen state: Guangdong country: China name: Xianjian Huang, Dr role: CONTACT lat: 22.54554 lon: 114.0683 facility: 904 Hospital of the People's Liberation Army Joint Logistic Support Force city: Wuxi state: Jiangsu country: China name: Likun Yang, Dr role: CONTACT lat: 31.56887 lon: 120.28857 facility: Huashan Hospital city: Shanghai state: Shanghai country: China name: Jin Hu, Dr role: CONTACT lat: 31.22222 lon: 121.45806 facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University city: Shanghai state: Shanghai country: China name: Jiyao Jiang, Dr role: CONTACT phone: 021-68383729 email: [email protected] name: Junfeng Feng, Dr role: CONTACT phone: 13611860825 email: [email protected] lat: 31.22222 lon: 121.45806 facility: First Affiliated Hospital of Zhejiang University city: Hangzhou state: Zhejiang country: China name: Xiaofeng Yang, Dr role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06358196 id: CESAH briefTitle: Complex Exploratory Study of Alcohol-Associated Hepatitis acronym: CESAH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-04-30 date: 2024-04-10 date: 2024-04-10 name: Pavol Jozef Safarik University class: OTHER name: L Pasteur University Hospital name: Hospital Agel Kosice-Saca name: Technical University in Kosice name: Western University name: University of Roma La Sapienza briefSummary: Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis. It is associated with high mortality and characterized by an absence of effective treatment, while corticosteroids, which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval. The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims. conditions: Alcoholic Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area measure: Threshold of alcohol consumption associated with (an increased risk of) developing AH measure: Diagnostic accuracy of NIAAA and NIAAAm-CRP measure: Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score measure: Prognostic performance of SOFA and CLIF-C measure: An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score measure: Alternative to Lille model measure: Prognostic model for 90 day survival measure: Uper limit of MELD or Maddrey scores beyond which patients no longer derive any therapeutic benefit from corticosteroid treatment measure: Natural course of nonsevere alcoholic hepatitis measure: Natural course of severe alcoholic hepatitis measure: Risk score for bacterial infection before corticosteroid treatment in patients with alcoholic hepatitis measure: Distinguishing sterile Inflammation from infection in alcoholic hepatitis measure: GUT microbiome and treatment response in alcoholic hepatitis measure: Hypothalamus-pituitary-adrenal axis and treatment response in alcoholic hepatitis measure: Adherence to outpatient psychiatric management measure: Nutritional status and treatment response in alcoholic hepatitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pavol Jozef Safarik University city: Kosice zip: 04012 country: Slovakia name: Jakub Gazda, MD, PhD role: CONTACT phone: +421911115288 email: [email protected] name: Martin Janicko, MD, PhD role: CONTACT email: [email protected] lat: 48.71395 lon: 21.25808 hasResults: False
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<|newrecord|> nctId: NCT06358183 id: ESC001 briefTitle: Surgical Capacity in Zimbabwean Public Hospitals overallStatus: COMPLETED date: 2019-04-24 date: 2024-02-25 date: 2024-03-15 date: 2024-04-10 date: 2024-04-10 name: Parirenyatwa Hospital class: OTHER briefSummary: This study aimed to understand how ready Zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. The researchers looked at hospitals across Zimbabwe to see what kind of surgery facilities, equipment, and specialists were available. conditions: Surgery conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 80 type: ACTUAL name: No intervention measure: Bellwether procedures measure: Procedures measure: SAO density measure: Infrastructure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Parirenyatwa Hospital city: Harare country: Zimbabwe lat: -17.82772 lon: 31.05337 hasResults: False
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<|newrecord|> nctId: NCT06358170 id: NYCU112169AF briefTitle: Effects of Circuit Training Combine With Square-Stepping Exercise, Strength Training and Balance Training on Senior Fitness and Fall Risk in Elderly in the Community acronym: SSE overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-10 date: 2024-04-10 name: Hsin-ching, Tsai class: OTHER briefSummary: According to the cause of death statistics compiled by the Ministry of Health and Welfare in 2022, among the causes of death among the elderly, falls ranked second among the causes of death from accidental injuries over the age of 65. Exercise has been proven to prevent falls in many studies, especially Square-Stepping Exercise can not only train strength and balance, but also improve cognitive function and reduce the fear of falling in the elderly. Therefore, this study will use Square-Stepping Exercise as the core and circuit training as the structure to design a set of exercise training that combines muscle strength and balance and is easy to implement in the community. The purpose of the study is to determine whether exercise training that combines circuit training with block stepping, muscle strength, and balance exercises can reduce the risk of falls among elderly people in the community (primary results: muscle strength, flexibility, cardiorespiratory endurance, balance; secondary results: cognitive function, Fear of falling, fall rate). This study will collect participant in the community, and subjects will be randomly assigned to the experimental group and the control group on a community basis. The experimental group will receive 12 weeks of exercise training, while the control group will follow their usual lifestyle, with 48 people in each group. The experimental design is exercise intervention for 12 weeks, twice a week, 90 minutes each time (30 minutes of main exercise). The exercise is designed into two stages according to the difficulty of Square-Stepping Exercise. The training of muscle strength and dynamic/static balance will also gradually increase in difficulty over the weeks. The research look forward to seeing the effects of multi-component exercise on physical fitness, cognitive function, fear of falling and fall rate. conditions: Circuit-Based Exercise conditions: Exercise Test conditions: Community Health Nursing conditions: Aged conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 126 type: ESTIMATED name: Circuit Training Combine with Square-Stepping Exercise measure: Senior Fitness - upper body muscle strength (Arm Curl Test) measure: Senior Fitness - lower body muscle strength (Chair Stand Test ) measure: Senior Fitness - upper body flexibility (Back Scratch Test) measure: Senior Fitness - lower body flexibility (Chair Sit and Reach Test) measure: Senior Fitness - cardio respiratory endurance ( 2 Minute Step in Place Test) measure: Senior Fitness - dynamic balance (8-Foot Up and Go Test) measure: Senior Fitness - static balance (Single-Leg Balance with Eyes Open) measure: cognitive function measure: Fear of falling measure: fall rate sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: Wei Tzu Lo role: CONTACT phone: 02-2823-9753 phoneExt: 66378 lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06358157 id: CLN02001 briefTitle: The Ladera Large Bore Closure Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2025-02 date: 2024-04-10 date: 2024-04-10 name: Ladera Medical class: INDUSTRY name: Avania briefSummary: This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath. conditions: Vascular Closure conditions: Femoral Arteriotomy Closure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ladera LBC System measure: Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications measure: Primary Performance Endpoint: Time to Hemostasis measure: Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications measure: Secondary Performance Endpoint: Time-to-Ambulation measure: Secondary Performance Endpoint: Time-to-Discharge Eligibility measure: Secondary Performance Endpoint: Incidence of Procedural Success measure: Secondary Performance Endpoint: Incidence of Device Technical Success sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06358144 id: IRB00111438 id: R01DA053209 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA053209 briefTitle: Cannabis Edibles Packaging Imagery Experiment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-07 date: 2024-04-10 date: 2024-04-10 name: Wake Forest University Health Sciences class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery. conditions: Cannabis Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will complete a 15-minute online survey, where they will be randomized to one of five conditions: four intervention conditions with a different image on the package and one without any imagery. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 1250 type: ESTIMATED name: Packaging imagery name: No Imagery (Control) measure: Product Appeal Scoring measure: Harm Perceptions (Absolute) Scoring measure: Willingness to Try Product Scoring measure: Appeal to Children Scoring measure: Harm Perceptions (Relative) Scoring measure: Perception of Quality Scoring sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Alexandra Zizzi, MSPH role: CONTACT lat: 36.09986 lon: -80.24422 hasResults: False
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<|newrecord|> nctId: NCT06358131 id: R.21.10.1493 briefTitle: Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy. overallStatus: RECRUITING date: 2022-01-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. conditions: Gastrointestinal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 656 type: ESTIMATED name: Endoscopy measure: Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events. measure: Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University status: RECRUITING city: Mansoura state: Dakhlia zip: 35516 country: Egypt name: Asmaa Gameel, MD role: CONTACT phone: 01025835429 email: [email protected] lat: 31.03637 lon: 31.38069 facility: MansouraU status: RECRUITING city: Mansoura country: Egypt name: Asmaa Gameel, MD role: CONTACT phone: 201025835429 email: [email protected] lat: 31.03637 lon: 31.38069 hasResults: False
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