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Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care. |
This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 626 type: ESTIMATED name: Quality life questionnaire AQoLS name: Quality life questionnaire Euroqol EQ-5D-5L name: Peer support consultations measure: Unplanned cessation of care at 6 months measure: Number of unfulfilled consultations measure: Euroqol-5D-5L questionnaire score measure: Difference in costs (in euros) measure: Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score measure: average number of standard drinks declared per week measure: Alcohol Quality of Life Scale (AQoLS) score measure: State-Trait Anxiety Inventory (STAI-Y) score measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score measure: Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score measure: type of opioid use measure: frequency of opioid use measure: type of psychostimulant use measure: frequency of psychostimulant use measure: Fagerström test score measure: Health Care Satisfaction Questionnaire (HCSQ) score measure: Number of hospitalisations measure: Service organization description measure: Description of type of support and missions performed by Peer Support measure: Acceptability of Intervention Measure (AIM) score measure: AIM score measure: Adoption of intervention measure: Intervention fidelity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH Le Vinatier city: Bron zip: 69500 country: France name: Monique GUENIN, MD-PhD role: CONTACT phone: +33 4 37 91 55 55 email: [email protected] name: Monique GUENIN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Beaujon city: Clichy zip: 92110 country: France name: Delphine MOISAN, MD-PhD role: CONTACT phone: +33 1 40 87 58 82 email: [email protected] name: Delphine MOISAN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.90018 lon: 2.30952 facility: GH Nord, Hospices Civils de Lyon city: Lyon zip: 69004 country: France name: Benjamin ROLLAND, Professor role: CONTACT name: Benjamin ROLLAND, Professor role: PRINCIPAL_INVESTIGATOR name: François BAILLY, MD-PhD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: CHS St Anne city: Paris zip: 75014 country: France name: Clément VANSTEENE, MD-PhD role: CONTACT name: Clément role: CONTACT name: VANSTEENE, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Bichat Hospital city: Paris zip: 75018 country: France name: Pierre-Alexis GEOFFROY, MD-PhD role: CONTACT phone: +33 1 40 25 82 60 email: [email protected] name: Pierre-Alexis GEOFFROY, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06381596 id: 2023-1715 id: A536000 type: OTHER domain: UW- Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW- Madison id: Protocol Version 3/6/2024 type: OTHER domain: UW- Madison briefTitle: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration acronym: FPF in AMD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is: |
* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy |
Participants will undergo FPF imaging using the OcuMet Beacon system. conditions: Geographic Atrophy conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: OcuMet Beacon measure: Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon measure: Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement measure: Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Visual Sciences city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: [email protected] name: Mihai Mititelu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06381583 id: 23228/EMERALD briefTitle: A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma acronym: EMERALD overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses. conditions: Esophagus Cancer conditions: Esophageal Cancer Stage conditions: Esophageal Cancer conditions: Esophageal Neoplasms conditions: Esophagus Adenocarcinoma conditions: Esophagus, Barrett conditions: Barrett Esophagus conditions: Barrett Adenocarcinoma conditions: Barrett Epithelium conditions: Barretts Esophagus With Dysplasia conditions: Barrett's Esophagus Without Dysplasia conditions: Barretts Esophagus With High Grade Dysplasia conditions: Barretts Esophagus With Low Grade Dysplasia conditions: Barrett Esophagus, Long-Segment conditions: Barrett's Esophagus With Dysplasia, Unspecified conditions: Barrett's Esophagus With Esophagitis conditions: Gastroesophageal Reflux conditions: Reflux Disease conditions: Esophageal Adenocarcinoma conditions: Esophageal Dysplasia conditions: Esophageal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Alessandro Mannucci, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False |
<|newrecord|> nctId: NCT06381570 id: VICTORY/OZM-138 briefTitle: Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas acronym: VICTORY overallStatus: RECRUITING date: 2024-03-21 date: 2026-03-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Daniel Morgenstern class: OTHER name: The Hospital for Sick Children briefSummary: This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories. |
The study will be conducted in two sequential phases: |
Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later conditions: Low-grade Glioma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Tovorafenib measure: MTD/RP2D measure: Safety and Tolerability measure: Overall response rate measure: Pharmacokinetics (Cmax vinblastine and tovorafenib) measure: Pharmacokinetics (AUC of vinblastine and tovorafenib) measure: Progression free survival measure: Duration of response measure: Clinical Benefit rate sex: ALL minimumAge: 0 Weeks maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: The Hospital for Sick Children status: RECRUITING city: Toronto state: Ontario zip: M5G 1X8 country: Canada name: Nirav Thacker role: CONTACT phone: 6137377600 phoneExt: 6525 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06381557 id: YRPG-PMS-ZYJN-RCT-2022-01 briefTitle: Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules acronym: CRF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-01 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: Qiang Fu class: OTHER name: Yangtze River Pharmaceutical Group Co., Ltd. briefSummary: Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer. conditions: Cancer-related Fatigue studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Zhengyuan Capsules name: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder measure: Fatigue degree with the Brief Fatigue Inventory（BFI） measure: Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R） measure: Fatigue degree with the MD Anderson Symptom Inventory（MDASI） measure: Change of patients' functional status with Karnofsky performance status (KPS) measure: Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23） measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381544 id: fbu_nurs_elmali_002 briefTitle: The Effect of Aromatherapy Use in Nursing Skills Training overallStatus: COMPLETED date: 2024-02-12 date: 2024-02-19 date: 2024-03-06 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning. |
Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration. |
RESEARCH HYPOTHESES: |
H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training. |
H1: Aromatherapy reduces the anxiety experienced by students during skills training. |
H2: Aromatherapy has a positive effect on students' learning nursing skills. conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 69 type: ACTUAL name: Aromatherapy application measure: Difference between skill learning of students in the aromatherapy group and the control group measure: Difference between anxiety levels of students in the aromatherapy group and the control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fenerbahce University city: Istanbul state: Atasehir zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 facility: Fenerbahce University city: Ataşehir state: Istanbul zip: 34758 country: Turkey lat: 40.9833 lon: 29.1167 hasResults: False |
<|newrecord|> nctId: NCT06381531 id: 4410 briefTitle: Tracing Brain Tumors Through Deep Time acronym: TRACE overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2027-06-10 date: 2027-06-10 date: 2024-04-24 date: 2024-04-24 name: Tata Memorial Centre class: OTHER name: Indian Statistical Institute, Kolkata briefSummary: Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology. conditions: Brain Tumor conditions: Oncology studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: Imaging with CT and MRI measure: Age-based density maps of brain tumor location measure: Anthropometric analysis of skulls sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tata Memorial Hospital city: Mumbai state: Maharashtra zip: 400012 country: India name: Dr Archya Dasgupta, MD role: CONTACT lat: 19.07283 lon: 72.88261 hasResults: False |
<|newrecord|> nctId: NCT06381518 id: Z2023165 briefTitle: Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease acronym: SHUFFLE overallStatus: ENROLLING_BY_INVITATION date: 2024-03-12 date: 2025-05-01 date: 2025-05-01 date: 2024-04-24 date: 2024-04-24 name: Zuyderland Medisch Centrum class: OTHER briefSummary: The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. |
Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks. |
The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch. conditions: IBD conditions: Infliximab conditions: Crohn Disease conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Switch to SC CT-P13. measure: Area under the curve (AUC) at steady state measure: Quality of life score measure: Patient satisfaction measure: Time expenditure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zuyderland Medical Centre city: Sittard country: Netherlands lat: 50.99833 lon: 5.86944 hasResults: False |
<|newrecord|> nctId: NCT06381505 id: STUDY02002103 briefTitle: RetracTOR/ Retractor for Image Guided Trans-Oral Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-26 name: Ryan J. Halter class: OTHER name: Dartmouth College briefSummary: This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients. conditions: Oral Cavity Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dartmouth-Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States name: Joseph Paydarfar, MD role: CONTACT phone: 603-650-8123 email: [email protected] lat: 43.64229 lon: -72.25176 hasResults: False |
<|newrecord|> nctId: NCT06381492 id: 2024-0057 id: A536130 type: OTHER domain: UW- Madison id: SMPH/ORTHO&REHAB/PHYS THER type: OTHER domain: UW- Madison id: Protocol Version 11/20/2023 type: OTHER domain: UW- Madison briefTitle: Quantifying Patellar Tendon Microstructure Using DTI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is: |
Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon. |
Participants will: |
* undergo MRI and ultrasound imaging |
* perform knee function test |
* complete questionnaires conditions: Patellar Tendinopathy conditions: Anterior Cruciate Ligament Reconstruction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: MRI name: Ultrasound (US) measure: Compare scalar parameters of known patellar tendon pathology to the contralateral tendon measure: Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53705 country: United States name: Maria Flory role: CONTACT phone: 608-262-8652 email: [email protected] lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06381479 id: B031 briefTitle: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms overallStatus: RECRUITING date: 2024-04-19 date: 2024-12-31 date: 2025-03-31 date: 2024-04-24 date: 2024-04-29 name: National Taiwan Sport University class: OTHER name: Bened Biomedical Co., Ltd. briefSummary: There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. conditions: Stress conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: probiotics name: placebo measure: Cortisol measure: Perceived Stress Scale (PSS) measure: Job Stress Scale measure: Overwork Survey measure: Insomnia Severity index (ISI) measure: The State Trait Anxiety Inventory (STAI) measure: Depression Anxiety Stress Scales (DASS-42) measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 measure: VAS-GI measure: Patient Global Impression scales of Improvement rated by patient, PGI-C measure: Serotonin measure: GABA measure: Norepinephrine measure: Immunoglobulin A, IgA measure: adrenocorticotropic hormone, ACTH measure: Total Antioxidant Capacity , TAC sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Graduate Institute of Sports Science, National Taiwan Sport University status: RECRUITING city: Taoyuan zip: 33301 country: Taiwan name: Chi-Chang Huang, PI role: CONTACT phone: +88633283201 phoneExt: 2409 email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False |
<|newrecord|> nctId: NCT06381466 id: D7250C00001 briefTitle: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants. overallStatus: RECRUITING date: 2024-04-01 date: 2025-03-20 date: 2025-03-20 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants. conditions: Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: AZD0233 name: AZD0233 Placebo measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233 measure: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233 measure: Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233 measure: Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233 measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233 measure: Terminal elimination half-life (t1/2) of AZD0233 measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233 measure: Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233 measure: Terminal rate constant (λz) of AZD0233 measure: Accumulation ratio for Cmax (Rac Cmax) of AZD0233 measure: Accumulation ratio for AUC (Rac AUC) of AZD0233 measure: Renal clearance (CLR) of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233 measure: Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False |
<|newrecord|> nctId: NCT06381453 id: 23-5037 briefTitle: Belimumab in Autoimmune Hepatitis acronym: BELief overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2029-04-30 date: 2024-04-24 date: 2024-04-24 name: University Health Network, Toronto class: OTHER name: GlaxoSmithKline briefSummary: Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\<2x ULN \& corticosteroids at a dose of \</= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH. conditions: Autoimmune Hepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Belimumab Auto-Injector [Benlysta] measure: To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH measure: To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To see the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of Belimumab on markers of AIH disease activity measure: To evaluate the effects of Belimumab on markers of AIH disease activity measure: To outline the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To assess the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To measure the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To evaluate the safety of Belimumab in patients with autoimmune hepatitis measure: To assess the safety of Belimumab in patients with autoimmune hepatitis measure: Safety and Tolerability measure: To report the safety of Belimumab in patients with autoimmune hepatitis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381440 id: PROGR-EX_MNESYS briefTitle: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability acronym: PROGR-EX overallStatus: RECRUITING date: 2023-11-15 date: 2024-11-30 date: 2024-11-30 date: 2024-04-24 date: 2024-04-24 name: University Hospital of Ferrara class: OTHER name: Universita di Verona name: Università degli Studi di Ferrara briefSummary: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Lokomat device (Hocoma AG, Volketswil, Switzerland). name: Conventional walking training measure: Walking function measure: Mobility measure: Walking endurance measure: Balance measure: Spasticity measure: Perceived quality of life measure: Perceived walking ability measure: Fatigue measure: Anxiety measure: Depression measure: Kinesiophobia measure: Adaptation to medical condition measure: Coping strategies measure: Muscle oxygen consumption measure: Hemodynamic cortical activation measure: Electrical brain activity measure: miRNA expression measure: Acceptability of robot intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara status: RECRUITING city: Ferrara state: Emilia Romagna zip: 44124 country: Italy name: Sofia Straudi, MD, PhD role: CONTACT phone: 0532236185 email: [email protected] name: Sofia Straudi, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Fabio Manfredini, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Nicola Lamberti, PhD role: SUB_INVESTIGATOR name: Andrea Baroni, PhD role: SUB_INVESTIGATOR name: Giulia Fregna, MSc role: SUB_INVESTIGATOR name: Michela Rimondini, PhD role: SUB_INVESTIGATOR name: Marialuisa Gandolfi, MD, PhD role: SUB_INVESTIGATOR name: Luigi Zerbinati, MD role: SUB_INVESTIGATOR lat: 44.83804 lon: 11.62057 hasResults: False |
<|newrecord|> nctId: NCT06381427 id: 01NVF22109 briefTitle: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure acronym: PeriOP-CARE HF overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: University of Giessen class: OTHER name: Deutsche Luft und Raumfahrt briefSummary: Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1057 type: ESTIMATED name: Interdisciplinary decision-making for perioperative care measure: combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation measure: Incidence of acute kidney injury measure: Incidence of any, treatable, suspected, or confirmed bacterial infection measure: Incidence of cardiac decompensation measure: Incidence of re-hospitalization measure: Mortality measure: Incidence of myocardial infarction (STEMI, NSTEMI) measure: Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS) measure: Quality of life assessed using PHQ-9 measure: Quality of life assessed using GAD-7 measure: Utilization of services and costs sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg city: Gießen zip: 35390 country: Germany name: Michael Sander, PhD role: CONTACT phone: +4964198544401 name: Birgit Aßmus, PHD role: CONTACT lat: 50.58727 lon: 8.67554 hasResults: False |
<|newrecord|> nctId: NCT06381414 id: ChildhoodEarlyOralAging briefTitle: Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-12-20 date: 2024-04-24 date: 2024-04-24 name: University of Nove de Julho class: OTHER briefSummary: The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 183 type: ESTIMATED name: Observation measure: Assessment of Tooth Wear and Dental Management measure: Presence of Enamel Defects measure: Vertical Dimension of Occlusion sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Nove de Julho University city: São Paulo state: SP zip: 03155-000 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False |
<|newrecord|> nctId: NCT06381401 id: MS-492-2023 briefTitle: Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-06-28 date: 2024-07-05 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications. |
To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious complications. |
The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery. |
To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery. |
This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia. |
We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia. |
This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). conditions: Surgical Field Visualization, Acute Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: bupivacaine 0.25% name: bupivacaine 0.125% measure: The total consumption of IV glyceryl trinitrate (GTN) measure: Fentanyl consumption measure: Postoperative pain measure: Postoperative hospital stay sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381388 id: NL86587.041.24 briefTitle: Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke acronym: InterAct overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-06-30 date: 2024-04-24 date: 2024-04-24 name: Jord Vink class: OTHER briefSummary: Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear. |
Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls. |
Study design: A prospective, open-label within-subject intervention study |
Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls. |
Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: cTBS measure: Interhemispheric inhibition (IHI) measure: Ipsilesional resting motor threshold (RMT) measure: Contralesional resting motor threshold (RMT) measure: TMS interference measure: Intracortical inhibition (ICI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: De Hoogstraat Revalidatie city: Utrecht country: Netherlands name: Anne Visser-Meily, MD, PhD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False |
<|newrecord|> nctId: NCT06381375 id: 24-2-2024 briefTitle: Drug-drug Interactions With Anti-tuberculous Drugs overallStatus: RECRUITING date: 2024-04-30 date: 2024-12-01 date: 2025-02-15 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients. conditions: Drug-drug Interaction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Anti Tuberculosis Drug measure: Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients measure: 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Omnia Azmy Nabeh status: RECRUITING city: Cairo zip: 11562 country: Egypt name: Omnia Azmy Nabeh, MD role: CONTACT phone: 01066969673 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06381362 id: IGOMIPS briefTitle: Italian Registry of Minimally Invasive Pancreatic Surgery acronym: IGOMIPS overallStatus: RECRUITING date: 2019-02-28 date: 2029-02-28 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: Associazione Italiana per lo Studio del Pancreas class: OTHER briefSummary: Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes conditions: Pancreatic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2300 type: ESTIMATED name: Minimally invasive pancreatic surgery measure: Postoperative short-term outcomes measure: Long-term oncological outcomes measure: Rate of cases that after a minimally invasive approach had to be converted to and open approach measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giovanni Capretti status: RECRUITING city: Milan country: Italy name: Giovanni Capretti, Dr. role: CONTACT phone: +390282247646 email: [email protected] name: Alessandro Zerbi, Prof. role: PRINCIPAL_INVESTIGATOR name: Giovanni Capretti, Dr. role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06381349 id: GPOEM-GEMS briefTitle: Predicting Outcomes of GPOEM Using Gastric Electrical Mapping acronym: GPOEM-GEMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-06-01 date: 2024-04-24 date: 2024-04-24 name: Chris Varghese class: OTHER briefSummary: Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months. conditions: Gastroparesis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Gastric Alimetry test measure: Gastroparesis Cardinal Symptom Index (GCSI) measure: Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) measure: EQ-5D scores measure: Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) measure: Patient Health Questionnaire - 8 (PHQ-8) measure: Generalized Anxiety Disorder 7-item (GAD-7) measure: Perceived Stress Scale 4 (PSS-4) measure: Brief Illness Perception Questionnaire-Revised measure: Alimetry® Gut-Brain Wellbeing (AGBW) measure: Work Productivity and Activity Impairment (WPAI) measure: Change in Gastric Alimetry Phenotype sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381336 id: TRAKSILVER2022 briefTitle: A Digital Home-Based Physiotherapy Program for Active Aging acronym: TRAK overallStatus: COMPLETED date: 2022-03-23 date: 2022-11-07 date: 2022-11-07 date: 2024-04-24 date: 2024-04-25 name: Trak Health Solutions S.L. class: INDUSTRY name: Basque Health Service name: University of the Basque Country (UPV/EHU) briefSummary: This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated. |
This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field. |
The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity. conditions: Frail Elderly Syndrome conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: TRAK-SILVER platform measure: Short Physical Performance Battery (SPPB measure: Gait Speed measure: Timed Up and Go Test measure: 6-minute walk test (6MWT) measure: Berg Balance Scale measure: Number of steps count measure: Geriatric Depression Scale-15 (GDS) measure: De Jong Gierveld Loneliness Scale (JGLS) measure: Quality of life (QoL) questionnaire measure: Client Satisfaction Questionnaire (CSQ) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Social Center of Orio (Zahartzaroa) city: Orio state: Basque Country zip: 20810 country: Spain lat: 43.2787 lon: -2.12537 hasResults: False |
<|newrecord|> nctId: NCT06381323 id: PA2024 briefTitle: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-04-01 date: 2024-04-24 date: 2024-04-24 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism. conditions: Primary Aldosteronism conditions: Finerenone conditions: Mineralocorticoid Receptor Antagonist studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: Finerenone measure: 24h systolic BP drop value measure: The change of diastolic BP from the baseline level after Finerenone treatment measure: Hypertension remission rate measure: Change of serum potassium level measure: Change of plasma renin activity measure: Change of ARR measure: Change of UACR measure: Change of eGFR measure: Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Dalong Zhu, MD,PhD role: CONTACT phone: 86-25-83-105302 email: [email protected] name: Ping Li, MD,PhD role: CONTACT phone: 86-25-83-105302 email: [email protected] name: Dalong Zhu, MD,PhD role: PRINCIPAL_INVESTIGATOR name: Ping Li, MD,PhD role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06381310 id: 202310077DINB briefTitle: Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-30 date: 2024-10-30 date: 2024-04-24 date: 2024-04-24 name: National Taiwan University Hospital class: OTHER name: National Taiwan University Hospital Bei-Hu Branch briefSummary: Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice. |
Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt. |
Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation. |
Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care. conditions: Successful Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: asus-handheld-ultrasound LU710L measure: cannulation success rate measure: cannulation satisfaction sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital Bei-Hu Branch status: RECRUITING city: Taipei City country: Taiwan name: Tsuei-Wun Chang role: CONTACT phone: 886-23717101 phoneExt: 218501 lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06381297 id: OndokusMU id: Ondokuz Mayıs University type: REGISTRY domain: Clinical research ethics committee briefTitle: Speech in Noise Discrimination Skills in Multiple Sclerosis Patients. overallStatus: COMPLETED date: 2020-10-09 date: 2023-03-23 date: 2023-04-23 date: 2024-04-24 date: 2024-04-24 name: Asuman Kucukoner class: OTHER briefSummary: The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group. |
The main questions it aims to answer are: |
Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated. conditions: Multiple Sclerosis-Relapsing-Remitting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Multiple sclerosis patient group and healthy control group. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ACTUAL name: Hearing test name: Speech in noise discrimination test name: Montreal Cognitive Assessment Scale name: Symbol Number Modalities Test (SDMT) measure: Pure tone Audiometry Test measure: Speech Audiometry measure: Speech Discrimination in Noise Test measure: Otoacoustic Emission Test measure: Contralateral Suppression Test measure: Montreal Cognitive Assessment Scale measure: Symbol Digit Modalities Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ondokuz Mayıs University city: Samsun zip: 55300 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False |
<|newrecord|> nctId: NCT06381284 id: MG-001 briefTitle: Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment overallStatus: RECRUITING date: 2024-03-28 date: 2024-05-27 date: 2025-05-27 date: 2024-04-24 date: 2024-04-26 name: ZS Associates class: INDUSTRY name: University of California, San Francisco briefSummary: This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG). conditions: Myasthenia Gravis conditions: Neuromuscular Manifestations conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Social media recruitment name: Self-Assessment name: Follow-up measure: Social media recruitment feasibility measure: MG Exercise Assessment Tool validity measure: Time to diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ZS Associates status: RECRUITING city: Evanston state: Illinois zip: 60201 country: United States name: Ananda V Pandurangadu, MD role: CONTACT phone: 1-847-448-1001 email: [email protected] name: Ananda Vishnu Pandurangadu, MD role: PRINCIPAL_INVESTIGATOR name: Pritikanta Paul, MD role: SUB_INVESTIGATOR lat: 42.04114 lon: -87.69006 hasResults: False |
<|newrecord|> nctId: NCT06381271 id: TRUST TAVR Registry briefTitle: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation overallStatus: RECRUITING date: 2018-10-30 date: 2034-10 date: 2034-10 date: 2024-04-24 date: 2024-04-24 name: Xijing Hospital class: OTHER briefSummary: The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected conditions: Aortic Valve Regurgitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Transcatheter aortic valve replacement measure: Combined clinical efficacy outcomes measure: Combined early safety and clinical efficacy outcomes measure: Rate of technical success measure: Rate of device success measure: Combined clinical efficacy outcomes measure: Rate of all-cause mortality measure: Valve-related long-term clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Rutao Wang, M.D., Ph.D. role: CONTACT phone: +86-15091095796 email: [email protected] name: Ruining Zhang, BSc role: CONTACT phone: +86-15802990370 email: [email protected] name: Ling Tao, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06381258 id: SDF briefTitle: Fetal Cardiac Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies. conditions: Fetal Growth Retardation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Ultrasound measure: Cardiac systolic function measure: Cardiac diastolic function sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381245 id: KB/265/2023 briefTitle: First-time Ablation of Atrial Fibrillation Registry acronym: DIPE overallStatus: RECRUITING date: 2023-12-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-24 date: 2024-04-24 name: Medical University of Warsaw class: OTHER briefSummary: Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success. |
The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. conditions: Atrial Fibrillation conditions: Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: PPG-based remote heart rhythm/rate monitoring name: ECG-based remote heart rhythm/rate monitoring name: Transthoracic and transesophageal echocardiography examination name: Liver ultrasound examination name: Rotational angiography with three-dimensional reconstruction name: Blood-derived biomarker analysis name: Mobile health-based spirometry measure: Late AF recurrence measure: Late recurrence of AF or atrial tachycardia or atrial flutter measure: Early recurrence of AF measure: Early recurrence of AF or atrial tachycardia or atrial flutter measure: Time to AF recurrence and the impact of early recurrence on late AF recurrence measure: The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring measure: Progression or regression of AF measure: Modification of treatment, including antiarrhythmic treatment measure: AF-related quality of life and symptoms measure: Periprocedural complications measure: Heart rate variability and rate measure: Blood biomarker levels measure: Ablation procedure parameters measure: Cardiac remodelling sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw country: Poland name: Monika Gawałko, MD, PhD role: CONTACT phone: 22 599 19 58 phoneExt: +48 email: [email protected] name: Monika Gawałko, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Paweł Balsam, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Piotr Lodziński, MD, PhD role: SUB_INVESTIGATOR name: Michał Marchel, MD, PhD role: SUB_INVESTIGATOR name: Michał Peller, MD, PhD role: SUB_INVESTIGATOR name: Bartosz Krzowski, MD, PhD role: SUB_INVESTIGATOR name: Cezary Maciejewski, MD, PhD role: SUB_INVESTIGATOR name: Maria Boszko, MD role: SUB_INVESTIGATOR name: Michał Gawlik, MD role: SUB_INVESTIGATOR name: Karolina Mitrzak, MD role: SUB_INVESTIGATOR name: Alicja Skrobucha, MD role: SUB_INVESTIGATOR name: Mateusz Wawrzeńczyk, MD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06381232 id: VIOME-001 briefTitle: Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population overallStatus: RECRUITING date: 2018-07-23 date: 2028-07-23 date: 2028-07-23 date: 2024-04-24 date: 2024-04-24 name: Viome class: INDUSTRY briefSummary: The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease. conditions: General Health conditions: Wellness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED name: No Intervention measure: Molecular Determinants of Health and Disease sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Viome Life Sciences status: RECRUITING city: Bothell state: Washington zip: 98011 country: United States name: Momchilo Vuyisich role: CONTACT phone: 425-300-6933 email: [email protected] lat: 47.76232 lon: -122.2054 hasResults: False |
<|newrecord|> nctId: NCT06381219 id: s67001 briefTitle: Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial overallStatus: RECRUITING date: 2023-12-19 date: 2026-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE. conditions: Eosinophilic Esophagitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of hen's egg in decreasingly heated forms measure: Maintained remission of EoE measure: Maintained remission only in step 1 of the diet measure: Association of remission with circulating IgG4 levels measure: Association of remission with IgG4 levels on biopsy measure: In vitro B cell test to mimic B cell activation after stimulation measure: Correlation between QoL and remission measure: Associated atopy measure: Associated food allergies sex: ALL minimumAge: 12 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Dominique Bullens, Prof. Dr. role: CONTACT phone: 0032 16 34 38 01 email: [email protected] name: Marleen Jannis role: CONTACT phone: 0032 16 34 38 01 email: [email protected] lat: 50.87959 lon: 4.70093 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-05 uploadDate: 2023-10-25T10:35 filename: Prot_000.pdf size: 696874 hasResults: False |
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