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Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch.
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The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. conditions: Menopause conditions: Insomnia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 222 type: ESTIMATED name: Estrogens and Progestogens name: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy measure: The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). sex: FEMALE minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06306391 id: IMIMFCTL/NLX_1 briefTitle: Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. overallStatus: RECRUITING date: 2024-03-05 date: 2024-09 date: 2024-09 date: 2024-03-12 date: 2024-03-15 name: Parc de Salut Mar class: OTHER name: Food and Drug Administration (FDA) briefSummary: This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Intravenous naloxone name: Intranasal naloxone measure: Effects of naloxone on heart rate (HR). measure: Effects of naloxone on systolic and diastolic blood pressure (BP). measure: Effects of naloxone on plasma cortisol at visit 1 and visit 4. measure: Adverse effects. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: IMIM (Hospital del Mar Medical Research Institute) status: RECRUITING city: Barcelona zip: 08003 country: Spain name: Rafael De la Torre Fornell, PharmD, PhD role: CONTACT phone: 00343160780 phoneExt: 1780 email: rtorre@imim.es lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06306378 id: XJTU1AF2023LSK-481 briefTitle: The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder overallStatus: RECRUITING date: 2023-12-04 date: 2024-03-30 date: 2024-04-30 date: 2024-03-12 date: 2024-03-12 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER name: Xi'an TCM Hospital of Encephalopathy briefSummary: Research background and project basis
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Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.
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Research purpose
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Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 60 type: ESTIMATED name: social memory levels and spindle levels measure: Recognition accuracy measure: Response delay time measure: Sleep spindle density measure: Sleep spindle average duration measure: Sleep spindle amplitude measure: Sleep spindle frequency sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: First Afflicated Hospital Xian Jiaotong University status: RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Yan Li, MD., PhD. role: CONTACT phone: 13720418610 email: liyanxjtu@xjtu.edu.cn name: Dongqi Cui, PhD. role: CONTACT phone: 18501059233 email: 18501059233@163.com lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06306365 id: PI-DOC003-WBOA briefTitle: Effects of Modern Board Games on Well Being in Older Adults acronym: JUMEMO3e+ overallStatus: RECRUITING date: 2024-02-07 date: 2024-06-28 date: 2024-06-28 date: 2024-03-12 date: 2024-03-12 name: European University Miguel de Cervantes class: OTHER name: Centro Doctor Villacián, Valladolid, Spain briefSummary: The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being. conditions: Executive Functions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: No masking. count: 35 type: ESTIMATED name: Modern board game-based learning measure: Examination for Mental Disorders of the Elderly measure: Trail Making Test to evaluate Executive Functions measure: Assessment of quality of life in older adults and people with disabilities measure: Psychometric development and practical use sex: ALL minimumAge: 65 Years maximumAge: 120 Years stdAges: OLDER_ADULT facility: European University Miguel of Cervante status: RECRUITING city: Valladolid zip: 47012 country: Spain name: Azael J. Herrero, PhD role: CONTACT phone: +34983001000 email: jaherrero@uemc.es name: Raquel Martínez-Sinovas, PhD role: CONTACT phone: +34983001000 email: rmsinovas@uemc.es lat: 41.65518 lon: -4.72372 hasResults: False
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<|newrecord|> nctId: NCT06306352 id: 1070 id: NL82999.091.22 type: OTHER domain: CCMO briefTitle: Vibrotactile Feedback in Exoskeletons overallStatus: COMPLETED date: 2023-03-06 date: 2023-06-21 date: 2023-06-21 date: 2024-03-12 date: 2024-03-12 name: Sint Maartenskliniek class: OTHER name: ABLE Human Motion S.L. name: Netherlands Organisation for Scientific Research briefSummary: This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI. conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 7 type: ACTUAL name: Vibrotactile feedback measure: Walking distance covered measure: Reach path ratio measure: Reach time measure: User experience questionnaire measure: Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device measure: Dutch System Usability Scale (D-SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sint Maartenskliniek city: Nijmegen country: Netherlands lat: 51.8425 lon: 5.85278 hasResults: False
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<|newrecord|> nctId: NCT06306339 id: hzVSF_v13-0015 briefTitle: A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-07 date: 2024-03-12 date: 2024-03-12 name: ImmuneMed, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA). conditions: Moderate to Severe Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Burfiralimab name: SOC (Standard of care) name: Placebo measure: Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12 measure: Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined measure: Clinical response at Week 12, assessed as remission defined measure: Improvement of physical function at Week 12 measure: Pain relief at Week 12 assessed by the (mean) change from Baseline measure: Health-related quality of life at Week 12, assessed as the change from Baseline sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Urtrecht city: Utrecht state: GA country: Netherlands lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06306326 id: pkussfatgrafting briefTitle: 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-12-01 date: 2029-03-01 date: 2024-03-12 date: 2024-04-18 name: Peking University class: OTHER briefSummary: Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis. conditions: Adipocytes conditions: Autografts conditions: Imaging, Three-Dimensional / Methods studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: 3dMD technology measure: Fat Retention Rate measure: Patient Satisfaction sex: ALL minimumAge: 3 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06306313 id: ReoGo briefTitle: Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke overallStatus: RECRUITING date: 2024-03-07 date: 2024-05-07 date: 2024-05-14 date: 2024-03-12 date: 2024-04-05 name: Pamukkale University class: OTHER briefSummary: The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.
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It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.
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In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period. conditions: Stroke conditions: Upper Extremity Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: ReoGo name: Conventional Physiotherapy measure: Fugl Meyer Upper Extremity Evaluation Scale measure: Functional Independence Scale sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University status: RECRUITING city: Denizli country: Turkey name: Fatih Tekin, Prof. role: CONTACT phone: +90258 296 4264 email: fzt.ftekin@hotmail.com lat: 37.77417 lon: 29.0875 hasResults: False
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<|newrecord|> nctId: NCT06306300 id: 445957/2020-4 briefTitle: Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil) acronym: HCVPCL05/20 overallStatus: RECRUITING date: 2022-07-04 date: 2025-12-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-25 name: Oswaldo Cruz Foundation class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study).
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The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS. conditions: Hepatitis C studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study I is a population-based cross-sectional screening study (n=30,000 individuals) to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (n=1,500 participants included in Study I). Study II is a phase IV open-label randomized clinical trial (1:1) to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30000 type: ESTIMATED name: Specialist - Epclusa 400Mg-100Mg Tablet name: Non- specialist - Epclusa 400Mg-100Mg Tablet measure: Prevalence of HCV infection measure: The effectiveness of the HCV treatment with test results. measure: Usability of the result of a self-test HCV measure: Proportion between positive and negative measure: Participants with fibrosis/cirrhosis measure: Participants who denied the treatment measure: cost per detected participant measure: Unscheduled visits during treatment measure: Improvement of liver fibrosis stage measure: Quality of life data measure: Cost of treatment for participant measure: Adherence to treatment measure: Participant´s Ability to use the test measure: Participant preference for types of tests measure: Participant understanding to interpret his result measure: Test Performance measure: Test Accuracy sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Evandro Chagas National Institute of Infectious Diseases status: RECRUITING city: Rio de Janeiro state: Rio De Janeiro/RJ zip: 21040-360 country: Brazil name: Hugo Perazzo, PhD role: CONTACT phone: +5521 3865-9587 email: hugo.perazzo@ini.fiocruz.br lat: -22.90278 lon: -43.2075 facility: Hugo Perazzo status: RECRUITING city: Rio De Janeiro country: Brazil name: Hugo Perazzo, PhD role: CONTACT phone: +552138659587 email: hugo.perazzo@ini.fiocruz.br lat: -22.90278 lon: -43.2075 hasResults: False
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<|newrecord|> nctId: NCT06306287 id: DA053660 briefTitle: Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use acronym: ASPIRE overallStatus: RECRUITING date: 2024-02-15 date: 2024-11-30 date: 2025-04-30 date: 2024-03-12 date: 2024-04-22 name: Oregon Research Institute class: OTHER briefSummary: Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:
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* Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)
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* Are outcomes for ePACE are superior to those for eFACE
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* Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months. conditions: Substance Use conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The investigators and the assessors will not have access to the conditions to which participants are assigned until all data are collected. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ePACE Personalized Intervention name: eFACE Fixed Intervention measure: Adolescent Substance Use from baseline to 3 months measure: Adolescent Substance Use from baseline to 6 months measure: Youth Report of Internalizing Problems from baseline to 3 months measure: Youth Report of Internalizing Problems Change from baseline to 6-months measure: Youth Report of Externalizing Problems from baseline to 3-months measure: Youth Report of Externalizing Problems from baseline to 6-months measure: Parent Report of Internalizing Problems from baseline to 3-months measure: Parent Report Internalizing Problems from baseline to 6-months measure: Parent Report Externalizing Problems from baseline to 3-months measure: Parent Report Externalizing Problems from baseline to 6-months measure: Problem-Solving Inventory from baseline to 3-months measure: Problem-Solving Inventory from baseline to 6-months measure: Child Global Assessment Scale (CGAS) from baseline to 3-months measure: Child Global Assessment Scale (CGAS) from baseline to 6-months measure: Peer Encouragement and Influence from baseline to 3 months measure: Peer Encouragement and Influence from baseline to 6 months measure: Emotion Regulation from baseline to 3 months measure: Emotion Regulation - baseline to 6 months measure: Change in Urine assay - baseline to 3 months measure: Change in Urine assay - 3 months to 6 months sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Research Institute status: RECRUITING city: Albuquerque state: New Mexico zip: 87109 country: United States name: Holly B Waldron, PhD role: CONTACT phone: 541-915-6196 email: hwaldron@ori.org name: Aleah A Montano, MA role: CONTACT phone: 5054538984 phoneExt: Waldron email: hollybarrettwaldron@gmail.com name: Holly B Waldron, PhD role: PRINCIPAL_INVESTIGATOR name: Ken C Winters, PhD role: PRINCIPAL_INVESTIGATOR name: Timothy J Ozechowski, PhD role: SUB_INVESTIGATOR name: Hyman Hops, PhD role: SUB_INVESTIGATOR lat: 35.08449 lon: -106.65114 hasResults: False
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<|newrecord|> nctId: NCT06306274 id: TACLE trial briefTitle: Topical Tacrolimus for Breast Cancer-related Lymphedema overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-30 date: 2025-11-30 date: 2024-03-12 date: 2024-03-12 name: Odense University Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:
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* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
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* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months. conditions: Lymphedema studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Tacrolimus name: Placebo measure: Lymphedema volume sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital city: Odense zip: 5000 country: Denmark name: Frederik Gulmark Hansen role: CONTACT phone: +4521734450 email: frederik.c.gulmark.hansen@rsyd.dk lat: 55.39594 lon: 10.38831 facility: Zealand University Hospital city: Roskilde zip: 4000 country: Denmark name: Michael Rose role: CONTACT lat: 55.64152 lon: 12.08035 facility: Lillebaelt Hospital city: Vejle zip: 4000 country: Denmark lat: 55.70927 lon: 9.5357 hasResults: False
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<|newrecord|> nctId: NCT06306261 id: TIMAEUS briefTitle: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis acronym: TIMAEUS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08 date: 2025-03-15 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists. conditions: Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: questionnaire measure: to evaluate mental stress/health as an impacting factor on UC progression sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Ospedale San Raffaele city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306248 id: PNRR-MAD-2022-12375716 briefTitle: Immune Activation, Neural Plasticity and Depression overallStatus: RECRUITING date: 2023-03-03 date: 2025-03-03 date: 2025-05-09 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up. conditions: Mood Disorders conditions: Major Depressive Disorder conditions: Sleep Deprivation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Total sleep deprivation measure: BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients. measure: Neurobiological markers of prediction and progression of antidepressant treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Sara SP Poletti, phd role: CONTACT phone: 390226433156 email: poletti.sara@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306235 id: 20.84-reva20.06 briefTitle: Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation? overallStatus: COMPLETED date: 2020-10-12 date: 2021-07-31 date: 2021-07-31 date: 2024-03-12 date: 2024-03-12 name: Jessa Hospital class: OTHER briefSummary: Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study).
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Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation. conditions: Cardiac Rehabilitation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: Questionnaire measure: Willingness to participate in telerehabilitation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jessa Hospital city: Hasselt state: Limburg zip: 3500 country: Belgium lat: 50.93106 lon: 5.33781 hasResults: False
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<|newrecord|> nctId: NCT06306222 id: GR-2021-12375430 briefTitle: Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease overallStatus: RECRUITING date: 2023-11-23 date: 2025-11-23 date: 2026-02-23 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL. conditions: Kidney Stone conditions: Ureteral Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Laser lithotripsy measure: Lithotripsy speed measure: Stone free rate sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan country: Italy name: Alessia D'Arma role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306209 id: DeFLAME briefTitle: Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach overallStatus: RECRUITING date: 2021-05-18 date: 2024-11-30 date: 2025-01-14 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients.
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Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes. conditions: Mood Disorders conditions: Major Depressive Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Treatment as usual (TAU), i.e., pharmacotherapy plus clinical management measure: The potential role of inflammation as the causal link between the quality of the environment and SSRI efficacy measure: interaction between early stress and recent stress on the response to treatment and the role of inflammation measure: identification of neurobiological predictors of response to treatment measure: identification of neurobiological predictors of response to treatment measure: identification of neurobiological predictors of response to treatment measure: epigenetic changes in cytokine regulating genes which could mediate the effect of stress on response to treatment. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Sara sp Poletti, phd role: CONTACT phone: +390226433156 email: poletti.sara@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306196 id: IVI Hecolin S001 briefTitle: Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-03-12 date: 2024-03-12 name: International Vaccine Institute class: OTHER name: Xiamen Innovax Biotech Co., Ltd name: Bill and Melinda Gates Foundation briefSummary: The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals conditions: Hepatitis E Virus Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Single whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 860 type: ESTIMATED name: Hecolin® Recombinant Hepatitis E Vaccine name: Isotonic Sodium Chloride injection measure: Seroresponse rate measure: Proportion of immediate adverse events measure: Proportion of solicited local and systemic adverse events measure: Proportion of unsolicited adverse events measure: Proportion of SAEs, MAAEs and AESIs measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: Safety in all participants as per gender distribution and serostatus sex: ALL minimumAge: 2 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06306183 id: 2024-2829 briefTitle: Effect of Vitamin C on Pain Reduction After an Emergency Department Visit acronym: Vicamed overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-11 date: 2028-03 date: 2024-03-12 date: 2024-03-12 name: Hopital du Sacre-Coeur de Montreal class: OTHER name: Hopital de l'Enfant-Jesus name: The Ottawa Hospital briefSummary: Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain.
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The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months.
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This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development. conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind randomized placebo-controlled trial primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 546 type: ESTIMATED name: Acetaminophen and Vitamin C with Naproxen rescue name: Acetaminophen and Placebo with Naproxen rescue measure: Daily pain intensity measure: NSAIDs consumption measure: Pain relief measure: New analgesic prescriptions measure: Adverse events measure: Quality of life improvement at seven days measure: Quantity of Healthcare visits measure: Prevalence of chronic pain measure: Prevalence of complex regional pain syndromes for limb fractures measure: Quality of life improvement at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital du Sacre-Coeur de Montreal city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06306170 id: GYN-ART briefTitle: Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART) acronym: GYN-ART overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2029-02-15 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed. conditions: Gynecologic Cancer conditions: Radiotherapy Side Effect conditions: Radiotherapy; Complications conditions: Survivorship conditions: Progression, Disease conditions: Progression, Clinical studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Image Guided Radiotherapy measure: Local Relapse Free Survival measure: Regional Relapse Free Survival measure: Distant Metastases Free Survival measure: Disease Free Survival measure: Overall Survival measure: Cancer Specific Survival measure: Acute toxicity measure: Late toxicity measure: Predictive factors for disease progression and death measure: Radiomic predictive factors for disease progression and death sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Scientific Institute status: RECRUITING city: Milan state: MI zip: 20132 country: Italy name: Andrei Fodor, M.D. role: CONTACT phone: +390226437634 email: fodor.andrei@hsr.it name: Nadia G Di Muzio, Prof role: CONTACT phone: +390226437643 email: dimuzio.nadia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306157 id: 2023-0667 briefTitle: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome acronym: LDN-CRPS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-07 date: 2026-10 date: 2024-03-12 date: 2024-03-12 name: Hospital for Special Surgery, New York class: OTHER briefSummary: Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study. conditions: Complex Regional Pain Syndrome conditions: Chronic Pain conditions: Causalgia conditions: Complex Regional Pain Syndrome Type I conditions: Complex Regional Pain Syndrome Type II studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a feasibility, randomized, placebo-controlled interventional drug study. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A quadruple blinded study where the patient, research team, treating clinician, and outcomes assessor are unaware of the randomization results until after study conclusion. The research pharmacy will not be blinded and will be responsible for preparing the medication and securely handing it off to the research assistant according to the pre-approved dispensation plan. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Low dose naltrexone name: Placebo sugar capsules measure: Number of study patients enrolled measure: Number of study patients randomized measure: Number of study patients who received the study medication measure: Incidence of side effects/adverse events measure: Average NRS pain measure: CRPS symptom severity measure: PROMIS-10 score measure: S-LANSS score measure: Blinding assessment measure: Enrollment rate measure: Study medication compliance measure: Reasons for study medication non-compliance measure: Drop-out rate measure: Reasons for drop-out sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: Marlena Komatz role: CONTACT phone: 646-714-2901 email: komatzm@hss.edu lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06306144 id: 69HCL23_0691 briefTitle: Early-phase Telecare Programs for Minor Stroke acronym: COGaDOM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-03-12 date: 2024-04-18 name: Hospices Civils de Lyon class: OTHER briefSummary: Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.
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However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.
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Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation. conditions: Minor Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Psychoeducation name: Computerised Cognitive Stimulation name: Usual Care measure: The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke. measure: to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux zip: 33000 country: France name: GLIZE Bertrand role: CONTACT phone: 05 56 79 56 79 email: bertrand.glize@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: CHU Lille city: Lille zip: 59037 country: France name: ALLART Etienne, Dr role: CONTACT phone: 03 20 44 48 71 email: etienne.allart@chu-lille.fr lat: 50.63297 lon: 3.05858 facility: Hôpital Henry Gabrielle city: Saint-Genis-Laval zip: 69230 country: France name: PUGNIET Virginie role: CONTACT phone: 04.78.86.50.64 email: virginie.pugniet@chu-lyon.fr lat: 45.69558 lon: 4.7934 hasResults: False
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<|newrecord|> nctId: NCT06306131 id: IG-23-002 id: 1R43HD107861-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R43HD107861-01A1 briefTitle: Phase II Study of Ovulation in Obese Women overallStatus: RECRUITING date: 2023-12-10 date: 2024-12-01 date: 2025-01-31 date: 2024-03-12 date: 2024-03-12 name: InnovaGyn, Inc. class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are:
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1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo.
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2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\].
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Participants will:
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* undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam,
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* maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding,
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* collect daily first morning voided urine from menstrual day 9 to 24,
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* undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14.
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* allow a blood sample to be drawn on days with ultrasound scans.
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* Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later.
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Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs conditions: Pregnancy Prevention studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle. primaryPurpose: OTHER masking: SINGLE maskingDescription: The intervention will be masked to the laboratory preforming the analysis of the urinary metabolites. The statistician, clinicians, coordinators and participants will be aware of the medication being studied. whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Levonorgestrel 0.15 milligram name: Meloxicam 15 milligram name: calcium carbonate 750 milligram measure: Interval from first dose to evidence of ovulation. measure: Change in blood pressure measure: Change in Pulse measure: Unscheduled endometrial bleeding and changes in interval, amount and duration of menstrual bleeding. sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Carolina Women's Research and Wellness Center status: RECRUITING city: Raleigh state: North Carolina zip: 27713 country: United States name: Andrea S. Lukes, MD role: CONTACT phone: 919-251-9223 email: andrealukes@cwrwc.com name: Janet F. Davis role: CONTACT phone: 9192519223 email: janet@cwrwc.com name: Andrea S. Lukes, MD role: PRINCIPAL_INVESTIGATOR lat: 35.7721 lon: -78.63861 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-17 uploadDate: 2023-10-16T10:12 filename: ICF_000.pdf size: 336680 hasResults: False
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<|newrecord|> nctId: NCT06306118 id: 35-046 ex 22/23 briefTitle: Autoguide Positioning Device for Multiple Stereotactic Biopsies acronym: AMB overallStatus: RECRUITING date: 2024-04-15 date: 2025-02 date: 2025-10 date: 2024-03-12 date: 2024-03-12 name: Medical University of Graz class: OTHER briefSummary: The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.
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The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.
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On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.
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To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision. conditions: Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection measure: Biopsy Results sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Stefan Wolfsberger, Prof. role: CONTACT phone: +43031638583102 email: stefan.wolfsberger@medunigraz.at lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06306105 id: 23-118-B briefTitle: Assessment of Anti-aging Efficacy of Marine Collagen Peptides overallStatus: RECRUITING date: 2024-03-04 date: 2024-10-31 date: 2024-12-01 date: 2024-03-12 date: 2024-03-19 name: TCI Co., Ltd. class: INDUSTRY briefSummary: To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human conditions: Skin Condition conditions: Hair Fragility conditions: Nails, Ingrown studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Marine Collagen Peptides name: placebo drink measure: The change of skin hydation measure: The change of skin wrinkles measure: The change of skin elasticity measure: The change of skin collagen density measure: The change of hair diameters measure: The change of hair loss amount measure: The change of hair roots diameters measure: The change of hair density measure: The change of hair follicle strength measure: The change of thumbs nail color measure: The change of nails appearence measure: The change of nails growth measure: The degree of nails fragility measure: The change of self-assessment skin, hair, and nails condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chia Nan University of Pharmacy & Science status: RECRUITING city: Pingtung zip: 928 country: Taiwan name: Chia-Hua Liang role: CONTACT phone: +886-06-2664911 phoneExt: 2441 email: tinna_ling@mail.cnu.edu.tw name: Ping Lin role: CONTACT phone: +886-02-879778111 email: candice.lin@tci-bio.com lat: 22.67135 lon: 120.48814 hasResults: False
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<|newrecord|> nctId: NCT06306092 id: 2023-02885-01 briefTitle: Promoting Teenage Sleep for Improved Mental Health and School Performance acronym: TeenSleep overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-06 date: 2030-06 date: 2024-03-12 date: 2024-03-12 name: Kristianstad University class: OTHER name: Karolinska Institutet name: Örebro University, Sweden name: Academic Primary Health Care Centre, Region Stockholm briefSummary: The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group). conditions: Mental Health Issue conditions: Insomnia conditions: Depression conditions: Anxiety conditions: Daytime Sleepiness conditions: Wellness, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Sleep on Schedule name: Technology restriction measure: Change in sleep duration, hours and minutes measure: Change in Hospital Anxiety and Depression Scale scores measure: Change in Adolescent Sleep Hygiene Scale scores measure: Change in Insomnia Severity Index score measure: Change in EuroQol Visual Analog Scale (EQ VAS) score measure: Change in CHU9D Child Health Utility 9D (CHU9D) scores measure: Change in Sleep knowledge measure: Change in electronic media use measure: Change in sleep habits measure: Change in meta-cognitions measure: Change in motivation sex: ALL minimumAge: 13 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-23 uploadDate: 2024-03-07T03:17 filename: Prot_SAP_000.pdf size: 264890 hasResults: False
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<|newrecord|> nctId: NCT06306079 id: KKUMC id: Abdullah Al Assiri type: OTHER domain: King Khalid University Medical City id: Prof Pip Logan type: OTHER domain: Professor of Rehabilitation Research, University of Nottingham, UK. id: Professor Ana Valdes type: OTHER domain: Professor of Molecular & Genetic Epidemiology, University of Nottingham, UK. id: Dr. Benjamin Smith type: OTHER domain: Doctor of Physiotherapy, Division of Rehabilitation and Ageing, University of Nottingham. UK. briefTitle: Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability. overallStatus: COMPLETED date: 2022-04-13 date: 2022-10-15 date: 2022-12-30 date: 2024-03-12 date: 2024-03-12 name: King Khalid University class: OTHER name: University of Nottingham briefSummary: A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.
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Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.
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This study aims to answer the following:
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* Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?
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* In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?
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The participants will be conducted over three phases:
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1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.
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2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).
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3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2). conditions: Osteoarthritis, Knee conditions: Pain conditions: Biomechanical Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day).
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* During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone.
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* Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability. primaryPurpose: OTHER masking: NONE count: 17 type: ACTUAL name: Lateral Wedge insole measure: Pain level measure: Western Ontario and McMaster Universities Arthritis Index-total measure: Likert scale measure: Likert scale sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Faisal Specialist Hospital & Research Centre city: Jeddah state: Western country: Saudi Arabia lat: 21.54238 lon: 39.19797 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-01-04 uploadDate: 2024-03-07T05:51 filename: Prot_000.pdf size: 234397 hasResults: False
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<|newrecord|> nctId: NCT06306066 id: 2015/962-31 briefTitle: Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome overallStatus: COMPLETED date: 2015-09-02 date: 2021-06-07 date: 2022-12-28 date: 2024-03-12 date: 2024-03-12 name: Karolinska Institutet class: OTHER name: Abbott briefSummary: Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).
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The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF. conditions: Coronary Artery Disease conditions: Microvascular Angina conditions: Coronary Microvascular Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 505 type: ACTUAL measure: Rate of all-cause mortality, MI and/or hospitalization due to CHF measure: Rate of all-cause mortality measure: Rate of hospitalization due to CHF. measure: Rate of all-cause mortality and/or MI measure: Rate of MI measure: Rate of stroke measure: Rate of ischemic stroke measure: Rate of unscheduled revascularization sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS) city: Stockholm zip: 182 88 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06306053 id: 2022/ST/217 briefTitle: A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring acronym: TechNoPain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-04-30 date: 2024-03-12 date: 2024-03-12 name: ASST Santi Paolo e Carlo class: OTHER name: University of Milan name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico name: Istituto Europeo di Oncologia briefSummary: Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: tDCS+EuleriaLab name: tDCS name: EuleriaLab measure: Visual Analogue Scale (VAS) measure: 12-item Short Form Survey (SF12) measure: Hospital Anxiety and Depression scale (HADS) measure: Brief Pain Inventory (BPI) measure: Pain Catastrophizing Scale (PCS) measure: Shared Decision-Making Questionnaire 9-Item (SDM-Q-9) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST-Santi Paolo e Carlo Hospital city: Milan country: Italy name: Alberto Priori, PhD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan country: Italy name: Fabiana Ruggiero, PsYD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituto Europeo di Oncologia city: Milan country: Italy name: Gabriella Pravettoni, PhD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06306040 id: Analgesia effect as on EA briefTitle: Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-11-03 date: 2025-01-30 date: 2024-03-12 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: • Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
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• Secondary outcome:
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* Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.
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* Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score
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* Parental satisfaction scores conditions: Emergence Delirium studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
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* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
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* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery primaryPurpose: PREVENTION masking: SINGLE maskingDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
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* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
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* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery whoMasked: PARTICIPANT count: 105 type: ESTIMATED name: Nalbuphine Versus Magnesium Sulfate measure: compare between analgesia effect on pediatric patient sex: MALE minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06306027 id: 2023/024 briefTitle: The Impact of Web-Based Education on Self-Care Power, Self-Efficacy, and Quality of Life in Knee Arthroplasty Patients. overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: KTO Karatay University class: OTHER briefSummary: The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services. conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Web-based education measure: Personal Information Form measure: Self-Care Power Scale measure: Self-Efficacy - Competence Scale measure: Short Form 36 Quality of Life Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya City Hospital status: RECRUITING city: Konya zip: 42020 country: Turkey name: Esra Nur BOZTAŞ, MScN role: CONTACT phone: 05312958337 email: esranurboztas44@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06306014 id: 69HCL22_980 id: 2023-506232-32-00 type: OTHER domain: EU CT Number briefTitle: Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients acronym: LIVEDIFF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-01-01 date: 2027-01-01 date: 2024-03-12 date: 2024-03-12 name: Hospices Civils de Lyon class: OTHER name: Exeliom Biosciences briefSummary: Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.
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Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.
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In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.
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Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.
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Among the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.
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The aim of this Phase I/II trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm). conditions: Clostridioides Difficile Infection conditions: Recurrent Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Part A: None (Open-label). Part B: Double-blind. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: EXL01 name: EXL01 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence measure: Evaluation of the safety and tolerability profile of oral EXL01 measure: Number of stools per day over the past 24 hours measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale measure: Number of stools per day over the past 24 hours measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale measure: Assessment of patient quality of life during treatment and follow-up measure: Assessment of recurrence of C. difficile infection measure: Evaluation of the presence of EXL01 in the fecal microbiota measure: Assessment of EXL01 persistence in the intestinal microbiota measure: 16S rRNA sequencing or shotgun measure: 16S rRNA sequencing or shotgun measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. measure: Assessment of recurrences of C. difficile infection requiring hospitalization measure: Assessment of recurrences of C. difficile infection requiring hospitalization measure: Assessment of recurrences of C. difficile infection requiring surgery measure: Assessment of recurrences of C. difficile infection requiring surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service d'hépato-gastroentérologie - CHU Estaing city: Clermont-Ferrand zip: 63003 country: France name: Julien SCANZI, MD role: CONTACT phone: 04 73 75 02 35 email: jscanzi@chu-clermontferrand.fr name: Julien SCANZI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: Service d'Hépato-gastroentérologie Hôpital de la Croix Rousse city: Lyon zip: 69004 country: France name: Nicolas BENECH, MD role: CONTACT phone: 04 26 10 94 35 phoneExt: +33 email: nicolas.benech@chu-lyon.fr name: Fanny JOUBERT role: CONTACT phone: 04 26 73 27 27 phoneExt: +33 email: Fanny.joubert@chu-lyon.fr name: Nicolas BENECH, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP) city: Paris zip: 75012 country: France name: Paul MCLELLAN, MD role: CONTACT phone: 01 49 28 20 00 phoneExt: +33 email: Paul.mclellan@aphp.fr name: Paul MCLELLAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Service d'infectiologie - Hôpital Nord / CHU Saint Etienne city: Saint-Étienne zip: 42100 country: France name: Elisabeth BOTHELO-NEVERS, Pr role: CONTACT phone: 04 77 12 77 89 phoneExt: +33 email: elisabeth.botelho-nevers@chu-st-etienne.fr name: Elisabeth BOTHELO-NEVERS, Pr role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 facility: Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de Toulouse city: Toulouse zip: 31059 country: France name: Laurent ALRIC, Pr role: CONTACT phone: 05 61 32 37 54 email: Alric.l@chu-toulouse.fr name: Laurent ALRIC, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Service de Maladies Infectieuses - CH de Valence city: Valence zip: 26000 country: France name: Julien SAISON, MD role: CONTACT phone: 04 75 62 57 32 phoneExt: +33 email: jsaison@ch-valence.fr name: Julien SAISON, MD role: PRINCIPAL_INVESTIGATOR lat: 44.93333 lon: 4.9 hasResults: False
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<|newrecord|> nctId: NCT06306001 id: IIRP-2023-1820/F1 briefTitle: Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-14 date: 2027-02 date: 2024-03-12 date: 2024-03-12 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:
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1. Whether MB treatment reduces death to any cause as compared to no MB treatment.
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2. Whether treatment with MB reduces the time to achieve normal blood pressure
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3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.
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4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours. conditions: Neonatal Sepsis conditions: Shock, Septic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The random allocation will be concealed using serially numbered opaque sealed envelopes. After opening the envelope, a research nurse will administer a bolus of the study drug or placebo behind a screen, shielded from other staff. The infusion will be drawn up in an opaque syringe by the research nurse and infused through an intravenous tubing covered completely with aluminum foil. The research nurses will not be masked to the study drug. The parents of the subject, the regular staff nurses and doctors working in the unit and the project coordinator will be masked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Methylene Blue name: Placebo measure: All-cause mortality within 7 days after randomization measure: Time taken to achieve therapeutic end-points within 7 days after randomization measure: Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation measure: Echocardiographic fractional shortening at 24 hour after randomization measure: Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization measure: Aortic diameter by echocardiography at 24 hour after randomization measure: Velocity time integral (LVI) by echocardiography at 24 hours after randomization measure: Echocardiographic fractional shortening at 48 hour after randomization measure: Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization measure: Aortic diameter by echocardiography at 48 hour after randomization measure: Velocity time integral (LVI) by echocardiography at 48 hours after randomization measure: Time taken to stop vasopressor treatment measure: Mortality during hospital stay measure: Serious adverse effects measure: Septic shock-related mortality sex: ALL minimumAge: 0 Days maximumAge: 28 Days stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-22 uploadDate: 2024-03-01T05:10 filename: Prot_SAP_000.pdf size: 210368 hasResults: False
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<|newrecord|> nctId: NCT06305988 id: LYG2023021 briefTitle: Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD overallStatus: RECRUITING date: 2023-08-01 date: 2024-07-31 date: 2024-07-31 date: 2024-03-12 date: 2024-03-15 name: Jian-Jun Ou class: OTHER briefSummary: In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed. conditions: ASD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Transcranial direct current stimulation measure: Autism assessment assessment index measure: EEG physiological detection index measure: Social Communication Changes index measure: Stereotyped behavior index measure: Sensory index measure: Abnormal behavior indicator measure: Sleep index measure: Plasma Metabolite Levels Assessment measure: Safety evaluation SAFTEE indicator sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Psychiatry, Xiangya Second Hospital, Central South University status: RECRUITING city: Changsha state: Hunan zip: 410000 country: China name: Jianjun Ou, doctor role: CONTACT phone: 17775861486 email: oujianjun@csu.edu.cn lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06305975 id: STUDY00003169 briefTitle: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery acronym: BluntFascial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-12 name: Cedars-Sinai Medical Center class: OTHER briefSummary: This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.
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The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.
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Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.
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Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Blunt fascial abdominal entry name: Veress needle abdominal entry measure: Insufflation time measure: Success upon peritoneal entry measure: Intraoperative complications measure: Postoperative complications measure: Patients pain scores measure: Analgesics use measure: Length of hospital stay sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06305962 id: 177Lu-RAD204.2023.0001 briefTitle: 177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2025-07 date: 2025-10 date: 2024-03-12 date: 2024-03-26 name: Radiopharm Theranostics, Ltd class: INDUSTRY briefSummary: This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests. conditions: PDL1 Gene Mutation conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: 177Lu-RAD204 measure: Time Activity Curves (TACs) measure: Radiation dosimetry of Lu177-RAD204im measure: Pharmacokinetics of 177Lu-RAD204im measure: Biokinetics of 177Lu-RAD204im measure: Safety and tolerability of 177Lu-RAD204tr measure: Recommended dose(s) of 177Lu-RAD204tr for future exploration measure: Safety and tolerability of a single dose of 177Lu-RAD204im measure: Recommended dose(s) of 177Lu-RAD204im for future exploration measure: Preliminary antitumor activity of 177Lu-RAD204tr measure: Radiation dosimetry of 177Lu-RAD204tr measure: Level of agreement between 177Lu-RAD204im and standard of care imaging measure: Effect of 177Lu-RAD204im and 177Lu-RAD204tr on tumor markers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Alexandra Hospital status: RECRUITING city: Woolloongabba state: Queensland zip: 4102 country: Australia name: Kenneth O'Byrne, MD role: CONTACT phone: +610449091958 email: kenneth.obyrne@health.qld.gov.au lat: -27.48855 lon: 153.03655 facility: Hollywood Private Hospital status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Joe Cardaci, MD role: CONTACT phone: 0893862844 email: jcardaci@dni.com.au lat: -31.98184 lon: 115.8073 hasResults: False
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<|newrecord|> nctId: NCT06305949 id: XC23DDDS0098 briefTitle: Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-12 name: NEUROPHET class: INDUSTRY name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: National Traffic Injury Rehabilitation Hospital name: Pusan National University Yangsan Hospital briefSummary: The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia. conditions: Deglutition Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Personalized transcranial Direct Current Stimulation measure: Functional Oral Intake Scale (FOIS) measure: Penetration-aspiration Scale (PAS) measure: Functional Oral Intake Scale (FOIS) measure: Penetration-aspiration Scale (PAS) measure: Videofluoroscopic Dysphagia Scale (VDS) measure: Korean Mann Assessment of Swallowing Ability (K-MASA) measure: Speech Mechanism Screening Test (SMST) measure: Urimal Test of Articulation and Phonology (U-TAP) measure: modified Rankin Scale (mRS) measure: Gugging Swallowing Screen measure: Eating Assessment Tool-10 (EAT-10) measure: Iowa Oral Performance Instrument (IOPI) measure: Motor-Evoked Potential (MEP) measure: Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale) measure: Respiratory muscle strength measure: Peak cough flow sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06305936 id: PLATE H-23042292 briefTitle: Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis acronym: PLATE overallStatus: RECRUITING date: 2024-02-15 date: 2024-07-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-15 name: Bispebjerg Hospital class: OTHER name: Glostrup University Hospital, Copenhagen briefSummary: In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.
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Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised feasibility study of an intervention group, receiving 100% plant-based diet and a control group primaryPurpose: OTHER masking: DOUBLE maskingDescription: Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Intervention with 100% plant-based diet measure: Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires measure: Evaluation of Study Acceptance measure: Recruitment measure: Retention measure: Intervention adherence measure: Disease Activity Score (DAS28) measure: Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ) measure: Pain (VAS) measure: Sleep measure: Anxiety/depression measure: Physical function measure: Impact of rheumatoid arthritis (RA) measure: The EuroQuality of Life (EQ-5D) measure: Height measure: Weight measure: Waist- and hip circumference measure: Disease activity measure: Body composition measure: Quantification of tender and swollen joints measure: C-reactive Protein (CRP) measure: Hemoglobin measure: Leukocytes measure: Thrombocytes measure: Hemoglobin (HbA1c) measure: D-vitamin measure: Low-density lipoprotein (LDL) measure: High-density lipoprotein (HDL) measure: Triglyceride measure: Total cholesterol sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Clinical Research and Prevention, BispebjergH status: ACTIVE_NOT_RECRUITING city: Frederiksberg zip: DK 2000 country: Denmark lat: 55.67938 lon: 12.53463 facility: The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup status: RECRUITING city: Glostrup zip: 2600 country: Denmark name: Tanja Thomsen, Ph.D. role: CONTACT phone: +4538163107 email: tanja.thomsen@regionh.dkdkTanja.thomsen@regionh.dk name: Kamille Torp, Ph.D. role: CONTACT phone: +4538163113 email: kamille.almer.bernsdorf.torp@regionh.dk name: Bente Appel Esbensen, Ph.D. role: SUB_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False
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