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* Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.
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Secondary Objectives within cmRCT cohort:
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* Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.
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* Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.
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* Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations). conditions: Pediatric Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The CIRCUS study has a cmRCT design to determine the effects of (eHealth) interventions in asthmatic children. Children are included in the prospective dynamic cohort during outpatient visits. Children and/or their parents are asked to sign consent for three parts of the cmRCT, of which at least consent for part 1 is needed to be eligible for participation:
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1. Participating in the prospective dynamic cohort and data collection.
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2. Willingness to participate in interventions.
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3. Willingness to fill out additional questionnaires and/or do additional measurements if a child is randomly selected for the control group of an intervention, which uses additional outcomes. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The masking is dependent of the future interventions. count: 300 type: ESTIMATED name: video directly observed therapy (vDOT) measure: Asthma control measure: Pediatric Asthma Quality of Life measure: Quality of care measure: Self-management capacity measure: Healthcare use measure: Wheather data measure: Air quality measure: Pollen measure: Medication delivery sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06278649 id: 2023-161-Multi-site briefTitle: Relaxation and Guided Imagery as an Intervention for Asthma overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-26 date: 2024-02-26 name: Pace University class: OTHER name: University of Connecticut name: Touro University briefSummary: The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer. conditions: Asthma conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Relaxation and Guided Imagery measure: Asthma measure: Asthma measure: Anxiety measure: Quality of Life sex: ALL minimumAge: 8 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278636 id: 5745 briefTitle: Laparoscopic Ultrasound Examination: Analysis of Feasibility acronym: LUXA overallStatus: RECRUITING date: 2023-07-18 date: 2024-12-30 date: 2025-01-30 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.
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The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon. conditions: Gynecologic Cancer conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Laparoscopi ultrasound examination measure: feasibility of the laparoscopic measure: the learning curve of fellow surgeons measure: the performance of fellow surgeons sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS status: RECRUITING city: Rome zip: 00168 country: Italy name: Floriana Mascilini, Dr role: CONTACT name: Antonia Carla Testa, Prof role: CONTACT name: Floriana Mascilini role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06278623 id: 4935 briefTitle: Focal Muscle Vibration in Parkinson's Disease overallStatus: RECRUITING date: 2023-05-11 date: 2025-12-01 date: 2025-12-01 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.
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The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations. conditions: Parkinson Disease conditions: Postural; Defect conditions: Rehabilitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: Focal Muscle Vibratory Energy (EVM) Treatment measure: Tinetti scale measure: NRS numeric rating scale of pain measure: Stabilometric Test measure: Mc Gill Pain questionnaire sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Gianpaolo Ronconi status: RECRUITING city: Roma zip: 00168 country: Italy name: gianpaolo ronconi role: CONTACT phone: +393477123940 email: gronconi@yahoo.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06278610 id: 3612 briefTitle: Pelvic Exenteration and Laterally Extended Pelvic Resection acronym: Pre-PEX overallStatus: RECRUITING date: 2020-11-19 date: 2024-12-30 date: 2025-01-31 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool. conditions: Gynecologic Cancer conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: PELVIC EXENTERATION measure: pelvic exenteration resection. measure: accuracy of US with the accuracy of MRI sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: ANTONIA CARLA Pr TESTA role: CONTACT email: antoniacarla.testa@policlinicogemelli.it name: NICOLO' DR BIZZARRI role: CONTACT phone: 3471771680 email: nicolo.bizzarri@policlinicogemelli.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2020-05-29 uploadDate: 2023-02-24T13:07 filename: Prot_000.pdf size: 598158 hasResults: False
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<|newrecord|> nctId: NCT06278597 id: GLC02-22 briefTitle: Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device overallStatus: RECRUITING date: 2023-09-05 date: 2024-01-20 date: 2025-01-24 date: 2024-02-26 date: 2024-02-26 name: Fondazione G.B. Bietti, IRCCS class: OTHER briefSummary: The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 65 type: ESTIMATED name: NACA Estimator measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy. measure: Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator measure: Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione GB Bietti status: RECRUITING city: Roma zip: 00184 country: Italy name: Carmela Carnevale, MD role: CONTACT phone: +390677052834 email: carmela.carnevale@fondazionebietti.it name: Francesco Oddone, PhD role: CONTACT phone: +390677052834 email: francesco.oddone@fondazionebietti.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06278584 id: 2020001-00 briefTitle: iLux Treatment for Meibomian Gland Dysfunction acronym: MGD overallStatus: COMPLETED date: 2020-10-15 date: 2021-02-01 date: 2022-02-28 date: 2024-02-26 date: 2024-02-26 name: Clínica de Oftalmología de Cali S.A class: OTHER briefSummary: Summary:
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Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).
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Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE. conditions: Meibomian Gland Dysfunction conditions: Eyes Dry Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ACTUAL name: iLUX Treatment System measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds. measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clínica de Oftalmología de Cali S.A city: Cali state: Valle Del Cauca zip: 760036 country: Colombia lat: 3.43722 lon: -76.5225 hasResults: False
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<|newrecord|> nctId: NCT06278571 id: R-2018-785-100 briefTitle: Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-01-30 date: 2025-04-30 date: 2025-12-03 date: 2024-02-26 date: 2024-02-26 name: Coordinación de Investigación en Salud, Mexico class: OTHER_GOV briefSummary: The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico.
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The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs.
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nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10.
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Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients). conditions: Female studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter clinical trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participants are unaware of other intervention arms whoMasked: PARTICIPANT count: 480 type: ESTIMATED name: Educational intervention with App and web site education name: Educational interventión with web site education name: Control group with nutritional therapy measure: Number of participants with glycosylated hemoglobin at control goals measure: Number of participants with iipid profile in control targets measure: Number of participants with body mass index profile in control target measure: Number of patients with changes to a healthy lifestyle measure: The proportion of patients with adequate knowledge of diabetes sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Instituto Mexicano Del Seguro Social status: RECRUITING city: Ciudad de mexico zip: 03100 country: Mexico name: LUBIA Velazquez, PhD role: CONTACT phone: 525523259424 email: lubia2002@yahoo.com.mx name: Gabriela Ortiz, Master role: CONTACT phone: 5543379062 email: lubia2002@yahoo.com.mx name: Abril V Muñoz, PhD role: SUB_INVESTIGATOR name: Jorge Escobedo, Phd role: SUB_INVESTIGATOR name: Ignacio Pineda, Master role: SUB_INVESTIGATOR lat: 19.42847 lon: -99.12766 hasResults: False
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<|newrecord|> nctId: NCT06278558 id: 2023-02-01 briefTitle: Psychological Factors Influencing Cancer Post-traumatic Growth acronym: CEMA-P overallStatus: RECRUITING date: 2023-11-10 date: 2026-11-10 date: 2027-11-10 date: 2024-02-26 date: 2024-02-26 name: Centre Hospitalier de Valenciennes class: NETWORK name: Ligue contre le cancer, France name: Centre Oscar Lambret name: Centre de Cancérologie Les Dentellières name: Clinique Teissier briefSummary: The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 289 type: ESTIMATED name: Interviews with a psychologist/psychiatrist measure: Post-traumatic growth measure: Post-traumatic growth measure: Post-traumatic growth measure: Satisfaction of supportive care needs measure: Satisfaction of supportive care needs measure: Satisfaction of supportive care needs measure: Emotional competence measure: Emotional competence measure: Emotional competence measure: Anxiety and depression symptoms measure: Anxiety and depression symptoms measure: Anxiety and depression symptoms measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Valenciennes status: RECRUITING city: Valenciennes zip: 59300 country: France name: FODIL Hanane role: CONTACT phone: 0327140665 email: fodil-h@ch-valenciennes.fr name: Anne Sophie Baudry role: PRINCIPAL_INVESTIGATOR lat: 50.35 lon: 3.53333 hasResults: False
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<|newrecord|> nctId: NCT06278545 id: MANFREDI PHRCK 2022 briefTitle: Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma acronym: FOLFORINOX SBA overallStatus: RECRUITING date: 2024-02-16 date: 2027-02 date: 2029-02 date: 2024-02-26 date: 2024-02-26 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.
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The primary objective is to assess the percentage of patients alive without prograssion at 8 months. conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: modified FOLFORINOX name: Modified FOLFOX measure: Assess the percentage of patients alive without progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Dijon Bourgogne status: RECRUITING city: Dijon zip: 21000 country: France name: Sylvain MANFREDI role: CONTACT phone: +33 03 80 29 37 50 email: sylvain.manfredi@chu-dijon.fr lat: 47.31667 lon: 5.01667 hasResults: False
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<|newrecord|> nctId: NCT06278532 id: NEGKOG briefTitle: Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS overallStatus: RECRUITING date: 2023-12-11 date: 2026-12-11 date: 2026-12-11 date: 2024-02-26 date: 2024-02-26 name: Lithuanian University of Health Sciences class: OTHER briefSummary: This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test. conditions: Schizophrenia conditions: Negative Symptoms in Schizophrenia conditions: Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis) conditions: Cognitive Deficit studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Brief Negative Symptoms Scale name: The Calgary Depression Scale for Schizophrenia name: The Schizophrenia Cognition Rating Scale measure: Validated Lithuanian version of the Brief Negative Symptoms Scale. measure: Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia. measure: Validated Lithuanian version of the Schizophrenia Cognition Rating Scale. measure: Correlation between negative symptoms and cognitive deficits of schizophrenia measure: Correlation between depressive symptoms and cognitive deficits of schizophrenia measure: Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics status: RECRUITING city: Kaunas zip: LT-50161 country: Lithuania name: Jonas Montvidas role: CONTACT phone: +37066240919 email: jonas.montvidas@lsmu.lt name: Eimantas Zauka role: CONTACT phone: +37069220076 email: eimantas.zauka@kaunoklinikos.lt lat: 54.90272 lon: 23.90961 facility: Jonas Montvidas status: RECRUITING city: Kaunas zip: LT-53137 country: Lithuania name: Jonas Montvidas role: CONTACT phone: +37066240919 email: jonas.montvidas@lsmu.lt name: Algirdas Musneckis role: CONTACT phone: +37061378748 email: algirdas.musneckis@kaunoklinikos.lt lat: 54.90272 lon: 23.90961 hasResults: False
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<|newrecord|> nctId: NCT06278519 id: CARAMBOLE briefTitle: CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE) acronym: CARAMBOLE overallStatus: RECRUITING date: 2024-03-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-26 date: 2024-03-12 name: Poitiers University Hospital class: OTHER name: Fédération Française de Cardiologie briefSummary: ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided.
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The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI.
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Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas:
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* Descriptive epidemiology of STEMI and myocardial reperfusion
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* Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi)
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* Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs
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* Quality of life, personal, familial, social and professional consequences of myocardial infarction
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* Research of new diagnostic and prognosis biomarkers
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* Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population)
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Participants will undergo:
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* a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up
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* biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up
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* questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI. conditions: Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 150 type: ESTIMATED name: Blood, urinary and feces collection name: Cardiac MRI name: Quality of life and cognitive status questionnaire measure: Major Adverse cardiac Events (MACE) measure: Infarct size measure: Infarct size measure: No-reflow size measure: No-reflow size measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Gut microbiota profiling measure: Gut microbiota profiling measure: Genitourinary microbiota profiling measure: Genitourinary microbiota profiling measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) measure: Codex test measure: Codex test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: C.H.U. of Poitiers status: RECRUITING city: Poitiers zip: 86000 country: France name: Claire BOULETI, MD role: CONTACT phone: +33 5 49 44 43 25 email: claire.bouleti@chu-poitiers.fr lat: 46.58333 lon: 0.33333 hasResults: False
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<|newrecord|> nctId: NCT06278506 id: 4612 briefTitle: Resection or Ablation of Small Kidney Tumors acronym: RESTART overallStatus: RECRUITING date: 2024-01-31 date: 2027-12 date: 2037-12 date: 2024-02-26 date: 2024-02-26 name: Karolinska University Hospital class: OTHER briefSummary: Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer. conditions: Kidney Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Ablation name: Surgery measure: Number of participants with surgical complications according to Clavien-Dindo grade 2-5 measure: Radiological signs of a residual tumor at the 6-month follow-up measure: Number of postoperative hospitalization days (LOS) measure: Cancer-specific survival (CSS) measure: Overall survival (OS) measure: Change in eGFR one year after treatment sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital status: RECRUITING city: Stockholm zip: 14186 country: Sweden name: Anders Kjellman, MD, PhD role: CONTACT phone: +46736995258 email: anders.kjellman@regionstockholm.se name: Per-Olof Lundgren, MD, PhD role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06278493 id: AL2846-I-0002 briefTitle: A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer overallStatus: COMPLETED date: 2018-08-23 date: 2021-10-25 date: 2023-05-01 date: 2024-02-26 date: 2024-02-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ACTUAL name: AL2846 capsules name: Gemzar measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Hospital city: Tianjin state: Tianjin zip: 300181 country: China lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06278480 id: LNC-MECA-003 briefTitle: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-23 date: 2024-02-29 date: 2024-02-29 date: 2024-02-26 date: 2024-02-26 name: L&C Bio class: INDUSTRY briefSummary: The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery. conditions: Osteoarthritis, Knee studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: MegaCarti® name: microfracture measure: Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment measure: Comparison of macroscopic status of regenerated cartilage measure: Comparison of IKDC score measure: Comparison of VAS score measure: Comparison of KOOS score measure: Comparison of WOMAC score measure: Comparison of Kellgren-Lawrence grade measure: Comparison of HKA angle, Posterior Tibial slope sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Health System, Gangnam Severance Hospital city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06278467 id: KonyaBeyhekimTRH2023 briefTitle: Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain overallStatus: COMPLETED date: 2022-03-01 date: 2023-12-15 date: 2024-02-12 date: 2024-02-26 date: 2024-02-26 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV briefSummary: This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60. conditions: Cognitive Dysfunction conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 107 type: ACTUAL name: visual pain scale (VASpain/fatigue), Beck depression index (BDI), name: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire name: Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36), name: Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT) measure: Montreal Cognitive Assessment Scale (MOCA) measure: Standard Mini mental test (SMMT) measure: Short Form-36 ( SF-36) measure: Beck depression scale (BDI) measure: Roland Morris Disability Questionnaire measure: A single Likert type question in the Pittsburgh questionnaire (Sleep quality) measure: VAS pain and VAS fatigue measure: Pain catastrophizing scale sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya Beyhekim Training and Research Hospital city: Konya state: Selçuklu zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation city: Konya zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06278454 id: NrtPac-1 id: CTR20240312 type: OTHER domain: Center for Drug Evaluation, NMPA briefTitle: Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-02-26 date: 2024-02-26 name: Chengdu New Radiomedicine Technology Co. LTD. class: INDUSTRY briefSummary: This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study. conditions: Unresectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: NRT6008 Injection + Systematic chemotherapy measure: Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D) measure: Dose-limiting toxicity (DLT) measure: Adverse events (AE) and severe adverse events (SAE) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Resection rate (R0 and R1) measure: Concentration of tumor biomarkers measure: Numeric rating scale (NRS) of pain measure: Distribution of NRT6008 injection in human body and radioactivity of biological samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan country: China name: Suxia Luo role: CONTACT name: Suxia Luo role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Second Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu country: China name: Duanmin Hu role: CONTACT name: Duanmin Hu role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 facility: Shanghai Changhai Hospital city: Shanghai state: Shanghai zip: +8602131162338 country: China lat: 31.22222 lon: 121.45806 facility: Chongqing University Cancer Hospital city: Chongqing country: China name: Weiqing Chen role: CONTACT name: Weiqing Chen role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Tianjin Medical University General Hospital city: Tianjin country: China name: Bangmao Wang role: CONTACT name: Bangmao Wang role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06278441 id: Zila Özlem KIRBAŞ briefTitle: The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing overallStatus: COMPLETED date: 2023-01-01 date: 2023-09-01 date: 2024-02-10 date: 2024-02-26 date: 2024-02-26 name: Karadeniz Technical University class: OTHER briefSummary: Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.
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Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of \>2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.
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Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p\<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p\<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p\<0.001).
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Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing. conditions: Healthy Newborns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is parallel-group, randomized controlled. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Due to the nature of the intervention, blinding could not be done for the participants, and the two researchers who collected the data, but the statistician and two other researchers who analyzed the results were unaware of group allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Kangaroo care and White noise measure: Ninety newborns were randomized into three groups (30 in each group). sex: ALL minimumAge: 32 Hours maximumAge: 72 Hours stdAges: CHILD facility: Bayburt University city: Bayburt zip: 69100 country: Turkey lat: 40.25631 lon: 40.22289 hasResults: False
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<|newrecord|> nctId: NCT06278428 id: DEE UMC briefTitle: Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age overallStatus: RECRUITING date: 2023-11-01 date: 2028-11-01 date: 2028-11-01 date: 2024-02-26 date: 2024-02-28 name: Number 2 Children's Hospital, Ho Chi Minh City class: OTHER briefSummary: According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.
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The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age? conditions: Epilepsy; Seizure conditions: Child Development conditions: Gene Abnormality conditions: Early Onset Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Genotye of early-onset developmental epileptic encephalopathy measure: Phenotye of early-onset developmental epileptic encephalopathy measure: Progression of epileptic encephalopathy and early onset developmental epileptic encephalopathy sex: ALL maximumAge: 23 Months stdAges: CHILD facility: Children hospital number 2 status: RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam name: Thuy-Minh-Thu LT NGUYEN, MD role: CONTACT phone: +84983966371 email: dr.thu.nguyen.neurology@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False
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<|newrecord|> nctId: NCT06278415 id: P2021/Neonat/PhyCord 1 briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery acronym: PhyCord1 overallStatus: RECRUITING date: 2024-01-21 date: 2024-08 date: 2024-09 date: 2024-02-26 date: 2024-02-28 name: Queen Fabiola Children's University Hospital class: OTHER name: The Belgian Kids Fund name: Fonds IRIS-Recherche name: Ars Statistica briefSummary: Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother. conditions: Transient Tachypnea of the Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Physiological based cord clamping name: Differed cord clamping measure: Rate of neonatal mortality measure: Rate of neonatal resuscitation measure: Rate of neonatal respiratory morbidity measure: Number of admission to the NICU or special care baby unit measure: Success of PBCC measure: Time to first breath/cry measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Early neonatal parameters measure: Early neonatal parameters measure: Hemoglobin level measure: Bilirubin level measure: Number of neonatal adverse events measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Number of maternal adverse events measure: Rate of maternal-infant bonding measure: Rate of maternal-infant bonding measure: Rate of maternal-infant bonding measure: Child developmental assessment measure: Parental satisfaction survey sex: ALL minimumAge: 37 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: CHU Brugmann status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Andrew CARLIN role: CONTACT phone: +3224773295 email: andrew.carlin@chu-brugmann.be name: Andrew CARLIN, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Hôpital Universitair Des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Anna AMORUSO role: CONTACT phone: +3224773250 email: anna.amoruso@hubruxelles.be name: Anna AMORUSO, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06278402 id: JinnahH briefTitle: Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi. overallStatus: COMPLETED date: 2023-07-01 date: 2024-01-06 date: 2024-01-16 date: 2024-02-26 date: 2024-02-26 name: Jinnah Hospital class: OTHER briefSummary: To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2. conditions: Alopecia Areata conditions: Alopecia Totalis conditions: Alopecia Universalis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23. primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Tofacitinib measure: Alopecia sex: ALL minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Misbah Zari Qadir city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06278389 id: ADYY-ACC017-101 id: CTR20240167 type: REGISTRY domain: chinadrugtrials.org.cn briefTitle: Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants overallStatus: RECRUITING date: 2024-01-24 date: 2024-04-23 date: 2024-04-23 date: 2024-02-26 date: 2024-03-05 name: Jiangsu Aidea Pharmaceutical Co., Ltd class: INDUSTRY name: Chengdu Aidea Pharmaceutical Technology Co., Ltd briefSummary: The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions:
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* Recommended dosage for ACC017 tablets used in phase Ib/IIa trial;
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* The pharmacokinetic (PK) characteristics of single dose ACC017 tablets;
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* The effect of food (FE) on the PK of ACC017 tablets;
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* Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II). conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: ACC017 tablets name: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets measure: Frequency, causality, severity, and expectedness of adverse events (AEs) measure: ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition) measure: Vital signs: temperature measure: Vital sign: pulse measure: Vital signs: blood pressure measure: Vital signs: respiration measure: Electrocardiogram (ECG): heart rate measure: Electrocardiogram (ECG): PR interval measure: Electrocardiogram (ECG): QRS duration measure: Electrocardiogram (ECG): QTc interval measure: ACC017 PK parameter: Cmax measure: ACC017 PK parameter: C24h measure: ACC017 PK parameter: AUC0-t measure: ACC017 PK parameter: AUC0-∞ measure: ACC017 PK parameter: Tmax measure: ACC017 PK parameter: t1/2 measure: ACC017 PK parameter: Vz/F measure: ACC017 PK parameter: CL/F measure: ACC017 PK parameter: λz measure: ACC017 PK parameter: AUC_%Extrap measure: ACC017 PK parameter: MRT0-t measure: ACC017 PK parameter: MRT0-∞ sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Ditan Hospital Capital Medical University status: RECRUITING city: Beijing zip: 100015 country: China name: Fujie Zhang role: CONTACT email: treatment@chinaaids.cn name: Chaoying Hu role: CONTACT email: hucarol@126.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06278376 id: f/2023/045 briefTitle: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-25 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Jessa Hospital class: OTHER briefSummary: The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans. conditions: Magnetic Resonance Imaging studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 410 type: ACTUAL measure: Incidence measure: Therapeutical implications: diagnosis measure: Therapeutical implications: treatment measure: Clinical indications measure: Evaluation of body part measure: Evaluation of symptoms measure: Clinical outcome: adverse event measure: Clinical outcome: surgery measure: Clinical outcome: admission to hospital measure: Clinical outcome: mortality measure: Evaluation of age measure: Influence of COVID-19 pandemic sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD facility: Jessa hospital city: Hasselt zip: 3500 country: Belgium lat: 50.93106 lon: 5.33781 hasResults: False
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<|newrecord|> nctId: NCT06278363 id: StrokeSex_23 briefTitle: Sexual Nursing Care in Stroke Patients acronym: StrokeSex_23 overallStatus: RECRUITING date: 2023-11-01 date: 2024-06-30 date: 2025-04-30 date: 2024-02-26 date: 2024-03-28 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.
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The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.
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Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.
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In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We aim to assess the effectiveness of an intervention in stroke subjects to increase awareness of sexual health, effectively manage sexual dysfunctions, reduce their frequency, and enhance psychophysical well-being. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participant Masking: Participants are unaware of the treatment they are receiving. This helps prevent biases in reporting outcomes based on knowledge of the treatment.
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Care Provider Masking: The individuals providing care, such as therapists or nurses, are also unaware of the treatment assigned to each participant. This prevents them from inadvertently influencing outcomes based on their knowledge of the treatment.
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Investigator Masking: The individuals responsible for collecting and analyzing the data are blinded to the treatment allocation. This helps ensure impartiality and prevents biases in data interpretation.
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Outcomes Assessor Masking: Individuals responsible for assessing the outcomes of the study, such as evaluating patient progress or interpreting test results, are blinded to the treatment group to which participants belong. This prevents biases in outcome assessment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 113 type: ESTIMATED name: Sexual Nursing care name: Standard Nursing Care measure: Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness measure: psychosocial well-being and relational dynamics of stroke patients and their partners sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo status: RECRUITING city: Messina state: Italy/Messina zip: 98124 country: Italy name: Maria Grazia Maggio, PsyD, PhD role: CONTACT phone: +39-09060128840 email: mariagrazia.maggio@irccsme.it name: Maria Grazia Maggio, PsyD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False
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<|newrecord|> nctId: NCT06278350 id: D2570-201 briefTitle: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis overallStatus: RECRUITING date: 2024-02-04 date: 2024-12-31 date: 2025-03-31 date: 2024-02-26 date: 2024-02-26 name: InventisBio Co., Ltd class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis . conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: D-2570 name: Placebo measure: Percentage of subjects with at least 75% improvement in PASI measure: Percentage of subjects with at least 75% improvement in PASI measure: Percentage of subjects with at least 90% improvement in PASI measure: Percentage of subjects with 100% improvement in PASI measure: Percentage improvement in PASI measure: Percentage of subjects with a PGA measure: The main PK parameters ：Time to maximum measured plasma concentration（Tmax） measure: The main PK parameters ：Peak Plasma Concentration（Cmax) measure: The main PK parameters：Area under the plasma concentration versus time curve（AUC） measure: The main PK parameters：Vz/F (apparent volume of distribution) measure: The main PK parameters： Half-life（t1/2） measure: The main PK parameters： Mean Residence Time (MRT) measure: The main PK parameters：CL/F (apparent clearance) measure: Weight and height will be combined to report BMI in kg/m^2 measure: Incidence and severity of AEs based on NCI CTCAE V5.0 measure: Incidence and severity of TEAEs based on NCI CTCAE V5.0 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing country: China name: Jianzhong Zhang role: CONTACT phone: 13911815813 email: rmzjz@126.com name: Cheng Zhou role: CONTACT phone: 010-88325470 email: zhoucheng@live.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06278337 id: C19-35 briefTitle: X-linked Moesin Associated Immunodeficiency acronym: X-MAIDReg overallStatus: RECRUITING date: 2021-08-12 date: 2026-08-12 date: 2027-01-12 date: 2024-02-26 date: 2024-02-26 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV briefSummary: Moesin deficiency was initially described in 7 male participants aged 4 to 69 years and is characterized by lymphopenia of the 3 lineages and moderate neutropenia. Genetically, 6 out of 7 participants had the same missense mutation in the moesin gene located on the X chromosome. The 7th patient has a mutation leading to the premature introduction of a STOP codon into the protein.Clinically the 7 participants with X-linked moesin-associated immunodeficiency all presented with recurrent bacterial infections of the respiratory, gastrointestinal or urinary tracts, and some had severe varicella.Therapeutically, in the absence of a molecular diagnosis and due to his SCID-like phenotype, one patient was treated with geno-identical hematopoietic stem cell transplantation . The remaining are untreated or treated with immunoglobulin substitution and/or prophylactic antibiotics.
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Since this study, the moesin gene has been integrated into DNA chips used for the molecular diagnosis of immune deficiencies in several countries. Physicians in Canada, the United States, Japan, South Africa and Europe have contacted us with a total of 16 known participants to date. Because of their very low severe, uncontrolled CMV infection and the absence of treatment recommendations, two 2 American participants were treated with allogeneic transplantation with severe post-transplant complications (1), and one of the participants died as a result of the transplant. Management of XMAID participants therefore varies widely from country to country, depending on age at diagnosis and clinical picture. It ranges from no treatment treatment (associated with recurrent infections and skin manifestations), IgIv substitution and/or antibiotic prophylaxis antibiotic prophylaxis, with low toxicity and apparent efficacy, and allogeneic transplantation, with all the risks risks involved (graft-related toxicity, graft versus host, disease, rejection, risk of infection). The Investigators therefore feel it is important to review the diagnosis, clinical presentation and management of X-MAID participants. The study the investigator propose will enable to understand the presentation of X-MAID participants, establish guidelines and provide the best treatment for each patient according to his or her clinical picture conditions: Immune Deficiency conditions: Autoimmune Diseases conditions: Infections conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 16 type: ESTIMATED name: genetic restrospective study measure: The main objective measure: Secondary objectives1 measure: secondary objectives 2 measure: secondary objective 3 measure: secondary objectives 4 measure: secondary objective 5 sex: MALE minimumAge: 4 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: Luigi Notarangelo, Doctor role: CONTACT lat: 38.98067 lon: -77.10026 facility: Perelman School of medecine status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19050 country: United States name: Jennifer Heimall, Pr role: CONTACT lat: 39.95233 lon: -75.16379 facility: Brown University status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02912 country: United States name: Anthony Hayward role: CONTACT lat: 41.82399 lon: -71.41283 facility: Genomic Research Centre, School of Biomedical Sciences Institute of Health and Biomedical Innovation status: NOT_YET_RECRUITING city: Brisbane zip: 4001 country: Australia name: Lyn Griffith, Pr role: CONTACT lat: -27.46794 lon: 153.02809 facility: Hôpital Universitaire de la Reine Fabiola status: NOT_YET_RECRUITING city: Bruxelles zip: 1020 country: Belgium name: Catherine Heijmans, Doctor role: CONTACT lat: 50.85045 lon: 4.34878 facility: Hôpital Necker status: RECRUITING city: Paris zip: 75015 country: France name: Benedicte NEVEN role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU Rennes, CNRS UMR 629 status: RECRUITING city: Rennes zip: 35000 country: France name: Virginie Gandemer, Doctor role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU St Etienne Hôpital Nord status: NOT_YET_RECRUITING city: Saint-Étienne zip: 42270 country: France name: Jean-Louis STEPHAN, Doctor role: CONTACT lat: 45.43389 lon: 4.39 facility: Tokyo Medical and Dental University (TMDU) status: NOT_YET_RECRUITING city: Bunkyō-Ku zip: 1138510 country: Japan name: Kohsuke Imai, Pr role: CONTACT lat: 35.37517 lon: 139.92991 facility: Departments of Internal Medicine and Immunology status: NOT_YET_RECRUITING city: Rotterdam country: Netherlands name: Virgil Dalm role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06278324 id: C1736 id: 2023-A02286-39 type: REGISTRY domain: ANSM briefTitle: Effectiveness of a Nasal Spray on Viral Respiratory Infections overallStatus: RECRUITING date: 2024-01-26 date: 2024-05 date: 2024-07 date: 2024-02-26 date: 2024-02-26 name: CEN Biotech class: INDUSTRY name: Urgo Research, Innovation & Development briefSummary: There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.
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The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.
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