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* Do children with GI issues show an altered lung microbiome?
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Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).
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Participants will provide:
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* airway samples (to investigate the lung microbiome)
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* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care
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* stool samples (to assess gut microbiome)
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* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis. conditions: Respiration Disorders conditions: Respiratory Disease conditions: Asthma in Children conditions: Wheezing conditions: Gastro-Intestinal Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: observational only - no interventions as part of study measure: Assess differences in gut and lung microbiota diversity between groups measure: Assess changes in gut and lung microbiota in children with asthma receiving biologics measure: Determine mediators of gut-lung axis in health and disease measure: Nutritional influence in gut-lung axis measure: Multi-omics integration sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow status: RECRUITING city: Glasgow country: United Kingdom name: Ross J Langley, MRCPCH role: CONTACT phone: 0141 451 6683 email: ross.langley@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 hasResults: False
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<|newrecord|> nctId: NCT06271200 id: MG-113-GP-03 briefTitle: Intervention on Metabolism and Related Chronic Diseases overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-01-19 date: 2027-12-31 date: 2024-02-21 date: 2024-02-21 name: National Health Research Institutes, Taiwan class: OTHER name: Tri-Service General Hospital name: Chang Gung Memorial Hospital name: National Taiwan University Hospital Hsin-Chu Branch name: Taichung Armed Forces General Hospital briefSummary: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks. conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Intermittent fasting and 10,000 steps per day measure: Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes city: Zhunan state: Miaoli County zip: 350 country: Taiwan name: Vivian Wang, Master role: CONTACT phone: +886-37-206166 phoneExt: 35374 email: ywwang@nhri.edu.tw lat: 22.57358 lon: 120.54147 hasResults: False
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<|newrecord|> nctId: NCT06271187 id: A-ER-110-507 briefTitle: Dynamic-orthosis Programs for Stroke Hand Function overallStatus: RECRUITING date: 2023-01-22 date: 2024-10-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Dynamic-orthosis name: Traditional stroke occupational therapy training measure: Fugl-Meyer Assessment- Upper Extremity measure: Box and Block Test measure: Motor Activity Log measure: Modified Ashworth scale measure: Upper limb joint range of motion sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: JER-HAO CHANG, PH.D. role: CONTACT phone: 886-6-2353535 phoneExt: 5912 email: jerhao@ncku.edu.tw lat: 22.99083 lon: 120.21333 hasResults: False
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<|newrecord|> nctId: NCT06271174 id: RC23_0009 briefTitle: Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children acronym: AWA3PASIC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-02-21 date: 2024-04-09 name: Nantes University Hospital class: OTHER name: Fondation Apicil briefSummary: Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.
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Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.
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This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.
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One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.
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The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.
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The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia". conditions: Persistent Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 208 type: ESTIMATED name: Carbocaine name: Profofol and/or Suxaméthonium and/or Sévoflurane measure: Persistent Postoperative Pain measure: Screening of neuropathic pain if persistent postoperative pain - 3 months measure: Screening of neuropathic pain if persistent postoperative pain - 6 months measure: Screening of neuropathic pain if persistent postoperative pain - 12 months measure: 1st EN score in immediate post-operative ICU before morphine titration measure: Persistent postoperative pain at 6 months. measure: Persistent postoperative pain at 12 months. measure: Postoperative nausea and vomiting measure: Time in Post Interventional Care Unit measure: Opioïd dose received - Per-operative measure: Opioïd dose received - in Post Interventional Care Unit measure: Opioïd dose received measure: Intravenous Morphine dose received in Post Interventional Care Unit sex: ALL minimumAge: 5 Years maximumAge: 183 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06271161 id: F002 briefTitle: The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting overallStatus: COMPLETED date: 2023-01-01 date: 2023-11-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Selcuk University class: OTHER briefSummary: The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting? conditions: Postoperative Pain conditions: Postoperative Nausea and Vomiting conditions: Throat, Sore conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 84 type: ACTUAL measure: The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used. measure: Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Funda Arun city: Selçuklu state: Konya zip: 42000 country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False
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<|newrecord|> nctId: NCT06271148 id: Mutah University id: Myah REC/133/2023 type: REGISTRY domain: Mutah university school of medicine briefTitle: Career and Lifestyle Among Female Surgeons in Jordan overallStatus: COMPLETED date: 2023-02-03 date: 2023-12-17 date: 2023-12-31 date: 2024-02-21 date: 2024-02-21 name: Mohammad Abu-Jeyyab class: OTHER briefSummary: A study conducted to evaluate the female surgeons in Jordan from different lifestyle conditions: Surgery conditions: Lifestyle studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 224 type: ACTUAL name: Interview measure: Career and Lifestyle Among Female Surgeons in Jordan measure: Working Hours measure: Sex Bias measure: inadequate mentorship measure: having 30 days of leave measure: salary sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mutah University city: Al-Karak zip: 61710 country: Jordan lat: 31.16368 lon: 35.76204 hasResults: False
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<|newrecord|> nctId: NCT06271135 id: LU20170508 briefTitle: Assessing the Quality of Life of Patients With Rosacea overallStatus: COMPLETED date: 2017-05-08 date: 2018-11-30 date: 2018-11-30 date: 2024-02-21 date: 2024-02-21 name: Medical University of Bialystok class: OTHER name: University of Lomza briefSummary: The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires. conditions: Rosacea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ACTUAL name: CAPILLARY REPAIR SERUM 30ml measure: Elements influenced on quality of life of participants with rosacea measure: Self-reported questionnaire measure: Dietary Questionnaire measure: The Physical Activity Questionnaire measure: DLQI (Dermatology Life Quality Index) measure: SWLS (Satisfaction With Life Scale) measure: BDI (Beck Depression Inventory) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Bialystok city: Białystok zip: 15-089 country: Poland lat: 53.13333 lon: 23.16433 hasResults: False
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<|newrecord|> nctId: NCT06271122 id: COMPET-1 briefTitle: Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients overallStatus: RECRUITING date: 2024-01-18 date: 2025-05-16 date: 2025-05-16 date: 2024-02-21 date: 2024-02-21 name: Korian class: OTHER briefSummary: Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.
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The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Voluntary activation assessed by magnetic stimulation measure: Central voluntary activation assessed by transcranial magnetic stimulation (TMS) measure: Muscle excitability assessed by femoral magnetic stimulation (FMS) measure: Contractile properties assessed by femoral magnetic stimulation (FMS) measure: Corticospinal excitability assessed by transcranial magnetic stimulation (TMS) measure: Intra-cortical inhibitions transcranial magnetic stimulation (TMS) measure: Voluntary activation assessed by femoral magnetic stimulation (FMS) sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique du Souffle La Vallonie status: RECRUITING city: Lodève zip: 34700 country: France name: Nelly Heraud, PhD role: CONTACT phone: +33467888491 email: nelly.heraud@clariane.fr name: Nicolas Oliver, MD role: PRINCIPAL_INVESTIGATOR lat: 43.71667 lon: 3.31667 hasResults: False
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<|newrecord|> nctId: NCT06271109 id: Soh-Med-24-01-04MD briefTitle: Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors overallStatus: ENROLLING_BY_INVITATION date: 2021-12-01 date: 2025-06-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-21 name: Sohag University class: OTHER briefSummary: aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors. conditions: Liver Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: Anatomical laparoscopic liver resection for liver neoplasms name: Non-Anatomical laparoscopic liver resection for liver neoplasms measure: complete resection of the neoplasm measure: residual liver tissue measure: recurrence rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06271096 id: 638/ADR/KMC briefTitle: Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children overallStatus: COMPLETED date: 2019-11-01 date: 2022-11-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-23 name: Arooj Khan class: OTHER briefSummary: IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures conditions: Seizures studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review primaryPurpose: TREATMENT masking: NONE count: 150 type: ACTUAL name: Intra muscular Midazolam name: Intravascular Diazepam measure: Fits Controlled sex: ALL minimumAge: 3 Months maximumAge: 5 Years stdAges: CHILD facility: Khyber Teaching Hospital city: Peshawar zip: 25000 country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False
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<|newrecord|> nctId: NCT06271083 id: 2023-06541-01 briefTitle: Internet-based Behavior Therapy for Adults With Tourette Syndrome acronym: TICNET overallStatus: RECRUITING date: 2024-02-02 date: 2026-05 date: 2028-05 date: 2024-02-21 date: 2024-02-21 name: Karolinska Institutet class: OTHER briefSummary: This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention. conditions: Tourette Syndrome conditions: Chronic Tic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Exposure with response prevention name: Brief psychoeducation with general psychological support measure: Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) measure: Yale Global Tic Severity Scale (YGTSS) - impairment scale measure: Clinical Global Impression (CGI) measure: Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL) measure: Montgomery-Asberg Depression Rating Scale (MADRS) measure: Adult Tic Questionnaire (ATQ) measure: Work and social adjustment scale (WSAS) measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P) measure: Assessing Quality of Life 6 Dimensions (AQoL-6D) measure: Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS) measure: Credibility/Expectancy Questionnaire (CEQ) measure: Working Alliance Inventory-Short Form Revised (WAI-SR) measure: Checklist for negative events measure: Events during treatment and adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm zip: 14157 country: Sweden name: Ekaterina Ivanova, PhD role: CONTACT phone: 0046765807416 email: ekaterina.ivanova@ki.se lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06271070 id: 2023-R23 briefTitle: Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study overallStatus: RECRUITING date: 2024-01-16 date: 2024-05-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: KAGOME CO., LTD. class: INDUSTRY name: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited briefSummary: To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam. conditions: Lifestyle Risk Reduction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED name: Non-intervention measure: Skin carotenoid level measure: Blood markers of lifestyle-related diseases measure: BMI measure: Body fat percentage measure: Blood pressure measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited status: RECRUITING city: Hanoi zip: 11612 country: Vietnam name: Nguyen Thuy Lan, Doctor role: CONTACT phone: +84 243 622 7799 lat: 21.0245 lon: 105.84117 hasResults: False
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<|newrecord|> nctId: NCT06271057 id: CARMOD briefTitle: Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-01-15 date: 2027-10-20 date: 2024-02-21 date: 2024-02-21 name: The Lymphoma Academic Research Organisation class: OTHER name: Lymphoma Study Association briefSummary: This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.
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Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.
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The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.
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The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator. conditions: Diffuse Large B-cell Lymphoma Refractory conditions: Refractory Primary Mediastinal Large B-Cell Lymphoma conditions: Refractory Transformed B-cell Non-Hodgkin Lymphoma conditions: Refractory High Grade B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: golcadomide measure: Complete metabolic response rate (CMR rate) measure: Objective response rate (ORR) measure: Objective response rate (ORR) measure: Complete response rate (CRR) measure: Duration of response (DR) measure: Event-free survival (EFS) measure: Progression-free survival (PFS) measure: Time To Next anti-Lymphoma Treatment (TTNLT) measure: Overall survival (OS) measure: Incidence of Adverse Events and Serious Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Henri Mondor city: Créteil zip: 94010 country: France lat: 48.78333 lon: 2.46667 facility: Chu Dijon Bourgogne city: Dijon zip: 21000 country: France lat: 47.31667 lon: 5.01667 facility: Chu de Grenoble city: La Tronche zip: 38700 country: France lat: 45.20429 lon: 5.73645 facility: Chru de Lille city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: Institut Paoli Calmettes city: Marseille zip: 13273 country: France lat: 43.29551 lon: 5.38958 facility: Chu de Montpellier city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 facility: Chu de Nantes city: Nantes zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: Hopital Saint-Louis city: Paris zip: 75475 country: France lat: 48.85341 lon: 2.3488 facility: Chu de Bordeaux city: Pessac zip: 33604 country: France lat: 44.81011 lon: -0.64129 facility: Chu Pontchaillou city: Rennes zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: Centre Henri Becquerel city: Rouen zip: 76038 country: France lat: 49.44313 lon: 1.09932 facility: Iuct Oncopole city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Chu Brabois city: Vandœuvre-lès-Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False
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<|newrecord|> nctId: NCT06271044 id: RAILESS briefTitle: a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS overallStatus: ACTIVE_NOT_RECRUITING date: 2014-10 date: 2024-12 date: 2027-12-31 date: 2024-02-21 date: 2024-02-21 name: Helsinki University Central Hospital class: OTHER briefSummary: To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level. conditions: to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up . primaryPurpose: OTHER masking: NONE maskingDescription: No masking. count: 61 type: ACTUAL name: With radioiodine treatment name: With postoperative radioiodine treatment measure: Event free situation during follow-up event free /disease free sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271031 id: LHS0211 briefTitle: Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection acronym: CSM-BSI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-03-31 date: 2024-02-21 date: 2024-02-21 name: Liverpool University Hospitals NHS Foundation Trust class: OTHER_GOV briefSummary: The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:
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* Interviews with healthcare staff to understand patient care pathways.
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* Analysis of historical data on bacteria causing infections and antibiotic treatments.
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* A 30-day observational study to observe patient treatment for bloodstream infections. conditions: Sepsis conditions: Bloodstream Infection conditions: Bacteraemia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Generation of a software simulation model that is fine tuned to the observed data. measure: Exploration of the performance of the model in different hypothesised scenarios. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-10-10 uploadDate: 2023-11-14T09:05 filename: Prot_ICF_000.pdf size: 2058603 hasResults: False
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<|newrecord|> nctId: NCT06271018 id: GMIO-2024-0001 briefTitle: TocILizumab in aorTitis in GCA (TILT) acronym: TILT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2028-04-01 date: 2024-02-21 date: 2024-02-21 name: GMIOFrance class: UNKNOWN briefSummary: This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).
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Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.
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Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.
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The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.
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Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.
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However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.
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This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA. conditions: Giant Cell Arteritis conditions: Aortitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: To evaluate the proportion of patients with remission of GCA measure: To assess the cumulative incidence of relapse measure: To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start measure: To assess the cumulative dose of prednisone measure: To assess the cumulative incidence of severe adverse events measure: To assess the proportion of radiological vascular progression measure: To assess the cumulative incidence of vascular revascularization procedures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271005 id: 000824 briefTitle: Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-21 date: 2024-02-21 name: Genetic Disease Investigators class: OTHER briefSummary: This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves. conditions: Dry Eye Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ESTIMATED name: NeuroTears name: Placebo measure: OSDI sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270992 id: 123R030 briefTitle: Oral Microbiome Diagnostics of Lung Cancer overallStatus: RECRUITING date: 2023-11-15 date: 2025-02-15 date: 2026-05-15 date: 2024-02-21 date: 2024-02-21 name: TC Erciyes University class: OTHER name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE briefSummary: The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 676 type: ESTIMATED name: NCCN (National Comprehensive Cancer Network) diagnosis measure: Diagnostics accuracy assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University Hospital status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: Aycan Gundogdu, PhD role: CONTACT phone: +90 352 207 6666 email: agundogdu@erciyes.edu.tr lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06270979 id: ISHA briefTitle: Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing. acronym: ISHA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Prof. Ivan Bautmans class: OTHER name: Leiehome vzw name: University Hospital, Antwerp name: Universiteit Antwerpen name: INNOVIRIS name: AAL briefSummary: In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
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The aims of the study are:
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1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.
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2. to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
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3. to explore individual trajectories of intrinsic capacity with the ISHA system. conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: ISHA measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Experiences with ISHA (usability, feasibility and acceptability outcome) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270966 id: 28287 08/11/2023 briefTitle: Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2024-12-01 date: 2025-12-01 date: 2024-02-21 date: 2024-02-21 name: University of Cagliari class: OTHER briefSummary: The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI) conditions: Mild Cognitive Impairment conditions: Cognitive Remediation conditions: Virtual Reality conditions: Psychiatric Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual Reality Cognitive Remediation measure: Side effects; Dropout rates; Proportion of recruited participants among those considered eligible measure: Short Form Health Survey, 12 items (SF-12) measure: Brief Social Rhythms Scale (BSRS) measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder-7 item (GAD-7) measure: Addenbrooke's Cognitive Examination (ACE-R) measure: Matrix test measure: Rey's Word Test measure: Trail Making Test (TMT) measure: Digit Span measure: Stroop Test measure: Frontal Assessment Battery (FAB) measure: Cognitive Estimates Test (CET) measure: Rey Figure Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: San Giovanni di Dio Hospital city: Cagliari state: CA zip: 09100 country: Italy lat: 39.23054 lon: 9.11917 hasResults: False
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<|newrecord|> nctId: NCT06270953 id: DZ_NX_US briefTitle: Non-invasive Monitoring: Impact on Patient Management and Outcomes overallStatus: RECRUITING date: 2024-01-19 date: 2024-03-30 date: 2024-06-30 date: 2024-02-21 date: 2024-02-28 name: Turtle Shell Technologies Pvt. Ltd. class: INDUSTRY briefSummary: Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery. conditions: No Specific Medical Conditions or Disease States studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Dozee Pro NX measure: Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions), measure: HCP experience response data measure: Care pathway mapping sex: ALL minimumAge: 18 Months maximumAge: 120 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oak Village Healthcare status: RECRUITING city: Lake Jackson state: Texas zip: 77566 country: United States name: Lindsay Darthard, LNFA role: CONTACT phone: 979-319-2306 email: lindsaydarthard@gcltc.com name: Lindsay Darthard, LNFA role: PRINCIPAL_INVESTIGATOR name: Marc A Wilson, MD role: SUB_INVESTIGATOR lat: 29.03386 lon: -95.43439 hasResults: False
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<|newrecord|> nctId: NCT06270940 id: 2023.0922 briefTitle: Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy acronym: PURPOSE overallStatus: RECRUITING date: 2024-03-04 date: 2025-10-31 date: 2026-02-28 date: 2024-02-21 date: 2024-04-24 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Pulsed Radiofrequency (PRF) Treatment measure: Duration PRF measure: Type of PRF measure: Pain intensity measure: Health Related Quality of life measure: Patient Global Impression of Change: PGIC measure: Use of opioids measure: PROMIS-29 measure: PROMIS Global-10 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam zip: 1081 HV country: Netherlands name: Katrin Stoecklein, Dr role: CONTACT phone: 0031 20 444 386 email: k.stoecklein@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06270927 id: 00003830 briefTitle: A Feasibility Study for Randomization of Code Stroke Imaging Strategies acronym: CSI overallStatus: RECRUITING date: 2023-10-23 date: 2024-03-30 date: 2024-07-10 date: 2024-02-21 date: 2024-02-21 name: University of Texas at Austin class: OTHER name: Lone Star Stroke Research Consortium briefSummary: The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort. conditions: Brain Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: MRI name: CT measure: compliance sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ascension Seton status: RECRUITING city: Austin state: Texas zip: 78712 country: United States name: Adrienne N Dula, PhD role: CONTACT phone: 512-495-5922 email: adrienne.dula@austin.utexas.edu name: Karinne Berstis, MA role: CONTACT email: karinne@austin.utexas.edu lat: 30.26715 lon: -97.74306 hasResults: False
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<|newrecord|> nctId: NCT06270914 id: IBIS briefTitle: Inclusive Positive Behaviour Supports acronym: IBIS overallStatus: RECRUITING date: 2023-08-25 date: 2025-09-30 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Uppsala University class: OTHER name: The Swedish Research Council briefSummary: Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups. conditions: Behavior Problem conditions: Social Skills studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post). primaryPurpose: PREVENTION masking: NONE count: 5000 type: ESTIMATED name: Inclusive Positive Behavior Interventions and Supports measure: Social emotional skills measure: Classroom environment measure: Students' achievement measure: Collective self-efficacy measure: Problem behavior in classroom and school measure: Implementation fidelity sex: ALL minimumAge: 9 Years maximumAge: 15 Years stdAges: CHILD facility: Department of Education status: RECRUITING city: Uppsala state: Uppland zip: 752 37 country: Sweden name: Martin Karlberg, PhD role: CONTACT phone: 018-471 1669 email: martin.karlberg@edu.uu.se name: Nina Klang, PhD role: CONTACT phone: 018-471 1674 email: nina.klang@edu.uu.se lat: 59.85882 lon: 17.63889 hasResults: False
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<|newrecord|> nctId: NCT06270901 id: BMEL: 2822EPS008 briefTitle: Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk acronym: LeguPlan_1 overallStatus: RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-07-30 date: 2024-02-21 date: 2024-04-15 name: University of Bonn class: OTHER name: Federal Ministry of Food and Agriculture (BMEL) name: Federal Office for Agriculture and Food (BLE) briefSummary: The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated. conditions: Cardiovascular Diseases conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: High Protein Planetary Health Diet name: Low Protein Planetary Health Diet name: High Protein Western Diet name: Low Protein Western Diet measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Blood amino acid profile measure: Blood urea measure: Uric acid in blood measure: Parameters of hunger and satiety in blood measure: Parameters of endothelial function in blood measure: Parameters of inflammation in blood measure: Endothelial function measure: Neuropsychological parameters measure: Neuropsychological parameters measure: Neuropsychological parameters sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology status: RECRUITING city: Bonn state: North-Rhine Westphalia zip: 53115 country: Germany name: Sarah Egert, Prof. Dr. role: CONTACT phone: + 49 (0) 228 / 73 59 email: s.egert@uni-bonn.de lat: 50.73438 lon: 7.09549 hasResults: False
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<|newrecord|> nctId: NCT06270888 id: IRB23-1011 briefTitle: Hypofractionation (Radiation) Trial for Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: University of Chicago class: OTHER briefSummary: This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Radiation measure: Maximum Tolerated Dose of Radiation of Per Fraction measure: Rate of Grade 3 or Higher Adverse Events measure: Rate of Long-Term Adverse Events measure: Overall Response Rate measure: Progression-free Survival measure: Local Control of the treated Lesion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Chicago Comprehensive Cancer Center city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06270875 id: PROJECT ADAPT-HF briefTitle: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF) acronym: ADAPT HF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-03 date: 2025-01-03 date: 2024-02-21 date: 2024-03-07 name: University of Alabama at Birmingham class: OTHER briefSummary: Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components). conditions: Heart Failure NYHA Class III conditions: Heart Failure NYHA Class IV conditions: Chronic Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: ADAPT HF measure: Feasibility of Intervention Delivery and Data Collection measure: Acceptability of Intervention Measure (AIM) measure: PROMIS Pain Intensity Scale measure: Pain Interference Scale Short Form 6b measure: Feasibility of Intervention Measure measure: Edmonton Symptom Assessment Scale (ESES-r) measure: Kansas City Cardiomyopathy Questionnaire- Short Form measure: Hospital Anxiety and Depression Scale (HADS) measure: PROMIS General Self-efficacy measure: Self-care of Heart Failure Index measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Patient Activation Measure (PAM) Short Form measure: Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q measure: Connor-Davidson Resilience Scale (CD-RISC-10) measure: Discrimination in Medical Settings Scale Scale measure: Cost/Resource Utilization Form measure: SF Global Health Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270862 id: SSHRC-PEG2023-AAT briefTitle: A Digital Active Aging Training Program for Older Adults acronym: AAT overallStatus: RECRUITING date: 2024-04-08 date: 2024-10-30 date: 2024-12-31 date: 2024-02-21 date: 2024-04-10 name: Toronto Metropolitan University class: OTHER name: Social Sciences and Humanities Research Council of Canada name: AGE-WELL and the Canadian Frailty Network name: Cogniciti name: Cognifit name: Aging in Cloud briefSummary: The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).
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The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.
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In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics. conditions: Healthy Aging conditions: Cognitive Change conditions: Psychological Stress conditions: Loneliness conditions: Social Interaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Resilience training name: cognitive training name: physical exercise name: social interaction name: workshop series measure: Exercise Self-efficacy level (ESES) measure: the 5-item World Health Organization WellBeing Index (WHO-5) measure: Kessler Psychological Distress Scale (K10) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Conner-Davidson Resilience Scale 10-item (CD RISC-10) measure: Emotional regulation Questionnaire (ERQ) measure: Positive and Negative Affect Schedule (PANAS) measure: Visual working memory test measure: Divided attention test measure: Visual memory test measure: Stroop test measure: Sustained attention to response test measure: Satisfaction with life scale (SWLS) measure: Instrumental Activities of Daily Living(IADL) measure: The 6-item De Jong Gierveld Loneliness Scale measure: The Brief Approach/Avoidance Coping Questionnaire (BACQ) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Aging Lab status: RECRUITING city: Toronto state: Ontario zip: M5B 2K3 country: Canada name: Lixia Yang, PhD role: CONTACT phone: 416-979-5000 phoneExt: 556522 email: lixiay@torontomu.ca name: Lixia Yang, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06270849 id: MTU-EC-SU-0-002/66 briefTitle: Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS overallStatus: COMPLETED date: 2023-02-24 date: 2023-12-31 date: 2024-01-20 date: 2024-02-21 date: 2024-02-21 name: Thammasat University Hospital class: OTHER briefSummary: The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis. conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire conditions: Reliability of Thai Version of the ICIQ-FLUTS LF studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ACTUAL name: Questionnaire measure: How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity. measure: The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency. measure: The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability. measure: The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Thammasat University Hospital city: Khlong Luang state: Pathumthani zip: 12120 country: Thailand lat: 14.06467 lon: 100.64578 hasResults: False
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<|newrecord|> nctId: NCT06270836 id: KS301P108 briefTitle: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) acronym: GLOW2 overallStatus: RECRUITING date: 2024-03-27 date: 2025-12-30 date: 2025-12-30 date: 2024-02-21 date: 2024-04-08 name: Kodiak Sciences Inc class: INDUSTRY briefSummary: This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR. conditions: Non-proliferative Diabetic Retinopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Tarcocimab name: Sham injection measure: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Retina Consultants of Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Global Research Management, Inc. - Lugene Eye Institute status: NOT_YET_RECRUITING city: Glendale state: California zip: 91204 country: United States lat: 34.14251 lon: -118.25508 facility: Northern California Retina Vitreous Associates status: NOT_YET_RECRUITING city: Mountain View state: California zip: 94040 country: United States lat: 37.38605 lon: -122.08385 facility: Retina Consultants of Southern California status: NOT_YET_RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Blue Ocean Clinical Research status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33761 country: United States lat: 27.96585 lon: -82.8001 facility: Florida Eye Associates status: NOT_YET_RECRUITING city: Melbourne state: Florida zip: 32901 country: United States lat: 28.08363 lon: -80.60811 facility: Center for Retina and Macular Disease status: NOT_YET_RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Southeast Retina Center status: NOT_YET_RECRUITING city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 facility: Springfield Clinic LLP status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62703 country: United States lat: 39.80172 lon: -89.64371 facility: Cumberland Valley Retina Consultants status: NOT_YET_RECRUITING city: Hagerstown state: Maryland zip: 21740 country: United States lat: 39.64176 lon: -77.71999 facility: Envision Ocular, LLC status: NOT_YET_RECRUITING city: Bloomfield state: New Jersey zip: 07003 country: United States lat: 40.80677 lon: -74.18542 facility: Cascade Medical Research Institute status: NOT_YET_RECRUITING city: Springfield state: Oregon zip: 97477 country: United States lat: 44.04624 lon: -123.02203 facility: Mid Atlantic Retina status: NOT_YET_RECRUITING city: Bethlehem state: Pennsylvania zip: 18017 country: United States lat: 40.62593 lon: -75.37046 facility: Southeastern Retina Associates PC status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37922 country: United States lat: 35.96064 lon: -83.92074 facility: Retina Research Institute of Texas status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists status: NOT_YET_RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Star Vision Research status: NOT_YET_RECRUITING city: Burleson state: Texas zip: 76028 country: United States lat: 32.54208 lon: -97.32085 facility: Texas Retina Associates status: NOT_YET_RECRUITING city: Plano state: Texas zip: 75075 country: United States lat: 33.01984 lon: -96.69889 facility: Strategic Clinical Research Group, LLC status: NOT_YET_RECRUITING city: Willow Park state: Texas zip: 76087 country: United States lat: 32.76263 lon: -97.65058 facility: Piedmont Eye Center status: NOT_YET_RECRUITING city: Lynchburg state: Virginia zip: 24502 country: United States lat: 37.41375 lon: -79.14225 facility: Emanuelli Research & Development Center, LLC status: NOT_YET_RECRUITING city: Arecibo zip: 00612 country: Puerto Rico lat: 18.47245 lon: -66.71573 hasResults: False
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<|newrecord|> nctId: NCT06270823 id: NIMR/HQ/R.8a/Vol.IX/4331 briefTitle: Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial overallStatus: RECRUITING date: 2024-02-14 date: 2025-02-14 date: 2025-02-14 date: 2024-02-21 date: 2024-02-21 name: Kilimanjaro Clinical Research Institute class: OTHER name: Leiden University Medical Center briefSummary: Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.
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The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care conditions: Transient Tachypnea of the Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 562 type: ESTIMATED name: Knee-to-chest-flexion manoeuvre measure: respiratory distress measure: adverse outcome of knee-to-chest flexion maneuver sex: ALL maximumAge: 30 Minutes stdAges: CHILD facility: Kilimanjaro Christian Medical Centre status: RECRUITING city: Moshi state: Kilimanjaro zip: P.O.Box 3010 country: Tanzania name: Febronia L Shirima, MD role: CONTACT phone: +255714143368 email: febbylaw17@gmail.com name: Bariki Mchome, PhD role: CONTACT phone: +255784280027 email: barikimchome@gmail.com name: Febronia L Shirima, MD role: SUB_INVESTIGATOR name: Bariki Mchome, PhD role: PRINCIPAL_INVESTIGATOR name: Blandina T Mmbaga, PhD role: PRINCIPAL_INVESTIGATOR lat: -3.35 lon: 37.33333 hasResults: False
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<|newrecord|> nctId: NCT06270810 id: Aero-PA briefTitle: Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-11 date: 2025-03-18 date: 2025-06-01 date: 2024-02-21 date: 2024-03-15 name: Kastamonu University class: OTHER briefSummary: The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.
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The main question it aims to answer is:
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• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?
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To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Aerobic Exercise name: Increasing non-Exercise Physical Activity measure: Low Density Lipoprotein (LDL) Cholesterol measure: High Density Lipoprotein (HDL) Cholesterol measure: Total Cholesterol measure: Glycated Hemoglobin (HbA1C) measure: Serum Triglycerides measure: Maximal Oxygen Consumption measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Body Fat Percentage measure: Fat-free Mass measure: Waist Circumference measure: Hip Circumference sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kastamonu University, Çatalzeytin Vocational School city: Çatalzeyti̇n state: Kastamonu zip: 37 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06270797 id: KMUHIRB-E(I)-20230184 briefTitle: Pre-anesthesia Imaging-based Respiratory Assessment and Analysis overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system. conditions: Clinical Decision Support System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED name: intubation for general anesthesia measure: A pre-anesthesia evaluation measure: Perform non-invasive imaging capture. measure: difficult intubation prediction measure: time to successfully extubate the nasotracheal tube after anesthesia measure: safely discharged from post-anesthesia care unit (postoperative recovery room) measure: side effects and adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung state: Sanmin Dist zip: 80756 country: Taiwan name: Tz Ping Gau, MD role: CONTACT phone: +886912060962 email: u9401066@gap.kmu.edu.tw lat: 22.61626 lon: 120.31333 hasResults: False
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<|newrecord|> nctId: NCT06270784 id: 09.2024.122 briefTitle: Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve overallStatus: RECRUITING date: 2024-01-17 date: 2024-07-17 date: 2024-09-17 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:
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-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?
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Participants will:
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