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<|newrecord|> nctId: NCT06367452 id: CAEP 107.001.23 briefTitle: Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate overallStatus: COMPLETED date: 2023-10-31 date: 2024-01-15 date: 2024-03-30 date: 2024-04-16 date: 2024-04-16 name: Tecnoquimicas class: INDUSTRY briefSummary: The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women, after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone. The main question it aims to answer is the amount of magnesium and/or aluminum, if any, absorbed into the plasma from this oral administration.
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Participants will take the medication 30 minutes after a standard breakfast. Both groups of participants will take the standard meal but one group will take the medication and the other one won't.
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Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption, quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication, when it applies. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ACTUAL name: Sodium alginate + sodium bicarbonate + magaldrate + simeticone measure: Cmax for Aluminum measure: AUC for Aluminum measure: Cmax for Magnesium measure: AUC for Magnesium measure: Amount of aluminum ions absorbed after drug administration vs amount provided by food sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: CAEP city: Campinas state: Sao Paulo zip: 13087-567 country: Brazil lat: -22.90556 lon: -47.06083 hasResults: False
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<|newrecord|> nctId: NCT06367439 id: FN-10984 briefTitle: Examining the Effects of Virtual Reality Exercise on Mental Health acronym: UVIC VR Fit overallStatus: RECRUITING date: 2024-03-19 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-26 name: University of Victoria class: OTHER name: Meta Platforms, Inc. briefSummary: The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time. conditions: Mental Health conditions: Mood conditions: Well-Being, Psychological conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will utilize a 10-week, two-arm, single-blinded, waitlist control, randomized controlled trial (RCT). Healthy adults (19-64 years) from the Victoria community participating in less than 75 minutes of vigorous physical activity per week will be randomized to either the Supernatural (SN) condition or the wait-list control (WLC) condition for a 10-week period. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Single - Primary Investigator whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Supernatural Condition name: Supernatural Condition measure: Depression and anxiety mood symptoms measure: Well-being: subjective vitality measure: Perceived cognitive function measure: Short-term Mood measure: Core Affect Measure - Feeling Scale measure: Core Affect Measure - Felt Arousal Scale measure: Perceived exertion measure: Supernatural Target Accuracy measure: Attitude towards physical activity measure: Attitude towards Supernatural physical activity measure: Perceived opportunity for physical activity measure: Perceived opportunity for Supernatural physical activity measure: Perceived capability for physical activity measure: Perceived capability for Supernatural physical activity measure: Intentions for physical activity behaviour measure: Intention for regular Supernatural physical activity behaviour measure: Behavioural regulation of physical activity behaviour measure: Behavioural regulation of Supernatural physical activity measure: Physical activity habit measure: Supernatural physical activity habit measure: Physical activity identity measure: Supernatural physical activity identity measure: Physical activity behaviour measure: Supernatural physical activity behaviour measure: Weekly Supernatural Physical Activity Behaviour measure: Direct assessment of Supernatural physical activity behaviour measure: Direct assessment of physical activity behaviour measure: Feasibility and Acceptability of Supernatural and the Meta Quest 3 headset measure: Supernatural usability measure: Meta Quest 3 headset usability measure: Personality measure: Physical Activity Environment sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Behavioural Medicine Lab status: RECRUITING city: Victoria state: British Columbia zip: V8W3N4 country: Canada name: Colin Wierts, PhD role: CONTACT name: Ryan Rhodes, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.43294 lon: -123.3693 hasResults: False
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<|newrecord|> nctId: NCT06367426 id: Pharmacobio briefTitle: A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People overallStatus: RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-16 date: 2024-04-16 name: Pharmacobio class: INDUSTRY briefSummary: The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: To maintain double-blindness, DDN-A-0101 tablets and placebo with the same formulation and properties that cannot be distinguished in appearance will be used, and sub-packaging will also be the same. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: DDN-A-0101 (SAD) name: DDN-A-0101 (MAD) name: Placebo (SAD) name: Placebo (MAD) measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG measure: Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University College of Medicine and Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: In-Jin Jang, Doctor role: CONTACT phone: 82-2-740-8290 email: ijjang@snu.ac.kr lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06367413 id: UTH-PRoNAC Study briefTitle: Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery acronym: PRoNAC overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-20 date: 2024-09-30 date: 2024-04-16 date: 2024-04-16 name: University of Thessaly class: OTHER briefSummary: Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between. conditions: Aseptic Muscle Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, double-blind, placebo-controlled, parallel group model. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, outcomes assessor and the principal investigator will be blinded until the intervention and the outcomes' assessment is done. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Placebo name: NAC name: NAC + Whey Protein measure: Change in maximal voluntary isometric muscle contraction. measure: Change in countermovement jump height. measure: Change in delayed onset of muscle soreness (DOMS) measure: Change in reduced glutathione content. measure: Change in oxidized glutathione content. measure: Change in catalase activity. measure: Change in protein carbonyl concentration measure: Change in myoglobin concentration in blood. measure: Participants' lean body mass measure: Participants' daily physical activity-related energy expenditure. measure: Participants daily dietary intake. measure: Participants' resting metabolic rate. measure: Participants' cardiorespiratory fitness status. measure: Participants' fat free mass. measure: Participants' fat mass. measure: Participants' body fat percent. sex: MALE minimumAge: 18 Years maximumAge: 27 Years stdAges: ADULT facility: Department of Physical Education and Sport Science, University of Thessaly status: RECRUITING city: Tríkala state: Karies zip: 42100 country: Greece name: Dimitrios Draganidis, PhD role: CONTACT phone: +30 2431047078 email: ddraganidis@uth.gr name: Ioannis G Fatouros, PhD role: CONTACT phone: +302431047047 email: ifatouros@uth.gr lat: 39.55493 lon: 21.76837 hasResults: False
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<|newrecord|> nctId: NCT06367400 id: SwePSQ briefTitle: Validation of Pediatric Sleep Questionnaire on a Swedish Cohort overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2034-12-31 date: 2024-04-16 date: 2024-04-16 name: Uppsala University class: OTHER name: Karolinska Institutet name: Örebro University, Sweden name: Umeå University name: Göteborg University briefSummary: This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing. conditions: Obstructive Sleep Apnea conditions: Sleep Disorder conditions: Sleep Disorders in Children conditions: Obstructive Sleep Apnea of Child studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 520 type: ESTIMATED name: Pediatric Sleep Questionnaire measure: Level of baseline PSQ measure: Changes of baseline PSQ after treatment measure: PSQ vs OSA-18 measure: PSQ vs. PSG measure: PSQ levels of healthy controls vs children with OSDB measure: 5 and 10 years follow-up sex: ALL minimumAge: 18 Months maximumAge: 15 Years stdAges: CHILD facility: Akademiska hospital status: RECRUITING city: Uppsala country: Sweden name: Isabella Sjölander role: CONTACT phone: 018-6110000 email: isabella.sjolander@uu.se lat: 59.85882 lon: 17.63889 hasResults: False
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<|newrecord|> nctId: NCT06367387 id: STUDY23080191 id: RM1DA055311 type: NIH link: https://reporter.nih.gov/quickSearch/RM1DA055311 briefTitle: Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment acronym: TREETOP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-12 date: 2024-04-16 date: 2024-04-16 name: Jessica Merlin class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).
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The research study is testing two different interventions along with usual clinical care:
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1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.
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2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.
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The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.
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There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention. conditions: Opioid Use Disorder conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap). primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: Patient-Oriented Dosing (POD) name: Pain Self-Management (PSM) name: Usual Care name: Standard Buprenorphine Dosing Condition measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline measure: Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline measure: Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline measure: Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Outpatient Addiction Treatment Services (OATS) city: Baltimore state: Maryland zip: 21201 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center city: Baltimore state: Maryland zip: 21223 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States name: Research Team role: CONTACT email: TREETOP@pitt.edu name: Sophia Purekal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Wells House city: Hagerstown state: Maryland zip: 21740 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.64176 lon: -77.71999 facility: Central City Concern (CCC) city: Portland state: Oregon zip: 97209 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Recovery Works Northwest (RWNW) city: Portland state: Oregon zip: 97233 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: OHSU Harm Reduction Bridges to Care (HRBR) city: Portland state: Oregon zip: 97239 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: OHSU Internal Medicine Clinic (IMC) city: Portland state: Oregon zip: 97239 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: UPMC Latterman Family Health Center city: McKeesport state: Pennsylvania zip: 15132 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.34785 lon: -79.86422 facility: UPMC St. Margaret Family Health Center city: New Kensington state: Pennsylvania zip: 15068 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.56979 lon: -79.76477 facility: UPMC Internal Medicine Recovery Engagement Program (IM-REP) city: Pittsburgh state: Pennsylvania zip: 15219 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: WVU Crisis Support & Recovery Center city: Martinsburg state: West Virginia zip: 25401 country: United States name: Research Team role: CONTACT phone: 304-290-9159 email: lychoo@hsc.wvu.edu name: Dorothy Van Oppen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.45621 lon: -77.96389 facility: WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT) city: Morgantown state: West Virginia zip: 26505 country: United States name: Research Team role: CONTACT phone: 304-290-9159 email: lychoo@hsc.wvu.edu name: Dorothy Van Oppen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.62953 lon: -79.9559 hasResults: False
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<|newrecord|> nctId: NCT06367374 id: BGB-11417-2002-IIT；BDH-CLL-004 briefTitle: MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2030-02-28 date: 2030-07-30 date: 2024-04-16 date: 2024-04-16 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
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The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Sonrotoclax name: Zanubrutinib measure: 4-Year Progressive Free Survival (PFS) Rate measure: Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD) measure: Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Time to Next Therapy (TTNT) measure: Overall survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06367361 id: SIDISI 201221 id: U01AI155323 type: NIH link: https://reporter.nih.gov/quickSearch/U01AI155323 briefTitle: One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-03 date: 2028-03 date: 2024-04-16 date: 2024-04-16 name: Universidad Peruana Cayetano Heredia class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Children and adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population PK modeling studies will be performed in the first 24 hours after the first dose of oxfendazole. conditions: Fascioliasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study arm 1: Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.
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Study arm 2: Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.
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Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 336 type: ESTIMATED name: Oxfendazole name: Triclabendazole measure: Parasitological cure rate of chronic fascioliasis measure: Egg reduction rate day 7 measure: Egg reduction rate day 30 measure: Safety information on day 0 measure: Safety information on day 3 measure: Safety information on day 7 measure: Safety information on day 30 measure: Laboratory safety information day 7 measure: Laboratory safety information day 30 measure: Population pharmacokinetics model constructs for oxfendazole measure: Population pharmacokinetics model constructs for oxfendazole sulfone measure: Population pharmacokinetics model constructs fenbendazole sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06367348 id: R01AA031445 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031445 id: R01AA031445 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031445 briefTitle: An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2028-05 date: 2028-05 date: 2024-04-16 date: 2024-04-24 name: University of California, San Francisco class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi. conditions: HIV/AIDS conditions: Alcohol Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Couples will be randomized 1:1 to intervention or control arm primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Mlambe measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Viral Suppression measured using whole blood viral load tests measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Medical appointment adherence assessment measure: Medical appointment adherence assessment measure: Medical appointment adherence assessment measure: Number of drinking days measured using the "Timeline follow-back" method measure: Number of drinking days measured using the "Timeline follow-back" method measure: Number of drinking days measured using the "Timeline follow-back" method measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: PEth level measured using a Phosphatidylethanol biomarker test measure: PEth level measured using a Phosphatidylethanol biomarker test measure: PEth level measured using a Phosphatidylethanol biomarker test measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Invest in Knowledge Initiative (IKI) city: Zomba country: Malawi lat: -15.38596 lon: 35.3188 hasResults: False
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<|newrecord|> nctId: NCT06367335 id: ETIC briefTitle: Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer acronym: ETIC overallStatus: COMPLETED date: 2022-06-01 date: 2022-09-01 date: 2022-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Milano Bicocca class: OTHER briefSummary: The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making. conditions: DILI studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 128 type: ACTUAL name: Ribociclib, palbociclib, abemaciclib measure: Incidence of DILI measure: withdrawal of therapy measure: delayed reprise of antineoplastic therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Milano-Bicocca, city: Monza zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 hasResults: False
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<|newrecord|> nctId: NCT06367322 id: EMP-PARA-20170-01 briefTitle: Statins and Post-ERCP Acute Pancreatitis (Stark Project) acronym: Stark overallStatus: COMPLETED date: 2017-01-10 date: 2018-07-31 date: 2018-09-30 date: 2024-04-16 date: 2024-04-16 name: Hospital General Universitario de Alicante class: OTHER name: European Pancreatic Club (EPC), Pancreas 2000 Educational Program briefSummary: Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP. conditions: Post-ERCP Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1016 type: ACTUAL name: Statin measure: To assess the incidence and relative risk of PEAP according to statin use. measure: To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP. measure: To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alicante city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 facility: Hospital General Universitario de Alicante city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False
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<|newrecord|> nctId: NCT06367309 id: 2023 - 02357 briefTitle: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair acronym: ALPINE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2030-12-31 date: 2024-04-16 date: 2024-04-16 name: University Hospital, Basel, Switzerland class: OTHER name: St. Clara Hospital, Basel, Switzerland name: Innklinikum Altötting, Germany briefSummary: This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.
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The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.
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The main questions it aims to answer are:
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* pain after the operation
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* rate of complications
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* rate of recurrence and reoperations
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* quality of life.
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Participants will:
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Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. conditions: Ventral Hernia conditions: Abdominal Wall Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: Extended totally extraperitoneal repair name: Intraperitoneal onlay mesh measure: primary outcome: pain numeric rating scale (NRS) measure: pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a measure: pain mid-term measure: recurrence and reoperation measure: LOS measure: Functional recovery measure: Adverse events measure: Quality of life (SF 12) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Clara Hospital city: Basel state: Basel-Stadt zip: 4058 country: Switzerland name: Fiorenzo Angehrn, MD role: CONTACT email: fiorenzo.angehrn@clarunis.ch lat: 47.55839 lon: 7.57327 hasResults: False
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<|newrecord|> nctId: NCT06367296 id: RETOPO2024 briefTitle: Resistance Exercise Training in the Older Population With Obesity acronym: RETOPO overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-28 date: 2025-06-01 date: 2024-04-16 date: 2024-04-16 name: Universidad de La Frontera class: OTHER briefSummary: Background:
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Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.
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Hypothesis:
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A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.
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Goals:
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The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.
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Methodology:
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The present clinical trial will consider 2 groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat \<25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % \>32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated. conditions: Aging conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Prolonged resistance exercise training measure: Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training measure: Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training measure: Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training. measure: Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training. measure: Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training. measure: Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training. measure: Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training. measure: Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training. measure: Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training. measure: Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise training. sex: FEMALE minimumAge: 60 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de La Frontera city: Temuco state: IX Región De La Araucanía zip: 4780000 country: Chile name: Nicolás Vidal-Seguel, MSc role: CONTACT phone: 998595445 email: nicolasenrique.vidal@ufrontera.cl name: GABRIEL MARZUCA, MSc, PhD role: CONTACT phone: 996343630 email: gabriel.marzuca@ufrontera.cl lat: -38.73965 lon: -72.59842 hasResults: False
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<|newrecord|> nctId: NCT06367283 id: 2023-509181-38-00 briefTitle: Metformin Treatment of Patients With Hand Osteoarthritis acronym: METRO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-04 date: 2024-04-16 date: 2024-04-16 name: Marius Henriksen class: OTHER briefSummary: To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms. conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Metformin name: Placebo measure: Finger pain measure: Function measure: Thumb base pain measure: Hand pain measure: Physician tender joint count measure: Patient global assessment measure: Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale measure: Hand strength measure: Number of treatment responders measure: Stiffness of both hands measure: Composite of pain, function and stiffness measure: Physical function measure: Physician global assessment measure: Swollen joint count measure: Fatigue measure: Sleep quality measure: Absence or presence of inflammation of target hand measure: Change in use of analgesics measure: Inflammatory biomarker measure: Metabolic outcomes measure: Metabolic outcomes measure: Vitamin K measure: Proteomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Parker Institute, Bispebjerg and Frederiksberg hospital city: Copenhagen state: Frederiksberg zip: 2000 country: Denmark name: Kasper Staberg Madsen, MD role: CONTACT phone: +4538164162 email: kasperstabergmadsen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06367270 id: UW 23-361 briefTitle: The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies acronym: PIPAC overallStatus: RECRUITING date: 2023-09-01 date: 2026-08-31 date: 2027-08-31 date: 2024-04-16 date: 2024-04-16 name: The University of Hong Kong class: OTHER briefSummary: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity. conditions: Peritoneal Metastases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pressured Intraperitoneal Aerosol Chemotherapy measure: Clinical benefit rate (CBR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Ian WONG, Dr. role: CONTACT phone: +852 2255 4774 email: iyhwong@hku.hk name: Ian WONG, Dr. role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06367257 id: Emento App briefTitle: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-06-30 date: 2024-04-16 date: 2024-04-16 name: University of Erlangen-Nürnberg Medical School class: OTHER briefSummary: Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition. conditions: Squamous Cell Carcinoma of Head and Neck studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 148 type: ESTIMATED name: App Usage name: Standard of Care measure: Change in rates of weight loss with additional app-based Patient Care measure: Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. measure: Frequency of additional app-triggered contacts of the clinic with the patients measure: Frequency of critical health conditions (physician-verified) detected earlier by the app. measure: Change in quality of life measured per questionnaires measure: Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. measure: Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. measure: Rate of therapy interruptions/discontinuations measure: Overall survival measure: Disease-free/progression-free survival measure: Change of Loco-regional tumor control sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Erlangen, Strahlenklinik city: Erlangen state: Bavaria zip: 91054 country: Germany name: Marlen Haderlein, PD role: CONTACT phone: +49913185 phoneExt: 33968 email: marlen.haderlein@uk-erlangen.de name: Studiensekretariat role: CONTACT phone: +49913185 phoneExt: 33968 email: studiensekretariat.ST@uk-erlangen.de name: Allison Lamrani role: PRINCIPAL_INVESTIGATOR name: Charlotte Schmitter, Dr. role: PRINCIPAL_INVESTIGATOR lat: 49.59099 lon: 11.00783 hasResults: False
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<|newrecord|> nctId: NCT06367244 id: TWP2023 briefTitle: Transplant Wellness Program acronym: TWP overallStatus: RECRUITING date: 2023-11-16 date: 2033-11 date: 2033-11 date: 2024-04-16 date: 2024-04-16 name: University of Calgary class: OTHER briefSummary: Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization. conditions: Transplantation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The TWP is a parallel study design with two arms. Participants are assigned to either the kidney or liver arm depending on the organ transplant they are listed or in evaluation for. Each arm will have a pre- or post- transplant group. Participants will be assigned to group depending on length of time between study enrollment and transplant surgery. Those with more than 12-weeks until surgery will complete the TWP pre-transplant and those with less than 12-weeks will complete the TWP post-transplant. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 420 type: ESTIMATED name: Transplant Wellness Program - Kidney and Liver measure: Self-reported exercise measure: Generic self-reported quality of life measure: Kidney disease quality of life. measure: Liver disease quality of life measure: Frailty measure: Hand grip strength measure: Lower extremity flexibility measure: Aerobic Endurance measure: Lower extremity muscular strength measure: Balance measure: Nutrition measure: Sleep measure: Mental Health measure: Self-efficacy measure: Program implementation and evaluation measure: Health economic evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calgary status: RECRUITING city: Calgary state: Alberta zip: T2N 1N4 country: Canada name: Maneka Perinpanayagam, PhD role: CONTACT phone: 403-944-3699 email: maneka.perinpanayagam@ucalgary.ca name: S. Nicole Culos-Reed, PhD role: PRINCIPAL_INVESTIGATOR name: Kelly Burak, MD role: PRINCIPAL_INVESTIGATOR name: Debra Isaac, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 hasResults: False
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<|newrecord|> nctId: NCT06367231 id: Pro00134554 briefTitle: SCGs as a Proxy for Determining the Cognitive Status of Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-16 date: 2024-04-16 name: University of Alberta class: OTHER briefSummary: Detecting memory problems early is crucial for treating conditions like Mild Cognitive Impairment (MCI), which often leads to dementia. Currently, doctors use tests in clinics to check for these issues. However, there's a growing need for better methods to monitor our cognitive skills over time. Computer games emerge as a cost-effective solution for assessing the brain functions of older adults.
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In our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. We developed the VibrantMinds platform, featuring five games: Whack-a-Mole, Bejeweled, Mahjong Solitaire, Word Search, and Memory Game. We have evaluated these games for ease of use, enjoyment, and their impact on brain functions. Now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults.
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We are collecting demographic data, game-playing data, and cognitive test results. Our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. Additionally, we will assess both the perceived and observed engagement of older adults as they play the games. conditions: Mild Cognitive Impairment conditions: Dementia conditions: Alzheimer Disease conditions: Healthy Aging conditions: Cognitive Decline studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 58 type: ESTIMATED name: VibrantMinds measure: Cognition - Global measure: Cognition - Global measure: Cognition - Executive Function measure: Game Performance measure: Game Engagement sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06367218 id: S058 briefTitle: Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-01 date: 2026-08-01 date: 2024-04-16 date: 2024-04-16 name: Tongji Hospital class: OTHER briefSummary: Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience. conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: opioid based strategy name: opioid-free strategy name: Laryngeal mask airway; Preserved spontaneous breathing name: Double lumen tracheal tube; Mechanical ventilation measure: Lung function 30 days after surgery measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Perioperative stage indicators measure: Perioperative stage indicators measure: Postoperative pain measure: Postoperative Lung function measure: Postoperative Lung function measure: Postoperative pulmonary complications measure: Postoperative gastrointestinal function measure: Postoperative depression/anxiety measure: Postoperative cognitive function measure: Time of first exercise after surgery measure: The 6-minute walking experiment measure: Length of stay measure: Quality of life measurement measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06367205 id: LY2023-135-A briefTitle: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations overallStatus: RECRUITING date: 2024-03-01 date: 2026-04-30 date: 2026-06-30 date: 2024-04-16 date: 2024-04-16 name: RenJi Hospital class: OTHER briefSummary: Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies. conditions: Delayed Graft Function conditions: End Stage Renal Disease conditions: Kidney Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 380 type: ESTIMATED name: Goal-Directed Fluid Therapy (GDFT) name: Regular Fluid Therapy measure: The incidence of delayed graft function (DGF) measure: The area under the curve of serum creatinine levels from postoperative day 1 to 7 measure: Duration of DGF measure: Number of dialysis sessions during postoperative hospitalization measure: Total urine output on the second postoperative day measure: Duration of intensive care unit (ICU) stay measure: Length of hospitalization measure: Incidence of readmission within 30 days post-discharge measure: The incidence of acute rejection during hospitalization measure: The survival rates of transplanted kidneys at the one-year postoperative mark measure: The survival rates of transplanted patients at the one-year postoperative mark measure: The occurrence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China name: Jianjun Yang, Dr. role: CONTACT lat: 34.75778 lon: 113.64861 facility: General Hospital of Northern Theatre Command status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110016 country: China name: Yugang Diao, Dr. role: CONTACT lat: 41.79222 lon: 123.43278 facility: Renji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Muyan Shi, B.S. role: CONTACT phone: +862168383702 email: jsqdsmy@163.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06367192 id: SKITS2 id: K23HL166697 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL166697 briefTitle: School Readiness Intervention for Preschool Children With Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2028-10 date: 2024-04-16 date: 2024-04-16 name: St. Jude Children's Research Hospital class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 4-6 years old).
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Primary Objective
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Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) diagnosed with sickle cell disease.
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Secondary Objectives
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Objective 1:
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Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (4-6) diagnosed with sickle cell disease.
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Objective 2:
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Examine implementation factors (i.e., barriers and facilitators) during post-intervention. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: The adapted Kids in Transition to School Intervention name: Standard school resources measure: Feasibility of Intervention Measure measure: Acceptability of Intervention Measure measure: Bracken School Readiness Assessment - 3rd Edition measure: Woodcock Johnson Tests of Achievement - Fourth Edition measure: NIH Toolbox Flanker Test measure: Head-Toes-Knees-Shoulders Revised measure: Behavior Rating Inventory of Executive Functioning Preschool or Child measure: The Parenting Scale sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: ANDREW HEITZER, PhD role: CONTACT name: ANDREW HEITZER, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06367179 id: 202401039RINC briefTitle: Virtual Reality and AI Wound-detecting System overallStatus: RECRUITING date: 2024-03-22 date: 2025-02-04 date: 2025-02-04 date: 2024-04-16 date: 2024-04-16 name: National Taiwan University Hospital class: OTHER briefSummary: This study is an experimental study. The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects. During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group. The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days. Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy. conditions: Pressure Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 92 type: ESTIMATED name: Virtual reality and AI use name: Health education leaflet measure: Accurate dressing change rate of pressure injury measure: Pressure injury dressing change of self-efficacy sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100225 country: Taiwan name: Cian Huei Wang role: CONTACT phone: (02)23123456 phoneExt: 263502 email: chw0710@ntuh.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06367166 id: RyazanSMU briefTitle: Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-16 date: 2024-04-16 name: Ryazan State Medical University class: OTHER briefSummary: The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin). conditions: Varicose Veins of Lower Limb conditions: Varix conditions: Vascular Diseases conditions: Leg Edema studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ACTUAL name: "Venarus®" (diosmin and hesperidin) name: Endovenous laser ablation (EVLA) with miniphlebectomy name: Elastic compression name: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores measure: changes in biomarkers of venous wall remodeling measure: Changes in biomarkers expression in venous wall sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RyazanSMU city: Ryazan country: Russian Federation lat: 54.6269 lon: 39.6916 hasResults: False
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<|newrecord|> nctId: NCT06367153 id: 1447-0007 id: 2023-510461-10-00 type: REGISTRY domain: CTIS id: U1111-1303-9187 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-08-24 date: 2024-08-24 date: 2024-04-16 date: 2024-04-17 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates). conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER interventionModelDescription: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence). primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: BI 1569912 name: repaglinide name: midazolam name: bupropion measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of the analyte in plasma (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06367140 id: SYU 2021-06-001-002 briefTitle: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke overallStatus: COMPLETED date: 2020-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-04-16 date: 2024-04-17 name: Sahmyook University class: OTHER name: Seoul National University Hospital name: Kyungdong University briefSummary: The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The evaluators were blinded to the intervention details of the participants. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: EMG-triggered CIMCT device name: general cycling training measure: Muscle Strength measure: Static Balance measure: Timed Up and Go (TUG) measure: Berg Balance Scale measure: Functional Reach Test (FRT) measure: Modified Barthel Index (MBI) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physicla Therapy, Sahmyook University city: Seoul zip: 01795 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06367127 id: Pingfanghu briefTitle: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening overallStatus: ENROLLING_BY_INVITATION date: 2023-10-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Shanghai Changzheng Hospital class: OTHER briefSummary: Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.
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Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.
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Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE. conditions: Hepatic Encephalopathy conditions: Covert Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Number of Beans Clamping in 1 minute measure: Participants' feedback on CBT1 test sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Changzheng hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06367114 id: ssCART-19-II-1 briefTitle: Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2025-12 date: 2024-04-16 date: 2024-04-19 name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd class: INDUSTRY name: The First Affiliated Hospital of Soochow University name: Peking University People's Hospital briefSummary: This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. conditions: Relapsed or Refractory Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ssCART-19 name: Fludarabine name: Cyclophosphamide measure: Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL). measure: Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. measure: Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion. measure: Duration of response (DOR) measure: Recurrence free survival (RFS) measure: Event Free Survival (EFS) measure: Overall survival (OS) measure: Incidence of adverse events following ssCART-19 infusion measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Anti-drug antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd. city: Shanghai state: Shanghai zip: 201210 country: China lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of Soochow University city: Suzhou country: China name: Depei Wu, Dr. role: CONTACT lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06367101 id: 202002525B0 briefTitle: AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease overallStatus: RECRUITING date: 2022-01-18 date: 2025-05-31 date: 2025-07-31 date: 2024-04-16 date: 2024-04-16 name: Chang Gung University class: OTHER briefSummary: A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms. conditions: Parkinson Disease(PD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: AR training with gait and HRV feedback measure: Walking Speed measure: Step Length measure: Step Time measure: Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR) measure: Time-Domain Index of HRV：pNN50 measure: Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD) measure: Frequency-Domain Index of HRV: Low Frequency (LF) measure: Frequency-Domain Index of HRV: High Frequency (HF) measure: Frequency-Domain Index of HRV: Ratio of LF to HF Power measure: Total Time to Complete the Time Up and Go test (TUG test) measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence measure: Total UPDRS-III Score measure: Total NFOG-Q Score measure: Overall PDQ-39 Score measure: Total HADS Score measure: Overall PSQI Score measure: Non-linear Index of HRV: SD1 measure: Non-linear Index of HRV: SD2 measure: Non-linear Index of HRV: Ratio of SD1-to-SD2 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06367088 id: Sophia briefTitle: Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER briefSummary: The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients. conditions: Triple-negative Breast Cancer conditions: Cadonilimab studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Cadonilimab measure: Objective Response Rate measure: AE measure: Progression-free survival measure: Overall survival measure: Disease control rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Jie Xiong role: CONTACT phone: +8615927611872 email: xxiongjie2000@163.com lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06367075 id: AK104-sarcoma-202401 briefTitle: A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-31 date: 2029-03-31 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER name: Sun Yat-sen University name: Xiangya Hospital of Central South University name: Yunnan Cancer Hospital name: The Affiliated Hospital Of Guizhou Medical University name: First Affiliated Hospital of Guangxi Medical University briefSummary: This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin. conditions: Advanced Soft-tissue Sarcoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cadonilimab (AK104) with adriamycin primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Cadonilimab name: Adriamycin measure: objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Adverse event (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06367062 id: SH9H-2023-T296 briefTitle: General Anesthesia/Surgical Exposure on White Matter Development in Children overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development. conditions: Neurodevelopmental Delay studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 210 type: ESTIMATED name: MRI measure: MRI-based assessment of brain development sex: ALL minimumAge: 12 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06367049 id: 2023-FXY-230-NPC briefTitle: Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-30 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-sen University class: OTHER name: Guangdong Women and Children Hospital name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University briefSummary: Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.
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DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.
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There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.
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Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer. conditions: Nasopharyngeal Carcinoma conditions: Early Diagnosis of Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 470 type: ACTUAL name: Methylation-specific PCR measure: Sensitivity measure: Specificity sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06367036 id: 2021-52 briefTitle: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain overallStatus: COMPLETED date: 2022-01-02 date: 2022-12-29 date: 2023-06-15 date: 2024-04-16 date: 2024-04-16 name: Uskudar University class: OTHER briefSummary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test. conditions: Pain conditions: Ecchymosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Two researchers do not know which site was injected. whoMasked: INVESTIGATOR count: 160 type: ACTUAL name: Topical hypericum perforatum oil intervention measure: Pain point measure: Ecchymosis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hatice Demirdağ city: Üsküdar state: İstanbul zip: 34672 country: Turkey lat: 41.02252 lon: 29.02369 hasResults: False
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<|newrecord|> nctId: NCT06367023 id: 32-2024 briefTitle: Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2025-03-30 date: 2024-04-16 date: 2024-04-16 name: Manipur International University class: OTHER name: Brahmakumaris briefSummary: Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention. conditions: Prevalence conditions: Depression conditions: Happiness conditions: Quality of Life conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ESTIMATED name: Rajyoga Meditation Practice measure: Anxiety score measure: Depression score measure: quality of life score measure: Rate of Relapse sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Rehabilitation center city: Biratnagar state: Koshi zip: 56613 country: Nepal name: Rajiv Ranjan Karn, MPH role: CONTACT phone: +9779842068053 email: rajiv2061@gmail.com name: Ajaya Bhattarai, PhD role: CONTACT phone: +9779842077434 email: bkajaya@gmail.com lat: 26.45505 lon: 87.27007 hasResults: False
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<|newrecord|> nctId: NCT06367010 id: MR-36-24-010942 briefTitle: Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-16 date: 2024-04-16 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ACTUAL name: Iodine-125 brachytherapy combine with Anlotinib measure: The CT images were used to measure the change in the maximum diameter of the lesion in millimeters. measure: Serological assessment measure: Use the Numerical Rating Scale (NRS) to record patients' pain scores. measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangxi Cancer Hospital city: Nanchang state: Jiangxi zip: 330029 country: China lat: 28.68396 lon: 115.85306 hasResults: False
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<|newrecord|> nctId: NCT06366997 id: CQGOG0207 briefTitle: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test overallStatus: COMPLETED date: 2019-10-09 date: 2023-04-18 date: 2023-05-05 date: 2024-04-16 date: 2024-04-16 name: Chongqing University Cancer Hospital class: OTHER name: Zhejiang Cancer Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: The First Affiliated Hospital of Zhengzhou University name: 3D Medicines Corporation briefSummary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study. conditions: Epithelial Ovarian Cancer conditions: Adnexal Mass studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1352 type: ACTUAL measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: No.181, Hanyulu Road, Shapingba District city: Chongqing state: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06366984 id: Adeel4 briefTitle: Outcome of Plastibell Circumcision Versus Open Method Circumcision overallStatus: COMPLETED date: 2022-01-11 date: 2022-07-11 date: 2022-08-11 date: 2024-04-16 date: 2024-04-16 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.
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Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition). conditions: Bleeding conditions: Site Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controll trial primaryPurpose: OTHER masking: SINGLE maskingDescription: outcome assessor is unaware of group allocated whoMasked: OUTCOMES_ASSESSOR count: 174 type: ACTUAL name: plastibell name: open method measure: infection sex: MALE minimumAge: 1 Day maximumAge: 12 Months stdAges: CHILD facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06366971 id: auhucgun01 briefTitle: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction overallStatus: COMPLETED date: 2023-12-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-16 date: 2024-04-16 name: Biruni University class: OTHER briefSummary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD. conditions: Sacroiliac Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: The Patient Education name: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training measure: The Level of Low Back Pain measure: Mobility measure: Flexibility measure: Lumbar Range of Motion measure: Posture measure: Trunk Muscle Endurance sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Atlas University city: Istanbul state: Kagıthane zip: 34408 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06366958 id: Dorsal wrist ganglion briefTitle: Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-02-02 date: 2025-04-02 date: 2024-04-16 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion conditions: Hand Ganglion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: excision of dorsal wrist ganglion measure: comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion measure: compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion sex: ALL minimumAge: 10 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06366945 id: SYSKY-2024-157-02 briefTitle: Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-12-30 date: 2029-05-30 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis conditions: Head and Neck Squamous Cell Carcinoma conditions: Head and Neck Cancer conditions: HNSCC conditions: Head Cancer Neck studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Carboplatin name: Tislelizumab name: Polymeric Micellar Paclitaxel name: Surgical Resection of Primary +/- Neck Dissection name: Post-operative radiation therapy measure: Major pathological response (MPR) rate of metastatic lymph nodes measure: Major pathological response (MPR) rate of primary tumor measure: Event-free survival (EFS) measure: Overall survival（OS） measure: Incidence of treatment-related adverse events measure: EORTC QLQ-C30 measure: pathological downstaging rate measure: Distant metastasis-free survival(DMFS) rate measure: logical regional-free survival(LRFS) rate measure: Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06366932 id: DermAtOmics-II briefTitle: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models overallStatus: RECRUITING date: 2023-09-25 date: 2025-09 date: 2025-09 date: 2024-04-16 date: 2024-04-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Second-line systemic treatment name: Folllow-up of second-line systemic treatment already started measure: Percentage of patients with primary non-response to second-line treatment. measure: Percentage of patients achieving EASI-75 measure: Time to treatment failure after week 16 measure: Mean percentage of change in Eczema Area and Severity Index (EASI) score measure: Percentage of change in SCORAD (SCORing Atopic Dermatitis) measure: Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) measure: Change of IGA (Investigator Global Assessment) measure: Time to IGA score of 0/1 (Investigator Global Assessment) measure: Change of BSA (Body surface area) measure: Change in NRS measure: Change in RECAP measure: Percentage of patients having a variation of 4 points in their improvement in DLQI measure: Change in POEM (Patient-Oriented Eczema Measure) measure: Rate of adverse events associated to second-line systemic treatment measure: Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Irene García, MD role: CONTACT phone: +34-912071466 email: irene.ucicec@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06366919 id: DPT/Batch-Fall19/559 briefTitle: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-05-15 date: 2024-06-15 date: 2024-04-16 date: 2024-04-16 name: Superior University class: OTHER briefSummary: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: Alexander Technique (AT) name: Feldenkrais Technique (FT) measure: Northwick Park Neck Pain Questionnaire measure: REEDCO Posture Assessment and Sleep Quality Scale sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06366906 id: SYSKY-2023-426-01 briefTitle: 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma overallStatus: COMPLETED date: 2023-05-10 date: 2024-02-10 date: 2024-02-10 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.
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Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.
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Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis. conditions: HNSCC conditions: AI conditions: Radiomic conditions: MRI studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 319 type: ACTUAL name: The Resnet50 deep learning (DL) model measure: AUC(the area under the curve) values of the model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 facility: Sun yat-sun memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06366893 id: PR(AG)297/2019 briefTitle: Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-04 date: 2025-03-04 date: 2024-04-16 date: 2024-04-19 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency.
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The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency.
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The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona. conditions: Infant, Premature, Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: DHA/AA emulsion supplement for preterm infant measure: Percentage comparison of erythrocyte membrane levels of DHA and AA measure: Tolerance of DHA emulsion administration measure: Compare the presence of pathologies in preterm infants between the supplemented group and the control group sex: ALL maximumAge: 7 Days stdAges: CHILD facility: Hospital Materno Infantil Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Félix Castillo Salinas, Dr. role: CONTACT phone: +34 934893899 email: felix.castillo@vallhebron.cat name: Félix Castillo Salinas, Dr. role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06366880 id: 2022.HPS.DI.434 briefTitle: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn overallStatus: RECRUITING date: 2024-03-11 date: 2024-12-15 date: 2025-12-15 date: 2024-04-16 date: 2024-04-16 name: Hospital Pediátrico de Sinaloa class: OTHER_GOV briefSummary: Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.
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The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.
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The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants. conditions: Cholestasis in Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Parenteral nutrition cycling measure: Incidence of cholestasis on Day 28 of admission. measure: are total plasma bilirrubine profiles measure: the incidence of hypoglycaemia sex: ALL minimumAge: 1 Hour maximumAge: 28 Days stdAges: CHILD facility: Hospital Pediatrico de Sinaloa status: RECRUITING city: Culiacán state: Sinaloa zip: 80200 country: Mexico name: Ana Karen Camargo Angulo, Dr. role: CONTACT phone: 6681890586 phoneExt: +52 email: anakarencamargo96@gmail.com lat: 24.79032 lon: -107.38782 hasResults: False
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<|newrecord|> nctId: NCT06366867 id: Pro00097579 briefTitle: An Open Platform of Serious Games for Cognitive Intervention overallStatus: RECRUITING date: 2022-08-03 date: 2025-08-01 date: 2025-12-01 date: 2024-04-16 date: 2024-04-16 name: University of Alberta class: OTHER name: Alberta Health services name: CapitalCare briefSummary: Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.
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VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.
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Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.
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The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning. conditions: Mild Cognitive Impairment conditions: Dementia conditions: Alzheimer Disease conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities. primaryPurpose: DEVICE_FEASIBILITY masking: DOUBLE maskingDescription: Random allocation, 1:1 ratio by a computer-based randomizer whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: VibrantMinds measure: Cognition - Global measure: Depression measure: Agitation measure: Occupational Performance measure: Engagement measure: Affect sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CapitalCare Group Inc Facilities status: RECRUITING city: Edmonton zip: T5J 3M9 country: Canada name: Adriana Rios Rincon, PhD, R.OT role: CONTACT phone: 7804921728 email: aros@ualberta.ca lat: 53.55014 lon: -113.46871 hasResults: False
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<|newrecord|> nctId: NCT06366854 id: IRAS: 332418 briefTitle: UK ANDROMEDA-Shock-2 RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-04-30 date: 2024-04-16 date: 2024-04-16 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: Pontificia Universidad Catolica de Chile name: University of Rotterdam, The Netherlands briefSummary: The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care. conditions: Septic Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Personalised fluid and haemodynamic resuscitation measure: hospital mortality measure: organ support measure: length of stay measure: mortality measure: vital organ support measure: length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06366841 id: 6439 briefTitle: Stigma and Psychological profilE in REctal-anal caNcer pAtients acronym: SERENA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time. conditions: Rectal Cancer conditions: Anal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 148 type: ESTIMATED name: Psychological tests administration measure: Evaluation of rectal and anal cancer stigma measure: Evaluation of psychological characteristics in rectal and anal cancer measure: Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version measure: Toronto Alexithymia Scale measure: EORTC QLQ - CR29 and EORTC QLQ-ANL27 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06366828 id: 11446 briefTitle: Prediction Models for Complications After CRT in Esophageal Cancer acronym: MODELS overallStatus: RECRUITING date: 2023-02-01 date: 2025-06 date: 2030-06 date: 2024-04-16 date: 2024-04-16 name: University Medical Center Groningen class: OTHER name: Dutch Cancer Society name: Comprehensive Cancer Centre The Netherlands name: Dutch Institute for Clinical Auditing (DICA) name: ZorgTTP briefSummary: The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer conditions: The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: retrospective measure: Multivariable NTCP models will be developed for the prediction of the following measure: Cardiac events grade II or higher (CTCAE v 5.0), including: measure: Mortality measure: Complication Sum Score, that will be determined in Delphi consensus measure: Patient-rated dysphagia measure: Patient-rated nausea measure: Patient-rated fatigue / daily functioning measure: Hospitalization after esophagectomy (days) measure: Intensive care unit stay after esophagectomy (days) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525GA country: Netherlands name: H. Rutten, MD role: CONTACT lat: 51.8425 lon: 5.85278 facility: Maastro clinic status: RECRUITING city: Maastricht state: Limburg zip: 6229ET country: Netherlands name: M. Berbee, MD, PHD role: CONTACT lat: 50.84833 lon: 5.68889 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: P. van Rossum, MD, PHD role: CONTACT name: H.W.M. van Laarhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015GE country: Netherlands name: J. Nuyttens, MD, PHD role: CONTACT name: B. Wijnhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Holland PTC status: NOT_YET_RECRUITING city: Delft country: Netherlands name: Yvonne Klaver, MD, PHD role: CONTACT lat: 52.00667 lon: 4.35556 facility: UMCG status: RECRUITING city: Groningen zip: 9715GZ country: Netherlands name: Christina Muijs, MD, PHD role: CONTACT phone: 0503616161 email: c.t.muijs@umcg.nl name: C. T. Muijs, MD, PHD role: PRINCIPAL_INVESTIGATOR name: J. A. Langendijk, Prof., MD, PHD role: SUB_INVESTIGATOR name: B. van Etten, MD, PHD role: SUB_INVESTIGATOR name: J. J. de Haan, MD, PHD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Zuyderland hospital status: RECRUITING city: Heerlen country: Netherlands name: Meindert Sosef, MD role: CONTACT lat: 50.88365 lon: 5.98154 facility: UMCU status: RECRUITING city: Utrecht zip: 3584CX country: Netherlands name: G Meijer, PHD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06366815 id: 4619 briefTitle: phenotypeS in Non Ambulant Duchenne Muscular Dystrophy acronym: GUP21003 overallStatus: RECRUITING date: 2022-08-30 date: 2024-09-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function conditions: Duchenne Muscular Dystrophy conditions: Natural History conditions: Motor Function; Retardation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Different Phenotypes of non ambulant patients with Duchenne Muscular Dystrophy measure: motor function measure: respiratory function measure: cardiac function measure: identify patterns of severity and of progression related to differnt genotypes sex: MALE minimumAge: 8 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: IRCCS catholic univeristy status: RECRUITING city: Roma country: Italy name: Marika Pane, prof role: CONTACT phone: 0038063015 phoneExt: 6742 email: marika.pane@policlinicogemelli.it name: Daniela Leone role: CONTACT phone: 00390630158821 email: daniela.leone@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06366802 id: Prognosis model-MM09 briefTitle: Cohort Construction and Prognostic Model Construction for Multiple Myeloma overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-03 date: 2027-05-02 date: 2027-05-02 date: 2024-04-16 date: 2024-04-16 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Overall survival measure: Progression free survival(PFS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China lat: 31.30408 lon: 120.59538 hasResults: False
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