text
stringlengths 0
197k
|
|---|
Participant Duration: Approximately 1 year. |
Aims: |
Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs. |
Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy. conditions: Hepatitis C conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Glecaprevir-pibrentasvir measure: Medication adherence and treatment completion rates. measure: Patient satisfaction Questionnaire measure: Virologic outcome and clinical success at Day 28 post treatment measure: Sample size estimation for future study sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barnes Jewish Hospital status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Tracey Bach role: CONTACT phone: 314-273-6075 email: [email protected] name: Laura Marks, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Washington Univeristy status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Laura Marks, MD,PhD role: CONTACT email: [email protected] name: Tracey Habrock-Bach, MBA role: CONTACT phone: 314-273-6075 email: [email protected] lat: 38.62727 lon: -90.19789 hasResults: False |
<|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. |
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. |
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 |
<|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 |
<|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: [email protected] lat: 37.566 lon: 126.9784 hasResults: False |
<|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: [email protected] name: Ioannis G Fatouros, PhD role: CONTACT phone: +302431047047 email: [email protected] lat: 39.55493 lon: 21.76837 hasResults: False |
<|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: [email protected] lat: 59.85882 lon: 17.63889 hasResults: False |
<|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). |
The research study is testing two different interventions along with usual clinical care: |
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. |
2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels. |
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. |
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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Dorothy Van Oppen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.62953 lon: -79.9559 hasResults: False |
<|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). |
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 |
<|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. |
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. |
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 |
<|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 |
<|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 |
<|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 |
<|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. |
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. |
The main questions it aims to answer are: |
* pain after the operation |
* rate of complications |
* rate of recurrence and reoperations |
* quality of life. |
Participants will: |
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: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False |
<|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: |
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. |
Hypothesis: |
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. |
Goals: |
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. |
Methodology: |
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: [email protected] name: GABRIEL MARZUCA, MSc, PhD role: CONTACT phone: 996343630 email: [email protected] lat: -38.73965 lon: -72.59842 hasResults: False |
<|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: [email protected] lat: 55.67594 lon: 12.56553 hasResults: False |
<|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: [email protected] name: Ian WONG, Dr. role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False |
<|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: [email protected] name: Studiensekretariat role: CONTACT phone: +49913185 phoneExt: 33968 email: [email protected] name: Allison Lamrani role: PRINCIPAL_INVESTIGATOR name: Charlotte Schmitter, Dr. role: PRINCIPAL_INVESTIGATOR lat: 49.59099 lon: 11.00783 hasResults: False |
<|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: [email protected] 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 |
<|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. |
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. |
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 |
<|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 |
<|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: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|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). |
Primary Objective |
Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) diagnosed with sickle cell disease. |
Secondary Objectives |
Objective 1: |
Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (4-6) diagnosed with sickle cell disease. |
Objective 2: |
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 |
<|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: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|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 |
<|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 |
<|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 |
<|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. |
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. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.