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• To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population
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Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.
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Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels. conditions: Dialysis conditions: Chronic Kidney Disease conditions: Diabetes Mellitus, Type 2 conditions: Diabetes Mellitus, Type 1 conditions: Hemodialysis conditions: Peritoneal Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Design: Prospective, open-label, two-stage randomised-crossover study.
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Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5).
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Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels.
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All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks.
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CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: 2nd Generation Automated Insulin Delivery (AID) system measure: Percent time in sensor glucose target range (3.9-10.0 mmol/L) measure: Proportion of time spent <2.8 mmol/L measure: Proportion of time spent <3.0 mmol/L measure: Proportion of time spent <3.3 mmol/L measure: Proportion of time spent <3.9 mmol/L measure: Proportion of time spent 3.9-7.8 measure: Proportion of time spent >10.0 mmol/L measure: Proportion of time spent >13.9 mmol/L measure: Proportion of time spent >16.7 mmol/L measure: Glucose variability (SD and coefficient of variation) measure: Mean glucose measure: HbA1c measure: Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes measure: Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia measure: eGFR (estimated glomerular filtration rate) measure: Potassium pre-dialysis measure: Urine albumine-to-creatinine ratio measure: Actigraph Metrics for sleep architecture measure: Sleep diary measure: Proportion of time Automode is active measure: Diabetic ketoacidosis measure: Severe hypoglycemia measure: Serious Adverse Event measure: Unanticipated Serious Adverse Device Event measure: Satisfaction with diabetes treatment measure: Satisfaction with diabetes treatment measure: Fear of hypoglycaemia measure: Hypoglycaemia awareness measure: Diabetes distress measure: Sleep Quality measure: Cognitive function measure: Sarcopenia measure: Semi-structured interview measure: Health-related quality of life measure: Frailty sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tobias Bomholt status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Tobias Bomholt, MD, PhD role: CONTACT phone: +4535457952 email: Tobias.bomholt@regionh.dk name: Christine Meyer Olesen, MD role: CONTACT phone: 21495144 email: clmolesen@gmail.com lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06330181 id: SC220178 id: HT9425-23-1-1019 type: OTHER_GRANT domain: Department of Depense briefTitle: Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury overallStatus: RECRUITING date: 2024-03 date: 2026-01 date: 2027-01 date: 2024-03-26 date: 2024-03-26 name: Texas A&M University class: OTHER name: United States Department of Defense name: Immersive Experience Labs briefSummary: The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury. conditions: Spinal Cord Injuries conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of two intervention arms. Both groups receive the same number of sessions, duration of sessions, and measures procured. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: VR Game 1 name: VR Game 2 measure: Change in Pain Intensity measure: Change in Pain Quality measure: Change in Pain Interference measure: Post treatment change measure: Change in mood measure: Change in quality of life measure: Neurological changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Texas A&M University status: RECRUITING city: College Station state: Texas zip: 77843 country: United States name: Amanda Higgins, M.E.d role: CONTACT phone: 804-569-5965 email: sci@vrwalk.org name: Zina Trost, PhD role: PRINCIPAL_INVESTIGATOR lat: 30.62798 lon: -96.33441 hasResults: False
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<|newrecord|> nctId: NCT06330168 id: 36264PR573/2/24 briefTitle: Paravertebral Calcitonin in Thoracotomy overallStatus: RECRUITING date: 2024-03-28 date: 2025-04-10 date: 2025-04-10 date: 2024-03-26 date: 2024-03-28 name: Tanta University class: OTHER briefSummary: This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy. conditions: Calcitonin conditions: Paravertebral conditions: Thoracotomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: bupivacaine-calcitonin-fentanyl name: Bupivacaine-fentanyl measure: morphine consumption measure: numerical rating scale scores measure: incidence of chronic pain measure: Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University Hospitals status: RECRUITING city: Tanta state: Gharbiya zip: 31527 country: Egypt name: Osama M Rehab, MD role: CONTACT phone: 01095210806 email: osamarehab@med.tanta.edu.eg lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06330155 id: 2024-01-032 briefTitle: A Genetic Study for Alzheimer Dementia: Case-control Study overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2026-12-31 date: 2026-12-31 date: 2024-03-26 date: 2024-04-04 name: MinYoung Kim, MD, PhD class: OTHER briefSummary: The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.
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The investigators want to identify genes that are importantly related to Alzheimer's dementia. conditions: Alzheimer Dementia (AD) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: genetic analysis measure: Measurement of Korean version of mini-mental state examination (K-MMSE) measure: Measurement of Clinical Dementia Rating (CDR) measure: Measurement of Geriatric Depression Scale (GDSd) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06330142 id: 2022-006 briefTitle: Hippotherapy Teenager-pediatric Radiotherapy acronym: T-QAP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-15 date: 2025-12-15 date: 2024-03-26 date: 2024-03-26 name: Institut de cancérologie Strasbourg Europe class: OTHER briefSummary: This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.
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The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion. conditions: Radiotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Participation in 10 horse-assisted therapy sessions measure: Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy measure: Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT measure: Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT measure: Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT measure: Assessing the acute side effects of radiotherapy at the start and end of irradiation measure: Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse measure: Evaluate participant's expectations and satisfaction with their care measure: Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation measure: Assessing the impact of HAT on the child during irradiation according to the MERT measure: Evaluate the rider's impression of the child's well-being of the child during HAT sessions measure: Assessing the impact of an alternative activity on parents' satisfaction with care sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Institut de Cancerologie Strasbourg Europe city: Strasbourg zip: 67033 country: France name: Valérie SARTORI role: CONTACT phone: 0368767223 email: v.sartori@icans.eu name: Manon VOEGELIN role: CONTACT phone: 0368767360 email: promotion-rc@icans.eu name: Laura BOINOT-FRITSCH role: PRINCIPAL_INVESTIGATOR name: Georges NOEL role: SUB_INVESTIGATOR name: Claire DOSSUN role: SUB_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False
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<|newrecord|> nctId: NCT06330129 id: Pegasus01_Val briefTitle: Validity and Reliability of Trunk Strength Device acronym: PEGASUS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Schulthess Klinik class: OTHER name: Balgrist Campus AG briefSummary: The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition. conditions: Trunk Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: CTT Pegasus measure: maximal isometric trunk muscle strength measure: MRI muscle morphology measure: Electromyography (EMG) activity sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06330116 id: 2023-05348-01 briefTitle: Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea acronym: SNORT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-29 date: 2025-03-28 date: 2025-03-28 date: 2024-03-26 date: 2024-03-26 name: Region Västerbotten class: OTHER_GOV name: Interreg name: Umeå University briefSummary: Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.
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Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro or serving as controls. Participants in Köge will be randomized to either training with Exciteosa, group training, or controls.
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The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.
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The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment. conditions: Sleep Apnea, Obstructive conditions: Snoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 141 consecutive adult subjects, 71 men and 70 women, referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sights, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the 3 different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Patients in Umeå will be randomized to either training with IQoro or serving as controls. Patients in Köge will be randomized to either training with Exciteosa group training, or controls. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators. whoMasked: OUTCOMES_ASSESSOR count: 141 type: ESTIMATED name: IQoro name: eXciteosa name: Grouptraining measure: Apnea-hyponpnea index (AHI) measure: Questionnaries measure: Snoring measure: Tounge strenght sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zealand University Hospital city: Köge state: Sjaelland zip: 4600 country: Denmark lat: 55.45802 lon: 12.18214 facility: Skåne University Hospital city: Lund state: Skåne zip: 22100 country: Sweden lat: 55.70584 lon: 13.19321 facility: Region Västerbotten city: Umeå state: Västerbotten zip: 901 85 country: Sweden lat: 63.82842 lon: 20.25972 hasResults: False
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<|newrecord|> nctId: NCT06330103 id: RayongH briefTitle: Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips overallStatus: COMPLETED date: 2023-05-01 date: 2023-07-31 date: 2023-07-31 date: 2024-03-26 date: 2024-03-26 name: Rayong Hospital class: OTHER name: Chulalongkorn University briefSummary: Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips
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ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.
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OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application. conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction conditions: Cardiac Failure conditions: Echocardiography conditions: Artificial Intelligence studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 923 samples that were evaluated for LVEF by certified cardiologists, 739 clips were used to train AI, while the remaining 184 clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV. primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 923 type: ACTUAL name: Easy EF measure: efficiency of AI in screening left ventricular cardiac function by use smartphone application sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rayong Hospital city: Rayong zip: 066 country: Thailand lat: 12.68095 lon: 101.25798 hasResults: False
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<|newrecord|> nctId: NCT06330090 id: NL84688.091.23 id: 101040534 type: OTHER_GRANT domain: European Research Council briefTitle: COgnitive Dynamics in Early Childhood acronym: CODEC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-12 date: 2027-12 date: 2024-03-26 date: 2024-03-26 name: Radboud University Medical Center class: OTHER briefSummary: The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:
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1. How does cognitive variability differ between individuals?
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2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
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3. What are the long-term consequences and outcomes associated with differences in cognitive variability? conditions: Cognitive Change studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Reaction times from the vocabulary cognitive task measure: Reaction times from the exploration cognitive task measure: Reaction times from the Working Memory cognitive task measure: Reaction times from the speed cognitive task measure: Reaction times from the fluid reasoning cognitive task measure: Mood score on smiley slider measure: Sleep score on smiley slider measure: MP-RAGE MRI sequence baseline measure: Functional MRI sequence of low time constraint reasoning task at baseline measure: gaze direction during reasoning task at baseline measure: pupil dilation during reasoning task at baseline measure: Naturalistic viewing fMRI at baseline measure: Naturalistic viewing fMRI at follow-up measure: Functional MRI sequence of high time constraint reasoning task at follow-up measure: gaze direction during reasoning task at baseline at follow-up measure: pupil dilation during reasoning task at baseline at follow-up measure: Functional MRI sequence of low time constraint reasoning task at follow-up measure: Sparse MP2-Rage MRI sequence baseline measure: Diffusion weighted imaging MRI sequence baseline measure: MP-RAGE MRI sequence follow up measure: Sparse MP2-Rage MRI sequence follow up measure: Diffusion weighted imaging MRI sequence follow up measure: Total score for Highly Sensitive Child scale at baseline measure: Total score for Strengths and difficulties questionnaire at baseline measure: Total score for BRIEF-2 questionnaire at baseline measure: Total score for BRIEF-2 questionnaire at follow-up measure: Total score for Strengths and difficulties questionnaire at follow-up measure: Total score for Mind Excessively Wandering Scale scale at baseline measure: Originality score for the Alternative Uses Tasks at baseline measure: Originality score for the Alternative Uses Tasks at follow-up measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline measure: Total score for Parent-reported Socio-demographic questionnaire at baseline measure: Total score for Parent-reported Socio-demographic questionnaire at follow-up measure: Total score for Mind Excessively Wandering Scale scale at follow-up measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up measure: Total score for Highly Sensitive Child scale at follow-up measure: motivation rating for cognitive tasks measure: Decibel of background noise during cognitive testing measure: Academic school result baseline measure: Academic school result follow-up measure: Parent reaction times on cognitive battery at baseline measure: Parent reaction times on cognitive battery at follow-up sex: ALL minimumAge: 7 Years maximumAge: 13 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06330077 id: APHP200027 id: 2021-003584-99 type: EUDRACT_NUMBER briefTitle: Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis acronym: MODIF-MS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-06 date: 2024-03-26 date: 2024-03-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Multiple sclerosis (MS) is the most frequently acquired demyelinating disease and the first cause of non-traumatic chronic disability in young adults. Major progress has been achieved in the treatment of MS through the development of therapies targeting the adaptative immune system, which drastically reduce the relapse rate, with various efficiency and safety profiles (Ontaneda, 2015). However, these drugs generally fail to prevent disability worsening along the disease course, and we are now assisting to a shift in therapeutic objectives from the development of new immune drugs towards the identification of therapeutic strategies that could prevent neurodegeneration by promoting myelin regeneration (Stangel, 2017; Stankoff, 2016), in order to prevent neurological disability in MS (Irvine and Blakemore, 2008; Patrikios, 2006; Duncan I, 2017, Bodini, 2016).
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Among the first candidate compounds developed to promote remyelination was the anti Lingo1 antibody, which enhance remyelination (Mi, 2009). Medium and large throughput screening of drug libraries subsequently identified several chemical classes of compounds with strong promyelinating properties, such as the antifongic drug miconazole (Najm, 2015) or the muscarinic antagonist clemastine (Wei, 2014). A recent innovative trial has investigated the effect of clemastine, compared to placebo, in a small sample of subjects (25 patients per group) and showed that clemastine could significantly improve the optic nerve conduction speed which reflecting myelin integrity and functionality (Green, 2017).
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Our preclinical research has allowed us to identify ifenprodil as a powerful drug to promote myelin repair in vitro and in vivo across species. In parallel our team recently pioneered and optimized a PET imaging approach for quantifying remyelination in the whole brain, that allowed to enhance the sensitivity to detect the myelin repair process, and showed that patients are characterized by heterogeneous profiles of spontaneous remyelination profiles that are closely linked to disability accrual (Bodini, 2016). conditions: Multiple Sclerosis conditions: Remitting Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Ifenprodil name: Placebo measure: Change in P100 latency according to visual evoked potential. measure: Proportion of voxels within white matter lesions classified as remyelinating measure: Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions measure: Change in amplitude of P100 on to visual evoked potential measure: Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT measure: Change in blood concentration of NfL fragments measure: Change in the brain atrophy rate measure: The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions measure: The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions measure: Incidence of adverse drug reactions sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hôpital Neurologique Pierre WERTHEIMER - HCL city: Bron zip: 69677 country: France name: Françoise DURAND DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 email: françoise.durand-dubief@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Groupe Hospitalier Pitié Salpêtrière - APHP city: Paris zip: 75013 country: France name: Bruno STANKOFF, MD role: CONTACT email: bruno.stankoff@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06330064 id: DS7300-203 id: 2023-509632-26 type: OTHER domain: EU CTR briefTitle: A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-04-10 date: 2026-12-01 date: 2028-07-01 date: 2024-03-26 date: 2024-04-16 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: This study is designed to assess the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); non-squamous non-small cell lung cancer (NSCLC); and urothelial carcinoma (UC). conditions: Recurrent or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: Ifinatamab deruxtecan measure: Objective Response Rate (ORR) as Assessed by Investigator measure: Number of Dose-limiting Toxicities in the HCC Cohort measure: Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) measure: Duration of Response (DoR) measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd measure: Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) measure: Percentage of Participants Who Have Treatment-emergent ADA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Alliance, Inc. status: RECRUITING city: Westbury state: New York zip: 11590 country: United States lat: 40.75566 lon: -73.58763 hasResults: False
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<|newrecord|> nctId: NCT06330051 id: KY 2023-184-02 briefTitle: The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China acronym: IMPROVE-II overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-03-18 date: 2025-04-20 date: 2024-03-26 date: 2024-03-26 name: Beijing Tiantan Hospital class: OTHER briefSummary: This study intends to construct the goal-oriented integrated intervention model for AIS in-hospital procedure through the spatiotemporal positioning and the P-D-C-A cycle for continuous improvement (FAST model). Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: After 2 months of baseline information collection,10 hospitals will be seleted and then randomly assigned to the control and intervention groups according to hospital level and baseline DNT to reduce the imbalance between the two groups. We will not indicate to any hospital the grouping type of other hospitals. If the selected hospital is unable to complete the study for some reason during the operation, the hospital with conditions to carry out the replacement will be selected from the hospitals of the same region, the same level and the same scale. whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: improvement acute reperfusion treatment quality for stroke through spatiotemporal computing measure: The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. measure: The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. measure: The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. measure: The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. measure: Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy. measure: Proportion of patients with 90-day favorable functional outcome. measure: Proportion of patients with 90-day independent functional outcome. measure: in-hospital mortality measure: 90-day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06330038 id: SMC 2024-01-065 briefTitle: Anesthesia and Non-small Cell Lung Cancer Recurrence acronym: GASTIVA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-26 date: 2024-03-28 name: Samsung Medical Center class: OTHER name: Seoul National University Hospital name: Asan Medical Center name: Severance Hospital name: Seoul St. Mary's Hospital name: Korea University Guro Hospital name: DongGuk University name: Inha University Hospital name: Konkuk University Medical Center name: Ewha Womans University name: Chungnam National University Hospital name: University of Virginia name: Memorial Sloan Kettering Cancer Center name: Yale University name: Mayo Clinic name: University of Texas Southwestern Medical Center name: University Hospitals Coventry and Warwickshire NHS Trust name: Khon Kaen University name: King Chulalongkorn Memorial Hospital name: The Affiliated Hospital of Qingdao University name: Beijing Hospital name: All India Institute of Medical Sciences, New Delhi briefSummary: There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials. conditions: Non-small Cell Lung Cancer conditions: Surgery conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 5384 type: ESTIMATED name: Propofol name: Inhaled anesthetics measure: Recurrence free survival measure: Overall survival measure: Postoperative complications sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06330025 id: 69HCL23_1180 briefTitle: Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8 acronym: MEDIALIME overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-03-26 date: 2024-03-26 name: Hospices Civils de Lyon class: OTHER briefSummary: Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.
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One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.
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The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.
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Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.
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The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.
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The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy. conditions: Undernutrition studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 102 type: ESTIMATED name: Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents measure: Grams of hospital meals consumed by the patients at lunch measure: Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital. sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: Hôpital Femme Mère Enfant de Lyon city: Bron zip: 69677 country: France name: Noël PERETTI, MD role: CONTACT phone: +33 (0)4.72.35.70.50 email: noel.peretti@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False
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<|newrecord|> nctId: NCT06330012 id: GeoMx_Breast briefTitle: The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients. overallStatus: RECRUITING date: 2024-03-18 date: 2025-01-15 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Samsung Medical Center class: OTHER briefSummary: This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: GeoMx data analysis with clinical outcome measure: Spatial transcriptomic analysis sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ji-Yeon Kim status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Ji-Yeon Kim role: CONTACT phone: 82-2-3410-3459 email: jyeon25@skku.edu name: MIRYOUNG HONG role: CONTACT phone: 82-2-2148-7147 email: ring7629@naver.com lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06329999 id: CMG-sAML-001 briefTitle: A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML overallStatus: RECRUITING date: 2024-02-03 date: 2025-12-31 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Ruijin Hospital class: OTHER name: Huadong Hospital name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine name: Huashan Hospital name: Army Medical Center of PLA name: Sun Yat-sen University name: RenJi Hospital name: Shanghai Jiading District Central Hospital name: The Second Affiliated Hospital of Dalian Medical University name: First Hospital of China Medical University name: Dalian Municipal Central Hospital name: Shanghai Zhongshan Hospital name: Shanghai Pudong Hospital name: Shanghai Public Health Clinical Center name: Xuhui Central Hospital, Shanghai name: The Affiliated People's Hospital of Ningbo University name: Taizhou First People's Hospital name: Wenzhou People's Hospital briefSummary: The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are:
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* Evaluation of the efficacy
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* Evaluation of the safety conditions: Recurrent Adult Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome conditions: Adult Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: CMGV measure: CRc measure: ORR measure: OS measure: RFS measure: MRD- measure: Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: xiaoqian Xu, Doctor role: CONTACT phone: 13816205940 email: Ellenxxq@qq.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06329986 id: SEDPTC20240109 briefTitle: Crossover RCT of TAMER Lenses in Myopia Control overallStatus: RECRUITING date: 2024-02-24 date: 2025-06 date: 2026-01 date: 2024-03-26 date: 2024-03-26 name: Shanghai Eye Disease Prevention and Treatment Center class: OTHER briefSummary: This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses. conditions: Myopia conditions: Progressive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: TAMER Lens Spectacle name: SV lenses measure: Spherical Equivalent change measure: Axial Length change measure: Spherical Equivalent change sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Shanghai Eye Disease Prevention and Treatment Center status: RECRUITING city: Shanghai state: Shanghai zip: 200041 country: China name: Xiangui He role: CONTACT phone: 021-62982727-817 lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06329973 id: 2023-237 briefTitle: Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer overallStatus: RECRUITING date: 2024-02-28 date: 2025-12-15 date: 2028-02-15 date: 2024-03-26 date: 2024-03-26 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies conditions: Metastatic Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Fruquintinib in combination with Sintilimab and CAPEOX measure: Objective response rate measure: Maximum tolerated dose measure: Overall Survival measure: Progression Free Survival measure: Disease Control Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450008 country: China name: Xiaobing Chen role: CONTACT phone: +8613937100233 lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06329960 id: 2024PHB019-001(3) briefTitle: Dorsal Scapular Nerve Injection Combined With Muscle Needle Release overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-11-30 date: 2024-03-26 date: 2024-04-16 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment. conditions: Dorsal Scapular Nerve Entrapment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ultrasound-guided injection combined with needle release measure: visual analogue scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiaan Zhu city: Beijing country: China name: Jiaan Zhu role: CONTACT email: canzhujia@126.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06329947 id: HMPL-012-SPRING-P106 briefTitle: A Phase II Study of Surufatinib Combined With PD-L1 and mFOLFOX6 as Second-line Treatment for Advanced PRAD overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2025-01-01 date: 2026-09-30 date: 2024-03-26 date: 2024-03-26 name: Rui-hua Xu, MD, PhD class: OTHER briefSummary: To preliminarily evaluate whether there is a survival benefit of surufatinib in combination with Caralizumab and mFOLFOX6 in the second-line treatment of advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer conditions: Advanced Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Surufatinib in combination with Caralizumab and mFOLFOX6 measure: objective response rate (ORR) measure: disease control rate (DCR) measure: Progression-Free Survival (PFS) measure: overall survival (OS) measure: quality of life (QoL) measure: adverse events (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SunYat-senUniversity Cancer Center city: Guangzhou country: China lat: 23.11667 lon: 113.25 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-03-18T20:39 filename: Prot_000.pdf size: 1380851 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-12 uploadDate: 2024-03-18T20:39 filename: ICF_001.pdf size: 541718 hasResults: False
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<|newrecord|> nctId: NCT06329934 id: XXZY-003 briefTitle: Refined Nursing in Rehabilitation Training overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-31 date: 2024-01-01 date: 2024-03-26 date: 2024-03-26 name: Xinxiang Central Hospital class: OTHER briefSummary: This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications. conditions: Brain Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ACTUAL name: Establishment of a hierarchical monitoring and management team name: Assessment of pressure injury name: Communication name: Intervention for pressure ulcer name: Rehabilitation training name: introduction of the current patient's condition to family members name: maintaining appropriate temperature and humidity in the ward name: careful observation of vital signs in patients measure: GCS scores measure: GCS scores measure: cognitive function scores measure: cognitive function scores measure: functional independence scores measure: functional independence scores measure: Newcastle Satisfaction with Nursing Scale (NSNS) measure: Newcastle Satisfaction with Nursing Scale (NSNS) measure: incidence of adverse reactions measure: incidence of adverse reactions sex: ALL minimumAge: 33 Years maximumAge: 43 Years stdAges: ADULT facility: Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study city: Xinxiang state: Henan zip: 453000 country: China lat: 35.19033 lon: 113.80151 hasResults: False
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<|newrecord|> nctId: NCT06329921 id: 232192 briefTitle: Inpatient Monitoring of Unfractionated Heparin overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-04 date: 2026-05 date: 2024-03-26 date: 2024-03-26 name: Vanderbilt University Medical Center class: OTHER briefSummary: Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster. conditions: Blood Clot conditions: Thrombosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 2000 type: ESTIMATED name: PTT protocol name: anti-Xa protocol measure: Time to therapeutic anticoagulation range measure: Measurements in therapeutic anticoagulation range measure: Coagulation laboratory measurements measure: New thrombotic events measure: New clinically relevant bleeding events measure: New coagulation events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States name: Benjamin Tillman, MD role: CONTACT lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06329908 id: TSLG-001 briefTitle: DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-30 date: 2026-10-31 date: 2024-03-26 date: 2024-03-26 name: Zhen-Yu Ding class: OTHER briefSummary: This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs. conditions: Lung Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single arm primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: LG002 measure: The safety of Neo-DCVac combined with ICIs. measure: The efficacy of Neo-DCVac combined with ICIs. measure: The efficacy of Neo-DCVac combined with ICIs. measure: Synergistic anti-tumor mechanism. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Si Chuan zip: 610000 country: China name: Zhengyu Ding, MD role: CONTACT phone: 18980601957 email: dingzhenyu@scu.edu.cn name: Qing Li, MD role: CONTACT phone: 18702848178 email: liqing@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06329895 id: 22252 briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-05-23 date: 2024-05-23 date: 2024-03-26 date: 2024-04-19 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.
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Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.
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In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.
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BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
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Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood.
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The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088:
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* Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time
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* Maximum observed concentration (Cmax): the highest amount of the drug in participants' blood
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In this study, participants will take the following treatments:
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* Dabigatran in the morning of Day 1 and 9.
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* Rosuvastatin in the morning of Day 3 and 12.
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* BAY2927088 two times a day in the morning and evening of Days 6 to 15.
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Participants will be in this study for about 8 weeks with 3 visits to the study clinic.
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Participants will visit the study clinic:
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* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
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* once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment
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* once, 7 to 10 days after last dose of BAY2927088, for a health check-up
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During the study, the doctors and their study team will:
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* do physical examinations
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* collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin and of BAY2927088
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* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
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* ask the participants questions about how they are feeling and what adverse events they are having
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An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: BAY2927088 name: Dabigatran etexilate name: Rosuvastatin measure: Cmax of unconjugated dabigatran when given with and without BAY2927088 measure: AUC of unconjugated dabigatran when given with and without BAY2927088 measure: Cmax of rosuvastatin when given with and without BAY2927088 measure: AUC of rosuvastatin when given with and without BAY2927088 measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International Early Phase Clinical Unit (London) status: RECRUITING city: Harrow zip: HA1 3UJ country: United Kingdom lat: 51.57142 lon: -0.33371 hasResults: False
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<|newrecord|> nctId: NCT06329882 id: 14789 briefTitle: Doxycycline in Type II Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-20 date: 2025-04-20 date: 2024-03-26 date: 2024-03-26 name: Mostafa Bahaa class: OTHER briefSummary: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open label primaryPurpose: TREATMENT masking: NONE maskingDescription: open label count: 60 type: ESTIMATED name: Sitagliptin 100mg name: Doxycyclin measure: Change in glycemic profile measure: Change in glycemic profile sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06329869 id: 202401158MIFD briefTitle: Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma acronym: SG-ESCC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-11 date: 2024-03-26 date: 2024-03-26 name: National Taiwan University Hospital class: OTHER name: Gilead Sciences briefSummary: The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma. conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Sacituzumab govitecan measure: Overall objective response rates (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Biomarkers-related endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06329856 id: 202301218RIND briefTitle: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2026-07 date: 2024-03-26 date: 2024-03-26 name: National Taiwan University Hospital class: OTHER briefSummary: Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.
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Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.
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The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline.
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Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.
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Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying. conditions: Terminal Cancer conditions: Hospice conditions: Palliative Medicine studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1270 type: ESTIMATED name: Administering of artificial hydration measure: Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics measure: Distributive statistics measure: Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06329843 id: Intermountain briefTitle: Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro overallStatus: RECRUITING date: 2024-02-12 date: 2024-05 date: 2024-05 date: 2024-03-26 date: 2024-03-26 name: Picterus AS class: INDUSTRY name: Intermountain Medical Center briefSummary: The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy. conditions: Neonatal Jaundice studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Picterus Jaundice Pro (JP) measure: Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. sex: ALL minimumAge: 12 Hours maximumAge: 192 Hours stdAges: CHILD facility: Intermountain Health status: RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Timothy M Bahr, MS MD role: CONTACT phone: 801-602-6523 email: Tim.Bahr@imail.org name: Kimberlee W Lewis, MS RN role: CONTACT phone: 801.507.7675 email: [kimberlee.weaverlewis@imail.org lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06329830 id: 2023-GAR-001 briefTitle: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer acronym: LUNAAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2028-05 date: 2024-03-26 date: 2024-03-27 name: Rohan Garje class: OTHER name: Janssen Scientific Affairs, LLC briefSummary: The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor. conditions: Metastatic Prostate Cancer conditions: Castration-resistant Prostate Cancer conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: 177Lu-PSMA-617 name: Niraparib abiraterone acetate name: Prednisone measure: Determination of the recommended phase 2 dose (RP2D) measure: Prostatic-specific antigen (PSA)-50 response rate measure: Radiographic progression-free survival (rPFS) measure: Overall survival (OS) measure: PSA-80 response rate measure: Duration of response (DOR) measure: Objective response rate (ORR) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Miami Cancer Institute city: Miami state: Florida zip: 33176 country: United States name: Rohan Garje, M.D. role: CONTACT phone: 786-596-2000 email: rohan.garje@baptisthealth.net name: Leslie Castaneda role: CONTACT phone: (786) 596-2000 email: leslie.castaneda@baptisthealth.net lat: 25.77427 lon: -80.19366 hasResults: False
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<|newrecord|> nctId: NCT06329817 id: A/28/ER/532/23 briefTitle: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position overallStatus: RECRUITING date: 2024-03-15 date: 2024-08 date: 2024-09 date: 2024-03-26 date: 2024-03-26 name: Pak Emirates Military Hospital class: OTHER briefSummary: One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia. conditions: Inguinal Hernia Bilateral studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Incidence of regurgitation in two different position. measure: Prevention of aspiration pneumonia sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: PEMH status: RECRUITING city: Rawalpindi state: Punjab zip: 44000 country: Pakistan name: PEMH role: CONTACT phone: +923317055191 email: rabbiafatimasattar555@gmail.com lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06329804 id: RM_01-11-21b briefTitle: The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals overallStatus: RECRUITING date: 2021-11-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-26 date: 2024-03-26 name: Swansea University class: OTHER name: National Taiwan Normal University briefSummary: It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).
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Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure. conditions: Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 45 type: ESTIMATED name: Isometric Handgrip Exercise Training (IHGT) measure: Resting Systolic Blood Pressure measure: Resting Diastolic Blood Pressure measure: Resting Mean Arterial Blood Pressure measure: Ratings of perceived exertion measure: Affective Valence sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: National Taiwan Normal University status: RECRUITING city: Taipei country: Taiwan name: Yung-Chih Chen, PhD role: CONTACT lat: 25.04776 lon: 121.53185 facility: Swansea University status: RECRUITING city: Swansea country: United Kingdom name: Richard Metcalfe role: CONTACT phone: 01792205678 phoneExt: 4779 email: r.s.metcalfe@swansea.ac.uk lat: 51.62079 lon: -3.94323 hasResults: False
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<|newrecord|> nctId: NCT06329791 id: AZ202401 briefTitle: A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-11 date: 2024-03-26 date: 2024-04-24 name: Azura Ophthalmics class: INDUSTRY name: ORA, Inc. briefSummary: This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months. conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: AZR-MD-001 name: Vehicle measure: Change from baseline in Meibomian Glands Yielding Liquid Secretion measure: Change from baseline in Total Ocular Surface Disease Index Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona Eye Center city: Chandler state: Arizona zip: 85225 country: United States name: Erin Fox role: CONTACT phone: 714-559-8435 email: michael.depenbusch@doctrials.com lat: 33.30616 lon: -111.84125 facility: Global Research Management, Inc city: Glendale state: California zip: 91204 country: United States name: Logi El-Harazi role: CONTACT email: logi@grmclinical.com lat: 34.14251 lon: -118.25508 facility: Eye Research Foundation city: Newport Beach state: California zip: 92663 country: United States name: Linda Wirta role: CONTACT email: linda.wirta@drwirta.com lat: 33.61891 lon: -117.92895 facility: Pankratz Eye Institute city: Columbus state: Indiana zip: 47203 country: United States name: Kristin Slevin role: CONTACT email: Kslevin@pankratzeye.com lat: 39.20144 lon: -85.92138 facility: The Eye Care Institute/Butchertown Clinical Trials city: Louisville state: Kentucky zip: 40206 country: United States name: Danielle Gulock role: CONTACT email: dgulock@eyecareinstitute.com lat: 38.25424 lon: -85.75941 facility: Ophthalmology Associates city: Saint Louis state: Missouri zip: 63131 country: United States name: Maggie Thompson role: CONTACT email: maggiethompson@eyecare-partners.com lat: 38.62727 lon: -90.19789 facility: NC Eye Associates city: Apex state: North Carolina zip: 27502 country: United States name: Ashley Cooper role: CONTACT email: acooper@nceyeassociates.com lat: 35.73265 lon: -78.85029 facility: Oculus Research, Inc. city: Garner state: North Carolina zip: 27529 country: United States lat: 35.71126 lon: -78.61417 facility: CORE city: Shelby state: North Carolina zip: 28150 country: United States name: Winnie Simmons role: CONTACT email: winniesimmons.core@gmail.com lat: 35.29235 lon: -81.53565 facility: Scott & Christie and Associates, PC city: Cranberry Township state: Pennsylvania zip: 16066 country: United States lat: 40.68496 lon: -80.10714 facility: Advancing Vision Research (AVR) - Goodlettsville city: Goodlettsville state: Tennessee zip: 37072 country: United States name: Megan Medlin role: CONTACT email: meganm@avrteam.com lat: 36.32311 lon: -86.71333 facility: Total Eye Care city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Advancing Vision Research (AVR) - Smyrna city: Smyrna state: Tennessee zip: 37167 country: United States name: Megan Medlin role: CONTACT email: meganm@avrteam.com lat: 35.98284 lon: -86.5186 facility: Piedmont Eye Center city: Lynchburg state: Virginia zip: 24502 country: United States name: Jennifer Frederick role: CONTACT email: jfrederick@piedmonteye.com lat: 37.41375 lon: -79.14225 hasResults: False
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<|newrecord|> nctId: NCT06329778 id: 50884b briefTitle: Home-Based Child Care Toolkit for Nurturing School-Age Children Study overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-31 date: 2024-10-27 date: 2024-03-26 date: 2024-03-26 name: Mathematica Policy Research, Inc. class: OTHER name: Department of Health and Human Services briefSummary: The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning \[DIF\]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey. conditions: Child Development studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 316 type: ESTIMATED measure: The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire measure: Emlen Scales measure: Multicultural Teaching Competency Scale measure: Family Child Care Program Quality Assessment (FCC PQA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mathematica Policy Research status: RECRUITING city: Washington state: District of Columbia zip: 20002 country: United States name: Ashley Kopack Klein role: CONTACT phone: 202-484-9220 email: lakopackklein@mathematica-mpr.com lat: 38.89511 lon: -77.03637 hasResults: False
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<|newrecord|> nctId: NCT06329765 id: HR- 4380 briefTitle: CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation overallStatus: RECRUITING date: 2023-08-07 date: 2025-04-04 date: 2025-04-04 date: 2024-03-26 date: 2024-03-26 name: Marquette University class: OTHER name: Medical College of Wisconsin briefSummary: The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped. conditions: Stroke conditions: Hemiplegia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group pretest-posttest primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training. measure: Paretic limb use in walking measure: Paretic limb use in pedaling measure: Interlimb coordination in walking measure: Interlimb coordination in pedaling measure: Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedaling measure: Absences measure: Adverse events measure: Muscle activity - timing measure: Muscle activity - amplitude measure: Physiological response to exercise - Blood pressure measure: Physiological response to exercise - Heart rate measure: Physiological response to exercise - Rate of perceived exertion sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marquette University status: RECRUITING city: Milwaukee state: Wisconsin zip: 53201 country: United States name: SHEILA M SCHINDLER-IVENS, PhD role: CONTACT phone: 414-288-7282 email: sheila.schindler-ivens@marquette.edu lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06329752 id: Not available yet briefTitle: Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department acronym: AnkleMan overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-26 date: 2024-03-26 name: IRCCS Policlinico S. Matteo class: OTHER briefSummary: The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
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The trial aims to assess:
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* The acceptability of sciatic nerve block
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* The technical feasibility of sciatic nerve block
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* The technical success of sciatic nerve block
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* The analgesic efficacy of sciatic nerve block
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In addition to that, this study aims to
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* Describe patient-reported and physician-reported satisfaction
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* Assess the Adverse Event rate at 48 hours post intervention conditions: Ankle Fractures conditions: Leg Fracture studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, single-arm, feasibility trial primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) measure: To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. measure: Technical success of US-guided sciatic nerve block measure: Analgesic efficacy of US-guided sciatic nerve block measure: Patient-reported and physician-reported satisfaction measure: Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emergency Department, IRCCS Fondazione Policlinico San Matteo city: Pavia zip: 27100 country: Italy name: Santi Di Pietro role: CONTACT phone: 3463153244 email: santi.dipietro@unipv.it lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06329739 id: NeuroPsico_Dopa&PD briefTitle: Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes overallStatus: RECRUITING date: 2021-12-14 date: 2031-12-14 date: 2031-12-14 date: 2024-03-26 date: 2024-03-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.
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The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.
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Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.
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Researchers will compare data collected from patients with genetic mutation versus patients without mutation. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: Clinical examinations and clinical scales administration measure: Montreal Cognitive Assessment measure: Beck Depression Inventory measure: State-Trait Anxiety Inventory measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson measure: Pittsburgh Sleep Quality Index measure: Parkinson's Disease Questionnaire-8 measure: Minnesota Multiphasic Personality Inventory 2-RF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Francesca Mameli role: CONTACT phone: 0255033621 email: francesca.mameli@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06329726 id: NeuroPsico_DBS&PD briefTitle: Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2021-12-13 date: 2031-12-15 date: 2032-12-15 date: 2024-03-26 date: 2024-03-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.
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