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Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. |
Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. |
Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point. conditions: Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: G-POEM measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. measure: Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. measure: Number and severity of (s)AEs in the treatment groups. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Zuid-Limburg zip: 6229 HX country: Netherlands name: Kim Sweerts, MD role: CONTACT phone: 0883887298 email: [email protected] lat: 50.84833 lon: 5.68889 hasResults: False |
<|newrecord|> nctId: NCT06372119 id: 13/23/DD-BVMD briefTitle: Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is: |
• Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation? |
Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe Femara® 2.5 milligrams (Novartis, Switzerland) at a dose of 5 milligrams/day for 5 days to stimulate follicular development and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day for luteal phase support. In contrast, the AC group will receive Valiera® 2 milligrams (Laboratories Recalcine, Chile) starting with a dose of 6 milligrams/day, up to a maximum dose of 12 milligrams/day) and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates. conditions: Embryo Transfer conditions: Irregular Menstruation conditions: Letrozole conditions: Hormone Replacement Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 480 type: ESTIMATED name: Letrozole-stimulated cycle strategy (LETS) name: Artificial cycle strategy (AC) measure: Live birth rate after one cycle of endometrial preparation measure: Positive pregnancy test after one cycle of endometrial preparation measure: Clinical pregnancy after one cycle of endometrial preparation measure: Ongoing pregnancy after one cycle of endometrial preparation measure: Multiple pregnancy after one cycle of endometrial preparation measure: Implantation rate after one cycle of endometrial preparation measure: Cycle cancellation rate measure: Ectopic pregnancy rate after one cycle of endometrial preparation measure: Threatened miscarriage rate before 12 weeks of gestation after one cycle of endometrial preparation measure: Early miscarriage rate after one cycle of endometrial preparation measure: Late miscarriage rate after one cycle of endometrial preparation measure: Gestational age at birth measure: Onset of labor measure: Mode of delivery measure: Very low birth weight measure: Low birth weight measure: High birth weight (macrosomia) measure: Very high birth weight (macrosomia) measure: Gestational diabetes (GDM) measure: Hypertensive disorders of pregnancy measure: Preterm birth measure: Stillbirth measure: Antepartum hemorrhage measure: Postpartum hemorrhage measure: Small for gestational age (singleton/twins) measure: Large for gestational age (singleton/twins) measure: Birth weight measure: Congenital anomalies measure: NICU admission measure: Reason for NICU admission measure: Neonatal mortality rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06372106 id: MA_PM_Mountain_2022_11496 briefTitle: Project Mountain - Comparing SpO2 and SaO2 for Accuracy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: Philips Clinical & Medical Affairs Global class: INDUSTRY briefSummary: The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation. conditions: SpO2 conditions: Nasal Alar Collapse, Bilateral conditions: Oxygen conditions: Measurement studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 560 type: ESTIMATED name: SaO2 Sampling measure: To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. measure: Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. measure: Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372093 id: PMH 2/11AII briefTitle: Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana overallStatus: COMPLETED date: 2023-03-16 date: 2024-02-26 date: 2024-02-26 date: 2024-04-17 date: 2024-04-17 name: Picterus AS class: INDUSTRY name: University of Copenhagen name: University of Botswana briefSummary: The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin. |
The specific objectives for this study are: |
i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin. |
ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin. conditions: Jaundice, Neonatal studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 172 type: ACTUAL name: Picterus Jaundice Pro measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP. measure: Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB measure: Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin sex: ALL minimumAge: 1 Day maximumAge: 14 Days stdAges: CHILD facility: Princess Marina Hospital city: Gaborone country: Botswana lat: -24.65451 lon: 25.90859 hasResults: False |
<|newrecord|> nctId: NCT06372080 id: 19/SPS/054 briefTitle: Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults overallStatus: COMPLETED date: 2020-01-06 date: 2021-09-29 date: 2023-03-31 date: 2024-04-17 date: 2024-04-17 name: Liverpool John Moores University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women. |
The main questions it aims to answer are: |
* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone? |
* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone? |
Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups. |
Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed. conditions: Healthy Participants conditions: Nutrition conditions: Exercise Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 23 type: ACTUAL name: Resistance training with hydrolyzed collagen ingestion in healthy young men name: Resistance training with hydrolyzed collagen ingestion in healthy young women measure: Maximal knee extensor (quadriceps) muscle strength measure: Maximal knee flexor (hamstring) muscle strength measure: Patellar tendon cross-sectional area measure: Patellar tendon stiffness measure: Vastus lateralis (VL) muscle size measure: Vastus lateralis (VL) muscle fascicle length measure: Vastus lateralis (VL) muscle fascicle pennation angle sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Research Institute for Sport and Exercise Sciences city: Liverpool state: Merseyside zip: L3 3AF country: United Kingdom lat: 53.41058 lon: -2.97794 hasResults: False |
<|newrecord|> nctId: NCT06372067 id: 17378 briefTitle: IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures acronym: HANDFIX overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2026-03-01 date: 2024-04-17 date: 2024-04-17 name: McMaster University class: OTHER briefSummary: When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work. conditions: Hand; Fracture, Phalanx studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, open-label, pilot randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively. whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Intramedullary screw name: Kirschner wire measure: Percentage of Patient Eligibility - Study Feasibility measure: Recruitment rate - Study Feasibility measure: Crossover rate - Study Feasibility measure: Compliance with intervention rate - Study Feasibility measure: Patient retention rate - Study Feasibility measure: Disability of the Arm, Shoulder, and Hand measure: Range of motion measure: Grip strength measure: Return to work measure: Complications/adverse events measure: Postoperative pain (visual analogue scale) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372054 id: TORNADO briefTitle: TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models overallStatus: RECRUITING date: 2024-02-05 date: 2025-02-05 date: 2027-02-05 date: 2024-04-17 date: 2024-04-17 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: University of Milan name: Italian Air Force name: A-Tono name: Ministry of Defense, Italy briefSummary: The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine. conditions: Oxidative Injury conditions: Stress Physiological conditions: Discogenic Pain conditions: Cardiovascular Risk Factor conditions: Space Maintenance conditions: Epigenetic Changes conditions: LONGEVITY 1 conditions: Neuroplasticity conditions: NGS studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biological sample collection measure: Assessment of flight-related exposure data and molecular modifications measure: Assessment of General Health measure: Assessment of Sleep Quality measure: Assessment of eating habits measure: Creation of reliable AI and disease-based models for personalized medicine sex: ALL minimumAge: 26 Years maximumAge: 38 Years stdAges: ADULT facility: CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy status: RECRUITING city: Milan zip: 20139 country: Italy name: Stefania E Navone, PhD role: CONTACT phone: 0256660100 phoneExt: +39 email: [email protected] name: Giovanni Marfia, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Stefania E Navone, PhD role: SUB_INVESTIGATOR name: Monica R Miozzo, PhD role: SUB_INVESTIGATOR name: Orazio Granato, PhD role: SUB_INVESTIGATOR name: Silvana Pileggi, PhD role: SUB_INVESTIGATOR name: Luisella Vigna, MD, PhD role: SUB_INVESTIGATOR name: Matteo Bonzini, MD, PhD role: SUB_INVESTIGATOR name: Laura Fontana, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06372041 id: 944/B briefTitle: Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS) acronym: BOOSTTACS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-05-14 date: 2024-04-17 date: 2024-04-17 name: IRCCS Eugenio Medea class: OTHER name: IRCCS National Neurological Institute "C. Mondino" Foundation name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcranial alternating current stimulation (tACS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tACS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, in light of findings showing that tACS effectively improves motor learning, the investigators hypothesized that active tACS might improve in a greater and more lasting extent than sham tACS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in pediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: transcranial Alternating Current Stimulation measure: Assisting Hand Assessment (AHA) measure: Box and Block Test (BBT) measure: Visuomotor task measure: Canadian Occupational Performance Measure (COPM) measure: Children's Hand-Use Experience Questionnaire (CHEQ) measure: Melbourne Assessment 2 (MA2) measure: Gross Motor Function Measure (GMFM-66) measure: Vineland Adaptive Behavior Scale Version 2 (VABS II) measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) measure: Cortical rhythms at rest and during the Visuomotor task measure: Heart rate (HR) measure: Oxygen saturation (SPO2) measure: Tolerability of the stimulation measure: number of patients who accept to complete the 2-week training measure: number of sessions completed per patient measure: acceptability of the training sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Alessandra Finisguerra role: CONTACT phone: +39031877652 email: [email protected] name: Cosimo Urgesi role: CONTACT phone: +39031877652 email: [email protected] name: Viola Oldrati role: SUB_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False |
<|newrecord|> nctId: NCT06372028 id: 944/A briefTitle: Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) acronym: (BOOSTTVNS) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-05-14 date: 2024-04-17 date: 2024-04-17 name: IRCCS Eugenio Medea class: OTHER name: IRCCS National Neurological Institute "C. Mondino" Foundation name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, taking into account that tVNS has the potential to facilitate in a bottom-up way neural plasticity, particularly in chronic disease conditions, the investigators hypothesized that active tVNS might improve in a greater and more lasting extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: transcutaneous vagus nerve stimulation (tVNS) measure: Assisting Hand Assessment (AHA) measure: Box and Block Test (BBT) measure: Visuomotor task measure: Canadian Occupational Performance Measure (COPM) measure: Children's Hand-UseExperienceQuestionnaire (CHEQ) measure: Melbourne Assessment 2 (MA2) measure: Gross Motor Function Measure (GMFM-66) measure: Vineland Adaptive Behavior Scale Version 2 (VABS II) measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) measure: Heart rate (HR). measure: Oxygen saturation (SPO2). measure: Tolerability of the stimulation measure: Number of patients who accept to complete the 2-week training measure: Number of sessions completed per patient measure: Acceptability of the training sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Alessandra Finisguerra role: CONTACT phone: +39031877652 email: [email protected] name: Cosimo Urgesi role: CONTACT email: [email protected] name: Viola Oldrati role: SUB_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False |
<|newrecord|> nctId: NCT06372015 id: RC2023-24 briefTitle: Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-17 date: 2024-04-17 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Notarnicola Maria name: Cozzolongo Raffaele name: Shahini Endrit name: De Pergola Giovanni name: Lippolis Giuseppe briefSummary: Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis. |
The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery. |
Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it. |
Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy. |
The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected. conditions: Obesity conditions: Liver Disease Parenchymal studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ESTIMATED name: Nutritional Approach name: Surgery Approach measure: Variation of lipidomic parameters measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis measure: Variation in the microRNA profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS "Saverio de Bellis" city: Castellana Grotte state: Bari zip: 70013 country: Italy name: Rossella Donghia, Biologyst role: CONTACT phone: 0804994652 email: [email protected] lat: 40.88643 lon: 17.16549 hasResults: False |
<|newrecord|> nctId: NCT06372002 id: 05/23 briefTitle: Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-16 date: 2024-07-31 date: 2024-07-31 date: 2024-04-17 date: 2024-04-17 name: Instituto de Mayores y Servicios Sociales (IMSERSO) class: OTHER_GOV name: University of Castilla-La Mancha name: Confederación Española de Alzheimer (CEAFA) briefSummary: This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia. |
The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group). conditions: Dementia conditions: Neurocognitive Disorders conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual: |
* First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study. |
* Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The technician in charge of the evaluation of those participating in the study must be blinded throughout the CST intervention, i.e., he/she will not know whether the users being evaluated belong to the intervention or the control group. |
The CRE Alzheimer professional responsible for randomization and data analysis will also be blinded. |
The participants and the technician performing the intervention cannot be blinded due to the nature of the intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 683 type: ACTUAL name: Cognitive Stimulation Therapy (CST) measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Resource utilization evaluated through Resource Utilization in Dementia (RUD) measure: Change in resource utilization evaluated through Resource Utilization in Dementia (RUD) measure: Sociodemographic information gathered through the sociodemographic questionnaire measure: Adherence to the intervention and dropouts evaluated through a session form sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca city: Alcoy state: Alicante country: Spain lat: 38.70545 lon: -0.47432 facility: AFA Castalla y Onil city: Castalla state: Alicante country: Spain lat: 38.59694 lon: -0.67207 facility: AFA Elda, Petrer y Comarca del Medio Vinalopo city: Elda state: Alicante country: Spain lat: 38.47783 lon: -0.79157 facility: AFA Teulada - Moraira (Marina Alta) city: Teulada state: Alicante country: Spain lat: 38.7294 lon: 0.10383 facility: Asociación Familiares de Personas con Alzheimer de Villena y Comarca city: Villena state: Alicante country: Spain lat: 38.6373 lon: -0.86568 facility: Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez" city: Mérida state: Badajoz country: Spain lat: 38.91611 lon: -6.34366 facility: Centro Alois II city: Cornellà De Llobregat state: Barcelona country: Spain lat: 41.35 lon: 2.08333 facility: Asociación de familiares de personas con Alzheimer y otras demencias del Maresme city: Mataró state: Barcelona country: Spain lat: 41.54211 lon: 2.4445 facility: Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI) city: Iniesta state: Cuenca country: Spain lat: 39.43333 lon: -1.75 facility: AFEAVA city: Hervás state: Cáceres country: Spain lat: 40.27081 lon: -5.86721 facility: AFA Faro de Chipiona city: Chipiona state: Cádiz country: Spain lat: 36.73663 lon: -6.43703 facility: Afa Puerto city: El Puerto De Santa María state: Cádiz country: Spain lat: 36.59389 lon: -6.23298 facility: Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez city: Fernán Núñez state: Córdoba country: Spain lat: 37.67044 lon: -4.7264 facility: AFAMO city: Montilla state: Córdoba country: Spain lat: 37.58627 lon: -4.63805 facility: AFASUR Genil city: Puente Genil state: Córdoba country: Spain lat: 37.38943 lon: -4.76686 facility: Asociación de familiares de enfermos de Alzheimer de Motril - Contigo city: Motril state: Granada country: Spain lat: 36.75066 lon: -3.5179 facility: AFAMA Pollença city: Pollença state: Islas Baleares country: Spain lat: 39.87678 lon: 3.01626 facility: Asociación Alzheimer Bierzo city: Ponferrada state: León country: Spain lat: 42.54664 lon: -6.59619 facility: Afa Santa Marina Del Rey city: Santa Marina del Rey state: León country: Spain lat: 42.51334 lon: -5.86065 facility: Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca city: Tàrrega state: Lleida country: Spain lat: 41.64704 lon: 1.13957 facility: AFA Pozuelo city: Pozuelo De Alarcón state: Madrid country: Spain lat: 40.43293 lon: -3.81338 facility: Asociación Alzheimer y otras Demencias Lorca city: Lorca state: Murcia country: Spain lat: 37.67119 lon: -1.7017 facility: Centro de día Alzheimer Estepona city: Estepona state: Málaga country: Spain lat: 36.42764 lon: -5.14589 facility: Centro de Día Nieves Barranco city: Marbella state: Málaga country: Spain lat: 36.51543 lon: -4.88583 facility: AFADAX city: Vélez-Málaga state: Málaga country: Spain lat: 36.78107 lon: -4.10266 facility: Asociación de Alzheimer "Virgen del Castillo" city: Lebrija state: Sevilla country: Spain lat: 36.92077 lon: -6.07529 facility: AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina city: Talavera De La Reina state: Toledo country: Spain lat: 39.96348 lon: -4.83076 facility: ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí) city: Algemesí state: Valencia country: Spain lat: 39.19042 lon: -0.43572 facility: AFA Alginet city: Alginet state: Valencia country: Spain lat: 39.26667 lon: -0.46667 facility: Centro de estimulación y Rehabilitación "La LLimera" de AFABALS city: Benifayó state: Valencia country: Spain lat: 39.28439 lon: -0.42598 facility: AFA Benavente y Comarca city: Benavente state: Zamora country: Spain lat: 42.00249 lon: -5.67826 facility: AFA Alicante city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Centre de Día AFA Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Club de la memoria - Alzhei Cáceres city: Cáceres country: Spain lat: 39.47649 lon: -6.37224 facility: AFA Alzhe de Cadiz city: Cádiz country: Spain lat: 36.52672 lon: -6.2891 facility: Asociación San Rafael de Alzheimer y Otras Demencias city: Córdoba country: Spain lat: 37.89155 lon: -4.77275 facility: AFA Huelva city: Huelva country: Spain lat: 37.26638 lon: -6.94004 facility: Alzheimer León city: León country: Spain lat: 42.60003 lon: -5.57032 facility: Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja) city: Logroño country: Spain lat: 42.46667 lon: -2.45 facility: AFALU city: Lugo country: Spain lat: 43.00992 lon: -7.55602 facility: AFA Málaga city: Málaga country: Spain lat: 36.72016 lon: -4.42034 facility: Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso city: Salamanca zip: 37008 country: Spain lat: 40.96882 lon: -5.66388 facility: AGADEA city: Santiago de Compostela country: Spain lat: 42.88052 lon: -8.54569 facility: AFAV (Asociación Familiares Enfermos de Alzheimer Valencia) city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Alzheimer Ávila city: Ávila country: Spain lat: 40.65724 lon: -4.69951 facility: AFARABA city: Gasteiz / Vitoria state: Álava country: Spain lat: 42.84998 lon: -2.67268 hasResults: False |
<|newrecord|> nctId: NCT06371989 id: 19/160 briefTitle: Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL acronym: BISUCO overallStatus: COMPLETED date: 2019-03-11 date: 2021-03-20 date: 2022-12-20 date: 2024-04-17 date: 2024-04-17 name: Hospital Universitario 12 de Octubre class: OTHER briefSummary: BACKGROUND AND CURRENT STATUS: |
Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative. |
OBJECTIVE: |
This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response. |
METHODS: |
A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma. conditions: Breast Cancer conditions: Breast Biopsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ACTUAL name: Image guided vacuum assisted biopsy measure: The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation sex: FEMALE minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sara Jimenez Arranz city: Madrid zip: 28020 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06371976 id: APH240230 briefTitle: Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery acronym: VASOCORT overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-17 date: 2024-04-17 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Vasoplegic syndrome after cardiac surgery is common and is associated with increased morbidity and mortality. It is characterized by early and prolonged arterial hypotension, with preserved cardiac output and low systemic vascular resistance. Vasoplegic syndrome therefore shares pathophysiological features with septic shock. There are no data in the literature on the function of the hypothalamic-pituitary-adrenal (HPA) axis during vasoplegic syndrome after cardiac surgery. In situations of acute stress and systemic inflammation, relative adrenal insufficiency has been reported in the most severe patients, particularly those in septic shock. The term ""CIRCI"" (Critical Illness-Related Corticosteroid Insufficiency) is currently defined as an increase in total plasma cortisol of less than 9 µg/dl after stimulation with 250 µg tetracosactide (synthetic ACTH), or a basal total plasma cortisol level of less than 10 µg/dl. However, recent studies have called into question the usefulness of the cosyntropin stimulation test for exploring the HPA axis in intensive care patients. |
Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis. |
The aim of this study is to evaluate, on an exploratory basis, the impact of the presence of a post-cardiac surgery vasoplegic syndrome on adrenal function by steroidome mapping (LC-MS/MS). conditions: Vasoplegic Syndrome in Adult Cardiac Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood sampling name: Vital status measure: Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. measure: Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome. measure: Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery. measure: To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome. measure: To assess the association between ""CIRCI"" and length of stay in intensive care. measure: Evaluate the association between ""CIRCI"" and in-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pitié-Salpêtrière city: Paris state: Ile-de-France zip: 75013 country: France name: Adrien Bouglé, MD, PhD role: CONTACT phone: 00 33 42 16 29 91 email: [email protected] name: Jérémie Guillemin, MD role: CONTACT phone: 00 33 84 82 82 58 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06371963 id: LinnaeusU REDs briefTitle: Relative Energy Deficiency in Sports (REDs) in Swedish Athletes acronym: REDs-Sweden overallStatus: RECRUITING date: 2022-05-10 date: 2024-05 date: 2026-12 date: 2024-04-17 date: 2024-04-18 name: Linnaeus University class: OTHER name: Swedish Olympic Committee name: Swedish Research Council for Sport Science name: World Anti-Doping Agency briefSummary: Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance). conditions: RED S conditions: Eating Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED measure: Self-reported eating disorders measure: Eating disorders measure: Self-reported reproductive function in females not using hormonal contraceptives measure: Reproductive function in females not using hormonal contraceptives measure: Self-reported reproductive function in males measure: Reproductive function in males measure: Gastrointestinal function measure: Injury measure: Self- reported symptoms of depression measure: Compulsive exercise measure: The motivation for behavioral changes measure: Psychological flexibility measure: Changes in immune markers from pre to post exercise measure: Microbiota measure: Dietary intake measure: Maximal aerobic capacity measure: Explosive lower body power measure: Whole body strength measure: Muscular power measure: Resting Metabolic Rate measure: Body composition measure: Body weight measure: Body height measure: Glucose levels sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Linnaeus University status: RECRUITING city: Kalmar state: Småland country: Sweden name: Anna Melin, PhD role: CONTACT phone: 0732629714 email: [email protected] lat: 56.66157 lon: 16.36163 hasResults: False |
<|newrecord|> nctId: NCT06371950 id: 123608 briefTitle: Gut Microbiome in Orthopaedics acronym: GUMBO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-01 date: 2027-01-01 date: 2024-04-17 date: 2024-04-17 name: Lawson Health Research Institute class: OTHER briefSummary: Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes. |
This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are: |
* to compare implant migration between groups from baseline to six weeks post-surgery |
* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery |
* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery conditions: Total Knee Arthroplasty conditions: Inflammation conditions: Gastrointestinal Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Probiotic Formula Bacillus subtilis name: Placebo measure: Implant Migration measure: Bone Density measure: Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake measure: Veterans Rand 12-Item Health Survey (VR-12) measure: EuroQol-5D (EQ-5D) measure: Western Ontario McMaster Osteoarthritis Index (WOMAC) measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) measure: Patient Global Assessment (PGA) measure: University of California, Los Angeles (UCLA) Activity Score measure: Oxford Knee Score - English for Canada measure: Knee Society Score (KSS) measure: Presence of MRSA measure: Microbial Diversity - Taxonomic Differences measure: Microbial Diversity - Taxonomic Correlation measure: Diet and Supplement Questionnaire measure: Histopathology measure: Immunohistochemistry measure: Inflammatory Blood Marker: C-Reactive Protein measure: Inflammatory Blood Marker: Interleukin-1B measure: Inflammatory Blood Marker: Interleukin-6 measure: Inflammatory Blood Marker: Interleukin-8 measure: Inflammatory Blood Marker: Tumor Necrosis Factor Alpha measure: Inflammatory Blood Marker: Erythrocyte Sedimentation Rate measure: Inflammatory Blood Marker: Alkaline Phosphatase measure: Inflammatory Blood Marker: Calcium measure: Inflammatory Blood Marker: Albumin measure: Inflammatory Blood Marker: Urate measure: Inflammatory Blood Marker: Total Protein measure: Inflammatory Blood Marker: Creatinine measure: Inflammatory Blood Marker: Vitamin D measure: Inflammatory Blood Marker: White Blood Cell Count measure: Inflammatory Blood Marker: Red Blood Cell Count measure: Inflammatory Blood Marker: Hemoglobin Concentration measure: Inflammatory Blood Marker: Hematocrit Percentage measure: Inflammatory Blood Marker: Platelet Count sex: FEMALE minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre city: London state: Ontario zip: N6A 5A5 country: Canada name: Rachel Vander Deen role: CONTACT phone: 519-685-8500 phoneExt: 34269 email: [email protected] name: Lyndsay Somerville, PhD role: CONTACT phone: 519-685-8500 phoneExt: 36645 email: [email protected] name: Brent Lanting, MD role: PRINCIPAL_INVESTIGATOR name: Jeremy Burton, PhD role: SUB_INVESTIGATOR name: Tom Appleton, PhD role: SUB_INVESTIGATOR name: Matthew Teeter, PhD role: SUB_INVESTIGATOR name: Jonath Thiessen, PhD role: SUB_INVESTIGATOR lat: 42.98339 lon: -81.23304 hasResults: False |
<|newrecord|> nctId: NCT06371937 id: 120687 briefTitle: iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease acronym: INFERENCE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2033-06-30 date: 2033-06-30 date: 2024-04-17 date: 2024-04-25 name: Lawson Health Research Institute class: OTHER name: Greenstone Biosciences, Inc. briefSummary: The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease. conditions: Cardiovascular Diseases conditions: Arrythmia conditions: Cardiomyopathies conditions: Heart Failure conditions: Cerebrovascular Accident conditions: Congenital Heart Disease conditions: Cardiometabolic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: REDCap Database measure: Induced pluripotent stem cell (iPSC) Biobank measure: Differentiation into Cardiovascular lineages measure: Molecular profiling of participants measure: Bioinformatics analysis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06371924 id: KCH23-156 briefTitle: Immunometabolism of Machine Perfusion Strategies acronym: iMaps overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05-31 date: 2026-05-31 date: 2024-04-17 date: 2024-04-17 name: King's College Hospital NHS Trust class: OTHER name: King's College London briefSummary: There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI). |
The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP). |
There are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers. |
The iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work. conditions: Liver Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators propose to conduct a randomised clinical trial in which 36 DCD human livers will be allocated to 1 of 3 treatment arms: |
i) SCS; ii)NRP; and iii) HOPE. This will be followed by a period of time in NMP in order to study the IRI response and determine if the quality of the livers is good enough to proceed to transplantation. This study will allow the doctors to decipher the mechanisms of liver IRI in humans in a much better way than what has been achieved to date. primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: Machine Perfusion measure: To determine the effect of different preservation strategies on the development of mitochondrial damage following reperfusion during NMP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06371911 id: 2023-A02762-43 briefTitle: Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment acronym: OPTIMACURE overallStatus: RECRUITING date: 2024-04-03 date: 2024-08-03 date: 2024-12-03 date: 2024-04-17 date: 2024-04-18 name: Centre Francois Baclesse class: OTHER name: Cureety briefSummary: Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group \[ECOG\] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred. |
In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital. |
A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse. |
Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff. |
Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients. |
Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls. |
There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival. |
Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%. |
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