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<\|newrecord\|> nctId: NCT06372418 id: KEMRI/SERU/CGMR-C/238/4326 briefTitle: Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants acronym: IBAMI-2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-02 date: 2024-04-18 date: 2024-04-18 name: University of Oxford class: OTHER briefSummary: The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.
Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital. conditions: Malnutrition, Infant conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial:
Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Breastfeeding peer support intervention name: Standard Care measure: Weight gain measure: Morbidity measure: Mortality sex: ALL minimumAge: 4 Weeks maximumAge: 12 Weeks stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06372405 id: PSP-501/D125/79/00000 briefTitle: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia overallStatus: RECRUITING date: 2024-03-18 date: 2024-12 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: University of Warsaw, Poland class: OTHER name: Duke University briefSummary: Misophonia is a disorder causing intense reactions to specific sounds, disrupting daily life. Current treatments lack evidence-based support. The goal of this study is to explore the effectiveness of cognitive reappraisal (CR) in reducing misophonic responses. The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training. Emotional regulation, symptoms of anxiety and depression, quality of life, and more will be assessed using various questionnaire-based measures; perseverations with a task-based test (Wisconsin Card Sorting Test); the presence of psychiatric and personality disorders using face-to-face interviews (The Mini-International Neuropsychiatric Interview (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD) conditions: Misophonia Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 108 type: ESTIMATED name: Cognitive reappraisal name: Schultz Autogenic Training measure: Change in misophonia symptoms measured by S-Five - Externalizing subscale measure: Change in misophonia symptoms measured by S-Five - Internalizing subscale measure: Change in misophonia symptoms measured by S-Five - Threat subscale measure: Change in misophonia symptoms measured by S-Five - Impact subscale measure: CHange in misophonia symptoms measured by S-Five - Outburst subscale measure: Change of aversiveness rating (valence/pleasure) on the Manikin Scales. measure: Change of arousal rating on the Manikin Scales. measure: Change in Galvanic Skin Response measure: Change in average HR during the trigger presentation measure: Diagnosis of personality disorders as a predictor of worse treatment outcome. measure: Working Alliance Inventory will be related to better treatment outcomes. measure: Meeting criteria for psychiatric disorders - measure: Hearing test - standard and high frequency pure-tone audiometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Psychology, University of Warsaw status: RECRUITING city: Warsaw state: Masovian Voivodeship zip: 00-183 country: Poland name: Marta Siepsiak, PhD role: CONTACT phone: 0048661152533 email: marta.siepsiak@psych.uw.edu.pl name: Marta Siepsiak, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False
<\|newrecord\|> nctId: NCT06372392 id: 1.0 briefTitle: Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps overallStatus: RECRUITING date: 2023-10-10 date: 2024-06-10 date: 2024-12-01 date: 2024-04-18 date: 2024-04-18 name: Tartu University Hospital class: OTHER name: Estonia Research Council briefSummary: Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport. conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Universal meal coefficient utilization measure: Time in range (TIR) measure: TBR measure: TAR measure: auto-corrections % measure: coefficient of variability sex: ALL minimumAge: 7 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: TartuUH status: RECRUITING city: Tartu state: Tartumaa zip: 50406 country: Estonia name: Aleksandr Peet role: CONTACT phone: 5532256 email: aleksandr.peet@kliinikum.ee lat: 58.38062 lon: 26.72509 hasResults: False
<\|newrecord\|> nctId: NCT06372379 id: 8780_UC2 briefTitle: Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments acronym: eCREAM-UC2 overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-01 date: 2027-09 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Astir S.r.l. name: Orobix Life S.r.l. name: Fondazione Bruno Kessler briefSummary: An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner. conditions: Emergency Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162000 type: ESTIMATED name: no intervention measure: Daschboards sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06372366 id: Dental caries and vit.difiency briefTitle: Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2024-10-15 date: 2025-12-15 date: 2024-04-18 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently. conditions: Dental Caries conditions: Vitamin Deficiency studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2 type: ESTIMATED measure: Caries prevalence sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06372353 id: 777 briefTitle: The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-24 date: 2023-06-06 date: 2024-04-18 date: 2024-04-18 name: Marmara University class: OTHER briefSummary: Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment method
Methods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period conditions: Pulmonary Fibrosis, Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ACTUAL name: Baduanjin Exercise measure: Functional capacity measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Respiratory muscle strength measure: Respiratory muscle strength measure: St. George's Respiratory Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul state: Fatih country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06372340 id: 2023BJYYEC-217-01 briefTitle: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-08-31 date: 2025-12-31 date: 2024-04-18 date: 2024-04-18 name: Beijing Hospital class: OTHER_GOV briefSummary: The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive. conditions: Pelvic Organ Prolapse conditions: Urinary Incontinence conditions: Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Assessments regarding pelvic floor muscle strength will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program. Due to the nature of the intervention neither participants nor care providers can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. An employee outside the research team will feed data into the computer in separate datasets so that the researchers can analyse data without having access to information about the allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. name: Standard pelvic floor muscle training(PFMT) program measure: Modified Oxford Scale (MOS) measure: Surface Electromyography Data measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) measure: The score of the Pelvic Floor Distress Inventory (PFDI-20) measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06372327 id: 73468 briefTitle: Move Often eVery Day 2.0 acronym: MOVD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-07 date: 2024-04-18 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This will be a 2 (Exercise snack number) x 2 (Exercise snack length) factorial design. primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Daily Exercise Snacks measure: Number of self-reported exercise snack breaks at work at week 7 measure: Number of self-reported exercise snack breaks at work at week 18 measure: Number of self-reported exercise snack breaks at work at week 30 during follow-up measure: Liking of exercise snacks sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False
<\|newrecord\|> nctId: NCT06372314 id: 1000081221 briefTitle: Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: The Hospital for Sick Children class: OTHER briefSummary: This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.
The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates. conditions: Stable Neonates Receiving Total Parenteral Nutrition (TPN) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Total parenteral nutrition (TPN): this is total nutrition provided by central vein. measure: Amino acid oxidation using a labelled amino acid. sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil city: Santa Maria country: Brazil name: Ivo Dr Prola, MD, PhD role: CONTACT phone: 6477815786 email: iprolla@gmail.com name: Beatriz Dr Porto, MD role: CONTACT phone: 6475002171 email: bsilveiraporto@gmail.com lat: -29.68417 lon: -53.80694 hasResults: False
<\|newrecord\|> nctId: NCT06372301 id: 1-10-72-179-23 briefTitle: Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy acronym: DobAttrAS overallStatus: RECRUITING date: 2024-04-02 date: 2025-11-01 date: 2026-04-01 date: 2024-04-18 date: 2024-04-18 name: Steen Hvitfeldt Poulsen class: OTHER briefSummary: The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard).
In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine. conditions: Transthyretin Amyloid Cardiomyopathy conditions: Aortic Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 24 type: ESTIMATED name: Dobutamine stress echocardiography measure: The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion. measure: Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels. measure: Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation. measure: Correlation between echo- and invasive measured SVI. measure: Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine measure: Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %. measure: Complication rate and symptomatic side effects during dobutamine challenge sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Department of Cardiology, Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Ali Hussein Jaber Mejren, MD role: CONTACT phone: 0045 91 65 18 48 email: alimej@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False
<\|newrecord\|> nctId: NCT06372288 id: 22-1754 briefTitle: Theta Burst TMS for Treatment of Methamphetamine Use Disorder overallStatus: RECRUITING date: 2023-12-20 date: 2024-12 date: 2025-12 date: 2024-04-18 date: 2024-04-26 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm. conditions: Methamphetamine Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Transcranial Magnetic Stimulation name: Sham Transcranial Magnetic Stimulation measure: Stimulant Craving Questionnaire (STCQ) measure: Urine Drug Screen (UDS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) measure: Hamilton Anxiety Scale (HAM-A) measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Carilion Clinic status: RECRUITING city: Roanoke state: Virginia zip: 24014 country: United States name: Sooraj John, M.D. role: CONTACT name: Maryann Hollen, B.S. role: CONTACT phone: 540-566-8081 lat: 37.27097 lon: -79.94143 hasResults: False
<\|newrecord\|> nctId: NCT06372275 id: 0000 briefTitle: Investigating Two Prototype Mobile App Interventions to Increase Physical Activity overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Mississippi State University class: OTHER name: Association for contextual behavioral science briefSummary: This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation. conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Values Clarification Mobile Application name: Self-Reflection Mobile Application measure: International Physical Activity Questionnaire (IPAQ) - Total physical activity measure: Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score measure: Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2 measure: Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Values Clarity Questionnaire (VCQ) measure: Self-Compassion Scale Short Form (SCS-SF) measure: Random responding question measure: Credibility & Expectancy Questionnaire (CEQ) measure: System Usability Scale (SUS) measure: Treatment Evaluation Inventory-Short Form (TEI-SF) measure: Exercise ecological momentary assessment (EMA) questions measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Emotion ratings measure: Current Motivation to Exercise measure: Previous Day Stress Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mindfulness and Acceptance Processes Lab city: Starkville state: Mississippi zip: 39759 country: United States lat: 33.45049 lon: -88.81961 hasResults: False
<\|newrecord\|> nctId: NCT06372262 id: Rowers2022 briefTitle: Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase acronym: Rowers overallStatus: COMPLETED date: 2022-06-01 date: 2022-06-30 date: 2022-06-30 date: 2024-04-17 date: 2024-04-17 name: Poznan University of Physical Education class: OTHER briefSummary: The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study. conditions: Endothelial Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 18 type: ACTUAL name: ergometer test measure: I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury measure: zonulin to measure tight junction leakage measure: LBP (lipopolysaccharide binding protein) to measure endotoxin measure: LPS (lipopolysaccharide) to measure endotoxin measure: Lactic acid to measure fatigue after the race measure: energy measure: fiber intake measure: protein measure: carbohydrate measure: body mass measure: Body composition - water measure: Body composition - fat measure: Lean body mass sex: MALE minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Poznan University of Physical Education city: Poznań country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
<\|newrecord\|> nctId: NCT06372249 id: 22-249 id: 2U54MD012388-06 type: NIH link: https://reporter.nih.gov/quickSearch/2U54MD012388-06 briefTitle: A Clinical Trial of Soluble Fiber for Asthma overallStatus: RECRUITING date: 2024-04-02 date: 2027-04 date: 2027-04 date: 2024-04-17 date: 2024-04-17 name: Phoenix Children's Hospital class: OTHER name: Northern Arizona University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet. conditions: Asthma in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: NOVELOSETM 3490 measure: Alpha diversity. measure: Asthma control. measure: Gut microbiome composition. measure: Nasal inflammatory response. measure: Quantification of circulating short chain fatty acids. sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Phoenix Children's status: RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States name: Destiny Ogbeama role: CONTACT lat: 33.44838 lon: -112.07404 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-04-02T16:19 filename: Prot_SAP_000.pdf size: 285020 hasResults: False
<\|newrecord\|> nctId: NCT06372236 id: PG-001-025 briefTitle: UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Peking University class: OTHER briefSummary: This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first. conditions: Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA06 injection primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: UTAA06 injection for treatment of advanced malignant solid tumors measure: MTD measure: To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors measure: To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen Anke Cellular Therapeutice Co.,Ltd status: RECRUITING city: Hefei state: Anhui zip: 230088 country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06372223 id: SPH5030-102 briefTitle: A Food Effect Study of SPH5030 Tablets. overallStatus: COMPLETED date: 2024-03-04 date: 2024-03-25 date: 2024-03-25 date: 2024-04-17 date: 2024-04-17 name: Shanghai Pharmaceuticals Holding Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: SPH5030 name: SPH5030 measure: Peak Plasma Concentration (Cmax) measure: Peak time（Tmax） measure: Area under the plasma concentration versus time curve (AUC) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second Hospital ,Sichuan University city: Chengdu country: China lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06372210 id: 031-201-00521 briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion overallStatus: COMPLETED date: 2023-06-26 date: 2023-07-19 date: 2023-07-19 date: 2024-04-17 date: 2024-04-17 name: Otsuka Pharmaceutical Development & Commercialization, Inc. class: INDUSTRY briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch. conditions: Mental Disorder conditions: Schizophrenia conditions: Major Depressive Disorder conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 54 type: ACTUAL name: Placebo IEM tablet name: Abilify MyCite® name: D-Tect Patch measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch measure: Cohort 1 and 2: Patch Detection Latency Period measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period measure: Cohort 1 and 2: Total Detection Latency Period measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research site city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 hasResults: False
<\|newrecord\|> nctId: NCT06372197 id: LIGPATD briefTitle: Low-Income Group Psilocybin Assisted Therapy for Depression acronym: LIGPATD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-08 date: 2024-10 date: 2024-04-17 date: 2024-04-17 name: Matthew Hicks class: OTHER briefSummary: Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.
Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.
Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.
The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Psilocybin measure: Recruitment Feasibility measure: Retention Feasibility measure: Acceptability measure: Preliminary Safety and Tolerability: incidence and severity of adverse events measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) measure: Altered State of Consciousness rating scale (11-ASC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06372184 id: WMT-AR-RCT briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2029-10-01 date: 2024-04-17 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR. conditions: Rhinitis, Allergic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Washed Microbiota Transplantation name: Placebo measure: Changes in the reflective total nasal symptom score (rTNSS) measure: Changes in the combined symptoms and medication score (CSMS) measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score measure: Changes in the single reflective nasal symptoms score measure: Specific IgE measure: Inflammatory factors measure: Flow cytometric analysis of lymphocyte clusters measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 measure: Changes in the Modified Lund-Kennedy endoscopic score measure: The changes in composition and metabolites of gut microbiota and nasal microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD,PhD role: CONTACT phone: 086-25-58509883 email: fzhang@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06372171 id: NYCU112182AEF briefTitle: Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Satge 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06372158 id: NYCU112181AE briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism overallStatus: RECRUITING date: 2024-04-08 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements. conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Stage 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: ChienYu Huang, Bachelor role: CONTACT phone: +886-955-879163 email: chienyu.ns11@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06372145 id: LTS17043 id: 2023-503631-18 type: REGISTRY domain: CTIS id: U1111-1287-6797 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. overallStatus: RECRUITING date: 2024-04-25 date: 2029-04-30 date: 2029-04-30 date: 2024-04-17 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).
SUBSTUDY: ToleDYNAMIC substudy conditions: Relapsing Multiple Sclerosis conditions: Secondary Progressive Multiple Sclerosis conditions: Progressive Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Tolebrutinib name: Placebo name: Teriflunomide measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs) measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies measure: Annualized Relapse Rate (ARR) for RMS only measure: Number of new and/or enlarging T2-hyperintense lesions per year measure: Change from baseline in total volume of T2-hyperintense lesions measure: ToleDYNAMIC substudy Change from baseline in biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site Number : 0560005 status: RECRUITING city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 hasResults: False
<\|newrecord\|> nctId: NCT06372132 id: NL85305.068.23 briefTitle: G-POEM vs PEG-J in Gastroparesis Patients overallStatus: RECRUITING date: 2024-03-14 date: 2027-01 date: 2028-01-01 date: 2024-04-17 date: 2024-04-17 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.
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: kim.sweerts@maastrichtuniversity.nl 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: stefania.navone@policlinico.mi.it 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: alessandra.finisguerra@lanostrafamiglia.it name: Cosimo Urgesi role: CONTACT phone: +39031877652 email: cosimo.urgesi@lanostrafamiglia.it 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: alessandra.finisguerra@lanostrafamiglia.it name: Cosimo Urgesi role: CONTACT email: cosimo.urgesi@lanostrafamiglia.it 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: rossella.donghia@irccsdebellis.it 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: adrien.bougle@aphp.fr name: Jérémie Guillemin, MD role: CONTACT phone: 00 33 84 82 82 58 email: jeremie.guillemin@aphp.fr 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: anna.melin@lnu.se 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: Rachel.VanderDeen@lhsc.on.ca name: Lyndsay Somerville, PhD role: CONTACT phone: 519-685-8500 phoneExt: 36645 email: Lyndsay.Somerville@lhsc.on.ca 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%.
This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent). conditions: Adult Patients Initiating Injectable Anticancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 192 type: ESTIMATED name: Cureety telemonitoring name: OPTIMA or equivalent programs measure: Effectiveness of adding Cureety telemonitoring to usual care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier de Bligny status: NOT_YET_RECRUITING city: Bligny country: France name: Jean-Baptiste MERRIC, MD role: CONTACT email: jb.meric@chbligny.fr name: Jean-Baptiste MERRIC, MD role: PRINCIPAL_INVESTIGATOR facility: Centre François Baclesse status: RECRUITING city: Caen zip: 14000 country: France name: Audrey Faveyrial, MD role: CONTACT email: a.faveyrial@baclesse.unicancer.fr name: Jean-Michel Grellard role: CONTACT email: jm.grellard@baclesse.unicancer.fr name: Audrey Faveyrial, MD role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: Centre de Radiothérapie et Oncologie Médicale d'Osny status: NOT_YET_RECRUITING city: Osny country: France name: Abderrezak LADOUANI, MD role: CONTACT email: a.ladouani@crom95.com name: Abderrezak LADOUANI, MD role: PRINCIPAL_INVESTIGATOR lat: 49.0701 lon: 2.06277 hasResults: False
<\|newrecord\|> nctId: NCT06371898 id: 29BRC24.0088 - MORDIGO briefTitle: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO) acronym: MORDIGO overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2025-06-17 date: 2025-06-17 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Brest class: OTHER briefSummary: Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded. conditions: Colonic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: 30 days severe morbidity measure: morbidity of ESD group measure: comparison of morbidity in both groups measure: reintervention measure: stomia measure: length of hospital stay measure: readmission measure: mortality measure: risk factors for morbidity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False
<\|newrecord\|> nctId: NCT06371885 id: P.T.REC/012/004646 briefTitle: Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-10 date: 2024-05-30 date: 2024-06-28 date: 2024-04-17 date: 2024-04-17 name: Cairo University class: OTHER briefSummary: "In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.
So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn. conditions: Hand Burn conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional (clinical trial) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double mask for both groups (participant) whoMasked: PARTICIPANT count: 52 type: ACTUAL name: shock wave therapy name: traditional physical therapy measure: Visual Analog Scale measure: Hand held dynamometer measure: Michigan hand out Comes questionnaire sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Shaimaa Mohamed Ahmed El Sayeh city: Cairo state: New Cairo zip: 02 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06371872 id: 2024-A00173-44 briefTitle: French Cohort of Patients With Rotator Cuff Lesions acronym: PRO-CUFF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2035-12 date: 2035-12 date: 2024-04-17 date: 2024-04-17 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment. conditions: Rotator Cuff Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 519 type: ESTIMATED name: total transfixing injury to the rotator cuff measure: Shoulder Pain and Disability Index measure: European quality of life scale - EQ5D sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Maussins-Nollet city: Paris zip: 75019 country: France name: Geoffroy NOURISSAT, MD role: CONTACT email: gnourissat@wanadoo.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06371859 id: 3-3031-2915/1 briefTitle: Human-AI Collaborative Intelligence for Improving Fetal Flow Management overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-01 date: 2025-12-01 date: 2024-04-17 date: 2024-04-23 name: Rigshospitalet, Denmark class: OTHER name: Slagelse Hospital name: Technical University of Denmark briefSummary: This randomized controlled study evaluates the effectiveness of explainable AI (XAI) in improving clinicians' interpretation of Doppler ultrasound images (UA and MCA) in obstetrics. It involves 92 clinicians, randomized into intervention and control groups. The intervention group receives XAI feedback, aiming to enhance accuracy in ultrasound interpretation and medical decision-making.
Objectives:

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