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Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;
* fitness, muscle strength and function tests,
* completion of questionnaires and computer-based brain puzzles
* having muscle and fat tissue biopsies and blood samples taken.
* The study also involves having MRI scans.
This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027. conditions: Sedentary Behavior conditions: Metabolic Syndrome conditions: Age-related Cognitive Decline conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-randomised, parallel design lifestyle intervention primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Decreased Physical Activity name: Increased Physical activity measure: Change in Cardiorespiratory fitness (VO2 max) measure: Change in Isometric leg strength measure: Change in time to leg fatigue measure: Change in incremental area under the curve (iAUC) for blood glucose concentration measure: Change in iAUC for serum insulin concentration measure: Change in fasting glucose oxidation rate measure: Change in 'fed' glucose oxidation rate measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score measure: Change in World Health Organisation Quality of Life (WHOQoL) score measure: Change in Pittsburgh Sleep Quality Index (PSQI) measure: Change in Stroop test; % Accuracy measure: Change in Stroop test; reaction time measure: Change in four-choice reaction time test; % Accuracy measure: Change in four-choice reaction time test; reaction time measure: Change in card sort test; % Accuracy measure: Change in card sort test; reaction time measure: Change in Logical reasoning test; % accuracy measure: Change in Logical reasoning test; reaction time measure: Change in serial subtractions test; number of responses in 2 minutes measure: Change in Corsi blocks test; score measure: Change in Muscle protein synthesis rate measure: Change in Muscle protein breakdown rate measure: Change in whole body fat volumes measure: Change in liver fat volumes measure: Change in thigh muscle fat volumes measure: Change in whole body muscle volumes measure: Change in muscle phosphocreatine synthesis rate measure: Change in cerebral volume measure: Change in cortical thickness measure: Change in plasma metabolome measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: David Greenfield Human Physiology Unit status: RECRUITING city: Nottingham state: Notts zip: NG72UH country: United Kingdom name: Sara Brown role: CONTACT phone: +44(0)115 8230434 email: [email protected] name: Joanne Mallinson, PhD role: CONTACT phone: +44(0)1158230434 email: [email protected] name: Paul Greenhaff, PhD role: PRINCIPAL_INVESTIGATOR name: Liz Simpson, PhD role: SUB_INVESTIGATOR name: Joanne Mallinson, PhD role: SUB_INVESTIGATOR name: Abhishek Sheth, MD role: SUB_INVESTIGATOR name: Penny Gowland, PhD role: SUB_INVESTIGATOR name: Sue Francis, PhD role: SUB_INVESTIGATOR name: Rosemary Nicholls, PhD role: SUB_INVESTIGATOR name: Aline Nixon role: SUB_INVESTIGATOR name: Sara Brown role: SUB_INVESTIGATOR name: Donald Peden, PhD role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False
<|newrecord|> nctId: NCT06377241 id: 2023-1436 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 2/23/2024 type: OTHER domain: UW Madison briefTitle: ScentAware and OCT in MCI vs HC overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:
* Whether the test is as effective and reliable as the standard test
* Whether there is a link between the results of the smell test and the structure of the back of the eye
Participants will:
* complete a short questionnaire
* have pictures of the inside of their eyes taken
* perform two smell tests conditions: Alzheimer Disease, Early Onset studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: ScentAware name: UPSIT measure: Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting measure: Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare baseline ScentAware test scores between cohorts measure: Compare baseline UPSIT test scores between cohorts measure: Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness measure: Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: [email protected] lat: 43.07305 lon: -89.40123 hasResults: False
<|newrecord|> nctId: NCT06377228 id: TAK-007-1001 briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2029-04-23 date: 2029-04-23 date: 2024-04-22 date: 2024-04-22 name: Takeda class: INDUSTRY briefSummary: The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007. conditions: Refractory Lupus Nephritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TAK-007 name: Chemotherapy Agents measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) measure: Number of Participants With Dose Limiting Toxicities (DLTs) measure: Cmax: Maximum Observed Plasma Concentration for TAK-007 measure: Tmax: Time to Reach the Cmax for TAK-007 measure: Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007 measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007 measure: Change From Baseline in CD19+ B Cell Counts measure: Duration of B Cell Depletion measure: Change From Baseline in Plasma Cytokine Levels measure: Change From Baseline in Physician's Global Assessment (PGA) Score measure: Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline measure: Percentage of Participants Achieving Complete Renal Response (CRR) measure: Time to CRR measure: Duration of CRR measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) measure: Time to LLDAS measure: Duration of LLDAS measure: Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria measure: Time to DORIS Remission measure: Duration of DORIS Remission measure: Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels measure: Change From Baseline in Antinuclear Antibody (ANA) Levels measure: Change From Baseline in Proteinuria Levels measure: Change From Baseline in Creatinine Levels measure: Change From Baseline in eGFR measure: Change From Baseline in Complement (C3, C4) Levels measure: Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR) measure: Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Site Contact role: CONTACT phone: 888-229-3065 email: [email protected] name: Jacqueline Madison role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: University of Rochester city: Rochester state: New York zip: 14642 country: United States name: Site Contact role: CONTACT phone: 585-486-0901 email: [email protected] name: Christopher Palma role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: UT Health Houston city: Houston state: Texas zip: 77030 country: United States name: Site Contact role: CONTACT phone: 713-486-3100 email: [email protected] name: Meera Subash role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06377215 id: Pro00041729 id: R01DC020514 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020514 briefTitle: Understanding Aided Speech Perception in Noise overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-03-01 date: 2028-03-01 date: 2024-04-22 date: 2024-04-22 name: University of South Florida class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention. conditions: Hearing Impairment, Sensorineural conditions: Spatial Perception conditions: Aging conditions: Hearing Aids studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 121 type: ESTIMATED name: Open-source master hearing aid measure: Digit Identification measure: Neural Segregation measure: Minimum Audible Angle (MAA) measure: Speech Localization Error measure: Fixed Spatial Release from Masking measure: Pure-tone Air Threshold (PTac) measure: Bone Conduction Threshold (PTbc) measure: Wideband Tympanometry (Equivalent Ear Canal Volume) measure: Wideband Tympanometry (Static Peak Pressure) measure: Wideband Tympanometry (Resonant Frequency) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C city: Tampa state: Florida zip: 33612 country: United States name: Erol Ozmeral, Ph.D. role: CONTACT phone: 813-974-9778 email: [email protected] name: Carrie Secor, Au.D. role: CONTACT phone: 813-974-4148 email: [email protected] name: Erol Ozmeral, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
<|newrecord|> nctId: NCT06377202 id: SynKIR-110 LTFU briefTitle: Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies overallStatus: RECRUITING date: 2023-11-15 date: 2038-12-15 date: 2038-12-15 date: 2024-04-22 date: 2024-04-24 name: Verismo Therapeutics class: INDUSTRY briefSummary: The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 measure: Number of subjects with persistence of SynKIR-110 modified cells measure: Number of subjects with potential/suspected RCL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Katie Elkins role: CONTACT phone: 215-615-6740 email: [email protected] name: Janos Tanyi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06377189 id: 2023-01910 briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study acronym: PLIMeC-P overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland class: OTHER name: Neuchâtel Psychiatry Centre (CNP) name: University of Lausanne Hospitals briefSummary: The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.
Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.
The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.
The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P. conditions: Mental Health Issue conditions: Depression/Anxiety conditions: Quality of Life conditions: Psychosomatic Disorders conditions: Patients Lived Experiences conditions: Doctor-Patient Relation conditions: Collaboration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.
For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings name: Control Arm - Treatment As Usual (TAU) measure: Evaluate the feasibility of the main PLIMeC study measure: Mental health - psychiatric symptoms measure: Mental health - Quality of life measure: Mental health - Self-report questionnaire measure: The lived experience of the participants measure: The lived experience of the implicated clinicians measure: Healthcare system complexity - Quantitative assessment measure: Healthcare system complexity - qualitative assessment measure: Access to mental healthcare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site city: Lausanne state: Vaud zip: 1010 country: Switzerland lat: 46.516 lon: 6.63282 facility: Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV) city: Yverdon-les-Bains state: Vaud zip: 1400 country: Switzerland name: Julien Elowe, MD role: CONTACT phone: 0041 21 314 54 38 email: [email protected] name: Julien Elowe, MD role: PRINCIPAL_INVESTIGATOR name: Gerrit Weber, MD role: SUB_INVESTIGATOR lat: 46.77852 lon: 6.64115 facility: Centre Neuchâtelois de Psychiatrie (CNP) city: Neuchâtel zip: 2000 country: Switzerland name: Stéphane Saillant, PD role: CONTACT phone: 0041 32 755 15 15 email: [email protected] name: Stéphane Saillant, PD role: PRINCIPAL_INVESTIGATOR name: Julie Gavin-Ramain, PhD role: SUB_INVESTIGATOR lat: 46.99179 lon: 6.931 hasResults: False
<|newrecord|> nctId: NCT06377176 id: NTUNHSEN briefTitle: Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament overallStatus: COMPLETED date: 2021-06-16 date: 2021-10-03 date: 2021-10-03 date: 2024-04-22 date: 2024-04-22 name: National Taipei University of Nursing and Health Sciences class: OTHER briefSummary: Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage. primaryPurpose: TREATMENT masking: NONE count: 102 type: ACTUAL name: Massage therapy measure: Depression measure: Stress measure: Fatigue measure: Infant temperament sex: ALL minimumAge: 1 Month maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Community Health Center city: Sleman state: Yogyakarta zip: 55584 country: Indonesia lat: -7.71556 lon: 110.35556 hasResults: False
<|newrecord|> nctId: NCT06377163 id: acquired pneumonia in children briefTitle: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children overallStatus: COMPLETED date: 2021-01-01 date: 2021-08-31 date: 2021-08-31 date: 2024-04-22 date: 2024-04-22 name: Delta University for Science and Technology class: OTHER briefSummary: Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.
This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate. conditions: Children Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ACTUAL measure: Complete blood count measure: C-reactive protein (CRP) measure: Blood culture and sensitivity on admission measure: Gastric lavage culture or sputum culture on admission sex: ALL minimumAge: 28 Days maximumAge: 10 Years stdAges: CHILD facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
<|newrecord|> nctId: NCT06377150 id: ABCA4-1382022BO2 briefTitle: Stargardt Disease in Childhood overallStatus: COMPLETED date: 2022-04-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-22 date: 2024-04-22 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease. conditions: Stargardt Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 39 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Fundus Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinography (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg, Germany zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False
<|newrecord|> nctId: NCT06377137 id: University of the Porto briefTitle: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction overallStatus: COMPLETED date: 2023-03-10 date: 2023-04-10 date: 2023-09-01 date: 2024-04-22 date: 2024-04-22 name: Universidade do Porto class: OTHER briefSummary: Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.
The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.
The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.
A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.
Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.
The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile. conditions: Obesity, Adolescent conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Small-sided soccer games groups (SSSG) name: Traditional soccer training groups (TSG) measure: Waist circumference measure: Cardiorespiratory fitness measure: Variation in fasting blood glucose concentration (mg/dL) measure: Variation in serum insulin concentration (mU/L) measure: Variation in HOMA-IR measure: Variation in glycosylated hemoglobin concentration (mg/dL) measure: Variation in high-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in low-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in total cholesterol concentration (mg/dL) measure: Variation in blood triglycerides concentration (mg/dL) measure: Variation in blood Alanine aminotransferase concentration (U/L) measure: Variation in blood Aspartate aminotransferase concentration (U/L) measure: Variation in blood Gamma glutamyl transferase concentration (U/L) measure: 6-minute walk test measure: Hand grip strength measure: Lower limb strength measure: Body composition measure: Body mass index measure: Neck circumference measure: Blood Pressure (mmHg) measure: Physical activity measure: Sleep quality measure: Perceived enjoyment of physical activity sex: MALE minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Faculty of Sport of the University of Porto city: Porto zip: 4200-450 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False
<|newrecord|> nctId: NCT06377124 id: UW21-507 briefTitle: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-03-31 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: The University of Hong Kong class: OTHER name: Queen Mary Hospital, Hong Kong name: The Queen Elizabeth Hospital name: United Christian Hospital briefSummary: Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.
The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The outcome assessor was not aware of which groups the patients belonged to. whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: 3S intervention name: GH information measure: Change in health-related quality of life measure: Change in health-related quality of life measure: Change in patient activation measure: Change in general self-efficacy measure: Change in acceptance of illness measure: Change in physical activity level measure: Change in diet habit measure: Change in smoking and drinking habits measure: Change in health status measure: Change in anxiety symptoms of patients measure: Change in depression symptoms of patients measure: Change in social and family support measure: Change in adherence to agreed preset health-related goals measure: Change in symptom severity measure: Change in functional exercise capacity measure: Change in lower limb strength measure: Change in hand grip strength measure: Change in flexibility measure: Change in balance measure: Change in body composition measure: Change in objective physical activity level measure: Change in objective sleep quality measure: Change in burden of family caregivers (For FCGs) measure: Change in quality of life of family caregivers (For FCGs) measure: Change in anxiety symptoms of family caregivers (For FCGs) measure: Change in depression symptoms of family caregivers (For FCGs) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital city: Hong Kong country: Hong Kong name: Agnes YK Lai, PhD role: CONTACT phone: 3970-2903 email: [email protected] name: Agnes Yuen Kwan Lai, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
<|newrecord|> nctId: NCT06377111 id: PANTHEON-IO briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: University Health Network, Toronto class: OTHER briefSummary: This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy. conditions: Melanoma (Skin) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: C-PAN name: Nivolumab name: Ipilimumab measure: To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI. measure: Evaluate the overall response rate (ORR) of the enrolled cohort. measure: Evaluate the progression free survival (PFS) of the enrolled cohort. measure: Incidence of immune-related colitis. measure: Correlation between baseline intestinal microbiome composition to the development of immune-related colitis. measure: Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis. measure: The incidence of treatment-related adverse events. measure: The incidence of treatment-related adverse events measure: Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR. measure: Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST. measure: Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network- Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Minge Xu role: CONTACT phone: 416-946-4501 phoneExt: 7754 email: [email protected] name: Samuel Saibil role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<|newrecord|> nctId: NCT06377098 id: UAB-300010901 id: UAB Dixon Endowed Ch/3102800 type: OTHER_GRANT domain: UAB Dixon Endowed Chair briefTitle: Intrapartum Sildenafil in Laboring Mothers acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2028-01-31 date: 2024-04-22 date: 2024-04-22 name: University of Alabama at Birmingham class: OTHER name: University Teaching Hospital, Lusaka, Zambia name: Egerton University name: Cameroon Baptist Convention Health briefSummary: The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.
The main questions it aims to answer are:
* What are the fetal heart rate monitoring practices in a low-resource setting?
* What are the indications for operative delivery in a low-resource?
* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?
* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.
Participants will:
* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor
* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.
* Have a neonatal neurological assessment prior to discharge
* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia. conditions: Neonatal Asphyxia conditions: Intrapartum Fetal Distress conditions: Development, Infant conditions: Intrapartum Asphyxia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The only person who will be unmasked will be the pharmacist who will dispense the study medication--either sildenafil 50mg or identical placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1000 type: ESTIMATED name: Sildenafil 50 mg Oral Tablet name: Placebo Oral Tablet measure: Percentage of perinatal mortality measure: Percentage of operative delivery measure: Indication for operative delivery measure: Percentage of mothers who received fetal heart rate monitoring measure: Indication for fetal heart rate monitoring measure: Apgar Score measure: Percentage of use of bag and mask ventilation in neonates measure: Percentage of neonates with neonatal encephalopathy measure: Percentage of neonates with neonatal encephalopathy measure: Percentage of neonates with hypoxemia measure: Percentage of infants with neonatal hypoxic-ischemic encephalopathy measure: Percentage of neonatal ICU admissions measure: Percentage of maternal rehospitalization measure: Percentage of neonatal rehospitalization measure: Infant/child developmental assessment sex: ALL minimumAge: 0 Days maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Cameroon Baptist Convention Health Services city: Douala country: Cameroon name: Pius Tih Muffih, PhD role: CONTACT phone: 677764781 email: [email protected] name: Rahel Kyeng Mbah role: CONTACT phone: 370 371378 email: [email protected] name: Akila Subramaniam, MD role: PRINCIPAL_INVESTIGATOR name: Pius Tih Miffih, PhD role: SUB_INVESTIGATOR lat: 4.04827 lon: 9.70428 facility: Egerton University/Nakuru County Referral Hospital city: Nakuru country: Kenya name: Amos Otara, MD role: CONTACT phone: 254 7222 7470 email: [email protected] name: Elizabeth G Kibaru, MbchB, Mmed role: CONTACT phone: 072 942 394 email: [email protected] name: Nora Switchenko, MD role: PRINCIPAL_INVESTIGATOR name: Amos Otara, MD role: SUB_INVESTIGATOR lat: -0.28333 lon: 36.06667 facility: University Teaching Hospital city: Lusaka country: Zambia name: Elwyn Chomba, MD role: CONTACT phone: 0211 254 655 email: [email protected] name: Musaku Mwenechanya, MD role: CONTACT phone: +260966722966 email: [email protected] name: Elwyn Chomba, MD role: PRINCIPAL_INVESTIGATOR name: Musaku Mwenechanya, MD role: SUB_INVESTIGATOR lat: -15.40669 lon: 28.28713 hasResults: False
<|newrecord|> nctId: NCT06377085 id: 809325 briefTitle: Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Shirley Ryan AbilityLab class: OTHER name: Rady Children's Hospital, San Diego briefSummary: In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to an improved quality of life in children with CP.
The main questions this study aims to answer are:
1. What is the optimal dose of AZA injection that can be used safely in children with CP?
2. Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?
Each participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.
Researchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP. conditions: Cerebral Palsy conditions: Contracture studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a "3 + 3" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 27 type: ESTIMATED name: Placebo for the AZA 10mg/m^2 name: Placebo for the AZA 20mg/m^2 name: Placebo for the AZA 35mg/m^2 name: Placebo for the AZA 75mg/m^2 name: 5-Azacytidine 10mg/m^2 name: 5-Azacytidine 20mg/m^2 name: 5-Azacytidine 35mg/m^2 name: 5-Azacytidine 75mg/m^2 measure: Dose-limiting toxicity (DLT). measure: Satellite Cell Fusion Index. measure: DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells. measure: DNA methylation profiling in Satellite Cells. measure: Chromatin immunoprecipitation sequencing (ChIP-seq), and assay for transposase-accessible chromatin sequencing (ATAC-seq) sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06377072 id: SHPL-W036-301 briefTitle: Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-03 date: 2024-04-22 date: 2024-04-22 name: Shanghai Hutchison Pharmaceuticals Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration. conditions: Cervical Spondylotic Myelopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 428 type: ESTIMATED name: Shenqi Sherong Pill name: Placebo measure: Change in Modified Japanese Orthopaedic Association (mJOA) score measure: Change in mJOA score measure: Change in sensation of mJOA score measure: Changes in pain or stiffness score for neck and shoulder measure: Change in chest tightness score measure: Changes in hand and arm numbness scores measure: Change in numbness (or pain) scores from the chest to the toes measure: Change in Motor dysfunction of the upper extremities of mJOA score measure: Proportion of participants with at least 1 grade decline in Nurick grades measure: Change in Traditional Chinese medicine (TCM) syndrome integrality measure: Change in TCM syndrome score measure: Serious adverse events measure: Adverse events measure: Vital sign (systolic and diastolic blood pressure after 10-minute rest) measure: Vital sign (body temperature) measure: Vital sign (respiration) measure: Vital sign (heart rate) measure: Laboratory test indicator (blood routine) measure: Laboratory test indicator (liver function) measure: Laboratory test indicator (kidney function) measure: Laboratory test indicator (fasting glucose) measure: Laboratory test indicator (urine routine and urinary sediment count) measure: Laboratory test indicator (stool routine and occult blood) measure: Electrocardiogram(ECG) QT Interval measure: ECG QTc Interval measure: ECG QRS Interval measure: ECG PR Interval measure: Pathological sign (Hoffmann sign) measure: Pathological sign (Babinski sign) measure: Concomitant medication sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06377059 id: 2024-RH-phase1-WARD briefTitle: Early Detection of Complications During Immunotherapy for Haematological Malignancy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2027-07-01 date: 2024-04-22 date: 2024-04-22 name: Rigshospitalet, Denmark class: OTHER briefSummary: Aims
* To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications
* Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment. conditions: Hematologic Cancer conditions: CRS - Cytokine Release Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: WARD measure: CRS measure: Immune response measure: severe physiological deviations measure: clinical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06377046 id: NL86643.068.24 briefTitle: Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial acronym: PACE-AF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Maastricht University Medical Center class: OTHER briefSummary: The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.
The main question it aims to answer is:
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.
Secondary questions it aims to answer are:
* To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.
* To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:
* NT pro BNP levels
* device detected atrial fibrillation burden and daily activity
* echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain conditions: Atrial Fibrillation conditions: Permanent Atrial Fibrillation conditions: Persistent Atrial Fibrillation conditions: Pacemaker DDD conditions: Paroxysmal Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, single center, prospective, single blinded, parallel group, pilot-trial. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Accelerated pacing name: Current standard of care measure: The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP. measure: The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP). measure: The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO). measure: The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure. measure: The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: Palpitations experienced as a result of (accelerated) pacing. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False