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<\|newrecord\|> nctId: NCT06331234 id: VCI briefTitle: Effects of Vena Cava Inferior Measurements on AKI and Mortality. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-01 date: 2024-03-26 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is \< 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality. conditions: Intensive Care Unit conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Vena cava inferior diameter measure: acute kidney injury measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331221 id: JSA_Fatigue_FADEUP briefTitle: Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense overallStatus: RECRUITING date: 2023-11-02 date: 2024-05-15 date: 2024-06-01 date: 2024-03-26 date: 2024-03-26 name: Universidade do Porto class: OTHER briefSummary: The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ESTIMATED name: Muscle fatigue Protocol measure: Absolute angular error measure: Relative angular error measure: Variable angular error sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Desporto, Universidade do Porto status: RECRUITING city: Porto zip: 4200 country: Portugal name: Joana Azevedo, MSc role: CONTACT phone: +351917910094 email: azevedojoana311@gmail.com lat: 41.14961 lon: -8.61099 hasResults: False
<\|newrecord\|> nctId: NCT06331208 id: LUNG-HF:16181/21; G-21-57 briefTitle: Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure acronym: LUNG-HF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-26 date: 2024-03-26 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.
There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.
Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling.
Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.
There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data. conditions: Heart Failure conditions: Pulmonary Hypertension conditions: Pulmonary Vascular Resistance Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 230 type: ESTIMATED name: non-contrast chest CT name: spirometry with diffusing lung capacity for carbon monoxide (DLCO) analysis name: Omics analysis of blood plasma obtained from pulmonary artery or peripheral blood name: supine bike exercise during right heart catheterisation name: Lung ventilation/perfusion SPECT measure: biomarker of pulmonary vasculopathy in HF measure: CT characteristics of pulmonary vasculopathy in HF measure: CT characteristics of presence of heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine - IKEM city: Prague zip: 140 21 country: Czechia name: Vojtech Melenovsky, MD, PhD role: CONTACT phone: 420 236055190 email: vome@ikem.cz lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06331195 id: DICA-HF_MAIN briefTitle: An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH) acronym: DICA-FH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-03-26 date: 2024-03-26 name: Hospital do Coracao class: OTHER name: University of Sao Paulo name: National Institute of Cardiology, Laranjeiras, Brazil name: Instituto Dante Pazzanese de Cardiologia briefSummary: The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.
Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up. conditions: Familial Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Placebo phytosterol name: Placebo krill oil name: Phytosterol name: Krill oil measure: LDL-c measure: Lp(a) measure: TC measure: HDL-c measure: TG measure: VLDL measure: NHDL measure: CI I measure: CI II measure: TG/HDL-c measure: AI measure: ox-LDL measure: APOAI measure: APOB100 measure: AE measure: Adherence sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331182 id: 36264PR552/2/24 briefTitle: Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain overallStatus: RECRUITING date: 2024-03-26 date: 2024-08-01 date: 2024-08-01 date: 2024-03-26 date: 2024-03-27 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain. conditions: Dexmedetomidine conditions: Ketamine conditions: External Oblique Intercostal Plane Block conditions: Post Thoracotomy Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketamine name: Dexmedetomidine name: Bupivacaine measure: Time to the 1st rescue analgesia measure: Intraoperative fentanyl consumption measure: Total morphine consumption in the 1st 24hr and 48 hr measure: Degree of pain measure: Heart rate measure: Mean arterial blood measure: The incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06331169 id: ALTER-BC-Ib-01 briefTitle: Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-06-30 date: 2024-03-26 date: 2024-03-26 name: Fudan University class: OTHER briefSummary: A Prospective Phase Ib Study of Anlotinib with Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Anlotinib name: Trastuzumab deruxtecan measure: Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan measure: Objective Response Rate (ORR) measure: Duration of Response (DCR) measure: Duration of Response (DOR) measure: Progression-free Survival (PFS) measure: Overall Survival (OS) measure: Number of Participants With Adverse Events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jian Zhang city: Shanghai state: Shanghai zip: 200433 country: China name: Jian Zhang, MD,PhD role: CONTACT phone: +8664175590 phoneExt: 85000 email: syner2000@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06331156 id: 218485 id: 2022-000708-36 type: EUDRACT_NUMBER briefTitle: A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-19 date: 2024-11-19 date: 2024-03-26 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY briefSummary: The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment. conditions: Gastroenteritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: HRV PCV-free name: IPV measure: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab) measure: Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs) measure: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64 measure: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab measure: Anti-RV IgA Ab geometric mean concentrations (GMCs) measure: Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) sex: ALL minimumAge: 6 Weeks maximumAge: 10 Weeks stdAges: CHILD facility: GSK Investigational Site status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: GSK Investigational Site status: RECRUITING city: Guang'an state: Sichuan zip: 638300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Neijiang state: Sichuan zip: 641200 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yulin Jing role: PRINCIPAL_INVESTIGATOR lat: 29.58354 lon: 105.06216 facility: GSK Investigational Site status: RECRUITING city: Wenshan state: Yunnan zip: 663300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqiang Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Wenshan zip: 663100 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqing Liu role: PRINCIPAL_INVESTIGATOR hasResults: False
<\|newrecord\|> nctId: NCT06331143 id: 36264PR551/2/24 briefTitle: Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion overallStatus: RECRUITING date: 2024-03-28 date: 2024-09-01 date: 2024-09-01 date: 2024-03-26 date: 2024-03-29 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery. conditions: Mid-Transverse Process Block conditions: Intrathecal Morphine conditions: Idiopathic Scoliosis conditions: Posterior Spinal Fusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block name: Morphine measure: Degree of pain measure: Heart rate measure: Mean arterial pressure measure: Patient satisfaction measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06331130 id: 6363 briefTitle: Mesenteric Infiltration in Ovarian Cancer acronym: MIO overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-30 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Danube University Krems name: Institut du Cancer de Montpellier - Val d'Aurelle name: Ente Ospedaliero Cantonale, Ticino, Switzerland briefSummary: To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents. conditions: Ovary Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 510 type: ESTIMATED name: Computed Tomography measure: Preoperative Artificial Intelligence assisted CT-based evaluation measure: Evaluation of the Radiologist Assessment of the CT measure: Prediction of Platinum Resistance measure: Prediction of Progression Free Survival (PFS) and Overall Survival (OS) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Radiology Center status: RECRUITING city: Roma zip: 00168 country: Italy name: Camilla Panico, MD role: CONTACT phone: +390630158637 email: camilla.panico@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06331117 id: 3776 briefTitle: Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies acronym: 3776 overallStatus: RECRUITING date: 2021-04-22 date: 2021-12-22 date: 2026-04-22 date: 2024-03-26 date: 2024-03-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.
Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments. conditions: RASopathy conditions: Costello Syndrome conditions: Noonan Syndrome conditions: Cardio-Facio-Cutaneous Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: Diagnostic test measure: Metabolomic profile of the RASopathies sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Chiara Leoni, MD, PhD role: CONTACT phone: 0039063381344 email: chiara.leoni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06331104 id: ChangyeZou briefTitle: Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone overallStatus: COMPLETED date: 2012-06-14 date: 2023-08-31 date: 2023-08-31 date: 2024-03-26 date: 2024-04-02 name: Changye Zou class: OTHER briefSummary: Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes. conditions: Giant Cell Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 145 type: ACTUAL name: gene expression levels measure: P27 expression levels measure: ESR1 expression levels sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Churong Yan city: Guangzhou state: Guangdong zip: 518010 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06331091 id: YuzuncuYıl2022/2 briefTitle: Physiotherapy and Reaction Time in Hemophilia overallStatus: COMPLETED date: 2022-12-10 date: 2024-01-19 date: 2024-01-19 date: 2024-03-26 date: 2024-04-02 name: Yuzuncu Yıl University class: OTHER briefSummary: This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions. conditions: Hemophilia Arthropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled study primaryPurpose: TREATMENT masking: NONE count: 21 type: ACTUAL name: Home exercise name: Manual therapy name: Neuromuscular electrical stimulation name: Supervised exercise measure: Hemophilia Joint Health Score measure: Reaction time sex: MALE minimumAge: 10 Years maximumAge: 32 Years stdAges: CHILD stdAges: ADULT facility: Van Yüzüncü Yıl University city: Van zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False
<\|newrecord\|> nctId: NCT06331078 id: 29.02.2024/45 briefTitle: Square Step Exercises in Healthy Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-02-01 date: 2025-08-01 date: 2024-03-26 date: 2024-03-29 name: Fenerbahce University class: OTHER briefSummary: This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults. conditions: Exercise conditions: Square Step Exercises conditions: Aerobic Exercise conditions: Cognitive Function conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Square Stepping Exercise training name: Aerobic Exercise Training measure: Schulte Grid Test measure: Stroop Test measure: Verbal Fluency Test measure: Digit Span Test measure: Vertical jump test measure: Horizontal jump test measure: Y Balance Test sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Marmara University city: Maltepe country: Turkey lat: 40.93567 lon: 29.15507 hasResults: False
<\|newrecord\|> nctId: NCT06331065 id: 69HCL21_1180 id: ID-RCB type: OTHER domain: 2023-A01756-39 briefTitle: Promoting Mental Health at Work Among Hospital Professionals acronym: PROMIND overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-06 date: 2024-03-26 date: 2024-03-26 name: Hospices Civils de Lyon class: OTHER briefSummary: Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders.
Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders.
According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management.
Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence.
Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others.
Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work.
The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit.
The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group.
The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ESTIMATED name: Information session on mindfulness meditation and questionnaires name: Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group measure: Psychological fulfilment at work measure: Psychological fulfilment at work measure: Mindful state measure: Aggressiveness measure: Impulsivity, experience of being disturbed by conflict, and psychological safety. measure: Occupational stress measure: Collective activity measure: Organizational leeway measure: Evolution of participants' representation of mindfulness meditation measure: The representation of mindfulness meditation among professionals measure: The representation of mindfulness meditation among professionals measure: The representation of mindfulness meditation among professionals measure: Fidelity and adherence to the mindfulness meditation intervention measure: Fidelity and adherence to the mindfulness meditation intervention measure: Barriers and facilitators to the implementation measure: Barriers and facilitators to the implementation measure: Mechanisms of the intervention effects measure: Mechanisms of the intervention effects measure: Mechanisms of the intervention effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Sandra Vukusic role: CONTACT phone: +33 4 72 35 72 16 email: sandra.vukusic@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Pediatric Intensive Care Unit - Continuous Monitoring, Femme Mère Enfant Hospital (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Etienne Javouhey role: CONTACT phone: +33 4 27 85 61 56 email: etienne.javouhey@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Department of Geriatrics, Edouard Herriot Hospital (Hospices Civils de Lyon) city: Lyon zip: 69003 country: France name: Géraldine Martin-Gaujard role: CONTACT phone: +33 4 72 11 95 31 email: geraldine.martin-gaujard@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Neonatology and neonatal intensive care unit, Croix-Rousse Hospital (Hospices Civils de Lyon) city: Lyon zip: 69004 country: France name: Olivier Claris role: CONTACT phone: +33 4 27 85 53 48 email: olivier.claris@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Department of Anesthesia and Intensive Care, Edouard Herriot Hospital (Hospices Civils de Lyon) city: Lyon zip: 69437 country: France name: Jullien Crozon-Clauzel role: CONTACT phone: +33 4 72 11 02 72 email: jullien.crozon-clauzel@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Anaesthesia - Intensive Care and Perioperative Medicine Department, Lyon South Hospital (Hospices Civils de Lyon) city: Pierre-Bénite zip: 69495 country: France name: Arnaud Friggeri role: CONTACT phone: +33 4 78 86 14 76 email: arnaud.frigerri@chu-lyon.fr lat: 45.7009 lon: 4.82511 facility: Department of Physical Medicine and Neurological Rehabilitation, Henry Gabrielle Hospital (Hospices Civils de Lyon) city: Saint-Genis Laval zip: 69230 country: France name: Jacques Luauté role: CONTACT phone: +33 4 72 35 71 69 email: jacques.luaute@chu-lyon.fr lat: 45.69558 lon: 4.7934 facility: Department of Geriatrics, Charpennes Hospital (Hospices Civils de Lyon) city: Villeurbanne zip: 69100 country: France name: Clémence Grange role: CONTACT phone: +33 4 72 43 23 24 email: clemence.grange@chu-lyon.fr lat: 45.76667 lon: 4.88333 hasResults: False
<\|newrecord\|> nctId: NCT06331052 id: 23-2431 id: 1R01NS125386-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01NS125386-01 briefTitle: 3-D Tractography FUS Ablation for Essential Tremor overallStatus: RECRUITING date: 2024-02-28 date: 2028-02-28 date: 2028-02-28 date: 2024-03-26 date: 2024-03-28 name: University of North Carolina, Chapel Hill class: OTHER name: Texas Tech University Health Sciences Center, El Paso name: University of Pittsburgh name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: MR-guided Focused Ultrasound Ablation measure: Number of Participants without Side Effects measure: Absolute Change in Tremor measure: Relative Change in Tremor measure: Number of Participants with Procedure-Related Side Effects measure: Relative Change in Tremor-Related Quality of Life measure: Number of Participants Who Are Satisfied with Treatment measure: Change in Tremor Based on Video Assessment measure: Change in Gait Based on Video Assessment sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27999 country: United States name: Mary Ann Barnett, MLS role: CONTACT phone: 919-966-8804 email: mary-ann_barnett@med.unc.edu name: Vibhor Krishna, MD, SM role: CONTACT phone: 919-445-2410 email: vibhor_krishna@med.unc.edu name: Vibhor Krishna, MD, SM role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06331039 id: CelalBayarU-5 briefTitle: The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-04-05 date: 2024-07-30 date: 2024-03-26 date: 2024-03-27 name: Celal Bayar University class: OTHER name: Dokuz Eylul University name: Saglik Bilimleri Universitesi briefSummary: Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.
The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence. conditions: Urinary Incontinence conditions: Pelvic Floor Muscle Weakness conditions: Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: PFMT name: PFMT+Balance measure: ankle muscle function measure: ankle range of motion measure: muscle strength measure: incontinence symptoms and severity measure: incontinence symptoms and severity measure: balance measure: bladdery diary measure: functional performance sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Melda BAŞER SEÇER city: Mani̇sa state: Yunusemre zip: 45000 country: Turkey name: Melda BAŞER SEÇER, PhD role: CONTACT phone: +905547285453 email: melda.secer@cbu.edu.tr name: Özge ÇELİKER TOSUN, Assos. Prof. role: CONTACT phone: +905055252029 email: ozge.tosun@deu.edu.tr lat: 38.61202 lon: 27.42647 hasResults: False
<\|newrecord\|> nctId: NCT06331026 id: GenSci004-106 briefTitle: A Bioequivalence Study of Two Different PEG-rhGH Preparations. overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2024-05-31 date: 2024-11-30 date: 2024-03-26 date: 2024-03-26 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation. conditions: Pediatric Growth Hormone Deficiency (PGHD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 87 type: ESTIMATED name: PEG-rhGH with new preparation (T) name: PEG-rhGH with present preparation (R) measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation measure: Safety and tolerability（Number of participants with treatment-related adverse events） measure: Anti-drug antibody (Number of Participants with positive ADA) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, Doctor role: CONTACT phone: +86-28-60212136 email: yongxlan@126.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06331013 id: IEO 1872 briefTitle: CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr acronym: PRO-SPEED overallStatus: RECRUITING date: 2023-02-20 date: 2024-12-31 date: 2029-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CyberKnife ultra-hypofractionated SBRT measure: Number of Participants with Acute GU and GI toxicities (RTOG) measure: Number of Participants with Late GU and GI toxicities (RTOG) measure: Evaluation of patient-reported toxicity measure: Evaluation of patient-reported quality of life sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06331000 id: 9248 briefTitle: Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment acronym: DIATRIM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-26 date: 2024-03-26 name: University Hospital, Strasbourg, France class: OTHER briefSummary: The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.
Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: elexacaftor-tezacaftor-ivacaftor treatment measure: Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor measure: Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl measure: Marker of metabolic status: HbA1c (mmol/l) measure: Marker of metabolic status: HbA1c (%) measure: Marker of metabolic status: C-Peptid (µg/L) measure: Marker of metabolic status: C-Peptid (nmol/L) measure: Markers of nutritional status: Evaluation of weight monitoring (kg) measure: Markers of nutritional status: Body Mass Index (BMI) measure: Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl) measure: Assessment of respiratory function parameters : number of IV antibiotics measure: Number patients with severe hypoglycaemia and serious adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330987 id: 15110_MANNELLA briefTitle: Fetal Autonomic Nervous sysTem Evaluation acronym: FANTE overallStatus: RECRUITING date: 2019-08-13 date: 2025-09-28 date: 2025-12-28 date: 2024-03-26 date: 2024-03-26 name: University of Pisa class: OTHER name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy briefSummary: The autonomic nervous system (ANS) is involved in cardiovascular, metabolic and cognitive processes, so its study in the fetus can provide relevant functional diagnostic and prognostic information. In particular, the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus.
The goal of this open-label, non-randomized, prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation.
The objetives are:
* To Evaluate Fetal Autonomic Nervous System (FANTE) through the analysis of maternal electrocardiogram (ECG) and others clinical parameters usually used in pregnancy monitoring.
* To identify any variations in the fetal ECG in the event of developmental or pathological maternal and/or fetal pregnancy.
Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent. conditions: Pregnancy Related conditions: Pregnancy Disease conditions: Pregnancy Complications conditions: Pre-Eclampsia conditions: Gestational Diabetes conditions: ECG Electrode Site Reaction conditions: Fetal Growth Retardation conditions: Fetal Complications studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 186 type: ESTIMATED name: electrocardiograph measure: Fetal Autonomic Nervous sysTem Evaluation (FANTE) measure: Maternal Assesment measure: Obstetric Complications and mode of Delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Pisana status: RECRUITING city: Pisa zip: 56126 country: Italy name: Paolo Mannella, MD. PhD. role: CONTACT phone: 0039.050.993523 email: paolo.mannella@unipi.it lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06330974 id: FinnATOPY briefTitle: Allergy, Asthma, and Atopic Eczema in Finland acronym: FinnATOPY overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2032-12 date: 2034-12 date: 2024-03-26 date: 2024-03-26 name: Tampere University class: OTHER name: Professor Lauri Lehtimäki name: Professor Mika Mäkelä name: Professor Sanna Toppila-Salmi name: Professor Ilkka Junttila briefSummary: The summary is available at --\> https://www.finnatopy.fi/summary conditions: Asthma conditions: Asthma in Children conditions: Allergy conditions: Rhinitis, Allergic conditions: Atopic Dermatitis conditions: Allergen Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000000 type: ESTIMATED name: No intervention measure: Epidemiology of atopic diseases and allergic sensitization profiles in Finland measure: Burden of atopic diseases (allergies, asthma, and atopic eczema) as well as comorbidities in Finland measure: Evaluate and improve the current use of diagnostic tests for atopic diseases measure: Use and effectiveness of allergen immunotherapy in real world setting measure: Direct and indirect costs related to atopic diseases and comorbidities sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University city: Tampere country: Finland lat: 61.49911 lon: 23.78712 hasResults: False
<\|newrecord\|> nctId: NCT06330961 id: 2023-MED-2756299 briefTitle: Effects of Different Kinds of Exercise in Low Back Pain overallStatus: RECRUITING date: 2024-01-08 date: 2024-06 date: 2025-02 date: 2024-03-26 date: 2024-03-26 name: University of Valencia class: OTHER briefSummary: Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.
The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:
* Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?
* Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?
* Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?
* Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.
Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Isometric exercise name: Aerobic exercise name: Placebo intervention measure: Pain intensity measure: Pain-pressure thresholds measure: Trunk flexion-extension electromyography (EMG) measure: Flexion-extension ratio (EMG) measure: Maximum ranges of lumbar and pelvic flexion measure: Trunk flexion-extension percentages of motion measure: Time of maximum flexion measure: Fear-avoidance beliefs measure: Pain distribution and supra-threshold stimulation measure: Anthropometric data: height measure: Anthropometric data: weight measure: Date of birth/ age measure: Sex/ gender measure: Basic clinical history and occupational data sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València status: RECRUITING city: Valencia zip: 46010 country: Spain name: Daniel Sánchez-Zuriaga, PhD, MD role: CONTACT phone: +343983522 phoneExt: 83522 email: daniel.sanchez@uv.es lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06330948 id: NYCU112183AEF briefTitle: Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-26 date: 2024-04-15 name: National Yang Ming University class: OTHER briefSummary: Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: SugarCut® Unripe Guava Fruit Extract name: Placebo group measure: GLUT4 gene expression 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: NCT06330935 id: 192-2023 briefTitle: Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-26 date: 2024-03-26 name: Mansoura University class: OTHER briefSummary: Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Tranexamic Acid (TXA) name: Normal saline measure: The early traumatic brain injury-related death in the hospital measure: The difference between treatment group in the Intracranial haemorrhage growth measure: The difference between the treatment groups in the incidence of mortality measure: Need for neurosurgical management measure: Days in the intensive care unit measure: Need for blood transfusion measure: Adverse events measure: Pediatric Quality of Life (PedsQL) measure: Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330922 id: 10.55776/V992 briefTitle: Muscle-tendon Pathology and Metabolic Dysregulation in CP overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: University of Graz class: OTHER name: Medical University of Graz name: Karolinska Institutet briefSummary: The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated.
The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners).
To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners. conditions: Cerebral Palsy, Spastic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Cardiorespiratory fitness training measure: Muscle fascicle length and muscle thickness measure: Muscle fascicle pennation angle measure: Passive muscle stiffness measure: Isometric muscle strength measure: Muscle tissue oxygenation measure: Exosome size measure: Exosome content measure: Micro ribonucleic acid (RNA) cargo measure: Metabolic parameters measure: Pro-inflammatory cytokines measure: Resting, mean, and peak heart rate measure: Resting blood pressure measure: Distance covered measure: Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak) measure: Peak respiratory frequency measure: Respiratory exchange ratio measure: VEpeak/VO2peak measure: VEpeak/VCO2peak measure: Perceived exertion measure: Well-being and quality of life measure: Total physical activity, time spent in different intensities measure: Passive range of motion (sagittal plane) of hip, knees, ankles measure: Step count measure: Body height measure: Body weight measure: Body mass index (BMI) measure: Modified Ashworth Scale Score of the Plantar flexors sex: ALL minimumAge: 14 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Institute of Human Movement Science, Sport and Health, University of Graz status: RECRUITING city: Graz zip: 8010 country: Austria name: Sebastian Ruin, Univ.-Prof. role: CONTACT phone: 00433163802336 email: sebastian.ruin@uni-graz.at lat: 47.06667 lon: 15.45 hasResults: False
<\|newrecord\|> nctId: NCT06330909 id: P003103 id: DRKS00022915 type: OTHER domain: Deutsches Register Klinische Studien briefTitle: Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt acronym: HypoF-SBRT overallStatus: RECRUITING date: 2022-08-18 date: 2025-08 date: 2030-02 date: 2024-03-26 date: 2024-03-26 name: University Hospital Freiburg class: OTHER name: German Federal Ministry of Education and Research briefSummary: Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy.
Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention). primaryPurpose: TREATMENT masking: NONE count: 374 type: ESTIMATED name: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT name: Radiotherapy (RT) Arm B - IMRT/IGRT measure: Relapse free survival measure: Time to local failure after randomization measure: Metastatic free survival after randomization measure: Overall (OS) and prostate cancer specific (PCSS) survival after randomization measure: Time to biochemical failure (phoenix definition) after randomization measure: Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26) measure: Patient reported late quality of life (QOL) measure: Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria measure: Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria measure: Dose constraints and prescription doses / recruited patients measure: Characterization of safety: adverse events sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center - University of Freiburg status: RECRUITING city: Freiburg state: Baden-Württemberg zip: 79106 country: Germany lat: 47.9959 lon: 7.85222 hasResults: False
<\|newrecord\|> nctId: NCT06330896 id: 346/2566(IRB3) briefTitle: Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing acronym: genetics MM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Siriraj Hospital class: OTHER briefSummary: The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:
* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing
* genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.
* disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.
* correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.
The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing. conditions: Plasma Cell Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 498 type: ESTIMATED measure: genetic landscape of PCD measure: genetic correlation measure: genetic landscape of relapse MM patients measure: overall survival measure: progression free survival measure: factor of genetic landscape differentiation measure: gender measure: age sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330883 id: 2021/507 briefTitle: Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality. overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-26 date: 2024-03-26 name: Selcuk University class: OTHER briefSummary: Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded. conditions: Frailty conditions: Mortality conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 148 type: ACTUAL name: Prognosis measure: Mortality measure: The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score measure: Thorax computed tomography (CT) imaging measure: Laboratory values measure: Respiratory support measure: Vasoactive drugs administered measure: Renal replacement therapy measure: Patient positions measure: Length of stay in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Selcuk University Hospital city: Konya state: Selçuklu country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06330870 id: BCBM_Breast briefTitle: Brain Metastasis Development Mechanism in BCBM Patients overallStatus: RECRUITING date: 2023-04-06 date: 2025-02-05 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Samsung Medical Center class: OTHER briefSummary: This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis conditions: Breast Cancer conditions: Brain Metastasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 30 type: ESTIMATED name: WGS/TME evaluation measure: Intracranial disease free survival sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ji-Yeon Kim status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Ji-Yeon Kim role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06330857 id: Dnr2021-06921-02 briefTitle: Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy overallStatus: ACTIVE_NOT_RECRUITING date: 2002-05-28 date: 2024-04-01 date: 2025-04-01 date: 2024-03-26 date: 2024-04-17 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years). conditions: Rectal Prolapse conditions: Fecal Incontinence conditions: Defecation Disorder conditions: Enterocele conditions: Rectocele studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Evaluation of recurrence with clinical examination and defecography. Evaluation of bowel function with a questionnaire. primaryPurpose: TREATMENT masking: NONE count: 25 type: ACTUAL name: Laparoscopic vaginorectopexy measure: Recurrence measure: Bowel function measure: Bowel related quality of life measure: Postoperative complications measure: Peroperative complications measure: Operative time measure: Conversions to open surgery measure: Hospital days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330844 id: RBSEF-MCI-CCT briefTitle: Race-Based Stress and Cognitive Training for MCI overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-09-15 date: 2027-03-15 date: 2024-03-26 date: 2024-03-26 name: Rosalind Franklin University of Medicine and Science class: OTHER briefSummary: This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.
Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.
Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups assignment - One group will complete the original ME-CCT training program. The other group will complete the newly developed RBSE-CCT-MCI. primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) name: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT) measure: Verbal learning and memory measure: Basic auditory attention and working memory measure: Psychomotor processing speed measure: Psychomotor processing speed; executive functioning measure: Self-report of prospective and retrospective memory measure: Self-report of cognitive concerns measure: The Patient Health Questionnaire-9 measure: Self-report symptoms of anxiety measure: Self-reported daily functioning measure: The Racial Microaggressions Scale measure: The Trauma Symptoms of Discrimination Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Rosalind Franklin University of Medicine and Science city: Chicago state: Illinois zip: 60064 country: United States name: Rachael Ellison, PhD role: CONTACT name: Rachael Ellison, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06330831 id: x2ghr8pc briefTitle: Intensive Group Based CIMT for Young Children overallStatus: COMPLETED date: 2016-05-09 date: 2023-06-28 date: 2023-07-01 date: 2024-03-26 date: 2024-03-26 name: Rockhurst University class: OTHER name: Ability KC briefSummary: This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer. conditions: Hemiplegic Cerebral Palsy conditions: Non-Accidental Traumatic Head Injury to Child studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Study 1 is a single group pre-post study of children who received 1 episode of the intensive, group based CIMT intervention (2 data points- pre CIMT 1 and post CIMT1). Study 2 is a repeated measures design to evaluate the long-term effects of the first episode and the effects of the second episode of intensive group based CIMT (4 data points- pre CIMT1; post CIMT1 (at the end of 1 month intervention); pre CIMT 2- 11 months after post of CIMT1; post CIMT 2- 12 months post CIMT 1) primaryPurpose: TREATMENT masking: NONE maskingDescription: No masking occurred for the participants or care providers since all parents/caregivers consented to have their children participate in the intensive group based CIMT intervention. The parents/ care providers knew who the interventionists were. The principal investigator was aware of all participants' assignment to the study. The principal investigator also delivered the intervention to the 2-3-year-old group and also served as the assessor of outcomes along with trained student investigators. The principal investigator attempted to limit bias by having all students achieve an inter-rater reliability level of 90% or above (intra-class correlation coefficient ICC\>.90) on the QUEST and by not allowing the student investigators or herself to consult the pre-intervention assessment outcome scores until after post-intervention outcome assessment scoring was completed. count: 35 type: ACTUAL name: Intensive, Group Based Constraint Induced Therapy (CIMT) measure: Quality Upper Extremity Skills Evaluation Test (QUEST) measure: Assisting Hand Assessment (AHA) measure: Canadian Occupational Performance Measure (COPM) measure: Pediatric Evaluation Disability Inventory (PEDI) sex: ALL minimumAge: 20 Months maximumAge: 6 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06330818 id: IMAGINE Moyamoya id: 528291394 type: OTHER_GRANT domain: German Research Council (DFG) briefTitle: Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients acronym: IMAGINE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-30 date: 2027-05-30 date: 2024-03-26 date: 2024-03-26 name: University Hospital Tuebingen class: OTHER name: University Hospital Freiburg briefSummary: Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.
Main tasks are:
* Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT
* Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling
* Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients conditions: Moyamoya Disease conditions: Moyamoya studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: MRI name: H2 15O PET/CT name: Biosampling measure: Value of CO2-triggered BOLD MRI compared to PET/CT measure: Vessel-Wall contrast enhancement measure: Circulating endothelial cells measure: PCR-based virus sampling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330805 id: OSU-23069 id: NCI-2024-00705 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Ohio State University Comprehensive Cancer Center class: OTHER name: Pfizer name: Myovant Sciences GmbH name: Sumitomo Pharmaceuticals America briefSummary: This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.
Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:
1. Comprehensive cardiac and exercise testing before and after starting ADT
2. Completion of quality-of-life questionnaires at specific intervals during the study period
3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers conditions: Prostate Adenocarcinoma conditions: Stage IIB Prostate Cancer AJCC v8 conditions: Stage IIC Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Biospecimen Collection name: Contrast Agent name: Leuprolide name: Magnetic Resonance Imaging name: Physical Performance Testing name: Relugolix measure: Physiologic alterations in cardiopulmonary function - Myocardial perfusion measure: Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption measure: Quality of life using EPIC-26 measure: Quality of life using EORTC QLQ-C30 measure: Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L) measure: Quality of life using PROMIS measure: Functional tests of strength and balance using Timed Up-and-Go measure: Functional tests of strength and balance using 10-meter walk time measure: Functional tests of strength and balance using Grip strength measure: Changes in body composition sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Shang-Jui Wang role: CONTACT phone: 614-366-9306 email: Shang-Jui.Wang@osumc.edu name: Shang-Jui Wang role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06330792 id: mechanical low back pain briefTitle: Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2024-08-01 date: 2024-12-01 date: 2024-03-26 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists conditions: Mechanical Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises.
Group (B) (Control Group): This group will receive core stability exercises only. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 66 type: ESTIMATED name: bio-mechanical awareness name: core stability exercises measure: intensity of low back pain measure: back muscle endurance measure: level of function (disability) associated with mechanical Low Back Pain measure: Fatigue Severity measure: psycho-social factors at work sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330779 id: UWest briefTitle: Trauma-adapted Yoga in Child & Adolescent Psychiatry. acronym: TAY-CAP overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-26 date: 2024-03-26 name: University West, Sweden class: OTHER name: Västra Götalands Region name: Region Stockholm name: Region Skåne name: Region Värmland name: Region Östra Gotland name: Region Örebro briefSummary: The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.
Within and between group (yoga group vs waiting list) analyses will be performed. conditions: ADHD conditions: PTSD conditions: Quality of Life conditions: Self-Control conditions: Pain conditions: Affect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 180 type: ESTIMATED name: Trauma-adapted yoga measure: Negative experience score CPSS-5-S measure: Inattention, impulsivity score measure: Resilience score measure: Pain frequency and intensity measure: affect measure: Self-directednes measure: Quality of life score sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330766 id: PET24 briefTitle: Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients acronym: DENTAVI overallStatus: RECRUITING date: 2020-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-26 date: 2024-03-26 name: Odense University Hospital class: OTHER briefSummary: In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023. conditions: Transcatheter Aortic Valve Implantation conditions: Dental conditions: Endocarditis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No preoperative dental screening measure: Number of Participants with Infectious Endocarditis measure: Number of Participants undergoing Oral surgical procedure at dental screening measure: Number of Participants undergoing Tooth extraction at dental screening measure: The different Bacteria types causing the infectious endocarditis assessed by blood culture measure: Number patients with Bacteremia assessed by positive blood culture measure: Number of Participants with IE caused by bacteria from oral foci measure: Number of Participants with Cardiac implantable electronic device risk of IE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital, Cardiology Department status: RECRUITING city: Odense zip: 5000 country: Denmark name: Jordi S Dahl, MD,PhD,DMSc role: CONTACT phone: 004524638899 email: Jordi.Sanchez.Dahl@rsyd.dk name: Lytfi Krasniqi, MD role: CONTACT phone: 004524638899 email: Lytfi.Krasniqi@rsyd.dk name: Jordi S Dahl, MD,PhD,DMSc role: PRINCIPAL_INVESTIGATOR name: Lytfi Krasniqi, MD role: PRINCIPAL_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06330753 id: 2024P000682 briefTitle: Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan acronym: TICP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-11-30 date: 2024-03-26 date: 2024-03-26 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are:
Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient.
Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters. conditions: Trauma and Stressor Related Disorders conditions: Violence, Structural conditions: Violence, Domestic conditions: Violence, Sexual studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective study designed to explore the acceptability, intervention appropriateness of trauma-informed care plans and the feasibility of trauma-informed care plans by patients and members of the health care team primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants (patients and providers) will be de-identified count: 200 type: ESTIMATED name: Trauma-informed Care Plan- measure: Acceptability of Trauma Informed Care Plans measure: Intervention Appropriateness of Trauma-Informed Care plans measure: Feasibility of the trauma-informed care plans sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330740 id: AAAU3416 briefTitle: Evaluations of CDS Systems overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-12 date: 2024-03-26 date: 2024-03-26 name: New York Presbyterian Hospital class: OTHER briefSummary: Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors. conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Clinical Decision Support measure: The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06330727 id: KY20231109-09 briefTitle: Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity overallStatus: RECRUITING date: 2024-02-05 date: 2024-10 date: 2024-10 date: 2024-03-26 date: 2024-03-26 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Coffee capsule name: Corn starch capsule measure: Continuous glucose monitoring parameters measure: glucose from a 75 g-oral glucose tolerance test （mmol/L） measure: insulin from a 75 g-oral glucose tolerance test （pmol/L） measure: C-peptide from a 75 g-oral glucose tolerance test (ng/ml) measure: glucagon from a 75 g-oral glucose tolerance test（pmol/L） measure: Glycated hemoglobin (HbA1c) ( % ) measure: Fasting total cholesterol (mmol/L) measure: Fasting high-density lipoprotein-cholesterol (mmol/L) measure: Fasting low-density lipoprotein-cholesterol (mmol/L) measure: Fasting triglycerides (mmol/L) measure: C-reactive protein measure: Interleukin-6 measure: Body mass index ( kg/m^2) measure: Fat mass (FM) measure: body fat percentage (BF) measure: visceral fat measure: skeletal muscle mass (SMM) measure: fat-free mass (FFM) measure: Adiponectin measure: Systolic blood pressure（mmHg） measure: Diastolic blood pressure（mmHg） measure: Heart rate （bpm） measure: Controlled attenuation parameter (CAP) measure: Standard deviation of heart rate variability (SDNN) sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: Jun Wang, M.D., PhD. role: CONTACT phone: 8613382079966 email: wangjun868@163.com name: Lin Li, PhD. role: CONTACT phone: 8615380998768 email: guobaolimu@126.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06330714 id: AV.RMH.v01-01 briefTitle: Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements acronym: REMOTE-HUB-1 overallStatus: COMPLETED date: 2018-07-01 date: 2018-11-30 date: 2018-12-30 date: 2024-03-26 date: 2024-03-26 name: Aventyn, Inc. class: INDUSTRY name: Intel Corporation briefSummary: This is planned as a feasibility study.
The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.
The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device conditions: Chronic Disease of Cardiovascular System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: Symptoms of chronic illness. measure: Mobile Home Device Hub Data Resiliency measure: Patient Self Monitoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Liver Health city: Chandler state: Arizona zip: 85248 country: United States lat: 33.30616 lon: -111.84125 hasResults: False
<\|newrecord\|> nctId: NCT06330701 id: 2023URO0001 briefTitle: Stone Access and Removal (STAR) Study acronym: STAR overallStatus: RECRUITING date: 2024-01-18 date: 2024-12-31 date: 2025-03-31 date: 2024-03-26 date: 2024-04-25 name: Auris Health, Inc. class: INDUSTRY briefSummary: The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology. conditions: Kidney Calculi studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Robotic-assisted mini-PCNL measure: Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed measure: Stone Free Rate (%) measure: Number of Adverse Events measure: Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana University status: RECRUITING city: Bloomington state: Indiana zip: 47401 country: United States lat: 39.16533 lon: -86.52639 facility: UW School of Medicine and Public Health status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06330688 id: ΕΒΔ 53/25.01.2024 briefTitle: Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique overallStatus: RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-03-26 date: 2024-03-26 name: Attikon Hospital class: OTHER briefSummary: The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside. conditions: Cholecystitis, Acute conditions: Cholecystitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: percutaneous cholecystostomy measure: Technical success measure: Procedure-related complications measure: duration of the procedure measure: intraprocedural and post-procedural pain measure: clinical success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon University Hospital status: RECRUITING city: Chaïdári state: Athens zip: 12461 country: Greece name: Stavros Spiliopoulos, MD, Associate Professor role: CONTACT phone: +302105831812 email: stavspiliop@gmail.com lat: 38.01135 lon: 23.66597 hasResults: False
<\|newrecord\|> nctId: NCT06330675 id: 2022-01820 briefTitle: Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT overallStatus: RECRUITING date: 2023-02-01 date: 2027-02-01 date: 2027-06-01 date: 2024-03-26 date: 2024-03-26 name: Caporali Elena class: OTHER name: Cardiocentro Ticino briefSummary: Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure. conditions: Pacemaker conditions: Defibrillators, Implantable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 558 type: ESTIMATED name: Early mobilization name: Standard of care measure: Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion measure: Post-operative pain measure: Sleep disturbance measure: Postoperative urinary retention measure: Delirium measure: Orthostatic intolerance measure: Quality of recovery measure: Pressure ulcer measure: Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiocentro Ticino Institute - EOC status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Elena Caporali, MD role: CONTACT lat: 46.01008 lon: 8.96004 hasResults: False
<\|newrecord\|> nctId: NCT06330662 id: 05-PA-30-19-6/2023. briefTitle: Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap overallStatus: ENROLLING_BY_INVITATION date: 2023-09-01 date: 2024-09-01 date: 2025-06-01 date: 2024-03-26 date: 2024-03-26 name: Andelina Sekelja class: OTHER briefSummary: The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA). conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization would first be generated using a computer-selected program, and then the protocol itself would be placed in opaque sealed envelopes and handed to the operator immediately before the procedure with a decision as to whether or not hyaluronic acid (HA) would be applied. In treated areas where HA will not be applied, the operative site will be treated only with saline. The patient as well as the researcher and the outcomes assesssor will not be informed which patient belongs to which group. Randomization and allocation of envelopes as well as allocation of patients to groups will be determined by a fourth party. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only measure: The effect of hyaluronic acid on recession reduction measure: To examine the effect of tissue thickness on recession coverage (KTt) measure: To examine keratinized gingiva width (KTw) measure: To examine changes in periodontal clinical parameters: PPD measure: To examine changes in periodontal clinical parameters: CAL measure: To examine changes in periodontal clinical parameters: REC measure: To examine changes in periodontal clinical parameters: FMPS (full mouth plaque score) measure: To examine changes in periodontal clinical parameters: FMBS (full mouth bleeding score) measure: Assess the healing quality of the operated area by using a RES scale measure: Schiff test tooth examination measure: To examine the impact of oral health on quality of life measure: To evaluate the level of pain postoperatively during the healing of the surgical wound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zagreb - School of dental medicine city: Zagreb state: Hrvatska zip: 10 000 country: Croatia lat: 45.81444 lon: 15.97798 hasResults: False
<\|newrecord\|> nctId: NCT06330649 id: 2024-0095 briefTitle: The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-08-31 date: 2024-03-26 date: 2024-03-26 name: The University of Texas at Arlington class: OTHER briefSummary: The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism conditions: Cardiovascular Diseases conditions: Hypertension conditions: Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Individuals will be randomly assigned to either an experimental or a control condition. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Energy Drink name: Water Control measure: Peripheral blood pressure in millimeters of mercury measure: Oxygen consumption milliliters per kilogram of body weight per minute measure: Heart rate in beats per minute sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: UT Arlington - Science and Engineering Innovation and Research Building status: RECRUITING city: Arlington state: Texas zip: 76019 country: United States name: Robert M Brothers, PhD role: CONTACT phone: 817-272-3288 email: matthew.brothers@uta.edu name: Alison Mancera, BS role: CONTACT phone: 8172723288 email: alison.mancera@mavs.uta.edu lat: 32.73569 lon: -97.10807 hasResults: False
<\|newrecord\|> nctId: NCT06330636 id: 336-0723 briefTitle: The Acute Effect of D-allulose Consumption on Postprandial Glycaemia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-11 date: 2024-03-28 date: 2024-07-31 date: 2024-03-26 date: 2024-04-09 name: University of Nottingham class: OTHER briefSummary: The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose. conditions: Sugar; Blood, High studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised, placebo controlled cross over design primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Allocation coded A and B, with independent researcher determining allocation and making up the test breakfasts for the study team. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: D-Allulose name: Sodium Saccharin measure: Incremental area under the curve (iAUC) 180 Glucose Test measure: iAUC 180 Glucose Placebo measure: Glycaemia Test measure: Glycaemia Placebo measure: Insulinemia Test measure: Insulinemia Placebo measure: iAUC 180 Insulin Test measure: iAUC 180 Insulin Placebo measure: iCAS Test measure: iCAS Placebo measure: abdominal discomfort test measure: abdominal discomfort placebo measure: Dietary Fibre measure: Carbohydrate % measure: Fat % measure: Protein % measure: Sugars % sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: David Greenfield Human Physiology Laboratories city: Nottingham state: Notts zip: NG72UH country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False
<\|newrecord\|> nctId: NCT06330623 id: 0929 id: 321895 type: OTHER domain: HRA briefTitle: Developing Personalised Relative Physical Activity Thresholds in COPD. acronym: IMPACT overallStatus: RECRUITING date: 2023-11-22 date: 2025-03-30 date: 2025-09-01 date: 2024-03-26 date: 2024-03-26 name: University of Leicester class: OTHER briefSummary: The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.
The main questions this study aims to answer are:

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