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1. Intra-articular displacement of ⩾ 2 mm
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2. Metaphyseal -diaphyseal translation \> 1 cm
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3. Angular deformity more than 10 degree in the coronal or sagittal view
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4. Open fracture , compartment syndrome and associated ligament injury require repair.
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5. Associated fractures of the ipsilateral tibia or fibula
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Frequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .
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We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate conditions: Tibial Plateau Fractures Schatzker Type II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: fixation of tibial plateau fractures measure: range of motion of knee joint using Rasmussen score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06353035 id: NaturalResourcesIFinland id: 346136 type: OTHER_GRANT domain: Strategic Research Council Finland id: 346138 type: OTHER_GRANT domain: Strategic Research Council Finland briefTitle: Biodiversity Interventions for Well-Being acronym: BIWE overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-30 date: 2027-06-30 date: 2027-09-30 date: 2024-04-08 date: 2024-04-08 name: Natural Resources Institute Finland class: OTHER_GOV name: Tampere University briefSummary: Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.
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In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.
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The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways. conditions: Microbial Colonization conditions: Immune System Diseases conditions: Well-Being, Psychological conditions: Nature, Human studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group. count: 30 type: ACTUAL name: Rewilding measure: Skin Gammaproteobacteria measure: Salivary cytokines measure: Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota measure: Difference in observed species richness of skin, saliva and stool microbiota measure: Difference in taxonomies of skin, saliva and stool microbiota measure: Difference in microbial gene pathways of saliva and stool microbiota measure: Cortisol levels measure: Perceived Stress Scale measure: Warwick-Edinburgh Mental Wellbeing Scale measure: Depression Scale measure: Nature Relatedness Scale measure: Metabolites in urine measure: Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Natural Resources Institute Finland city: Helsinki state: Uusimaa zip: 00970 country: Finland lat: 60.16952 lon: 24.93545 hasResults: False
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<|newrecord|> nctId: NCT06353022 id: RC23_0267 id: 2023-508310-41 type: EUDRACT_NUMBER briefTitle: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma acronym: IFm2022-01 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2030-06-20 date: 2024-04-08 date: 2024-04-08 name: Nantes University Hospital class: OTHER name: Janssen Pharmaceutica briefSummary: This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).
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The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Teclistamab name: Talquetamab name: Lenalidomide name: Bortezomib name: Daratumumab name: Dexamethasone measure: Rate of sustained MRD negativity (NGS, 10^-5) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5) measure: Number of adverse events measure: Rate of sustained MRD negativity (NGS, 10^-6) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-6). measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5). measure: Number of the death measure: Number of responses measure: Number of progression-free survival measure: Percentage of duration of response measure: Percenatge of time to response measure: Percentage of value of biological prognostic factors influencing outcome and response. measure: Percentage of score of quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH de la Côte Basque city: Bayonne zip: 64109 country: France lat: 43.48333 lon: -1.48333 facility: CHU Caen city: Caen zip: 14033 country: France lat: 49.18585 lon: -0.35912 facility: CHRU DIjon city: Dijon zip: 21000 country: France lat: 47.31667 lon: 5.01667 facility: Chd Vendee city: La Roche-sur-Yon zip: 85925 country: France lat: 46.66667 lon: -1.43333 facility: CHRU LILLE - Hôpital Claude Huriez city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: CHU Limoges city: Limoges zip: 87000 country: France lat: 45.83153 lon: 1.25781 facility: CH Lyon Sud city: Lyon zip: 69495 country: France lat: 45.74848 lon: 4.84669 facility: IPC Marseille Institut Paoli Calmettes city: Marseille zip: 13009 country: France lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 facility: CHU de Nantes city: Nantes zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: APHP Hôpital Saint Louis city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital Saint-Antoine city: Paris zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital La Pitié Salpétrière city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: CHU BORDEAUX - Hôpital du Haut Lévêque city: Pessac zip: 33604 country: France lat: 44.81011 lon: -0.64129 facility: CHU Poitiers city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 facility: CHRU Rennes - Hôpital de Pontchaillou city: Rennes zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: ICANS Institut de Cancérologie Strasbourg Europe city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU Toulouse city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: CHU Tours Hôpital Bretonneau city: Tours zip: 37044 country: France lat: 47.38333 lon: 0.68333 facility: CHRU Nancy - Hôpitaux de Brabois city: Vandœuvre-lès-Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False
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<|newrecord|> nctId: NCT06353009 id: ICM 2021-2720 briefTitle: Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography acronym: SUPPER overallStatus: COMPLETED date: 2020-08-20 date: 2023-04-28 date: 2023-04-28 date: 2024-04-08 date: 2024-04-08 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET).
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The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly.
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This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries. conditions: Myocardial Endothelial Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 15 type: ACTUAL name: NOVA4 meal name: NOVA1-3 meal measure: Myocardial blood flow values (ml/min/g) at maximum dose of adenosine. measure: Myocardial blood flow values (ml/min/g) at rest and myocardial reserve. measure: Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine. sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Matthieu Pelletier-Galarneau city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06352996 id: Dentist Anas Kassas briefTitle: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-09 date: 2024-03-09 date: 2024-07-30 date: 2024-04-08 date: 2024-04-08 name: Mansoura University class: OTHER briefSummary: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.
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Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.
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Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction. conditions: Power Arm Canine Retraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm name: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm measure: Canine tipping measure: Canine mobility measure: Implant stability measure: Pain assessment measure: canine rotation measure: canine retraction rate sex: ALL minimumAge: 14 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Faculty of dentistry Mansoura University city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06352983 id: 2014/11 briefTitle: Zirconium Dioxide Fixed Dental Prosthesis. overallStatus: COMPLETED date: 2017-12-20 date: 2019-09-27 date: 2023-01-20 date: 2024-04-08 date: 2024-04-08 name: Malmö University class: OTHER briefSummary: The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications. conditions: Missing Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Both participant, care providers, dental technicians and the investigator are blinded in the process. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 31 type: ACTUAL name: Fixed dental prosthesis measure: Fractures measure: De-bonding measure: Caries measure: Endodontic measure: Function measure: Esthetics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Malmo university city: Malmo state: Skane zip: 214 21 country: Sweden lat: 55.60587 lon: 13.00073 facility: Malmo university city: Malmo state: Skane zip: 21421 country: Sweden lat: 55.60587 lon: 13.00073 hasResults: False
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<|newrecord|> nctId: NCT06352970 id: LundU-2024 briefTitle: Effects of Tuberculosis Infection on Development and Function of the Placenta overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER name: Addis Ababa University name: Armauer Hansen Research Institute, Ethiopia briefSummary: The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.
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The main questions it aims to answer are:
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* Does TB infection affect the structure of the placenta?
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* Does TB infection affect the function of the placenta?
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Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:
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* Pathological lesions of the placenta
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* Gene and protein expression patterns linked to pregnancy-related disorders
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* Infant outcome at birth and at 6 weeks after birth conditions: Pregnancy Related conditions: Tuberculosis Infection conditions: Placenta Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: TB infection measure: Proportion of women with pathological placental findings according to the Amsterdam consensus criteria measure: Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders measure: Proportions of infants (born to participating women) with adverse outcome sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06352957 id: 23022022CERC briefTitle: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study acronym: ETERNITY-ITA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Istituto di Fisiologia Clinica CNR class: OTHER briefSummary: The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.
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The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months. conditions: Hemodialysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Levels of VKDP measure: Calcium measure: Phosphate measure: Magnesium measure: ALP measure: PTH measure: 25(OH)D measure: P1NP measure: CTX measure: TRAP 5b measure: BSAP measure: cFGF23 measure: Klotho measure: Sclerostin measure: DKK1 measure: Fetuin A measure: Zinc measure: Irisin measure: Serum Calcification Propensity T50 test measure: Hemoglobin (Hb) measure: Hematocrit (Ht) measure: Plates (PLTS) measure: Reticulocytes measure: Iron measure: Ferritin measure: Transferrin measure: Transferrin Saturation measure: Albumin measure: KT/V measure: Aluminium measure: C-reactive Protein (CRP) measure: Cholesterol measure: Triglycerides measure: Cholesterol HDL measure: Cholesterol LDL measure: Vascular Calcification measure: Vertebral Fractures measure: BMD: Bone Mineral Density measure: Association between Verterbal Fractures and Vascular Calcificatiom measure: Novel quantitative computer-assisted scoring method for vascular calcifications. measure: Effect of Etelcalcetide on cardiovascular events and all-cause mortality. measure: Etelcalcetide Safety: Number of participants with treatment-related adverse events. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06352944 id: AssiutMD briefTitle: Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2026-07 date: 2024-04-08 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ) conditions: Non-cystic Fibrosis Bronchiectasis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: procalcitonin measure: procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06352931 id: TCD & TCUS in infants briefTitle: Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-30 date: 2025-07-30 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging. conditions: Trancranial Doppler studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: transcranial and transcranial dopp;er measure: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler sex: ALL minimumAge: 1 Day maximumAge: 1 Year stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06352918 id: B.30.2.ATA.0.01.00/395 briefTitle: Peripheral Central Catheter (PICC) Care acronym: PICC overallStatus: COMPLETED date: 2023-05-01 date: 2023-11-30 date: 2023-12-31 date: 2024-04-08 date: 2024-04-08 name: Ataturk University class: OTHER briefSummary: Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.
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Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies. conditions: NEWBORN conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Palmar grasp reflex stimulation measure: Pain level measure: Comfort sex: ALL minimumAge: 28 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Ataturk University city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06352905 id: 2157711 briefTitle: Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease overallStatus: RECRUITING date: 2022-09-01 date: 2025-04 date: 2025-04 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER name: University of St. Augustine for Health Sciences briefSummary: This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Whole body vibration (WBV) name: Control measure: 3-meter backward walk test (3MBWT) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Anne Boddy role: CONTACT phone: 904-806-2126 email: [email protected] lat: 31.54933 lon: -97.14667 hasResults: False
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<|newrecord|> nctId: NCT06352892 id: 20210201 briefTitle: A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-09-03 date: 2024-09-03 date: 2024-04-08 date: 2024-04-08 name: Amgen class: INDUSTRY briefSummary: The main objective of the study is to assess the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) administration in overweight or obese Chinese participants. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: AMG 133 measure: Maximum Observed Plasma Concentration (Cmax) of AMG 133 measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133 measure: AUC from Time Zero Extrapolated to Infinity (AUCinf) of AMG 133 measure: Number of Participants with Treatment-emergent Adverse Events measure: Number of Participants with Serious Adverse Events measure: Number of Participants with Anti-AMG 133 Antibodies sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06352879 id: 18-Al-KindyCM briefTitle: Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq. overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-06-15 date: 2024-04-08 date: 2024-04-08 name: Al-Kindy College of Medicine class: OTHER briefSummary: The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:
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* What is the prevalence of incontinence among the targeted group?
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* What are the types of incontinence and what is the frequency of each type among the targeted group?
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* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors. conditions: Urinary Incontinence conditions: Urge Incontinence conditions: Stress Incontinence studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED measure: Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) measure: Risk factors for urinary incontinence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baghdad Al- Karkh Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: [email protected] name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 facility: Baghdad Al-Russafa Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: [email protected] name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False
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<|newrecord|> nctId: NCT06352866 id: CASE3A23 briefTitle: Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-04-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-16 name: Jack Khouri class: OTHER briefSummary: The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion. conditions: Multiple Myeloma conditions: Cytokine Release Syndrome conditions: Refractory Multiple Myeloma conditions: Immune Effector Cell Associated Neurotoxicity Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open label single cohort feasibility and efficacy study of siltuximab prophylaxis prior to infusion of teclistamab for treatment of RRMM. There is no planned dose escalation and no separate cohorts.
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Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Siltuximab name: Teclistamab(FDA-approved) measure: Change in CRS Rate measure: Safety assessment of a single dose of siltuximab as CRS prophylaxis measure: Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis measure: Incidence of all grade ICANS after siltuximab prophylaxis measure: Incidence of adverse events after siltuximab prophylaxis measure: Overall response rate measure: Progression free survival measure: Overall survival measure: Hospitalization rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio city: Cleveland state: Ohio zip: 44195 country: United States name: Jack Khouri, MD role: CONTACT phone: 866-223-8100 email: [email protected] name: Jack Khouri, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06352853 id: Diathermy and skin incision cs briefTitle: Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section overallStatus: COMPLETED date: 2022-04-01 date: 2022-09-01 date: 2022-10-01 date: 2024-04-08 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications. conditions: Skin Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 120 type: ACTUAL name: Skin incision in Cesarean Section by Diathermy name: Skin incision in Cesarean Section by Scalpel measure: Skin incision time in scalpel versus diathermy group measure: Estimation of incision blood loss in both groups measure: Postoperative pain in both groups measure: Postoperative wound healing in both groups sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Shaimaa El Shemy city: Giza state: Cairo zip: 11562 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06352840 id: HUM00231526 id: 5K23HD099283-03 type: NIH link: https://reporter.nih.gov/quickSearch/5K23HD099283-03 briefTitle: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
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The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach. conditions: Chronic Pelvic Pain conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both participants and outcome assessors will be blinded to study group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 125 type: ESTIMATED name: My Pelvic Plan Website name: Control Group website measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Sara Till, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06352827 id: HUM00228948 id: 1K23DK134752-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK134752-01 briefTitle: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation. conditions: Constipation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: Surveys measure: Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment measure: Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Brenda Ayala role: CONTACT phone: 734-936-4780 email: [email protected] name: Eric Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06352814 id: 1977152 briefTitle: Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-08 date: 2027-05-30 date: 2027-05-30 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER briefSummary: The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy. conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Activities-based locomotor training (physical therapy) measure: Gross Motor Function Measure-66 (GMFM) measure: Pediatric Neuromuscular Recovery Scale (PedsNRS) measure: Pediatric Evaluation of Disability Inventory (PEDI-CAT) measure: Pediatric Quality of Life Inventory CP Module (PedsQL-CP) measure: Functional near-infrared spectroscopy measure: Electromyography measure: ActiGraph sensors sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Megan Flores role: CONTACT phone: 512-529-4421 email: [email protected] lat: 31.54933 lon: -97.14667 hasResults: False
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<|newrecord|> nctId: NCT06352801 id: EA230530 briefTitle: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder overallStatus: RECRUITING date: 2023-12-28 date: 2026-05-31 date: 2026-05-31 date: 2024-04-08 date: 2024-04-09 name: The University of Hong Kong class: OTHER briefSummary: The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.
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The intervention program includes the following components:
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Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.
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To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.
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Study Objectives:
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1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being
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2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong
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Hypotheses:
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1. AD/HD traits negatively predicts psychological well-being
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2. AD/HD traits positively predicts perceived criticism or rejection sensitivity
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3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being
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4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being
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5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
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6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
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7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group. conditions: ADHD conditions: Self-Compassion conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session.
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Wait-list Control: receives the same intervention in Phase 2 primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Self-Compassion Intervention measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Growth Mindset Scale measure: Growth Mindset Scale measure: Growth Mindset Scale sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Kwan Lok TANG role: CONTACT phone: +852-66532947 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06352788 id: 202007224 briefTitle: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices acronym: AFOSVA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-08-31 date: 2028-09-01 date: 2024-04-08 date: 2024-04-08 name: Jason Wilken class: OTHER name: Mayo Clinic name: Vanderbilt University Medical Center name: Navy Medical Center San Diego name: Minneapolis Veterans Affairs Medical Center name: Johns Hopkins University briefSummary: This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. conditions: Foot Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Modular Carbon Fiber Custom Dynamic Orthosis (CDO) name: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) measure: PROMIS Physical Function measure: PROMIS Pain Interference measure: OPUS Satisfaction with Device and Services measure: Modified Socket Comfort Score - Comfort measure: Modified Socket Comfort Score - Smoothness measure: Numerical Pain Rating Scale measure: Preference - Ranked measure: Preference - CDO Configuration measure: Four Square Step Test (seconds) measure: Sit to Stand 5 Times (seconds) measure: Center of Pressure Velocity Magnitude (m/s) measure: Center of Pressure Velocity Timing (%stance) measure: Ankle Zero Moment Crossing (%stance) measure: Peak Ankle Dorsiflexion (degree) measure: Peak Ankle Plantarflexion Moment (Nm/kg) measure: Peak Ankle Push-Off Power (W/kg) measure: PROMIS Satisfaction with Participation in Social Activities measure: PROMIS Satisfaction with Participation in Discretionary Social Activities measure: PROMIS Depression measure: 10 Meter Shuttle Run (seconds) measure: Self Selected Walking Velocity (m/s) measure: Ankle Range of Motion (degrees) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06352775 id: IRB00107112 briefTitle: Calcium Carbonate on Labor Induction overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Aurora Health Care class: OTHER briefSummary: The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes. conditions: Pregnancy conditions: Uterine Contraction studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Calcium Carbonate measure: Duration of induction time measure: Rate of labor dystocia measure: Rate of cesarean deliveries measure: Total amount of oxytocin after cervical ripening measure: Gastrointestinal side effects measure: Blood loss measure: Rate of postpartum hemorrhage (>/= 500mL) measure: Neonatal composite adverse outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aurora Sinai Medical Center city: Milwaukee state: Wisconsin zip: 53233 country: United States name: Marie Forgie, DO role: CONTACT phone: 414-219-5800 email: [email protected] name: Emily Malloy, PhD, CNM role: CONTACT phone: 414-219-6649 email: [email protected] lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06352762 id: Izmir Dokuz Eylul University briefTitle: The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy overallStatus: COMPLETED date: 2017-02-15 date: 2017-08-15 date: 2017-12-15 date: 2024-04-08 date: 2024-04-08 name: Izmir Bakircay University class: OTHER briefSummary: Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).
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Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level. conditions: Spastic Hemiplegic Cerebral Palsy conditions: Upper Extremity Paresis conditions: Robotic Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way. primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: Conventional physiotherapy name: Robotic Rehabilitation measure: Muscle Tone measure: Upper Extremity Motor Function measure: Manual Ability measure: Functional Independence sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nuriye Büyüktaş city: Bursa state: Nilüfer zip: 16130 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
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<|newrecord|> nctId: NCT06352749 id: BasqueCU2024 briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH) acronym: ExerMOT-NH overallStatus: RECRUITING date: 2024-03-18 date: 2025-11-30 date: 2025-11-30 date: 2024-04-08 date: 2024-04-08 name: University of the Basque Country (UPV/EHU) class: OTHER name: Fundación Miranda name: Residencia Albiz Santiago Llanos name: Aspaldiko name: Residencia Nuestra Señora de Begoña, Santurtzi briefSummary: The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active. conditions: Physical Function conditions: Cognitive Decline conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Advice to increase physical activity and reduce sedentary behavior name: Online Physical Exercise name: Face-to-Face Exercise measure: Trail Making Test (TMT) measure: Spanish Version of the Yesavage Depression Scale measure: 30-seconds Chair Sit to Stand test measure: MoCA (Montreal Cognitive Assessment) measure: Wechsler Adult Intelligence Scale III (WAIS-III) measure: EuroQol-5 dimensions (EQ-5D-5L) measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008) measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008) measure: Satisfaction with Life Scale measure: Short Physical Performance Battery (SPPB) measure: The Biceps Curl Test measure: The 2-minute Walk Test (2-MWT) measure: The 8 Feet Up-and-Go test measure: Handgrip strength test measure: Serum Brain Derived Neurotrophic Factor (BDNF) measure: Serum Klotho measure: Serum Glucose measure: Serum Urea measure: Serum Creatinine measure: Serum Uric Acid measure: Serum Cholesterol measure: Serum Triglycerides measure: Serum HDL-Cholesterol measure: Serum LDL-Cholesterol measure: Serum Glutamate Pyruvate Transaminase measure: Serum Glutamate Oxaloacetate Transaminase measure: Serum gamma glutamyl transferase measure: Serum Alkaline Phosphatase measure: Serum Creatin Kinase measure: Serum Lactate Dehydrogenase measure: Serum Bilirubin measure: Serum Sodium measure: Serum Potassium measure: Serum Chloride measure: Serum C Reactive Protein measure: Serum Albumin measure: Serum Total Protein measure: Serum Calcium measure: Serum Phosphorus measure: Serum D Vitamin measure: Erythrocyte count measure: Hemoglobin measure: Hematocrit measure: Mean Corpuscular Volume (MCV) measure: Mean Corpuscular Hemoglobin (MCH) measure: Mean Corpuscular Hemoglobin Concentration (MCHC) measure: Red Cell Distribution Width (RDW) measure: Leucocyte Count measure: Neutrophil Count and Percentage measure: Lymphocyte Count and Percentage measure: Monocyte Count and Percentage measure: Eosinophil Count and Percentage measure: Basophil Count and Percentage measure: Platelet Count measure: Platelet Mean Volumen measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry measure: Fried's frailty phenotype score measure: Frail-NH frailty scale measure: The Pittsburgh Sleep Quality Index measure: Attendance rate measure: Dose modification measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Residencia Aspaldiko status: RECRUITING city: Portugalete state: Bizkaia zip: 48920 country: Spain name: Alvaro Mosquera role: CONTACT phone: 34-946250000 email: [email protected] lat: 43.32099 lon: -3.02064 facility: Residencia Nuestra Señora de Begoña status: NOT_YET_RECRUITING city: Santurtzi state: Bizkaia zip: 48980 country: Spain name: Janire R Ochoa role: CONTACT phone: 944836875 email: [email protected] lat: 43.32842 lon: -3.03248 facility: Residencia Albiz Santiago LLanos status: NOT_YET_RECRUITING city: Sestao state: Bizkaia zip: 48910 country: Spain name: Olatz Larrinaga role: CONTACT phone: 946572220 email: [email protected] lat: 43.30975 lon: -3.00716 facility: Fundación Miranda status: NOT_YET_RECRUITING city: Barakaldo state: Vizcaya zip: 48902 country: Spain name: Celia Gómez role: CONTACT phone: 944382675 email: innovación@fundaciónmiranda.org lat: 43.29639 lon: -2.98813 hasResults: False
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<|newrecord|> nctId: NCT06352736 id: LUTS2023 briefTitle: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community overallStatus: RECRUITING date: 2023-06-01 date: 2025-10-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-15 name: Chinese PLA General Hospital class: OTHER briefSummary: This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding. conditions: Lower Urinary Tract Symptoms studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 12567 type: ESTIMATED measure: International Prostate Symptom Score(IPSS) measure: Overactive Bladder Syndrome Score(OABSS) measure: International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF) measure: Quality of Life Score（QOL） measure: Prostatic volume measure: Maximum urinary flow rate measure: Residual urine measure: free prostatic specific antigen(fPSA) measure: total prostatic specific antigen(tPSA) measure: fPSA/ tPSA sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital status: RECRUITING city: Beijing zip: 100853 country: China name: Qing Yuan, Doctor's degree role: CONTACT phone: 18910980422 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06352723 id: 2024P000856 briefTitle: Cenobamate in the Intensive Care Unit acronym: CENOBITE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-04-08 date: 2024-04-08 name: Brigham and Women's Hospital class: OTHER briefSummary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.
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Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome. conditions: Epilepsy conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Cenobamate measure: Target level measure: Maintenance level measure: Seizure cessation measure: Seizure burden change sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06352710 id: 2022-01510 briefTitle: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project overallStatus: RECRUITING date: 2023-06-12 date: 2025-06-12 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Cantonal Hospital of St. Gallen class: OTHER briefSummary: Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.
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