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This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.
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Eligible patients:
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Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
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Study intervention:
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Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules. conditions: Surgical Complication studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized controlled prospective interventional trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% NaCl (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures.
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Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 3000 type: ESTIMATED name: Tranexamic Acid 100 MG/ML name: 0.9%sodium chloride measure: Postoperative re-bleeding measure: Postoperative wound infection measure: Postoperative wound rupture measure: Postoperative thromboembolic events measure: Postoperative seroma measure: Any other postoperative complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270394 id: MJX briefTitle: FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application overallStatus: SUSPENDED date: 2022-04-28 date: 2023-07-28 date: 2027-03-31 date: 2024-02-21 date: 2024-02-21 name: The First Affiliated Hospital of Anhui Medical University class: OTHER name: National Natural Science Foundation of China briefSummary: This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:
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Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.
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Investigators will screen suitable participants among patients undergoing routine FDG examination.
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* Participants will sign an informed consent form
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* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
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* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.
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The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test. conditions: Malignant Tumors conditions: Positron-Emission Tomography studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-Fibroblast activation protein inhibitor measure: 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG measure: Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FirstHAnhuiMU city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06270381 id: UIDB/05299/2020 briefTitle: Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder overallStatus: RECRUITING date: 2023-08-07 date: 2024-11-01 date: 2024-11-01 date: 2024-02-21 date: 2024-02-21 name: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida class: OTHER briefSummary: The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment. conditions: Grief Disorder, Prolonged studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: EMPOWER name: Treatment as usual (TAU) measure: Prolonged Grief measure: Anxiety and depression measure: Sociodemographic data measure: Risk Assessment for Grief measure: Coping strategies measure: Adult attachment measure: Psychological inflexibility measure: Social Support measure: Therapeutic alliance measure: Posttraumatic Growth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde Santa Maria status: RECRUITING city: Lisboa country: Portugal name: Alexandra Coelho, PhD role: CONTACT phone: 919957534 email: alexandra.moura.coelho@gmail.com lat: 38.71667 lon: -9.13333 hasResults: False
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<|newrecord|> nctId: NCT06270368 id: PREHMO briefTitle: Children Born Preterm: Sustainable Health Monitoring overallStatus: RECRUITING date: 2020-08-05 date: 2025-08-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Meyer Children's Hospital IRCCS class: OTHER name: IRCCS Fondazione Stella Maris briefSummary: Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 650 type: ESTIMATED measure: Infant development measure: Childhood development measure: Presence of visual or hearing impairement measure: Presence of asthma measure: Access to care sex: ALL minimumAge: 20 Months maximumAge: 66 Months stdAges: CHILD facility: Azienda Ospedaliero-Universitaria Careggi (AOUC) status: RECRUITING city: Firenze country: Italy name: Simone Pratesi role: CONTACT lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Vieri Lastrucci role: CONTACT email: vieri.lastrucci@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Pisana (AOUP) status: RECRUITING city: Pisa country: Italy name: Rosa Scaramuzzo role: CONTACT lat: 43.70853 lon: 10.4036 facility: Azienda Ospedaliero Universitaria Senese (AOUS) status: RECRUITING city: Siena country: Italy name: Carlo Valerio Bellieni role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False
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<|newrecord|> nctId: NCT06270355 id: 2023-06555-01 briefTitle: Stockholm Mammography Risk Stratified Trial acronym: SMART overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2028-04-08 date: 2032-04-08 date: 2024-02-21 date: 2024-02-28 name: Karolinska Institutet class: OTHER briefSummary: SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 70000 type: ESTIMATED name: Risk based screening measure: Incidence of interval cancers measure: Number of recalled women measure: Number of biopsies measure: Breast cancer measure: Tumor characteristics - Stage measure: Tumor characteristics - Multifocality measure: Tumor characteristics - Receptor status measure: Tumor characteristics - Proliferation measure: Cancer worry measure: Cancer anxiety measure: Side effects related to contrast enhanced mammography measure: Cost-effectiveness measure: Willingness-to-pay sex: FEMALE minimumAge: 40 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270342 id: DTMS briefTitle: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-01 date: 2023-12-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ACTUAL name: dual task assessment measure: The Minnesota Manual Dexterity Test measure: Dual Task Questionnaire measure: Edinburgh Handedness Questionnaire measure: Expanded Disability Status Scale measure: Brief International Cognitive Assessment Battery for Multiple Sclerosis measure: Beck Depression Scale measure: Fatigue Impact Scale measure: Multiple Sclerosis Quality of Life Questionnaire-54 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False
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<|newrecord|> nctId: NCT06270329 id: NMTwithKOA briefTitle: Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis) acronym: OA overallStatus: COMPLETED date: 2022-01-15 date: 2023-01-15 date: 2023-06-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA). conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial design primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Neuromuscular training program name: conventional physical therapy program measure: Visual Analog Scale measure: Western Ontario and McMasterUniversities Osteoarhritis Index measure: Time on One Leg Standing measure: Five Times Sit to Stand Test measure: Manual Muscle Test measure: Short Form sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Science University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False
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<|newrecord|> nctId: NCT06270316 id: CT-AMT-191-01 briefTitle: Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-29 date: 2024-02-21 date: 2024-02-21 name: UniQure Biopharma B.V. class: INDUSTRY briefSummary: This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal. conditions: Fabry Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: AMT-191 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Duration of Vector deoxyribonucleic acid (DNA) shedding presented in blood, saliva, feces, semen, and urine sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06270303 id: 2023-00383-01 briefTitle: Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2036-03-01 date: 2024-02-21 date: 2024-02-21 name: Göteborg University class: OTHER name: Johann Wolfgang Goethe University Hospital name: Charite University, Berlin, Germany name: King's College London name: Queen Mary University of London name: Geistlich Pharma AG name: Vastra Gotaland Region briefSummary: The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?
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200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated. conditions: Periodontitis conditions: Furcation Defects studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical assessments following intervention will be conducted by assessors unaware of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Access flap & surgical debridement name: Application of bone substitute material (BioOss Collagen) measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Rate of adverse events. measure: Rate of adverse events. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Change of inflammatory markers. measure: Change of inflammatory markers. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Periodontology, Institute of Odontology city: Göteborg zip: 40530 country: Sweden name: Jan Derks, PhD role: CONTACT phone: 0046 76 618 3124 email: jan.derks@odontologi.gu.se name: Jan Derks, PhD role: PRINCIPAL_INVESTIGATOR name: Karolina Karlsson, PhD role: SUB_INVESTIGATOR name: Kostas Bougas, PhD role: SUB_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06270290 id: 327648 briefTitle: The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls acronym: COSP-RBD overallStatus: RECRUITING date: 2024-04-22 date: 2025-03-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-23 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).
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The main questions it aims to answer are:
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* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?
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* Is this proportion higher to that in control patients without a diagnosis of RBD?
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Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.
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Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ. conditions: REM Sleep Behavior Disorder conditions: Concussion, Brain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 140 type: ESTIMATED name: Exposure to contact sports or history of concussions measure: Proportion of history of contact sports practice / concussion in RBD and control participants. measure: Differences in concussions characteristics between RBD and control participants. measure: Demographic or clinical differences between RBD participants with and without concussions history. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guy's & St Thomas' NHS Foundation Trust status: RECRUITING city: London zip: SE1 9RT country: United Kingdom name: Gill Radcliffe role: CONTACT phone: 02071888070 email: gillian.radcliffe@gstt.nhs.uk lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06270277 id: 30.01.2024-4272 briefTitle: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease overallStatus: COMPLETED date: 2024-02-14 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-22 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues. conditions: Inflammatory Bowel Diseases conditions: Psychosocial Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). primaryPurpose: DIAGNOSTIC masking: NONE count: 159 type: ACTUAL name: Pediatric Quality of Life Inventory (PedsQL) name: Strengths and Difficulties Questionnaire (SDQ) measure: Pediatric Quality of Life Inventory (PedsQL) score measure: Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06270264 id: 111-2023 briefTitle: Nociception Monitoring in Intensive Care overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-15 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Haseki Training and Research Hospital class: OTHER briefSummary: Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care. conditions: Unconscious State conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, prospective and controlled primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: the Nociception level index monitoring measure: total fentanyl consumption measure: systolic blood pressure measure: heart rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital city: Istanbul state: Sultangazi country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06270251 id: PSYCH-2023-32292 briefTitle: Modeling Tic Change During Behavior Therapy for Tics overallStatus: RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-09-01 date: 2024-02-21 date: 2024-04-01 name: University of Minnesota class: OTHER briefSummary: Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.
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CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.
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The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. conditions: Chronic Tic Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CBIT measure: Tic Severity measure: Sheehan Disability scale measure: Behavior Rating Inventory of Executive Function measure: Ask Suicide-Screening Questions (ASQ) measure: Child Attitudes Toward Illness Scale (CATIS) measure: Rosenberg Self-Esteem Scale measure: Caregiver Strain Questionnaire measure: Clinical Global Impressions (CGI) measure: Parent/Adult Tic Questionnaire measure: Premonitory Urge for Tics Scale measure: Tic Suppression Task measure: Stop signal task sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Brianna Wellen role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False
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<|newrecord|> nctId: NCT06270238 id: 2023-11-164 briefTitle: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients overallStatus: RECRUITING date: 2024-02-13 date: 2025-09-30 date: 2025-09-30 date: 2024-02-21 date: 2024-02-29 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: High-Frequency1 name: cTBS1 name: High-Frequency2 name: cTBS2 name: High-Frequency3 name: cTBS3 measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: wh.chang@samsung.com lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06270225 id: SSGJ-613-PGF-II-01 briefTitle: A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. overallStatus: RECRUITING date: 2024-03-30 date: 2024-06 date: 2024-12 date: 2024-02-21 date: 2024-04-10 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment. conditions: Gout Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg name: Colchicine 0.5 mg measure: Numbers of acute gout flares measure: Numbers of acute gout flares measure: Proportions of subjects with at least 1 acute gout flare measure: Proportions of subjects with at least 1 acute gout flare measure: Time from randomization to first acute flare. measure: Duration of acute gout flares. measure: Duration of acute gout flares. measure: Subject's overall assessment of response to treatment measure: Investigator's overall assessment of response to treatment measure: 36-item Short Form Survey (SF-36) measure: Adverse events (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Huashan Hospital Fudan University-Rheumatology status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Hejian Zou, MD role: CONTACT phone: +86 13311881366 email: hjzou@fudan.edu.cn name: Hejian Zou role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06270212 id: CIV-ID 23-08-043797 briefTitle: Medical Device for Airway Patency During Sedation acronym: STAIRWAY-2 overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Stairway Medical AB class: INDUSTRY name: Lund University briefSummary: OVERALL SYNOPSIS
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PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants
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* of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position
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* of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.
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PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration
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* of adjuvant manual airway support and ventilation
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* of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])
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* of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and
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* of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients. conditions: Airway Obstruction conditions: Sedation Complication conditions: Perioperative Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B).
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The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions.
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However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions.
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The number of enrolled study participants reported below (46) refers to evaluable ones. whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: STAIRWAY name: NO DEVICE measure: Transpharyngeal distance during moderate-to-deep steady-state sedation. measure: Duration of manual airway support during PS for clinical procedures. measure: Transpharyngeal distance during mild steady-state sedation. measure: Duration of interrupted capnometric monitoring during sedation. measure: Duration of manual airway support during induction of steady-state sedation. measure: Sedational comfort measure: Conditions for sedation measure: Conditions for procedural intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö state: Skåne zip: 20502 country: Sweden name: Magnus Ljungvall, MD role: CONTACT phone: +46-705445502 email: magnus.ljungvall@med.lu.se name: Jonas Åkeson, PhD, Professor role: CONTACT phone: +46-708311113 email: jonas.akeson@med.lu.se lat: 55.60587 lon: 13.00073 hasResults: False
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<|newrecord|> nctId: NCT06270199 id: PULMESCELL-2 briefTitle: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia. overallStatus: RECRUITING date: 2024-01-11 date: 2025-12 date: 2026-12 date: 2024-02-21 date: 2024-02-21 name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients. conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Group Assignment primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Control name: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions name: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia measure: feasibility variable measure: Incidence of BPD and PH in very low birth weight babies treated with MSC measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. measure: Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age measure: Date of hospital discharge and respiratory care at discharge. measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). measure: Duration of invasive and non-invasive mechanical ventilation. measure: Use of postnatal corticosteroids indicated measure: Respiratory readmission rates. measure: Bayley Neurodevelopmental Scale at 24 months measure: Date and cause of death. sex: ALL minimumAge: 1 Month maximumAge: 28 Weeks stdAges: CHILD facility: Complejo Hospitalario La Coruña status: RECRUITING city: La Coruña country: Spain name: Alejandro Dávila role: CONTACT lat: 43.37135 lon: -8.396 facility: Hospital Clínico San Carlos status: RECRUITING city: Madrid country: Spain name: Luis Arruza role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz status: RECRUITING city: Madrid country: Spain name: Paloma Lopez role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Carlos Haya status: RECRUITING city: Málaga country: Spain name: Tomás Sánchez Tamayo role: CONTACT lat: 36.72016 lon: -4.42034 facility: Hospital Vírgen del Rocío status: RECRUITING city: Sevilla country: Spain name: Antonio Pavón Delgado role: CONTACT name: María José Moreno Valera role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitario y Politécnico La Fe status: RECRUITING city: Valencia country: Spain name: Máximo Vento role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06270186 id: 20-AOIP-04 briefTitle: Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach acronym: GoodDiagNMD overallStatus: WITHDRAWN date: 2023-11 date: 2024-11 date: 2024-11 date: 2024-02-21 date: 2024-02-21 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.
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Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.
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In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.
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The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy. conditions: Myotonic Dystrophy 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 0 type: ACTUAL name: Type 1 myotonic dystrophy measure: Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1 measure: Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session measure: To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session measure: Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests measure: Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270173 id: TWM-C-2202 briefTitle: Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures overallStatus: RECRUITING date: 2024-02-16 date: 2025-07-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiltrom Co., Ltd. class: INDUSTRY name: Maxis Medical GmbH briefSummary: The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis. conditions: Osteoporotic Vertebral Compression Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) measure: Proportion of participants with study success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Friedrichshafen status: NOT_YET_RECRUITING city: Friedrichshafen state: Baden-Württemberg zip: 88048 country: Germany name: Ludwig Oberkircher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 47.65689 lon: 9.47554 facility: University Hospital Mannheim status: NOT_YET_RECRUITING city: Mannheim state: Baden-Württemberg zip: 68167 country: Germany name: Frederic Bludau, PD Dr med role: PRINCIPAL_INVESTIGATOR lat: 49.4891 lon: 8.46694 facility: Johann Wolfgang Goethe University Frankfurt/Main status: NOT_YET_RECRUITING city: Frankfurt am Main state: Hesse zip: 60596 country: Germany name: Thomas Vogl, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.11552 lon: 8.68417 facility: Krankenaus Mechernich status: RECRUITING city: Mechernich state: North-Rhine-Westphalia zip: 53894 country: Germany name: Robert Pflugmacher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.59304 lon: 6.65224 hasResults: False
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<|newrecord|> nctId: NCT06270160 id: KampalaLivelihoodsStudy briefTitle: Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-12-31 date: 2024-02-21 date: 2024-03-01 name: University of Toronto class: OTHER briefSummary: Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.
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Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala. conditions: Financial Stress conditions: Social Functioning conditions: Social Skills studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey after the study is complete. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 432 type: ESTIMATED name: HIVST name: mHealth name: Creating Futures Livelihoods program measure: Number of participants engaged in HIV testing measure: Number of participants with knowledge of their HIV status measure: Number of participants linked to confirmatory HIV testing measure: Frequency of linkage to HIV care measure: Brief HIV Knowledge Questionnaire measure: Sexual Risk sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Young African Refugees for Integral Development status: RECRUITING city: Kampala country: Uganda name: Robert Hakiza role: CONTACT phone: 256 2009 12345 email: roberthakiza2001@gmail.com lat: 0.31628 lon: 32.58219 hasResults: False
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<|newrecord|> nctId: NCT06270147 id: 16935 briefTitle: Timing of TAP Blocks in Bariatric Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-06-28 date: 2024-06-28 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER briefSummary: This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs. conditions: Opioid Use conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bupivacaine-epinephrine measure: Opioid Consumption measure: Length of Stay measure: Anesthesia requirements measure: Sedation requirements measure: Nausea and vomiting measure: Respiratory Status measure: Opioid consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270134 id: 14410 briefTitle: Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2029-01 date: 2029-01 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel. conditions: Hemolysis conditions: Renal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. primaryPurpose: TREATMENT masking: NONE count: 5000 type: ESTIMATED name: Bicarbonate measure: Non-elective hospitalizations or mortality measure: Hospitalizations and fractures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270121 id: R2111483 briefTitle: Development of a Healthcare Service Platform for Successful Aging overallStatus: RECRUITING date: 2020-10-21 date: 2026-11-30 date: 2030-11-30 date: 2024-02-21 date: 2024-02-21 name: Sunmi Song class: OTHER briefSummary: The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are:
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* Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults
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* Develop digital health monitoring service to inform individualized daily health status of older adults users
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* Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information.
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Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers.
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If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group. conditions: Depression in Old Age conditions: Chronic Pain conditions: Sleep Disorder Insomnia Chronic studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Control group was informed that they participated in the study with a repeated measure survey about digital healthcare for elderly without detailed descriptions on the living-lab intervention. whoMasked: PARTICIPANT count: 84 type: ESTIMATED name: Living-lab digital intervention group measure: Patient Health Questionnaire-9 (PHQ-9) measure: Sleep fragmentation index measure: Daily steps measure: Intensity of physical activity measure: Heart rate variability measure: Geriatic depression measure: SF-12 Quality of life measure: Pain related functional limitations measure: Chronic pain sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Korea University status: RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: Sunmi Song, PhD role: CONTACT phone: +821087489593 email: sunmi.song0715@gmail.com lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06270108 id: 22/SS/0040 id: 299382 type: OTHER domain: Integrated Research Application System briefTitle: The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia acronym: RESTORE overallStatus: RECRUITING date: 2022-11-14 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-03-05 name: King's College London class: OTHER name: South London and Maudsley NHS Foundation Trust briefSummary: The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:
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To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.
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To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.
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To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.
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