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<|newrecord|> nctId: NCT06371365 id: KMUHIRB-E(II)-20220204 briefTitle: Adverse Events for Free Flap Surgery in Head and Neck Cancer overallStatus: COMPLETED date: 2022-10-19 date: 2023-09-24 date: 2023-09-24 date: 2024-04-17 date: 2024-04-18 name: Kaohsiung Medical University class: OTHER name: Kaohsiung Medical University Chung-Ho Memorial Hospital briefSummary: This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022. conditions: Surgical Flaps conditions: Flap Failure Risk Factors conditions: Hematoma Risk Factors conditions: Thrombosis Risk Factors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 540 type: ACTUAL name: Free Flap surgery measure: Number of participants with flap failure measure: Number of participants with hematoma measure: Number of participants with thrombosis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung country: Taiwan lat: 22.61626 lon: 120.31333 hasResults: False |
<|newrecord|> nctId: NCT06371352 id: JagiellonianU73 briefTitle: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-05 date: 2024-04-17 date: 2024-04-17 name: Jakub Antczak class: OTHER name: Institute of Psychiatry and Neurology, Warsaw briefSummary: Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression. conditions: Unipolar Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: iTBS name: cTBS name: Sham measure: Beck Depression Inventory 2 measure: Pittsburgh Sleep Quality Index measure: Brief Psychiatric Rating Scale measure: Epworth Sleepiness Scale measure: Fatigue Assessment Scale measure: Quality of Life in Depression Scale measure: Sleep propensity non-rapid eye movement 1 sleep stage measure: Sleep propensity non-rapid eye movement 2 sleep stage sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Psychiatry and Neurology city: Warsaw zip: 02957 country: Poland name: Bogdan Stefanowski role: CONTACT phone: +48 22 45 82 532 email: [email protected] name: Jakub Antczak, MD role: CONTACT phone: +48 12 400 25 50 email: [email protected] lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06371339 id: 23 VADS 03 briefTitle: Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases acronym: THIDOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Institut Claudius Regaud class: OTHER name: Laboratoire IJCLab briefSummary: This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated. |
Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population. The camera will be used to measure the 131I uptake/fixation rates during the thyroid scintigraphy. |
20 patients will be included in the study. conditions: Hyperthyroidism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Additional acquisitions with the investigational gamma-camera " MoTI ". measure: The clinical feasibility of using an ambulatory gamma camera. measure: The level of acceptance of the gamma camera by operators for carrying out examinations measure: The quality of the images for the expected clinical use measure: The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS) measure: The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula) measure: The 131I fixation rates will be measured in percent at different times. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IUCT-O city: Toulouse country: France name: Slimane ZERDOUD role: CONTACT phone: 05 31 15 56 28 email: [email protected] lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06371326 id: BJQLZT002004 briefTitle: A Study of ZT002 Injection in Participants With Overweight or Obesity overallStatus: ENROLLING_BY_INVITATION date: 2023-11-21 date: 2024-08-30 date: 2024-09-30 date: 2024-04-17 date: 2024-04-17 name: Beijing QL Biopharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity. conditions: Overweight or Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: ZT002 Injection name: Placebo measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events. measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events. measure: The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity. measure: The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity. measure: The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False |
<|newrecord|> nctId: NCT06371313 id: GuangdongWCH-LiLi03 briefTitle: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism overallStatus: COMPLETED date: 2023-05-01 date: 2024-03-05 date: 2024-03-05 date: 2024-04-17 date: 2024-04-17 name: Guangdong Women and Children Hospital class: OTHER briefSummary: This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS. conditions: PCOS studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 42 type: ACTUAL measure: Testosterone measure: Androstenedione measure: Dehydroepiandrosterone Sulfate measure: Sex Hormone Hinding Globulin measure: Free Androgen Index measure: Fasting Insulin measure: White Blood Cell Count measure: Neutrophil Count measure: High-sensitivity C-reactive Protein measure: Interleukin-6 sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Guangdong Women and Children Hosptial city: Guanzhou state: Guangdong zip: 511400 country: China hasResults: False |
<|newrecord|> nctId: NCT06371300 id: HLS21156 briefTitle: Photobiomodulation With REd vs BluE Light (REBEL) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-12 date: 2024-04-17 date: 2024-04-23 name: Aston University class: OTHER briefSummary: The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids). |
Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group. conditions: Dry Eye Syndromes conditions: Meibomian Gland Dysfunction conditions: Blepharitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each participant is randomised to either of 3 groups: Red light only group, red plus blue light group, or sham treatment group. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Red LLLT name: Blue LLLT name: Sham Red LLLT name: Sham Blue LLLT measure: Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aston Dry Eye Clinic city: Birmingham state: West Midlands zip: B4 7ET country: United Kingdom name: Jeremy Chung Bo Chiang, PhD role: CONTACT phone: +441212043934 phoneExt: 3934 email: [email protected] lat: 52.48142 lon: -1.89983 hasResults: False |
<|newrecord|> nctId: NCT06371287 id: 64696022.1.0000.5346 briefTitle: Effect of Musical Auditory Training on Subjects With Tinnitus Disorder overallStatus: RECRUITING date: 2023-02-20 date: 2024-08-10 date: 2025-02-10 date: 2024-04-17 date: 2024-04-24 name: Universidade Federal de Santa Maria class: OTHER briefSummary: Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults. conditions: Tinnitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Treinamento Auditivo Musical name: Placebo measure: Changes in latency of the long latency auditory evoked potential (LLAEP) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane Domeneghini Didoné role: CONTACT phone: 553220-9362 email: [email protected] name: Dayane Domeneghini Didoné D Dayane Domeneghini Didoné role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane D Didoné, Professora role: CONTACT phone: 553220-9362 email: [email protected] name: Christine G Schumacher, Mestranda role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 hasResults: False |
<|newrecord|> nctId: NCT06371274 id: ZYYY-IIT-TNBC-001 briefTitle: A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-17 date: 2024-04-17 name: First Affiliated Hospital of Zhejiang University class: OTHER name: Shanghai Longfine Biotechnology Co., Ltd. name: TopAlliance briefSummary: To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: ATRA name: Toripalimab measure: Objective Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Duration of Response (DOR) measure: Overall Survival (OS) measure: Incidence of Treatment-Emergent Adverse events as assessed by NCI-CTCAE 5.0 measure: Exploratory biomarkers-peripheral blood lymphocyte analysis measure: Exploratory biomarkers-Serum Metabolomics Analysis measure: Exploratory biomarkers-Fecal Microbiota Analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang Province, P.R. China zip: 310003 country: China name: Meihua Lin, MS role: CONTACT name: Jian Liu, MS role: PRINCIPAL_INVESTIGATOR name: Xiaochen Zhang, MD role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06371261 id: 2023/CHU/07 briefTitle: Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis acronym: ACHROMO-MUCO overallStatus: RECRUITING date: 2024-02-29 date: 2027-03 date: 2027-03 date: 2024-04-17 date: 2024-04-26 name: Centre Hospitalier Universitaire de la Réunion class: OTHER briefSummary: The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned. |
However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification. |
In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ESTIMATED name: Biological analyses measure: Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients. measure: Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status. measure: Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses. measure: Presence of virulence factors in these strains using genomic analyses measure: Search for genes responsible for antibiotic resistance by genomic analysis of these strains measure: To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU la Réunion North status: RECRUITING city: Saint-Denis country: Réunion name: VERHILLE Juliette, MD role: CONTACT email: [email protected] name: Juliette VERHILLE, MD role: PRINCIPAL_INVESTIGATOR lat: -20.88231 lon: 55.4504 facility: CHU la Réunion South status: RECRUITING city: Saint-Pierre country: Réunion name: PERISSON Caroline, MD role: CONTACT email: [email protected] name: Caroline PERISSON, MD role: PRINCIPAL_INVESTIGATOR lat: -21.3393 lon: 55.47811 hasResults: False |
<|newrecord|> nctId: NCT06371248 id: 2850 briefTitle: Steady Feet: Preventing Falls in the Community overallStatus: COMPLETED date: 2018-11-19 date: 2019-12-20 date: 2019-12-20 date: 2024-04-17 date: 2024-04-17 name: Changi General Hospital class: OTHER briefSummary: The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program. conditions: Fall conditions: Feasibility conditions: Older Adults conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 65 type: ACTUAL name: Steady Feet name: Usual care for fall prevention measure: Short Physical Performance Battery (SPPB) measure: CONFbal measure: Six-minute walk test (6MWT) measure: Timed up and go (TUG) measure: Four square step test (FSST) measure: Feedback and satisfaction survey measure: Attendance and completion rates measure: Safety of Steady Feet sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False |
<|newrecord|> nctId: NCT06371235 id: 2024-A00739-38 briefTitle: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier acronym: Pregiferon overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-09 date: 2027-03 date: 2024-04-17 date: 2024-04-17 name: CerbaXpert class: OTHER briefSummary: The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy. conditions: Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: Pregiferon measure: Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06371222 id: BSMMU/2023/6502 briefTitle: Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-31 date: 2024-02-01 date: 2024-04-17 date: 2024-04-17 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) \[1\]. |
One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes \[2\]. |
In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease \[3\]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers \[4\]. |
However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm. conditions: Mitral Stenosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 42 type: ACTUAL name: Ivabradine name: Beta blocker measure: effect of ivabradine in MS patients measure: quality of life of MS patients sex: ALL minimumAge: 17 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BSMMU city: Dhaka zip: 1200 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False |
<|newrecord|> nctId: NCT06371209 id: 2022P000619 briefTitle: Kinematics of Ewing Amputees overallStatus: ENROLLING_BY_INVITATION date: 2022-05-17 date: 2024-06-29 date: 2024-07-01 date: 2024-04-17 date: 2024-04-17 name: Brigham and Women's Hospital class: OTHER briefSummary: The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis. |
The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation. |
The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees. conditions: Lower Extremity Amputation conditions: Trans-Tibial Amputation conditions: Traumatic Lower Extremity Amputation conditions: Agonist-Antagonist Myoneural Interface studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 32 type: ESTIMATED name: Modified Amputation name: Standard Amputation measure: Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of ankle power generation measure: Symmetry of peak knee flexion during stance measure: Symmetry of step length sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mass General Brigham city: Boston state: Massachusetts zip: 02129 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06371196 id: BBD-PBC 2024-03 briefTitle: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-07-25 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Mei Han class: OTHER briefSummary: 1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; |
2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin. conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Babaodan Capsule measure: Total bilirubin (TBil) reversion rate measure: Total bilirubin (TBil) efficacy rate measure: biological response rate measure: ALT measure: AST measure: ALP measure: TBA measure: DBil measure: IBil measure: 5-D Pruritus Scale Score measure: Fatigue section of the PBC-40 questionnaire measure: Immunological indicators - serum IgM measure: Immunological indicators - serum IgG measure: Immunological indicators - serum IgA measure: Immunological indicators - anti-gp210 antibody measure: Immunological indicators - anti-sp100 antibody measure: Immunological indicators - autoantibodies AMA/AMA-M2 measure: Histopathology of the liver - grading of inflammatory activity measure: Histopathology of the liver - staging of the degree of fibrosis measure: 12-lead electrocardiogram measure: Physical examination measure: Routine blood test measure: Renal Function Tests-BUN measure: Renal Function Tests-UA measure: Renal Function Tests-Scr measure: Urinalysis measure: Coagulation tests-PT measure: Coagulation tests-APTT measure: Coagulation tests-TT measure: Coagulation tests-FIB measure: Urine beta-hCG pregnancy test measure: adverse event measure: Body temperature measure: Heart rate measure: Number of breaths in 1 min measure: Blood pressure-Diastolic blood pressure(mmHg) measure: Blood pressure-Systolic blood pressure(mmHg) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06371183 id: AOMSaidB briefTitle: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children on June 2024 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-30 date: 2027-05-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: A Comparative study of clinical, endoscopic and histopathological features of colitis in children conditions: Role of Ileoscopy in Diagnosis of Colitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients who complaining of lower GI manifestations primaryPurpose: DIAGNOSTIC masking: NONE count: 196 type: ESTIMATED name: Colonoscope measure: Role of ileoscopy in diagnosis of colitis measure: To correlate clinical manifestations by colonoscopic picture sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06371170 id: CCPC- 001/22 briefTitle: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2027-01-01 date: 2024-04-17 date: 2024-04-19 name: Azienda Ospedaliero, Universitaria Ospedali Riuniti class: OTHER briefSummary: The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment? |
Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis. conditions: Intracardiac Thrombus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Rivaroxaban measure: Thrombus resolution measure: Bleeding sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: CCPC status: RECRUITING city: Ancona state: Marche zip: 60123 country: Italy name: Francesco Bianco, M.D. role: CONTACT phone: +39 071 596 5316 email: [email protected] lat: 43.5942 lon: 13.50337 hasResults: False |
<|newrecord|> nctId: NCT06371157 id: AK104-308 briefTitle: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-02 date: 2025-10-25 date: 2026-05-23 date: 2024-04-17 date: 2024-04-17 name: Akeso class: INDUSTRY briefSummary: A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 469 type: ESTIMATED name: AK104 name: Lenvatinib name: TACE name: Placebo for AK104 name: Placebo for Lenvatinib measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) measure: Overall Survival (OS) measure: PFS per RECIST 1.1 measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST measure: Time to Response (TTR) per RECIST 1.1 and mRECIST sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450004 country: China name: Hailiang Li role: CONTACT lat: 34.75778 lon: 113.64861 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410006 country: China name: Shanzhi Gu role: CONTACT lat: 28.19874 lon: 112.97087 facility: Zhongda Hospital Southeast University city: Nanjing state: Jiangsu zip: 210009 country: China name: Gaojun Teng role: CONTACT lat: 32.06167 lon: 118.77778 facility: Shanxi Cancer Hospital city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 facility: Sichuan Cancer Hospital city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Yunnan Cancer Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Guoliang Shao role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06371144 id: NHREC/16/05/22/130 briefTitle: A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia overallStatus: COMPLETED date: 2022-06-03 date: 2022-09-10 date: 2022-09-10 date: 2024-04-17 date: 2024-04-17 name: Darlington-Peter Chibuzor Ugoji class: OTHER briefSummary: ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects. |
OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs. |
METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded. |
10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects. conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double blinded whoMasked: PARTICIPANT count: 194 type: ACTUAL name: Paracetamol measure: Mean pain score sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: AEFUTHA city: Abakaliki state: Ebonyi zip: 234 country: Nigeria lat: 6.32485 lon: 8.11368 hasResults: False |
<|newrecord|> nctId: NCT06371131 id: PONV of Thyroid Surgery briefTitle: Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting overallStatus: RECRUITING date: 2023-04-17 date: 2024-05-30 date: 2024-08-30 date: 2024-04-17 date: 2024-04-26 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action. conditions: Stellate Ganglion Block conditions: Thyroid Surgery conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Right -stellate ganglion block measure: Incidence of Postoperative nausea and vomiting measure: Incidence of Postoperative nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during hospitalization measure: Hemodynamic parameters after preemptive analgesia measure: Postoperative pain intensity measure: Recovery of gastrointestinal function measure: Sleep quality measure: Satisfaction score and postoperative analgesia satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: ling Dan, BD role: CONTACT phone: 86 13983072922 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False |
<|newrecord|> nctId: NCT06371118 id: PI 20210032 briefTitle: HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme acronym: HERSELF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-11 date: 2024-04-17 date: 2024-04-17 name: Universidade do Porto class: OTHER name: Unidade de Saúde Familiar de Garcia de Orta, Porto name: Unidade de Saúde Familiar da Prelada, Porto name: Unidade de Saúde Familiar de Cedofeita, Porto name: Instituto Portugues de Oncologia, Francisco Gentil, Porto briefSummary: This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening. |
An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post. |
Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway. conditions: Papillomavirus Infections conditions: Early Detection of Cancer conditions: Cervix Cancer conditions: Self-Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Directly mailed self-sampling kit to collect a vaginal sample name: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure name: Standard of care - screening in a clinical setting measure: Adherence to conventional screening in control group measure: Adherence to HPV self-sampling in intervention 1 (directly mailed) group measure: Adherence to HPV self-sampling in intervention 2 (opt-in) group measure: Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group measure: Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group measure: Adherence to first follow-up step in control group measure: Adherence to first follow-up step in intervention 1 (directly mailed) group measure: Adherence to first follow-up step in intervention 2 (opt-in) group measure: Adherence to first follow-up step in control group among women referred for follow-up measure: Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up measure: Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up measure: Adherence to colposcopy in control group measure: Adherence to colposcopy in intervention 1 (directly mailed) group measure: Adherence to colposcopy in intervention 2 (opt-in) group measure: Adherence to colposcopy in control group among women referred for colposcopy measure: Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy measure: Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group measure: Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy measure: Proportion of HR-HPV positivity in control group measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group measure: Proportion of HR-HPV positivity in control group among women who adhered to conventional screening measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample measure: Proportion of HR-HPV 16/18 positivity in control group measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group measure: Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample measure: Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard measure: Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard sex: FEMALE minimumAge: 26 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06371105 id: 014_2018 briefTitle: Aquatic_Training in Obese Women overallStatus: COMPLETED date: 2019-01-02 date: 2019-03-30 date: 2019-03-30 date: 2024-04-17 date: 2024-04-17 name: University of Taipei class: OTHER briefSummary: This study aims to assess the effects of 10-week water-based aerobic training (thrice a week) on anthropometrics, biochemicals, cardiovascular parameters, and explosive strength in young overweight and obese women. The findings indicate that water-based aerobic training could be a useful program to enhance body composition, biochemical, cardiovascular, and explosive strength parameters in young overweight and obese women compared to inactive persons conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ACTUAL name: 10-week water-based aerobic training measure: fasting glycemia in millimoles per liter measure: total cholesterol in millimoles per liter measure: high-density lipoprotein cholesterol in millimoles per liter measure: low-density lipoprotein cholesterol in millimoles per liter measure: triglyceride concentrations in millimoles per liter measure: systolic blood pressure in millimeters of mercury measure: diastolic blood pressure in millimeters of mercury measure: heart rate in beat per minute measure: fasting glycemia in millimoles per liter measure: total cholesterol in millimoles per liter measure: high-density lipoprotein cholesterol in millimoles per liter measure: low-density lipoprotein cholesterol in millimoles per liter measure: triglyceride concentrations in millimoles per liter measure: systolic blood pressure in millimeters of mercury measure: diastolic blood pressure in millimeters of mercury measure: heart rate in beat per minute measure: countermovement jump in centimetres measure: squat jump in centimeters measure: chest 3-kg medicine ball throw in meters measure: countermovement jump in centimetres measure: squat jump in centimeters measure: chest 3-kg medicine ball throw in meters sex: FEMALE minimumAge: 29 Years maximumAge: 35 Years stdAges: ADULT facility: Department of Exercise and Health Sciences, University of Taipei city: Taipei zip: 11153 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06371092 id: 2023/01 briefTitle: Efficacy of a Desensitizing Agent During At-home Bleaching overallStatus: COMPLETED date: 2023-01-31 date: 2023-02-22 date: 2023-03-01 date: 2024-04-17 date: 2024-04-17 name: University of Santiago de Compostela class: OTHER briefSummary: The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching. conditions: Sensitivity, Tooth studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, triple-blind clinical trial primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: UltraEZ name: Placebo measure: Questionnaire of dental sensitivity measure: Shade evaluation with a dental spectrophotometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Medicine and Dentistry city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False |
<|newrecord|> nctId: NCT06371079 id: NO-OVD-ICL briefTitle: Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Loay Abdulmutalib Almusawi class: OTHER briefSummary: The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation. |
The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery. conditions: Refractive Errors conditions: Myopia conditions: Myopic Astigmatism conditions: Hypermetropia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: phakic intraocular lens implantation traditional name: phakic intraocular lens implantation reduced OVD measure: unaided visual acuity after the procedure measure: best corrected visual acuity after the procedure measure: Intraocular pressure postoperatively measure: Specular microscopy parameter: endothelial cell density measure: Specular microscopy parameter: endothelial cells hexagonality measure: Specular microscopy parameter: coefficient of variation of corneal endothelial cells measure: postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Al-Ferdows private eye hospital status: RECRUITING city: Baghdad country: Iraq name: Sohaib A Mahmood, CABMS role: CONTACT phone: 00971585358111 email: [email protected] name: Sami A Hasoon role: CONTACT phone: +9647901867279 email: [email protected] name: Sohaib A Mahmood, CABMS role: PRINCIPAL_INVESTIGATOR name: Loay A Almusawi, FIBMS role: SUB_INVESTIGATOR name: Hamid M Altaha, CABMS role: SUB_INVESTIGATOR name: Bashar Alwash, CABMS role: SUB_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False |
<|newrecord|> nctId: NCT06371066 id: EAkyuz-2 briefTitle: The Effect of Video-based Training on the Knowledge Levels of Nursing Students overallStatus: COMPLETED date: 2021-02-01 date: 2021-04-01 date: 2021-06-10 date: 2024-04-17 date: 2024-04-17 name: Kırıkkale University class: OTHER briefSummary: Although face-to-face education is widely used as a traditional method, emerging computer technology has allowed new training approaches such as video-based training (VBT) platforms to flourish, especially in the last four decades. Educators adopted VBT as a cost-effective and accessible medium to address some of their training needs. It contains purposely designed visual cues and draws learners' attention during the learning process, and the dynamic details enable learners to better understand the learning contents. The use of new technologies such as e-learning, computer-assisted learning, VBT, and web-based applications for clinical skill education has increased learner satisfaction compared with conventional education methods. Preoperative patient preparation is a crucial element of preoperative nursing care. A surgical nurse is a specialized coordinator of patient care, and the main purposes of this role are to meet the patient's and the family's needs individually and to prepare them for the scheduled procedure and postoperative recovery. Preoperative patient preparation contains multiple components and steps such as preoperative education, including physical, social, psychological, and legal preparation, and preparation for the night and day of surgery. the nature of the process has many components and steps, it is not easy for students to learn this subject, and nursing educators were able to experience this in a clinical practice environment. And the educators started to search for new teaching techniques to teach this subject like the other colleagues. the investigator's aim in this project is to determine the effect of VBT on the knowledge levels of nursing students on preoperative patient preparation when compared to traditional training methods. conditions: Student Nursing conditions: Medical-surgical Nursing conditions: Nursing Care conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention, control primaryPurpose: OTHER masking: SINGLE maskingDescription: it was an educational intervention. All participants were in the same class so we blinded only statisticians. whoMasked: OUTCOMES_ASSESSOR count: 97 type: ACTUAL name: experimental group name: Control group measure: The Student Information Form measure: The Knowledge Form for Preoperative Patient Preparation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirikkale University city: Kirikkale country: Turkey lat: 39.84528 lon: 33.50639 hasResults: False |
<|newrecord|> nctId: NCT06371053 id: community - dementia briefTitle: The Effect of Community Intervention on Different Degrees of Dementia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-17 date: 2024-04-17 name: Babujinaya Cela class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Community Intervention measure: Mini-Mental State Examination measure: Barthel Index measure: Functional near-infrared spectroscopy sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06371040 id: V1.0, CART-20230619 briefTitle: Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Ting Chang, MD class: OTHER briefSummary: This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited. conditions: Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: CD19-BCMA Targeted CAR-T Dose 1 5.0 e5/ kg CD19-BCMA CAR-T positive T cells |
CD19-BCMA Targeted CAR-T Dose 2 1.5 e6/ kg CD19-BCMA CAR-T positive T cells |
CD19-BCMA Targeted CAR-T Dose 2 5 e6/ kg CD19-BCMA CAR-T positive T cells primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CD19-BCMA Targeted CAR-T Dose 1 name: CD19-BCMA Targeted CAR-T Dose 2 name: CD19-BCMA Targeted CAR-T Dose 2 measure: Frequency, type, and severity of adverse events measure: Frequency, type, and severity of abnormal laboratory indicators related to treatment measure: Changes of blood pressure measure: Changes of pulse rate measure: Changes of weight measure: Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) scores measure: Changes of Quantitative Myasthenia Gravis (QMG) scores measure: Changes of Myasthenia Gravis Composite (MGC) scores measure: Proportion of subjects who achieved improvement measure: Time to achieve clinical improvement measure: Changes of myasthenia gravis-specific autoantibody titers measure: Changes of immunoglobulins measure: Changes in proportion of peripheral blood immune cell measure: serum inflammatory markers levels sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tangdu Hospital, The Fourth Military Medical University city: Xi'an state: Shaanxi zip: 710038 country: China lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06371027 id: RECO6U/22-2022 briefTitle: Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial overallStatus: COMPLETED date: 2022-11-01 date: 2024-02-15 date: 2024-04-01 date: 2024-04-17 date: 2024-04-17 name: October 6 University class: OTHER briefSummary: Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects. conditions: Intrabony Periodontal Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane name: Minimally Invasive Surgery Technique (MIST) + collagen membrane name: Minimally Invasive Surgery Technique (MIST) measure: Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: faculty of dentistry O6U city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06371014 id: Ondansetron mouth soluble film briefTitle: Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy acronym: Ondansetron overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Shanghai Children's Medical Center class: OTHER briefSummary: Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy conditions: To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Ondansetron oral membrane measure: Complete Remission Rates in the Acute Phases measure: Complete Remission Rates in the Delayed Phases sex: ALL minimumAge: 4 Years maximumAge: 15 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06371001 id: Helicobacter Pyloi and CKD briefTitle: Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical Complex overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 122 type: ESTIMATED name: disease measure: Helicobacter pylori infection and Chronic kidney diseased patient measure: possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370988 id: 4343 briefTitle: Theta-Burst Stimulation for Bipolar Depression acronym: TRIBE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-04-17 date: 2024-04-22 name: Centre for Addiction and Mental Health class: OTHER name: University Health Network, Toronto briefSummary: The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion. conditions: Bipolar Depression conditions: Bipolar Disorder conditions: Treatment- Resistant Bipolar Disorder conditions: Type 2 Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 A/P coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling, in which both the sham and active coils are contained internally. Its symmetric design ensures there is no indication of which side is active or sham with only the side of the coil delivering the treatment differing. The sham coil has been designed in such a way that it produces a similar auditory experience as the active coil. To account for the tactile sensation of active stimulation, both treatment allocations will have scalp electrodes placed that deliver a weak electrical stimulation to mask this tactile sensation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: iTBS Stimulation name: Sham iTBS Stimulation measure: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) measure: Symptoms of Mania sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Eileen Lam role: CONTACT phone: 437-553-0367 email: [email protected] name: Daphne Voineskos, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre for Addiction and Mental Health city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Elizabeth Clancy role: CONTACT phone: 416-535-8501 phoneExt: 36434 email: [email protected] name: Tyler Kaster, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06370975 id: Fluid resuscitation in trauma briefTitle: Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08 date: 2025-09 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: The study aims to investigate the effect of 3% hypertonic saline resuscitation on lactate clearance in comparison to ringer's lactated solution and 0.9% normal saline in traumatic injury patients. |
Also to provide insights into the optimal fluid resuscitation strategy for traumatic injury patients conditions: Fluid Resuscitation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: 3% hypertonic Saline name: Ringer's lactated solution name: 0.9% Normal saline measure: Rate of lactate clearance following resuscitation with different solutions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370962 id: 69HCL24_0076 id: 2024-A00343-44 type: OTHER domain: ID-RCB briefTitle: Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators acronym: CHRONO-MUCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-01 date: 2024-04-17 date: 2024-04-17 name: Hospices Civils de Lyon class: OTHER briefSummary: Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life. |
Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening. |
The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbα could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances. |
In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment. |
Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset. |
The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Result of the Horne and Ostberg questionnaire. sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois city: Nancy zip: 54500 country: France name: Iulia IOAN, MD role: CONTACT phone: 03.83.15.47.94 phoneExt: +33 email: [email protected] name: Iulia IOAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau city: Paris zip: 75012 country: France name: Jessica TAYTARD, MD role: CONTACT phone: 01 44 73 63 46 phoneExt: +33 email: [email protected] name: Jessica TAYTARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06370949 id: 2024-01/17 briefTitle: The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-30 date: 2024-11-30 date: 2024-04-17 date: 2024-04-17 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients. |
Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. conditions: Colorectal Cancer conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 84 type: ESTIMATED name: Bupivacain name: bupivacain+dexmedetomidine measure: Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital city: Ankara state: Cankaya zip: 06110 country: Turkey name: Hazal E Guran Aytug, MD role: CONTACT phone: 05078448449 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06370936 id: NL84824.091.23 id: NL84824.091.23 type: OTHER domain: CCMO / Toetsingonline briefTitle: The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health acronym: EXPLAIN overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-17 date: 2024-04-17 name: Wageningen University class: OTHER briefSummary: Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited. |
The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms. |
114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years will be included in the study. Participants will follow both an 8-week completely controlled diet in which all meats are of plant-based origin (PBMAs) and an 8-week diet in which all meats are of animal origin in randomized order with a 10-week wash-out period. Before the intervention starts, the participants will be characterized to describe them on anthropometrics, glucose tolerance and insulin sensitivity, genetics, sleep patterns, and stress levels. Before the start and at the end of each 8-week dietary intervention period, several measurements, including systolic blood pressure monitoring and secondary outcome measures will be done. Additionally, systolic and diastolic blood pressure will be monitored throughout the dietary interventions and a small quantity of parameters related to the secondary objectives will be measured. conditions: Blood Pressure conditions: Cardiometabolic Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will follow both an 8-week completely controlled dietary intervention followed by a 10-week washout period followed by another 8-week completely controlled dietary intervention. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Treatment order (PBMA intervention - Meat intervention versus Meat intervention - PBMA intervention) is masked for the researchers. The order is not masked for participants. whoMasked: INVESTIGATOR count: 114 type: ESTIMATED name: Standardized diet with commercially available animal meats (comparator products) name: Standardized diet with commercially available PBMAs (intervention products) measure: Systolic blood pressure measure: Diastolic blood pressure measure: Home systolic blood pressure measure: Home diastolic blood pressure measure: Home heart rate measure: Fasting blood HbA1c levels measure: Fasting blood glucose levels measure: Fasting blood insulin levels measure: Fasting blood lipid spectrum measure: Fasting blood metabolite profile measure: Fasting blood proteomic profile measure: Fasting blood cell transcriptomic profile measure: Fasting blood nutritional status measure: Blood immune markers measure: Blood immune cell populations measure: Metabolites in 24-hour urine measure: Interstitial glucose profile measure: Physical activity measure: Fecal microbiome composition measure: Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge measure: Oral microbiome composition measure: Microbiome metabolites measure: Microbiome functionality measure: Self-reported gastro-intestinal symptoms measure: Self-reported constipation measure: Self-reported stool consistency and frequency measure: Gastro-intestinal transit time measure: Self reported product-specific attitude towards meat and PBMAs measure: Self reported meal-specific satiety with meat and PBMAs measure: Self-reported general attitude toward meat and PBMAs measure: Body composition measure: Genetic variation measure: Oral glucose tolerance test (OGTT) measure: Habitual dietary intake measure: Perceived stress measure: Chronotype assessment measure: Sleeping habits measure: Self reported habitual meat and PBMA consumption measure: 24-hour dietary recall measure: Home environment microbiome composition sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wageningen University, Division of Human Nutrition status: RECRUITING city: Wageningen state: Gelderland zip: 6708 WE country: Netherlands lat: 51.97 lon: 5.66667 hasResults: False |
<|newrecord|> nctId: NCT06370923 id: 1R01MH133488-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH133488-01 briefTitle: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention acronym: IMPERATIVE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2028-12 date: 2024-04-17 date: 2024-04-17 name: University of Stellenbosch class: OTHER name: Biomedical Research and Training Institute, Zimbabwe name: Imperial College London name: University of Lincoln name: University College London Hospitals name: University of Copenhagen name: University of Washington name: Heidelberg University briefSummary: Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA. |
The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe. |
The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomised trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Analysts blinded to allocation whoMasked: OUTCOMES_ASSESSOR count: 3591 type: ESTIMATED name: Peer Distribution name: Community Health Worker Distribution measure: PrEP initiation measure: PrEP adherence measure: ART adherence measure: Confirmatory tests sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-07 uploadDate: 2024-04-11T04:41 filename: Prot_000.pdf size: 766804 hasResults: False |
<|newrecord|> nctId: NCT06370910 id: CAAE 58569421.5.0000.5327 briefTitle: Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction acronym: CL overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-05 date: 2024-01-10 date: 2024-04-17 date: 2024-04-17 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery. |
Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies. |
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