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3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Main study(0\~12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001
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Extension study(12\~24 weeks) Experimental: AST-001 Comparator: AST-001 primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: AST-001 name: Placebo of AST-001 measure: K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II) measure: CGI (Clinical Global Impression) measure: SRS-2 (Social Responsiveness Scale-2) measure: K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form) sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Soon Chun Hyang University Hospital Cheonan status: RECRUITING city: Cheonan state: Chungcheongnam-do country: Korea, Republic of lat: 36.8065 lon: 127.1522 facility: Hallym University Medical Center status: RECRUITING city: Anyang state: Gyeonggi-do country: Korea, Republic of lat: 37.3925 lon: 126.92694 facility: Samsung Changwon Medical Center status: RECRUITING city: Changwon state: Gyeongsangnam-do country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Pusan National University Yangsan Hospital status: RECRUITING city: Yangsan state: Gyeongsangnam-do country: Korea, Republic of lat: 35.34199 lon: 129.03358 facility: Jeonbuk National University Hospital status: RECRUITING city: Jeonju state: Jeollabuk-do country: Korea, Republic of lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital status: RECRUITING city: Daejeon country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Asan Medical Center status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Koera University Guro Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06333951 id: 20230167 briefTitle: AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) overallStatus: RECRUITING date: 2024-06-03 date: 2026-10-08 date: 2029-10-07 date: 2024-03-27 date: 2024-04-25 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors. conditions: Thoracic Tumors conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: AMG 193 name: Carboplatin name: Paclitaxel name: Pembrolizumab name: Pemetrexed name: Sotorasib measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG 193 measure: Time to Maximum Plasma Concentration (tmax) of AMG 193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 measure: Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ) measure: Intracranial Disease Control (IDC) per RANO-BM measure: Intracranial Duration of Response (IDOR) per RANO-BM measure: Time to Intracranial Radiation Therapy per RANO-BM sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope (COH) status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06333938 id: 01968 briefTitle: Veterans Enhanced Recovery Using Integrative Treatments Around Surgery acronym: VERITAS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2025-06 date: 2024-03-27 date: 2024-03-27 name: Durham VA Medical Center class: FED briefSummary: The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA). conditions: Anesthesia conditions: Surgery conditions: Knee Arthropathy studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Bridge name: BFA measure: Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 measure: Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate. measure: Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. measure: Fidelity of Treatment among Patients as assessed by a Fidelity Checklist measure: Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. measure: Fidelity of Treatment among Providers as assessed by a Fidelity Checklist measure: Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. measure: Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333925 id: Pro00114183 briefTitle: Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study acronym: MISO-STIM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-31 date: 2026-10-31 date: 2024-03-27 date: 2024-03-27 name: Duke University class: OTHER name: Misophonia Research Fund briefSummary: Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress.
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Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits. conditions: Misophonia conditions: Emotion Dysregulation conditions: Sensory Processing Disorder conditions: Auditory Over Responsivity conditions: Anxiety Disorder conditions: Sound Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In regards to the neurostimulation used in the study, there will be two conditions, receiving either active or sham neurostimulation. Both conditions will receive behavioral training in cognitive restructuring (CR; a type of emotion regulation skill). Randomization procedures will match participants on age, gender at birth, and misophonia impairment severity. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants will engage in a behavioral training session (Cognitive Restructuring).
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The study team member who will conduct the behavioral session will be kept blind to the type of neurostimulation the participant will receive. Participants will also be kept blinded to what neurostimulation they receive and their perception of what they received will be assessed at follow-up. The intervention provider will also be kept blind to the treatment condition to ensure non-biased administration of the intervention.
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Participants will only be told about the type of neurostimulation at the end of the study to protect against different expectations whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS) name: Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS) name: Cognitive Restructuring measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds measure: Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds measure: Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds measure: Change in misophonia impairment and severity using a composite measure: Skin conductance level (scl) measure: Change in Subjective Unites of Distress (SUDS) measure: Changes in self-reported psychopathology measure: Changes in clinician-assessed psychopathology measure: Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS) measure: Changes in self-reported cognitive flexibility measure: Changes in self-reported cognitive skills measure: Baseline emotional dysregulation measure: Baseline hyperacusis measure: Baseline Affect Intensity measure: Change in Emotional distress measure: Change in self-reported Emotion regulation measure: Change in Sensory sensitivity measure: Change in Interoceptive Awareness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Duke University Medical Center city: Durham state: North Carolina zip: 27710 country: United States name: Jessica Choi, MA role: CONTACT phone: 919-684-4432 email: jessica.choi@duke.edu name: Lisalynn D Kelley, BA, CCRP role: CONTACT phone: 919-684-6701 email: lisalynn.kelley@duke.edu name: Andrada D Neacsiu, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06333912 id: ridgesplittingguided briefTitle: Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement overallStatus: COMPLETED date: 2023-08-02 date: 2024-01-29 date: 2024-02-27 date: 2024-03-27 date: 2024-03-27 name: Alexandria University class: OTHER briefSummary: Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: dental implant placement with ridge splitting. measure: Assessing the accuracy of guided surgery measure: the bone-width increase between control and study group. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Alexandria University, Faculty of dentistry city: Alexandria zip: 21619 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06333899 id: CONNECT2111 briefTitle: Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2034-09-01 date: 2024-03-27 date: 2024-03-27 name: Nationwide Children's Hospital class: OTHER name: Pfizer briefSummary: The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy. conditions: High Grade Glioma conditions: Diffuse Intrinsic Pontine Glioma conditions: Anaplastic Astrocytoma conditions: Infant Type Hemispheric Glioma conditions: Glioblastoma conditions: Glioblastoma Multiforme conditions: WHO Grade III Glioma conditions: WHO Grade IV Glioma conditions: Diffuse Midline Glioma, H3K27-altered studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Lorlatinib name: Lorlatinib with chemotherapy1 name: Lorlatinib with chemotherapy 2 name: Lorlatinib post Radiation measure: Disease Control Rate measure: Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0 measure: Objective Response Rate (ORR) in HGG measure: Overall Survival (OS) in HGG measure: Progression-Free Survival in HGG sex: ALL minimumAge: 1 Year maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States name: Kathleen Dorris, MD role: CONTACT email: kathleen.dorris@childrenscolorado.org lat: 39.72943 lon: -104.83192 facility: Children's National Medical Center city: Washington state: District of Columbia zip: 20010 country: United States name: Eugene Hwang role: CONTACT email: ehwang@childrensnational.org lat: 38.89511 lon: -77.03637 facility: Ann & Robert H. Lurie Children's Hospital of Chicago city: Chicago state: Illinois zip: 60611 country: United States name: Ashley Plant, MD role: CONTACT email: Aplant@luriechildrens.org lat: 41.85003 lon: -87.65005 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Susan Chi role: CONTACT email: Susan_chi@dfci.harvard.edu lat: 42.35843 lon: -71.05977 facility: Duke University Health System city: Durham state: North Carolina zip: 27708 country: United States name: David Ashley, MD role: CONTACT email: david.ashley@duke.edu lat: 35.99403 lon: -78.89862 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States name: Peter de Blank, MD role: CONTACT email: Peter.deBlank@cchmc.org lat: 39.12713 lon: -84.51435 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43235 country: United States name: Maryam Fouladi, MD, MSc role: CONTACT email: Maryam.fouladi@nationwidechildrens.org lat: 39.96118 lon: -82.99879 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Michael J Fisher, MD role: CONTACT email: fisherm@email.chop.edu lat: 39.95233 lon: -75.16379 facility: Texas Children's Hospital city: Houston state: Texas zip: 77030 country: United States name: Patricia Baxter, MD role: CONTACT email: pabaxter@txch.org lat: 29.76328 lon: -95.36327 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States name: Sarah Leary role: CONTACT email: sarah.leary@seattlechildrens.org lat: 47.60621 lon: -122.33207 facility: Sydney Children's Hospital city: Randwick state: New South Wales zip: 2031 country: Australia name: David Ziegler, MD role: CONTACT email: d.ziegler@unsw.edu.au lat: -33.91439 lon: 151.24895 facility: Queensland Children's Hospital city: South Brisbane state: Queensland zip: 4101 country: Australia name: Tim Hassall, MD role: CONTACT email: tim.hassall@health.qld.gov.au lat: -27.48034 lon: 153.02049 facility: Perth Children's Hospital city: Perth state: Western Australia zip: 6000 country: Australia name: Nicholas G Gottardo, MBChB role: CONTACT email: nick.gottardo@health.wa.gov.au lat: -31.95224 lon: 115.8614 facility: The Hospital for Sick Children (SickKids) city: Toronto state: Ontario zip: M5G1X8 country: Canada name: Eric Bouffet role: CONTACT email: eric.bouffet@sickkids.ca lat: 43.70011 lon: -79.4163 facility: Montreal Children's Hospital city: Montréal state: Quebec zip: H4A3J1 country: Canada name: Genevieve Legault, MD role: CONTACT email: Genevieve.legault4@mcgill.ca lat: 45.50884 lon: -73.58781 facility: Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) city: Heidelberg state: Baden-Württemberg zip: 69120 country: Germany name: Olaf Witt, MD role: CONTACT email: o.witt@kitz-heidelberg.de lat: 49.40768 lon: 8.69079 facility: Princess Máxima Center city: Utrecht zip: 3720 country: Netherlands name: Jasper van der Lugt role: CONTACT email: J.vanderLugt@prinsesmaximacentrum.nl lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06333886 id: ciusss-nordmtl_ESG briefTitle: Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2028-12-31 date: 2028-12-31 date: 2024-03-27 date: 2024-03-27 name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal class: OTHER briefSummary: Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery. conditions: Spinal Cord Injuries conditions: Neurogenic Bowel conditions: Neurogenic Bladder Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Sacral electromyography measure: Precise assessment and evaluation of neuro-sacral dysfunction measure: Assessment of clinical phenotypes measure: Clinical prognosis assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital du Sacré-Coeur de Montréal city: Montréal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06333873 id: P22-09 briefTitle: Impact of Age-related Macular Degeneration on Daily Living Activitie acronym: AMDAY overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-06 date: 2029-06 date: 2024-03-27 date: 2024-03-27 name: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts class: OTHER briefSummary: The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA) conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: patient-reported outcome measure: Validity of criteria measure: Validity of content measure: Reproducibility of results sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333860 id: M24-541 briefTitle: A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2025-03-24 date: 2026-03-31 date: 2024-03-27 date: 2024-03-27 name: AbbVie class: INDUSTRY briefSummary: Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.
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This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants
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Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.
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There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Moderate Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 336 type: ESTIMATED name: Risankizumab name: Deucravacitinib measure: Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline measure: Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR). measure: Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline measure: Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population measure: Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333847 id: K2023-059 briefTitle: Is Multimorbidity a Source of Non-response Bias in Patients With Spinal Pain? - A Pilot Study overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2024-04-20 date: 2024-04-20 date: 2024-03-27 date: 2024-03-27 name: Jacob Christiansen Gandløse class: OTHER name: Aalborg Municipality name: Aalborg University name: Aalborg University Hospital briefSummary: The purpose of this study is to investigate whether the number of chronic diseases, the treatment burden resulting from multimorbidity, and health-related quality of life contribute to non-response bias in individuals with chronic back pain. Data is collected from patients at Aalborg University Hospital's Rheumatology Department through electronic means and medical records. The statistical analyses consist of two wave analyses, where we examine differences between patients who respond to invitations to participate in the study based on their response patterns; whether they respond after the first, second, or third invitation. Based on baseline data, a one-way ANOVA is conducted to identify any between-group differences in the aforementioned factors, followed by a repeated measures ANOVA to assess if there are differences between the groups over time. Finally, statistical tests are also performed to examine differences in age and gender distribution between those who complete the questionnaires at baseline compared to those who do not respond to the invitation to participate. conditions: Back Pain conditions: Low Back Pain conditions: Neck Pain conditions: Comorbidities and Coexisting Conditions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Multimorbidity Treatment Burden Questionnaire (MTBQ). measure: Health-related quality of life (EQ-5D-5L) measure: Brief Pain Inventory - Short form measure: Insomnia Severity Index measure: Patient Health Questionnaire measure: Generalized Anxiety Disorder measure: Work ability score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aalborg University Hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False
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<|newrecord|> nctId: NCT06333834 id: Dosis Seriada de Alacramyn briefTitle: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-08-01 date: 2024-08-30 date: 2024-03-27 date: 2024-03-27 name: Selene Guadalupe Huerta Olvera class: OTHER briefSummary: The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated. conditions: Centruroides Envenomation studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 121 type: ESTIMATED name: Traditional scorpion antivenom regimen name: Serial dose of scorpion antivenom regimen measure: Time to resolution of signs and symptoms measure: Serum venom concentration measure: Mortality measure: Length of intrahospital stay measure: Serum antivenom concentration sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicios Médicos Municipales de San Pedro Tlaquepaque. city: Tlaquepaque state: Jalisco zip: 45560 country: Mexico name: Héctor A González-Ruiz, PhD Student role: CONTACT phone: +52 33 1787 9139 email: andresgonzru@gmail.com name: Selene G Huerta-Olvera, PhD role: CONTACT phone: +52 392 111 0753 email: selene.huerta@academicos.udg.mx lat: 20.64091 lon: -103.29327 hasResults: False
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<|newrecord|> nctId: NCT06333821 id: BPL-Nim-CC-3003 briefTitle: A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-03-27 date: 2024-03-27 name: Biotech Pharmaceutical Co., Ltd. class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.
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The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival. conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 460 type: ESTIMATED name: Nimotuzumab name: Cisplatin name: External Beam Radiotherapy (EBRT) name: Brachytherapy name: placebo for Nimotuzumab measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR) measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator measure: 3-,5-Year Overall Survival (OS) measure: 3-,5-Year Disease Free Survival(DFS) measure: 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS) measure: 3-,5-Year Distant Metastasis-free Survival (DMFS) measure: Tumor Regression Rate(TRR) measure: Complete Response Rate measure: Complete Response Rate measure: Objective Response Rate measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score measure: Incidence of Treatment-Emergent Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333808 id: GS-US-621-6290 id: 2023-510022-33 type: OTHER domain: European Medicines Agency briefTitle: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy acronym: ARTISTRY-2 overallStatus: RECRUITING date: 2024-03-25 date: 2025-12 date: 2029-12 date: 2024-03-27 date: 2024-04-17 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).
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The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH. conditions: HIV-1-infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 546 type: ESTIMATED name: Bictegravir name: Lenacapavir name: B/F/TAF name: Placebo to match B/F/TAF name: Placebo to match BIC/LEN measure: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm measure: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm measure: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48 measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm measure: Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48 measure: Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruane Medical and Clinical Research Institute status: RECRUITING city: Los Angeles state: California zip: 90036 country: United States lat: 34.05223 lon: -118.24368 facility: Therafirst Medical Center status: RECRUITING city: Fort Lauderdale state: Florida zip: 33308 country: United States lat: 26.12231 lon: -80.14338 facility: Midway Immunology and Research Center status: RECRUITING city: Fort Pierce state: Florida zip: 34982 country: United States lat: 27.44671 lon: -80.32561 facility: Infectious Disease Specialists of Atlanta status: RECRUITING city: Decatur state: Georgia zip: 30033 country: United States lat: 33.77483 lon: -84.29631 facility: Southhampton Community Healthcare, Inc. status: RECRUITING city: Saint Louis state: Missouri zip: 63139 country: United States lat: 38.62727 lon: -90.19789 facility: South Jersey Infectious Disease status: RECRUITING city: Somers Point state: New Jersey zip: 08244 country: United States lat: 39.31762 lon: -74.5946 facility: The Crofoot research Center, INC. status: RECRUITING city: Houston state: Texas zip: 77098 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06333795 id: 1-10-72-131-23 briefTitle: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis acronym: FaeMiCue overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Aarhus class: OTHER briefSummary: This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis. conditions: Diarrhea conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The study is blinded throughout the active study period, both the patient and investigator are blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Faecal Microbiota Transplantation (FMT) name: Placebo measure: Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo). measure: Patient-reported treatment outcome on symptoms measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported overall symptom burden measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the low-dose CT scan. measure: Breath Test measure: Faecal microbiota composition measure: Faecal-calprotectin measure: Blood plasma proteomics measure: Blood plasma Fibrosis markers measure: Blood parameters measure: Health-related Quality of life measure: Patient perception of FMT treatment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06333782 id: 2023-EU-GEN-01 id: 2023-A02012-43 type: OTHER domain: ANSM briefTitle: Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-07-01 date: 2025-07-01 date: 2024-03-27 date: 2024-04-02 name: Bioscience Cosmetics SL class: INDUSTRY name: Eurofins briefSummary: The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.
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The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).
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Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.
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An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection conditions: Vulvar Atrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1 primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blind whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: Experimental- Genefill Contour® name: Marketed comparator - Desirial®Plus measure: Mean of number of occurred ADEs (Adverse device effects) measure: Global Aesthetic Improvement Scale (GAIS) assessment by investigator measure: Global Aesthetic Improvement Scale (GAIS) assessment by participant measure: Patient (Atrophy/Hypotrophy) symptoms measure: Sexual function Assessment, The Female Sexual Function Index (FSFI) measure: Patient´s satisfaction measure: Pain during injection-Visual Analogical Scale (VAS) measure: Adverse Events collection (Global safety during the study period) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabinet renaissance city: Levallois-Perret state: Paris zip: 92300 country: France name: Massimo Gianfermi, MD role: CONTACT lat: 48.89389 lon: 2.28864 facility: Palais Flore city: Lyon zip: 69006 country: France name: Johanna Gratadour, MD role: CONTACT lat: 45.74848 lon: 4.84669 facility: Medical Center "Tu sie leczy" city: Gdańsk state: Gdansk country: Poland name: Katarzyna Kopacz-Petranyuk, MD role: CONTACT lat: 54.35205 lon: 18.64637 hasResults: False
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<|newrecord|> nctId: NCT06333769 id: CATIMOR briefTitle: A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-12-01 date: 2024-03-27 date: 2024-03-27 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: To explore the complete response (CR) rate of improved short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer conditions: Mid-low Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 31 type: ESTIMATED name: Short-course Radiotherapy name: Tislelizumab name: capecitabine name: Oxaliplatin measure: complete response (CR) rate measure: 3y-DFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333756 id: YM110099E briefTitle: Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle acronym: YM110099E overallStatus: COMPLETED date: 2021-05-01 date: 2022-04-30 date: 2022-08-01 date: 2024-03-27 date: 2024-03-27 name: National Yang Ming University class: OTHER briefSummary: We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.
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Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parallel Assignment primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ACTUAL name: Cross education measure: Corticocortical coherence measure: Corticomuscular coherence measure: Maximal voluntary contraction sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: National Yang-Ming University city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06333743 id: ZhuLan briefTitle: Laser Ablation in the Treatment of High-grade Cervical Lesions overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-05 date: 2024-03-27 date: 2024-03-27 name: Peking Union Medical College Hospital class: OTHER name: Obstetrics & Gynecology Hospital of Fudan University briefSummary: Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL. conditions: High-Grade Squamous Intraepithelial Lesions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 308 type: ESTIMATED name: laser ablation name: LEEP or Conization measure: the rate of HSIL recurrence measure: the satisfaction with the treatment measure: the length of the cervix measure: Psychological state change related to the treatment sex: FEMALE maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06333730 id: PMC briefTitle: Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-30 date: 2024-06-20 date: 2024-03-27 date: 2024-03-27 name: Prime Foundation class: OTHER briefSummary: Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.
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Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.
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Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.
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Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.
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Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison. conditions: Symptomatic Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: inferior alveolar nerve block name: mental nerve block measure: COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peshawar Dental College status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Prof. Dr. Iftikhar Akbar, FCPS, CHIPE role: CONTACT phone: 00923479368676 email: driftikhar156@hotmail.com name: Marghalara Noor, BDS role: CONTACT phone: 00923359631393 email: marghalaranoor96@gmail.com name: Saifa Rashad, BDS role: SUB_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False
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<|newrecord|> nctId: NCT06333717 id: Dnr 2020-03709 briefTitle: Impact of Whole Grain Rye Bread on Health acronym: FBS overallStatus: COMPLETED date: 2021-03-03 date: 2021-03-03 date: 2021-11-05 date: 2024-03-27 date: 2024-03-27 name: Örebro University, Sweden class: OTHER briefSummary: This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance. conditions: Healthy Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: double blinding whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 33 type: ACTUAL name: Whole grain bread name: Control bread measure: Microbiota composition baseline vs after intervention using 16S RNA gene sequencing measure: Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing measure: Concentrations of circulatory short-chain fatty acids SCFA measure: Concentrations of faecal SCFA measure: Concentrations of blood glucagon like peptide-1 (GLP-1) measure: Concentrations of blood glucagon like peptide-2 (GLP-2) measure: Concentrations of blood peptide YY (PYY) measure: Concentrations of blood gastric inhibitory polypeptide (GIP) measure: Concentrations of blood neuroactive peptide Y (NPY) measure: Concentrations of blood brain-derived neurotrophic factor (BDNF) measure: Concentrations of blood cytokines measure: Concentrations of blood alkylresorcinols measure: Concentrations of blood lipopolysaccharide-binding protein (LBP) measure: Concentrations of blood soluble CD-14 (sCD-14) measure: Concentrations of sugars in urine measure: Concentrations of saliva cortisol during stress test measure: Concentrations of saliva alpha-amylase during stress test measure: Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS) measure: Food habits measured by an electronic food frequency questionnaire Mealq measure: Food habits measured by a Food diary measure: Physical activity measured by the International Physical Activity Questionnaire (IPAQ) measure: Quality of life measured by the Euro Quality of Life questionnaire measure: Perceived stress measured by a Visual analog scale questionnaire measure: Cognitive control using Eriksen flanker task (Flanker task) measure: Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task) measure: Electrocardiogram (ECG) using the Biopac system measure: Electrodermal activity (EDA) using the Biopac system sex: ALL minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: Örebro University city: Örebro country: Sweden lat: 59.27412 lon: 15.2066 hasResults: False
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<|newrecord|> nctId: NCT06333704 id: mRNA-1273-P924 briefTitle: Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. overallStatus: RECRUITING date: 2023-03-10 date: 2026-12-07 date: 2026-12-07 date: 2024-03-27 date: 2024-03-27 name: ModernaTX, Inc. class: INDUSTRY briefSummary: The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population. conditions: SARS-CoV-2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3300 type: ESTIMATED name: SPIKEVAX Bivalent name: SPIKEVAX X measure: Number of Participants With AEs sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yonseimin Clinic status: RECRUITING city: Wonju state: Gangwon-do zip: 26428 country: Korea, Republic of lat: 37.35139 lon: 127.94528 facility: Hyundai Clinic status: RECRUITING city: Bucheon state: Gyeonggi-do zip: 14483 country: Korea, Republic of lat: 37.49889 lon: 126.78306 facility: Ma Hak ki Family Medicine Clinic status: RECRUITING city: Bucheon state: Gyeonggi-do zip: 14614 country: Korea, Republic of lat: 37.49889 lon: 126.78306 facility: Nalee Hospital status: RECRUITING city: Gimpo state: Gyeonggi-do zip: 10108 country: Korea, Republic of facility: COA ENT Clinic status: RECRUITING city: Goyang state: Gyeonggi-do zip: 10234 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Joon Pediatric Clinic status: RECRUITING city: Gwangmyeong state: Gyeonggi-do zip: 14250 country: Korea, Republic of facility: Janghyeon Medicine Clinic status: RECRUITING city: Siheung state: Gyeonggi-do zip: 14998 country: Korea, Republic of facility: Hanyang Union Rehabilitation Medicine Clinic status: RECRUITING city: Yangju state: Gyeonggi-do zip: 11404 country: Korea, Republic of lat: 37.83311 lon: 127.06169 facility: KimHyungjoo Clinic status: RECRUITING city: Yangju state: Gyeonggi-do zip: 11456 country: Korea, Republic of lat: 37.83311 lon: 127.06169 facility: Kium Children Hospital status: RECRUITING city: Gunsan state: Jeollabuk-do zip: 54072 country: Korea, Republic of lat: 35.97861 lon: 126.71139 facility: Sinsegie ENT Clinic status: TERMINATED city: Busan zip: 48111 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Jeil Family Medicine Clinic status: WITHDRAWN city: Gwangju zip: 61108 country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Bupyeong Yonsei Medical Clinic status: RECRUITING city: Incheon zip: 21405 country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Inha University Hospital status: RECRUITING city: Incheon zip: 22332 country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Woori Medical Clinic status: RECRUITING city: Seoul zip: 01684 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Yonsei Kids Pediatrics Clinic status: RECRUITING city: Seoul zip: 01851 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Star Pediatrics Clinic status: RECRUITING city: Seoul zip: 03912 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Seoul Bon Clinic status: RECRUITING city: Seoul zip: 04032 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Dr Cho's Family Medical Clinic status: RECRUITING city: Seoul zip: 05351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Songpa Korea Neurosurgical Clinic status: RECRUITING city: Seoul zip: 05769 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: GF Pediatrics Clinic status: RECRUITING city: Seoul zip: 06568 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kim Il Joong Internal Medicine Clinic status: RECRUITING city: Seoul zip: 06727 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: New Yonsei ENT Clinic status: RECRUITING city: Seoul zip: 07327 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Soo Orthopedics Clinic status: TERMINATED city: Seoul zip: 08701 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06333691 id: Aya Mohammed briefTitle: Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin overallStatus: COMPLETED date: 2022-10-01 date: 2024-02-01 date: 2024-02-15 date: 2024-03-27 date: 2024-03-27 name: Minia University class: OTHER briefSummary: Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.
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Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.
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This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens. conditions: Ovarian Hyperstimulation Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ACTUAL name: Calcium Gluconate measure: the incidence rate of moderate to severe OHSS. sex: FEMALE minimumAge: 23 Years maximumAge: 39 Years stdAges: ADULT facility: Minia University, Faculty of Pharmacy city: Minya country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False
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<|newrecord|> nctId: NCT06333678 id: 22-321 briefTitle: A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) overallStatus: RECRUITING date: 2024-03-20 date: 2027-03 date: 2027-03 date: 2024-03-27 date: 2024-03-27 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Amgen briefSummary: In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib). conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase II randomized trial primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Durvalumab name: Sotorasib measure: Progression-free survival (PFS) measure: Incidence of dose-limiting toxicity (DLT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.70038 lon: -73.59291 hasResults: False
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<|newrecord|> nctId: NCT06333665 id: Wei G briefTitle: PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-20 date: 2024-04-20 date: 2024-05-20 date: 2024-03-27 date: 2024-03-27 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\<7.0%) is associated with improved survival. conditions: Esophageal Squamous Cell Carcinoma conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 605 type: ACTUAL name: Whether there is type 2 diabetes mellitus before surgery measure: Overall survival measure: Disease-free survival measure: postoperative adverse events measure: perioperative 90-day mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of the People's Liberation Army city: Chongqing state: Chongqing zip: 400042 country: China lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06333652 id: 22-009239 briefTitle: Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders overallStatus: RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2028-12-31 date: 2024-03-27 date: 2024-04-22 name: Mayo Clinic class: OTHER briefSummary: The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome. conditions: Preeclampsia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Ravulizumab measure: Alternative Complement Pathway Biomarkers at time of delivery measure: Pregnancy duration measure: Clinical biomarkers of severe features of preeclampsia and HELLP syndrome measure: Hospitalization length in the postpartum period measure: Meningococcal infection after use of ravulizumab sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Maria L. Gonzalez Suarez, MD,PhD role: CONTACT phone: 507-284-4083 email: gonzalezsuarez.maria@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06333639 id: 24Chirortho01 briefTitle: Implementing Virtual Reality in the Operating Room acronym: IRVABO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-15 date: 2024-10-15 date: 2024-03-27 date: 2024-03-27 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: "Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.
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However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.
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The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.
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The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour." conditions: General Surgery conditions: Orthopedic Procedures studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: orthopaedic surgery name: orthopaedic surgery and fitted with a virtual reality headset measure: To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset. measure: 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset. measure: Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU NiICE city: Nice state: Alpes Maritimes zip: 0600 country: France name: GAUCI Marc-Olivier role: CONTACT phone: 04 92 03 69 04 phoneExt: +33 email: gauci.mo@chu-nice.fr lat: 43.70313 lon: 7.26608 hasResults: False
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<|newrecord|> nctId: NCT06333626 id: 2020281 briefTitle: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-03-27 date: 2024-03-27 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound. conditions: Nausea and Vomiting, Aspiration, Intraoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: multi-vitamin carbohydrate measure: Gastric antrum area measure: vomiting measure: The pH of vomiting fluid sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06333613 id: CR-6565 briefTitle: Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers overallStatus: RECRUITING date: 2024-03-26 date: 2024-05-20 date: 2024-05-20 date: 2024-03-27 date: 2024-04-24 name: Johnson & Johnson Vision Care, Inc. class: INDUSTRY briefSummary: This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes. conditions: Visual Acuity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) measure: Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear sex: ALL minimumAge: 13 Years maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Scripps Poway Eyecare & Optometry status: RECRUITING city: San Diego state: California zip: 92131 country: United States lat: 32.71533 lon: -117.15726 facility: Omega Vision Center status: RECRUITING city: Longwood state: Florida zip: 32779 country: United States lat: 28.70305 lon: -81.3384 facility: Maitland Vision Center - North Orlando Ave status: RECRUITING city: Maitland state: Florida zip: 32751 country: United States lat: 28.62778 lon: -81.36312 facility: Kannarr Eye Care status: RECRUITING city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Procare Vision Centers status: RECRUITING city: Granville state: Ohio zip: 43023 country: United States lat: 40.06812 lon: -82.5196 hasResults: False
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<|newrecord|> nctId: NCT06333600 id: Soh-Med-23-07-05 briefTitle: Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss overallStatus: RECRUITING date: 2023-05-20 date: 2024-04-01 date: 2024-05-01 date: 2024-03-27 date: 2024-03-27 name: Sohag University class: OTHER briefSummary: The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases conditions: Dermatology conditions: Female Pattern Baldness studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Topical minoxidil name: Topical Vitamin D name: Saline spray measure: Change of Sinclaire grading of Female pattern hair loss measure: Change of Trichoscopic parameters (Hair dermoscopy) sex: FEMALE minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Facult of Medicine, Sohag Uniiversity status: RECRUITING city: Sohag zip: 82515 country: Egypt name: Doaa G Abdelbaset, MSc role: CONTACT phone: 01022330810 phoneExt: 002 email: dodygaber64@yahoo.com name: Doaa G Abdelbaset, Msc role: CONTACT phone: 01014733007 phoneExt: 002 email: dodygaber64@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06333587 id: IEO 1810 briefTitle: Minimally Invasive Treatments of the Thyroid acronym: MIPA-MITT overallStatus: RECRUITING date: 2022-10-10 date: 2025-12-31 date: 2035-12-31 date: 2024-03-27 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC) conditions: Papillary Thyroid Microcarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 270 type: ESTIMATED name: image-guided thermal ablation measure: The proportion of patients with major complications occurring within one month after the date of intervention measure: Percentage of patients with local recurrence at 10 years measure: Percentage of patients with distant metastasis at 10 years measure: Percentage of patients died at 10 years sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Giovanni Mauri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06333574 id: CDUTCM20240313 briefTitle: Weight Management of Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: qinxiu zhang class: OTHER briefSummary: The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:
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* \[Improve the self-compliance of dialysis patients with weight management\]
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* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\'s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.
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Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\' family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management. conditions: Hemodialysis conditions: Life Quality conditions: Interdialytic Weight Gain conditions: Cardiovascular Events conditions: Hypertension conditions: Dry Weight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Family weight self-measurement and remote follow-up management based on wechat. name: Routine care measure: Adverse event rate measure: Rate of completion measure: dialysis related symptoms measure: Laboratory index measure: level of Ga measure: level of P measure: level of PTH measure: level of K measure: level of Na measure: level of Cl measure: concentration of albumin and prealbumin measure: Laboratory index of total protein measure: Dialysis efficiency \ dialysis adequacy (KTV) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333561 id: Liver Project 7 briefTitle: HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-27 date: 2024-03-27 name: Sun Yat-sen University class: OTHER briefSummary: Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC. conditions: Hepatocellular Carcinoma conditions: Lenvatinib conditions: PD-1 Inhibitor conditions: Hepatic Arterial Infusion Chemotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Hepatic arterial infusion chemotherapy name: Lenvatinib name: Tislelizumab name: Toripalimab name: Sintilimab name: Camrelizumab measure: Overall survival measure: Progression-Free-Survival measure: Objective response rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Qunfang Zhou, Md role: CONTACT phone: 8619868000115 email: zhouqun988509@163.com name: Feng Duan, MD role: CONTACT phone: 8613910984586 email: duanfeng@vip.sina.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06333548 id: KSH_MB_2024_1 briefTitle: Cord Blood Alarin Levels in Term Babies overallStatus: COMPLETED date: 2023-09-18 date: 2023-12-23 date: 2024-01-15 date: 2024-03-27 date: 2024-03-29 name: Konya City Hospital class: OTHER briefSummary: In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin. conditions: Birth Weight studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 87 type: ACTUAL name: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM measure: Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight. sex: ALL minimumAge: 1 Minute maximumAge: 5 Minutes stdAges: CHILD facility: MELEK city: Konya state: Sıhhiye zip: 06100 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06333535 id: 2022/568 briefTitle: Foot and Abdominal Massage Applied to After Colonoscopy overallStatus: COMPLETED date: 2023-06-01 date: 2024-01-01 date: 2024-02-25 date: 2024-03-27 date: 2024-03-27 name: TC Erciyes University class: OTHER briefSummary: The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale conditions: Abdominal Pain conditions: Distention conditions: Satisfaction, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 96 type: ACTUAL name: foot massage name: abdominal massage name: foot and abdominal massage measure: abdominal pain measure: Abdominal distension measure: Patient Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Kayseri zip: 38000 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06333522 id: 23-00979 briefTitle: Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-27 date: 2024-03-27 name: NYU Langone Health class: OTHER briefSummary: The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm. conditions: Arthrofibrosis of Knee studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: Losartan measure: Change in range of motion measure: Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06333509 id: CT071-HM-01 briefTitle: Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2027-12-31 date: 2024-03-27 date: 2024-03-27 name: CARsgen Therapeutics Co., Ltd. class: INDUSTRY briefSummary: A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. conditions: Multiple Myeloma conditions: Primary Plasma Cell Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1. primaryPurpose: TREATMENT masking: NONE maskingDescription: N/Ap count: 166 type: ESTIMATED name: CT071 measure: Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD). measure: Phase 2: Objective response rate measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 2: Evaluate additional Safety of CT071. measure: Phase 1 and 2: Assess immunogenicity of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333496 id: AB20240102H briefTitle: Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-02 date: 2024-03-29 date: 2024-04-08 date: 2024-03-27 date: 2024-04-15 name: Alpine Biotech LLC class: INDUSTRY briefSummary: BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.
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PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.
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SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints. conditions: Blood Sugar; High conditions: Overweight and Obesity conditions: Fat Burn conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: GLP1 Booster (GB) measure: blood glucose level measure: blood HbA1c level measure: blood insulin level measure: blood GLP1 level measure: blood cholesterol level measure: body weight measure: body fat mass measure: body lean mass measure: body mass index measure: body fat index measure: waist hip ratio measure: Satiety score measure: Resting metabolic rate measure: Blood pressure measure: Heart rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alpine Bio city: Salt Lake City state: Utah zip: 84109 country: United States lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06333483 id: AUTO1-SL1 id: 2023-508236-60-00 type: CTIS briefTitle: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) acronym: CARLYSE overallStatus: RECRUITING date: 2024-02-02 date: 2024-11 date: 2025-10 date: 2024-03-27 date: 2024-03-27 name: Autolus Limited class: INDUSTRY briefSummary: This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Obecabtagene autoleucel (obe-cel) measure: Dose limiting toxicities measure: Adverse events measure: Remission rate according to Definition of Remission in SLE (DORIS) measure: Response over time according to Definition of Remission in SLE (DORIS) measure: Time to response according to Definition of Remission in SLE (DORIS) measure: Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) measure: Change over time in Physician's global assessment (PGA) measure: Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacodynamics: B cell aplasia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University College London Hospitals NHS Foundation Trust status: RECRUITING city: London country: United Kingdom name: Maria Leandro role: CONTACT email: uclh.car-ttrials@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06333470 id: 2024KYPJ025 briefTitle: Liwan Eye Study: the Fourth Follow-up overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-09-30 date: 2024-09-30 date: 2024-03-27 date: 2024-03-28 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER briefSummary: Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG. conditions: Primary Angle-Closure Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: Primary angle closure diseases measure: The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years measure: The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG) measure: The 20-year incidence of visual impairment in Chinese population aged over 50 years sex: ALL minimumAge: 70 Years maximumAge: 100 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333457 id: EA4/024/24 briefTitle: Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality acronym: PRE-VR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-01 date: 2025-02-01 date: 2024-03-27 date: 2024-03-27 name: Charite University, Berlin, Germany class: OTHER briefSummary: Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.
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Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.
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Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET. conditions: Alcohol Dependence studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: VR Cue-Exposure Therapy measure: Craving measure: Craving measure: Craving measure: Relapse rates measure: Quality of Life measure: Motion Sickness measure: Presence in VR sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychiatric University Hospital Charité at St. Hedwig Hospital city: Berlin zip: 10115 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06333444 id: n. 08, 09/03/2021 briefTitle: Counselling Intervention for College Students Experienced Psychological Distress acronym: TRESPASS overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Campania "Luigi Vanvitelli" class: OTHER briefSummary: The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.
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The main question it aims to answer are:
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* is the psychological counselling intervention useful in improving psychological distress and academic motivation
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* which psychological variables predict the intervention outcome conditions: University Students conditions: Psychological Intervention conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Four weekly psychological counselling intervention primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: four weekly psychological counselling intervention measure: psychological distress measure: Academic motivation measure: Emotion regulation ability measure: perceived loneliness measure: drop-out intention sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Campania status: RECRUITING city: Caserta zip: 81100 country: Italy name: ALDA TRONCONE role: CONTACT email: alda.troncone@unicampania.it lat: 41.07262 lon: 14.33231 hasResults: False
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<|newrecord|> nctId: NCT06333431 id: WN/WF briefTitle: Effects of WN and WF During Gastroscopy acronym: WF/WN_GCPY overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-05-30 date: 2024-06-08 date: 2024-03-27 date: 2024-03-27 name: Suleyman Demirel University class: OTHER briefSummary: Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.
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Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group. conditions: Misadventure During Endoscopic Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 156 type: ESTIMATED name: Glass Waterfall group name: white noise group measure: Patient Information Form measure: Visual Analogue Scale (VAS) measure: State and Trait Anxiety Scale (STAI) measure: The Patient Observation Form measure: Pulse rate before and after gatroscopy procedure measure: Respiratory rate before and after gatroscopy procedure measure: Systolic and diastolic blood pressure before and after gatroscopy procedure measure: Oxygen saturation values before and after gatroscopy procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333418 id: VR/WF briefTitle: Effects of VR and Glass WF Colonoscopy acronym: VR/WN_colon overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-05-30 date: 2024-06-08 date: 2024-03-27 date: 2024-03-27 name: Suleyman Demirel University class: OTHER briefSummary: Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.
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Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information. conditions: Misadventure During Endoscopic Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double (Participant, Investigator) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: Virtual Reality Glasses Group name: Glass waterfall measure: Patient Information Form measure: Visual Analogue Scale (VAS) measure: State and Trait Anxiety Scale (STAI) measure: The Patient Observation Form measure: Pulse rate before colonoscopy procedure measure: Respiratory rate before colonoscopy procedure measure: Systolic and diastolic blood pressure before colonoscopy procedure measure: Oxygen saturation values before colonoscopy procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06333405 id: FMTNEC/01/2024 briefTitle: Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-27 date: 2024-03-27 name: Medical University of Warsaw class: OTHER briefSummary: The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.
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This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects. conditions: Necrotizing Enterocolitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group, open label, observational study with intervention (FMT) primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Fecal Microbiota Transplantation measure: Adverse reactions monitoring sex: ALL minimumAge: 24 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Medical University of Warsaw, Pediatric Surgery Clinic city: Warsaw state: Mazovian Voivodeship zip: 02-097 country: Poland name: Marek Wolski, MD, PhD role: CONTACT phone: 665578922 phoneExt: +48 email: marek.wolski@wum.edu.pl name: Ewa A. Biegańska, MD role: CONTACT phone: 692542543 phoneExt: +48 email: ewa.bieganska@wum.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06333392 id: TotalUnderwater_REK577567 briefTitle: Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Vestre Viken Hospital Trust class: OTHER name: Ullevaal University Hospital name: Sahlgrenska University Hospital, Sweden name: Ostfold Hospital Trust briefSummary: Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:
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1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.
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2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.
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3. uEMR is eased.
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4. Improved bowel cleansing
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The goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.
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The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.
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The project has five main hypotheses:
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1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.
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2. TUC increases the rate of complete resection of lesions \>= 10mm.
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3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.
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4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.
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5. TUC reduces the carbon footprint by reduced use of single use accessories.
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If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.
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The trial can be linked to three of the Global Goals:
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* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).
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* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.
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* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced. conditions: Colorectal Neoplasia conditions: Screening Colonoscopy conditions: Colorectal Cancer conditions: Colorectal Cancer Screening conditions: Vasovagal Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1070 type: ESTIMATED name: Total underwater colonoscopy name: Conventional colonoscopy measure: Proximal sessile serrated lesion detection rate measure: Complete resection rate for lesions > 10mm measure: Rate of painful procedures and vasovagal reactions measure: Leakage after colonoscopy measure: Detection rate for other neoplasia than SSL measure: Withdrawal time measure: Total procedure time measure: Bowel cleansing quality measure: Complications measure: Number of colonoscopies to achieve polyp free colon measure: Single use accessories for the procedure sex: ALL minimumAge: 55 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06333379 id: SichuanPPHLC04 id: 2020LY01 type: OTHER_GRANT domain: Sichuan Provincial People's Hospital briefTitle: Aspergillosis Detection Via EBC-GM in Ventilated Patients overallStatus: COMPLETED date: 2023-01-02 date: 2023-12-30 date: 2024-01-10 date: 2024-03-27 date: 2024-03-27 name: Lin Chen class: OTHER briefSummary: Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.
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Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.
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Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.
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