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Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
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Participants will be divided into two groups randomly, with different nutritional support respectively. conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Basic treatment name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Number of cases of successful extubation measure: Body mass index measure: Concentration of Serum albumin measure: Concentration of Hemoglobin measure: Clinical Pulmonary Infection Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328933 id: IOE feeding amount briefTitle: Intermittent Oral Tube on Feeding Amount overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Nutritional status-prealbumin measure: Feeding Amount measure: Body weight measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328920 id: IOE Yicongxing briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Rehabilitation Treatment Compliance Questionnaire measure: Patient Health Questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328907 id: IOE Social Condition briefTitle: Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Swallowing-Quality of Life questionnaire measure: The Reintegration to Normal Living Index measure: Functional Oral Intake Scale measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328894 id: IOE Psychological briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: Generalized Anxiety Disorder 7 measure: Patient Health Questionnaire-9 measure: Self-made questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328881 id: IOE Parkinson briefTitle: Effect of Intermittent Oral Tube on Dysphagia in Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
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• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.
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Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation training name: Intermittent Oro-esophageal Tube name: Nasogastric tube measure: Concentration of Serum albumin measure: Concentration of Hemoglobin measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328868 id: IOE Nasopharyngeal Carcinoma briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.
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Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Concentration of Hemoglobin measure: Concentration of Serum albumin measure: Body Mass Index measure: Concentration of Serum prealbumin measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Swallowing-Quality of Life questionnaire measure: Feeding amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328855 id: IOE Dysphagia in Stroke briefTitle: Intermittent Oro-esophageal Tube Feeding on Dysphagia in Stroke Survivor overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy name: Nasogastric Tube Feeding measure: Penetration-Aspiration Scale measure: Body weight measure: Nutritional status-total protein measure: Nutritional status-albumin measure: Yale pharyngeal residue severity rating scale measure: Patient health questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328842 id: IOE Cerebral Small Vessel briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Video Fluoroscopic Swallowing Study measure: Functional Oral Intake Scale measure: Body mass index measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328829 id: IOE Alzheimer briefTitle: Intermittent Oral Tube in Alzheimer's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Conventional Care name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric tube measure: Concentration of Hemoglobin measure: Concentration of Serum albumin measure: Concentration of Total serum protein measure: Concentration of Serum prealbumin measure: Body Mass Index measure: Pulmonary Infections measure: Mini Nutritional Assessment measure: Standardized Swallowing Assessment sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328816 id: Computer-based Training briefTitle: Computer-based Training on Cognitive Dysphagia in Stroke Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Computer-assisted Cognitive Function Training measure: Montreal Cognitive Assessment measure: The coordination of swallowing measure: Penetration-Aspiration Scale measure: Swallowing reflex sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328803 id: Active Breathing Exercises briefTitle: Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation training name: Active Breathing Exercises measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray Secretion Scale measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328790 id: PNRR-MAD-2022-12376826 briefTitle: Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD) overallStatus: RECRUITING date: 2023-05-31 date: 2025-05 date: 2025-05 date: 2024-03-25 date: 2024-03-26 name: Michele Tinazzi, MD, PhD class: OTHER name: IRCCS Ospedale San Raffaele name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona briefSummary: Functional motor disorders (FMD) are prevalent and highly disabling conditions characterized by abnormal movements (functional weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs are still misunderstood, diagnosed with delay, and not adequately treated, leading to reduced independence and high healthcare costs. Symptoms are physiologically associated with voluntary movement (distractibility, resolution with placebo) but are reported as involuntary. How this happens is yet a matter of debate. Identifying diagnostic and prognostic disease-specific biomarkers is an unmet need. The investigators will investigate motor, exteroceptive and interoceptive domains in a large cohort of FMD patients by a comprehensive set of behavioural, neurophysiological, and MRI tests. Ad-hoc eXplainable Artificial Intelligence (XAI) methods will develop disease-specific diagnostic and prognostic biomarker algorithms. conditions: Functional Motor Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Multidisciplinary Rehabilitation Training name: Cross-sectional study on patients with FMD and patients with structural/organic diseases name: Cross-sectional study on patients with FMD and healthy controls (HC) measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Brief Pain Inventory (BPI) score measure: Beck Anxiety Inventory (BAI) score measure: Beck Depression Inventory (BDI-II) score measure: 12-item Short-Form Health Survey (SF-12) score measure: Toronto Alexithymia Scale (TAS-20) score measure: Direct adn indirect index of Sensory Attenuation (SA) measure: Joint angle at the elbow vibrated and reproduced measure: N2/P2 amplitude measure: Objective/Subjective heart rate ratio measure: Cortical thickness and gray matter volumes measure: Clinical Global Impression (CGI) score measure: Gait speed (cm/sec) measure: Swing time (%) measure: Stride time (s) measure: Stride length (cm) measure: Sway area (mm2) measure: Stance time (sec) measure: Total excursion path (mm) measure: Velocity of Cop displacement in the anteroposterior directions (mm/s) measure: Velocity of Cop displacement in the mediolateral directions (mm/s) measure: Autism spectrum Quotient (AQ) measure: Schizotypal Personality Questionnaire (SPQ) measure: Number of drop-out measure: Number of patients who refuse the treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona status: RECRUITING city: Salerno state: Campania zip: 84131 country: Italy name: Maria Teresa Pellecchia, PhD role: CONTACT phoneExt: +39 email: mpellecchia@unisa.it lat: 40.67545 lon: 14.79328 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano state: Lombardia zip: 20132 country: Italy name: Federica Agosta, PhD role: CONTACT phoneExt: +39 email: agosta.federica@hsr.it name: Elisabetta Sarasso, PhD role: CONTACT email: sarasso.elisabetta@hsr.it lat: 45.46427 lon: 9.18951 facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona status: RECRUITING city: Verona zip: 37131 country: Italy name: Michele Tinazzi, PhD role: CONTACT phone: 0458124768 phoneExt: +39 email: michele.tinazzi@univr.it name: Marialuisa Gandolfi, PhD role: CONTACT phone: 3491656108 phoneExt: +39 email: marialuisa.gandolfi@univr.it lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06328777 id: CAB-201-003 briefTitle: RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-07 date: 2029-07 date: 2024-03-25 date: 2024-04-26 name: Cabaletta Bio class: INDUSTRY briefSummary: RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis conditions: Systemic Sclerosis conditions: Scleroderma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CABA-201 measure: To evaluate incidence of adverse events measure: To evaluate adverse events and laboratory abnormalities measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacokinetics (PK) measure: To evaluate efficacy sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: James St. Clair role: CONTACT phone: 734-936-5615 email: ssc-coordinator@umich.edu name: Neda Kortam role: CONTACT phone: 734-763-4866 email: ssc-coordinator@umich.edu name: Monalisa Ghosh, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06328764 id: CS-101-11 briefTitle: A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2026-01-30 date: 2024-03-25 date: 2024-03-25 name: CorrectSequence Therapeutics Co., Ltd class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CS-101 measure: Frequency and severity of adverse events(AEs)as assessed by CTCAE v5.0 measure: Time to neutrophil and platelet engraftment measure: Proportion of subjects with engraftment measure: Incidence of transplant-related mortality measure: All-cause mortality measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months measure: Time to last red blood cell(RBC) transfusion measure: Change in total hemoglobin(Hb) concentration over time measure: Change in fetal hemoglobin(HbF) concentration over time measure: Chimerism level in Peripheral blood and bone marrow sex: ALL minimumAge: 6 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 hasResults: False
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<|newrecord|> nctId: NCT06328751 id: 76043823.0.0000.0004 briefTitle: Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-06-30 date: 2025-08-30 date: 2024-03-25 date: 2024-03-25 name: Emily Santos Montarroyos class: NETWORK name: AC Camargo Cancer Center briefSummary: Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients. conditions: Cancer Pain conditions: Quality of Life conditions: Palliative Medicine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Randomization will be carried out using a specific application called Randomizer ® for Clinical Trial Lite, which is a secure and validated application that works with encrypted network traffic using Transport Layer Security (TLS), a strong encryption. There will be 3 groups which will be divided into the Case Group, the Active Control Group and the Passive Control Group. Each patient will be seen individually wearing a Samsung® smartwatch and will not know about the other patients' meditation. The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the Oncology Control Center Foundation (FCECON) office, using Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound at the office. The passive control group will perform breathing exercises based on the healthcare professional's instructions for 4 minutes in the office. whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: Case group name: Active control group name: Passive control group measure: Brief Pain Inventory (Reduced version) measure: McGill Quality of Life Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: The Edmonton Symptom Assessment Scale (ESAS) measure: The National Comprehensive Cancer Network® (NCCN) Distress Thermometer sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328738 id: ELVN-002-003 briefTitle: ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2027-01 date: 2028-07 date: 2024-03-25 date: 2024-03-26 name: Enliven Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer. conditions: HER2-positive Breast Cancer conditions: HER2-positive Gastric Cancer conditions: HER2 Positive Solid Tumors conditions: HER2 Amplification conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a will be a dose escalation of ELVN-002 in combination with fixed doses of trastuzumab or trastuzumab + chemotherapy according to the Bayesian Optimal Interval Design model. Phase 1b will be a dose expansion at one or more doses of ELVN-002. primaryPurpose: TREATMENT masking: NONE count: 255 type: ESTIMATED name: ELVN-002 name: Trastuzumab name: 5-Fluorouracil name: Oxaliplatin name: Capecitabine name: Eribulin name: paclitaxel name: Leucovorin measure: Incidence of dose limiting toxicities (DLTs; Phase 1a only) measure: Incidence of adverse events (AEs) measure: Incidence of laboratory abnormalities measure: Incidence of electrocardiogram abnormalities measure: PK parameter of area under the curve of ELVN-002 (Phase 1a only) measure: PK parameter of maximum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of minimum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of terminal half life of ELVN-002 (Phase 1a only) measure: Confirmed objective response rate (ORR) measure: Duration of response (DOR; Phase 1b only) measure: Brain metastases response (Phase 1b only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD role: CONTACT phone: 703-636-1473 lat: 38.84622 lon: -77.30637 hasResults: False
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<|newrecord|> nctId: NCT06328725 id: EN001_POWER briefTitle: Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Duchenne Muscular Dystrophy conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: \<Phase 1 Clinical Trial\> A total of 6-12 participants (3-6 participants per cohort).
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\<Phase 2 Clinical Trial\> A total of 76 participants (a minimum of 30 participants per group, considering a dropout rate of 20%, resulting in 38 participants per group). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The investigational drug for the clinical trial of the following cohort or group will be administered intravenously (IV) three times at 6-week intervals.
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\<Phase 1 Clinical Trial\> Cohort 1: EN001 5.0x10\^5 cells/kg / Cohort 2: EN001 2.5x10\^6 cells/kg
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\<Phase 2 Clinical Trial\> Experimental Group: Recommended Phase 2 Dose (RP2D) for EN001 / Control Group: Placebo for EN001 whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: EN001 measure: <Phase 1> Adverse drug reactions related to dose limiting toxicity (DLT) measure: <Phase 1> Adverse drug reactions related to discontinuation of clinical trial drug administration measure: <Phase 2> Change in time to stand test (TTSTAND) measure: <Phase 1> Time to stand test (TTSTAND) change amount measure: <Phase 1> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 1> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 1> TTRW velocity (1/TTRW) change amount measure: <Phase 1> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 1> Time to climb 4 steps test (TTCLIMB) change amount measure: <Phase 1> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 1> 6-minute walk test (6MWT) change amount measure: <Phase 1> Changes amount in muscle strength by region measure: <Phase 1> Changes amount in parameters related to pulmonary function measure: <Phase 1> Changes amount in parameters related to cardiac function measure: <Phase 1> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Time to stand test (TTSTAND) change amount measure: <Phase 2> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 2> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 2> TTRW velocity (1/TTRW) change amount measure: <Phase 2> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 2> Time to climb 4 steps test (TTCLIMB) change measure: <Phase 2> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 2> 6-minute walk test (6MWT) change amount measure: <Phase 2> Changes amount in muscle strength by region measure: <Phase 2> Changes amount and rate of change in whole thigh muscle volume and index assessed by MRI measure: <Phase 2> Changes amount in parameters related to pulmonary function measure: <Phase 2> Changes amount in parameters related to cardiac function measure: <Phase 2> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Pediatric Outcomes Data Collection Instrument (PODCI) item score and total score change measure: <Phase 2> Pediatric Quality of Life inventory™ (PedsQL™) item scores and total score change measure: <Phase 1> Adverse Event measure: <Phase 1> Laboratory examination measure: <Phase 1> Vital sign measure: <Phase 2> Adverse Event measure: <Phase 2> Laboratory examination measure: <Phase 2> Vital sign sex: MALE minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: Samsung Medical Center city: Seoul country: Korea, Republic of name: Jeehun Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of name: Jong-Hee Chae role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06328712 id: EN001_MIRACLE1 briefTitle: Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A overallStatus: RECRUITING date: 2024-03 date: 2024-10 date: 2024-10 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: An Open, Dose-escalation, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A (CMT1A) conditions: Charcot-Marie-Tooth Disease Type 1A studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: EN001 measure: Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration measure: CMTNSv2 score change measure: CMT examination score change measure: Rasch-modified CMTNSv2 score change measure: Rasch-modified CMTES score change measure: FDS score change measure: ONLS score change measure: 10MWT score change measure: Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale) measure: Change in Motor Nerve Conduction Velocity (Unit: m/s) measure: Change in Compound Muscle Action Potential (Unit: ㎷) measure: Change in Sensory Nerve Action Potential (Unit: ㎶) measure: Change in Sensory Nerve Conduction Velocity (Unit: m/s) measure: SF-36v2 score change measure: Adverse Event measure: Vital sign measure: Laboratory examination measure: electrocardiography measure: X-ray measure: Physical Examinations sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Byung-Ok Choi role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06328699 id: STUDY00006456 id: EU6011-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: K01AT010488 type: NIH link: https://reporter.nih.gov/quickSearch/K01AT010488 id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation overallStatus: RECRUITING date: 2023-10-30 date: 2024-05-01 date: 2024-11-15 date: 2024-03-25 date: 2024-04-01 name: Emory University class: OTHER name: National Cancer Institute (NCI) name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation. conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Spiritual Therapy name: Best Practice measure: Feasibility - patient enrollment and treatment-specific retention rates measure: Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT] measure: Acceptability - Chaplain Satisfaction Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Erin Brauer, MPH role: CONTACT email: erin.graf.brauer@emory.edu lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06328686 id: STUDY00005787 id: NCI-2023-10895 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00005787 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: WINSHIP5883-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-19 name: Emory University class: OTHER name: National Cancer Institute (NCI) briefSummary: This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy. conditions: Metastatic Malignant Neoplasm in the Brain conditions: Metastatic Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Arginine name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: Spectroscopy name: Whole-Brain Radiotherapy measure: Peak plasma L-arginine (arginine) and arginine metabolite concentration measure: Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy measure: Side effect profile of oral and IV arginine measure: Frontal cortex blood volume/flow changes with L-arginine administration measure: Describe The Immunological Effects of Oral versus IV Arginine measure: Describe The Metabolic Effects of Oral versus IV Arginine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute city: Atlanta state: Georgia zip: 30322 country: United States name: Lisa Sudmeier, MD, PhD role: CONTACT phone: 404-712-9625 email: lsudmei@emory.edu name: Agnes Harutyunyan role: CONTACT email: aharuty@emory.edu name: Lisa Sudmeier, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06328673 id: DM919-001 briefTitle: A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-28 name: D2M Biotherapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumors
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The main questions it aims to answer are:
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What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab??
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Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: DM919 name: Pembrolizumab measure: Number of treatment-emergent events (TEAEs) in Dose Escalation measure: RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab measure: All cohorts measure: All cohorts measure: All cohorts measure: All cohorts measure: Dose Expansion measure: Dose Expansion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78216 country: United States name: Shiraj Sen role: CONTACT phone: 972-893-8800 lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06328660 id: EX-MKTG-155 briefTitle: Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-06-18 date: 2024-06-18 date: 2024-03-25 date: 2024-03-25 name: Coopervision, Inc. class: INDUSTRY briefSummary: The purpose of this study is to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market. conditions: Presbyopia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ACTUAL name: Lens 1 name: Lens 2 measure: Overall Lens Handling measure: Overall logMAR Visual Acuity sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ocular Technology Group city: London zip: SW1E6AU country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06328647 id: 24-010 briefTitle: Quantra Point-of-Care Hemostasis Monitoring acronym: QUANTRA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-23 name: The Cleveland Clinic class: OTHER briefSummary: The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion). conditions: Bleeding conditions: Hemostatic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 666 type: ESTIMATED name: POC Quantra QPlus System name: Routine care measure: Blood and blood component transfusions measure: Bleeding measure: PT/aPTT measure: INR measure: Platelet measure: Fibrinogen measure: hematocrit/hemoglobin measure: ICU length of stay measure: Hospital length of stay. measure: In-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328634 id: LOCAL/2014/FV-01 briefTitle: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital overallStatus: COMPLETED date: 2008-01-01 date: 2012-12-31 date: 2012-12-31 date: 2024-03-25 date: 2024-03-25 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: OBJECTIVES:
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We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.
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METHODS:
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We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients. conditions: Bacillus Cereus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 76 type: ACTUAL measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328621 id: 19594 id: NCI-2021-05881 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19594 type: OTHER domain: City of Hope Medical Center id: P30CA033572 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA033572 briefTitle: Lung Cancer Risk Assessment and Etiology overallStatus: RECRUITING date: 2021-07-02 date: 2029-06-15 date: 2029-06-15 date: 2024-03-25 date: 2024-03-25 name: City of Hope Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer. conditions: Lung Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Electronic Health Record Review name: Survey Administration measure: Frequency of germline alterations measure: Frequency of abnormal radiographic findings measure: Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes measure: Liquid biopsy (LB) test sensitivity measure: LB test specificity measure: LB test positive predictive value measure: LB test negative predictive value measure: LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Stacy W. Gray role: CONTACT phone: 626-218-6639 email: stagray@coh.org name: Stacy W. Gray role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06328608 id: CLI-06657AA1-01 id: 2022-503128-29 type: REGISTRY domain: Clinical Trial Information System (CTIS) - EU briefTitle: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease acronym: FLY overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-12 date: 2028-03 date: 2024-03-25 date: 2024-03-25 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY name: ICON plc briefSummary: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease. conditions: Fabry Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: PRX-102 1 mg/kg every two weeks measure: Incidence of Treatment Emergent Adverse Events (TEAEs) measure: Incidence of Infusion Related Reactions (IRRs) measure: Incidence of Injection site reactions (ISRs) measure: Change in Tanner stage measure: Change from baseline of 12-lead ECG quantitative parameters: Mean Heart Rate measure: Change from baseline of 12-lead ECG quantitative parameters: PR Interval measure: Change from baseline of 12-lead ECG quantitative parameters: QRS Duration measure: Change from baseline of 12-lead ECG quantitative parameters: QT Interval measure: Change from baseline of 12-lead ECG quantitative parameters: QTc Interval measure: Change from baseline of 12-lead ECG quantitative parameters: ST Segment measure: Incidence of treatment-emergent Anti-Drug Antibodies (ADAs) measure: Incidence of premedication use at each visit and change of infusion premedications from baseline measure: Pharmacokinetics: Time to maximum plasma concentration (tmax) measure: Pharmacokinetic : Area under the plasma concentration-time curve from time 0 to time t (AUC0 t) measure: Pharmacokinetics: Area under the curve from time 0 to 2 weeks (AUC0-2wk) measure: Pharmacokinetics: Area under the curve from time 0 to infinity (AUC0-∞) measure: Pharmacokinetics: Terminal half-life (t1/2) measure: Pharmacokinetics: Area under the curve over a dosing interval (AUCτ) measure: Pharmacokinetics: Observed drug concentration at the end of the dosing interval (Cτ) measure: Pharmacokinetics: Clearance (Cl) measure: Pharmacokinetics: Volume of distribution (Vz) measure: Change in eGFR measure: Change in annualized eGFR slope measure: Change in urine albumin levels measure: Change in urine protein levels measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Incidence of any cardiac arrythmias as assessed by Holter ECG measure: Change in plasma levels of cardiac biomarkers measure: Change in plasma level of Gb3 concentration (nM) measure: Change in plasma level of lyso-Gb3 (nM) measure: Change in urine level of lyso-Gb3 (nM) measure: Incidence of change from baseline in the number of different pain medications measure: Incidence of Fabry Clinical Events measure: Change from baseline of Mainz Severity Score Index (MSSI) scores measure: Change from baseline of PedsQL-GI (or GSRS for subjects who reaches 18 yrs of age) scores measure: Change from baseline of FPHPQ scores measure: Change from baseline of PedsQL-PPQ (or BPI-SF for subjects who reaches 18 yrs of age) scores measure: Change from baseline of EQ-5D-Y (or EQ-5D-5L for subjects who reaches 18 yrs of age) scores sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06328595 id: Cross sectional briefTitle: Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria overallStatus: COMPLETED date: 2022-04-22 date: 2023-05-04 date: 2023-08-20 date: 2024-03-25 date: 2024-03-26 name: Syrian Private University class: OTHER briefSummary: Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue conditions: Musculoskeletal Pain conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1039 type: ACTUAL measure: The Demographic characteristics were classified into four groups: Gender, Residual area, education level. sex: ALL minimumAge: 18 Years maximumAge: 78 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamad Zaid Ahmad Abdalla city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-24 uploadDate: 2024-03-22T04:16 filename: Prot_SAP_000.pdf size: 235804 hasResults: False
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<|newrecord|> nctId: NCT06328582 id: Zhenjiu Post-stroke dysphagia briefTitle: Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Routine rehabilitation training name: Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Gugging Swallowing Screen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328569 id: VR Wallenberg Syndrome briefTitle: Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:
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the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.
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Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy. conditions: Wallenberg Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Virtual Reality Therapy name: Conventional dysphagia treatment measure: standardized swallowing assessment measure: Murray secretion scale measure: penetration-aspiration scale measure: swallowing-quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328556 id: Ultrasound-guided Botulinum briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations. conditions: Cricopharyngeal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: botulinum toxin type A name: Injection measure: functional oral intake scale measure: Penetration-Aspiration Scale measure: The Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray secretion scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328543 id: N-20210046 4th project briefTitle: Itch Sensation Induced by Multiple Applications of Pruritogens (Temporal Summation) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-25 name: Aalborg University class: OTHER briefSummary: In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The participants will randomly receive applications of cowhage and histamine primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens whoMasked: PARTICIPANT count: 26 type: ESTIMATED name: Histamine name: Cowhage measure: Assessment of itch measure: Assessment of pain measure: Microvascular reactivity measure: Alloknesis measure: Mechanically evoked itch sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06328530 id: N-20210046 3rd project briefTitle: Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-25 name: Aalborg University class: OTHER briefSummary: In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The participants will randomly receive applications of cowhage and histamine. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens. whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Cowhage name: Histamine measure: Assessment of itch measure: Assessment of pain measure: Alloknesis measure: Mechanically evoked itch sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06328517 id: 2023-305 briefTitle: The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models overallStatus: RECRUITING date: 2023-11-01 date: 2026-11-01 date: 2026-11-01 date: 2024-03-25 date: 2024-03-25 name: Juan Kang class: OTHER briefSummary: Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.
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Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis. conditions: Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Death measure: complication sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: juan Kang role: CONTACT phone: +8613996112052 email: 68368892@qq.com lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06328504 id: Cashew Protocol briefTitle: Efficacy of Cashew Nut Protein Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-04-21 date: 2027-04-21 date: 2024-03-25 date: 2024-03-25 name: Medical University of Warsaw class: OTHER briefSummary: It is a randomized, sigle-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Cashew immunotherapy measure: Cashew full tolerance measure: Cashew partial tolerance measure: OIT safety measure: Wheal diamater in skin prick tests measure: SIgE and IgG 4 levels measure: BAT scores measure: Quality of life- FAQLQ measure: Air condensate sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD facility: Medical University of Warsaw city: Warsaw state: Mazowieckie zip: 02-091 country: Poland name: Agnieszka Szczukocka-Zych, MD role: CONTACT phone: +48 22 3179427 email: agnieszka.szczukocka-zych@wum.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06328491 id: OZUHN-014 id: 22-5325 type: OTHER domain: University Health Network briefTitle: Erdafitinib in Metastatic Steroid-cell Ovarian Cancer overallStatus: COMPLETED date: 2022-05-30 date: 2022-08-22 date: 2022-08-22 date: 2024-03-25 date: 2024-03-25 name: University Health Network, Toronto class: OTHER briefSummary: This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary. conditions: Ovarian Cancer conditions: Steroid Cell Tumor, Malignant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: Erdafitinib measure: Tumor response measure: Overall health status sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06328478 id: Predictors of AKI in PICU. briefTitle: Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-25 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year. conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Observational prospective study. measure: Incidence of acute kidney injury and survival to discharge from the PICU. sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06328465 id: IEO 1108 briefTitle: fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases acronym: fREEDOM overallStatus: RECRUITING date: 2019-11-22 date: 2028-12-31 date: 2028-12-31 date: 2024-03-25 date: 2024-03-25 name: European Institute of Oncology class: OTHER briefSummary: The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI. conditions: Invasive Breast Cancer conditions: HER2-positive Breast Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 145 type: ESTIMATED name: Diffusion whole body MRI measure: 5-year overall survival measure: Overall survival of patients underwent local treatment measure: Breast cancer specific survival measure: Safety of local treatment measure: Anxiety assessment measure: Health state assessment measure: Ability to Cope With Trauma assessment measure: Personality assessment measure: Acceptability and perception of DWB-MRI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Monica Iorfida, MD role: CONTACT phone: +390257489970 email: monica.iorfida@ieo.it name: Mara Negri role: CONTACT phone: +390257489536 email: mara.negri@ieo.it name: Monica Iorfida, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06328452 id: MASLD briefTitle: Risk Factors and Impact MASLD in Patients With IBD acronym: MASLD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Assiut University class: OTHER briefSummary: Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing.
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In about 5-50% of patients with IBD, there are several extraintestinal manifestations as primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and non-alcoholic fatty liver disease (NAFLD).
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Metabolic dysfunction-associated steatotic liver disease "MASLD"(formerly NAFLD) is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus.
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The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.
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Limited data are available on the frequency and risk factors of MASLD in Egyptian patients with IBD, and no published Egyptian study has addressed the clinical utility of serum steatosis markers in MASLD prediction in IBD population. Moreover, the impact of MASLD on IBD course is unclear. Therefore, we will conduct our study to shed some light on this issue. conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: FibroScan measure: Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic measure: Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course measure: Performance of serum steatosis markers in prediction of steatosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328439 id: ANS014004-I-CN-01 briefTitle: A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-03-19 date: 2027-12-31 date: 2028-01-31 date: 2024-03-25 date: 2024-03-25 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY name: Shanghai Chest Hospital name: Hunan Cancer Hospital name: Henan Cancer Hospital name: Zhejiang Cancer Hospital name: Peking University Cancer Hospital & Institute briefSummary: Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.
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* The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).
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* During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria.
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1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors.
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2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.
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All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Cohort1: 7.5mg Cohort2: 15mg Cohort3: 30mg Cohort4: 45mg Cohort5: 60mg primaryPurpose: TREATMENT masking: NONE count: 216 type: ESTIMATED name: ANS014004 measure: Incidence of Adverse Events (AEs) measure: Incidence of Serious Adverse Events (SAEs) measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol measure: Incidence of baseline laboratory finding, ECG and vital signs changes measure: Proportion of patients with radiological response (ORR) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Progression free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetics of ANS014004: Plasma PK concentrations measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) measure: Pharmacokinetics of ANS014004: Clearance measure: Pharmacokinetics of ANS014004: Half-life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai country: China name: Shun Lu, Ph.D role: CONTACT phone: +8618017321551 email: shunlu_shchest@sina.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06328426 id: Anti-osteoarthritis briefTitle: Vitamin D With Omega-3 or Metformin in Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: Assiut University class: OTHER briefSummary: To determine the efficacy of vitamin D with omega-3 or metformin for reducing knee symptoms and effusion synovitis in patients with symptomatic knee osteoarthritis. conditions: Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Vitamin D name: Omega-3 name: Metformin name: Placebo measure: Effusion-synovitis volume on musculoskeletal ultrasound. sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328413 id: KAEK-302 briefTitle: L-PRF vs PBM on Extraction Socket Healing overallStatus: COMPLETED date: 2020-04-20 date: 2021-06-21 date: 2021-09-21 date: 2024-03-25 date: 2024-03-25 name: Akdeniz University class: OTHER briefSummary: The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets. conditions: Healing Surgical Wounds conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: photobiomodulation name: Leukocyte and Platelet Rich Fibrin measure: Newly formed bone (Healing at extraction sockets) measure: Soft tissue healing measure: Probing depth measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Akdeniz University city: Antalya state: Merkez zip: 07058 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06328400 id: VV116-RSV-02 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension overallStatus: RECRUITING date: 2024-03-27 date: 2024-06-30 date: 2024-08-30 date: 2024-03-25 date: 2024-04-24 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Deuremidevir Hydrobromide for Suspension name: Deuremidevir Hydrobromide for Suspension Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Cmax measure: Tmax measure: AUC0- t measure: AUC0-∞ measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hushan Hospital Fudan university status: RECRUITING city: Shanghai state: Shanghai zip: 201900 country: China name: Xiaojie Wu role: CONTACT phone: 13524686330 email: maomao_xj@163.com name: Jufang Wu role: CONTACT phone: 13816357099 email: 13816357099@163.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06328387 id: SYSKY-2024-064-03 briefTitle: HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer overallStatus: RECRUITING date: 2024-01-29 date: 2026-02-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group.
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Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival.
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To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer. conditions: Advanced Breast Cancer conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research model consists of four arms:
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1. arm A: SG.
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2. arm B: HCQ+SG.
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3. arm C: T-DXd .
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4. arm D: HCQ+T-DXd. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Hydroxychloroquine name: Sacituzumab Govitecan name: Trastuzumab Deruxtecan measure: Dose Limiting Toxicity, DLT measure: Adverse event, AE measure: Objective Response Rate, ORR measure: Progression-Free Survival, PFS measure: Overall Survival, OS measure: Clinical Benefit Rate, CBR measure: Disease Control Rate, DCR measure: The rate of adverse events measure: Quality of life scale score, QoL measure: Exploration of biomarkers sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Jianli J Zhao, doctorate role: CONTACT phone: 15920589334 email: zhaojli5@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06328374 id: 240420 briefTitle: Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2026-12 date: 2024-03-25 date: 2024-03-26 name: Vanderbilt University Medical Center class: OTHER briefSummary: This research study is investigating whether people with Alzheimer's disease experience more changes to voice and swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe Alzheimer's Disease is high (85-93%) and voice is also often negatively impacted by Alzheimer's disease. The overall objective of this study is to evaluate the voice and swallowing function of adults with and without Alzheimer's disease. The investigators will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of voice and swallowing impairments on the primary caregivers of those with Alzheimer's Disease.
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Healthy adults and individuals with Alzheimer's disease will:
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* undergo tests of cough, voice, and swallow function
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* undergo tests of grip and tongue strength
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* complete questionnaires
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Caregivers of individuals with Alzheimer's disease will also complete questionnaires. conditions: Alzheimer Disease conditions: Caregiver Burden conditions: Healthy Aging conditions: Dysphonia conditions: Dysphagia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Swallowing safety measure: Voluntary cough peak expiratory flow measure: Vocal fold bowing index measure: Swallowing and Eating Related Fatigue Questionnaire (SERF) measure: Swallowing Related Quality of Life Questionnaire (SWAL-QOL) measure: Voice Handicap Index (VHI) measure: Aging Voice Index (AVI) measure: Grip Strength measure: Tongue strength measure: Clinical frailty scale measure: Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire measure: Caregiver Self-Assessment Questionnaire sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328361 id: R24008 briefTitle: Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer acronym: NORPPA-1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2032-12-31 date: 2024-03-25 date: 2024-03-25 name: Tampere University Hospital class: OTHER name: Tampere University name: Helsinki University Central Hospital name: Turku University Hospital name: Kuopio University Hospital name: Oulu University Hospital name: Jyväskylä Central Hospital name: Seinajoki Central Hospital name: Satakunta Central Hospital name: North Karelia Central Hospital name: Tartu University Hospital name: East Tallinn Central Hospital name: West Tallinn Central Hospital name: North Estonia Medical Centre briefSummary: The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are
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* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere
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* what is the organ preservation rate
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* what is the local regrowth rate conditions: Rectal Cancer conditions: Rectal Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Nonoperative surveillance measure: Disease-free survival measure: Overall survival measure: TME-free survival measure: ctDNA-free survival measure: Post local regrowth disease-free survival measure: Post local regrowth overall survival measure: Local regrowth-free survival measure: Local recurrence-free survival measure: Distant metastases-free survival measure: Disease-free survival measure: Salvage rate after local regrowth measure: Quality of life score measure: Complication rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: East Tallinn Central Hospital city: Tallinn country: Estonia lat: 59.43696 lon: 24.75353 facility: North Estonia Medical Centre city: Tallin country: Estonia name: Indrek Seire, MD, PhD role: CONTACT email: indrek.seire@ut.ee lat: 59.43696 lon: 24.75353 facility: West Tallinn Central Hospital city: Tallin country: Estonia name: Kaur Liivak, MD, PhD role: CONTACT email: kaur.liivak@keskhaigla.ee lat: 59.43696 lon: 24.75353 facility: Tartu University Hospital city: Tartu country: Estonia name: Jaan Soplepman, MD, PhD role: CONTACT email: jaan.soplepmann@kliinikum.ee lat: 58.38062 lon: 26.72509 facility: Helsinki University Central Hospital city: Helsinki zip: 00290 country: Finland name: Anna H Lepistö, MD, PhD role: CONTACT email: anna.lepisto@hus.fi lat: 60.16952 lon: 24.93545 facility: North Karelia Central Hospital city: Joensuu country: Finland name: Markku Matikainen, MD, PhD role: CONTACT email: markku.matikainen@siunsote.fi, lat: 62.60118 lon: 29.76316 facility: Jyväskylä Central Hospital city: Jyväskylä country: Finland name: Kyösti Tahkola, MD, PhD role: CONTACT email: kyosti.tahkola@hyvaks.fi lat: 62.24147 lon: 25.72088 facility: Kuopio University Hospital city: Kuopio country: Finland name: Anne Fageström, MD, PhD role: CONTACT email: anne.fagerstrom@pshyvinvointialue.fi lat: 62.89238 lon: 27.67703 facility: Oulu University Hospital city: Oulu country: Finland name: Karoliina Paarmio, MD, PhD role: CONTACT email: karoliina.paarnio@pohde.fi lat: 65.01236 lon: 25.46816 facility: Satakunta Central Hospital city: Pori country: Finland name: Jyrki Haikonen, MD, PhD role: CONTACT email: jyrki.haikonen@sata.fi lat: 61.48333 lon: 21.78333 facility: Seinajoki Central Hospital city: Seinäjoki country: Finland lat: 62.79446 lon: 22.82822 facility: Tampere University Hospital city: Tampere zip: 33400 country: Finland name: Toni T Seppälä, MD, PhD role: CONTACT phone: +358444722846 email: toni.seppala@tuni.fi lat: 61.49911 lon: 23.78712 facility: Turku University Hospital city: Turku country: Finland name: Pirita Varpe, MD, PhD role: CONTACT email: Pirita.Varpe@tyks.fi lat: 60.45148 lon: 22.26869 hasResults: False
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<|newrecord|> nctId: NCT06328348 id: SW010 briefTitle: Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms overallStatus: COMPLETED date: 2023-07-18 date: 2023-11-30 date: 2023-12-30 date: 2024-03-25 date: 2024-03-25 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.
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The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.
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The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power. conditions: Menopause Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 96 type: ACTUAL name: supplementation name: placebo measure: Change in the Menopause Rating Scale (MRS) score measure: Follicle-Stimulating Hormone (FSH) change measure: Estradiol change measure: Number of any adverse events sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation lat: 55.0415 lon: 82.9346 hasResults: False
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<|newrecord|> nctId: NCT06328335 id: Orthostatic Hypotension briefTitle: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:
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Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom conditions: Orthostatic Hypotension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation training name: Rise-bed Training measure: Composite Autonomic Symptom Scale 31 measure: Orthostatic Hypotension Questionnaire measure: Orthostatic Grading Scale sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328322 id: Soh-Med-24-03-02MD briefTitle: Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: Sohag University class: OTHER briefSummary: Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomes
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The left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategies
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Among the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral walls
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The selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process conditions: Left Main Coronary Artery Disease With Acute Coronary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Percutaneous Coronary Intervention in Left Main Artery Disease measure: major adverse cardiac events (MACE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06328309 id: Myofascial Traumatic Brain briefTitle: Impact of v Release on Dysphagia in Patients With Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:
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• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: Patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328296 id: Myofascial Parkinson's Dysphag briefTitle: Impact of Myofascial Release on Dysphagia in Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Parkinson's Patients. The main question it aims to answer is:
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• Can Myofascial Release Therapy improve swallowing function in Parkinson's Patients? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328283 id: Soh-Med-24-02-01MD briefTitle: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Sohag University class: OTHER briefSummary: Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.
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HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015). conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: measure of Glutamine synthetase and BCLFAF1 measure: glutamine synthetase sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital city: Sohag state: Sohagm country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
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