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<|newrecord|> nctId: NCT06328270 id: 03.09.2019 / 2505 briefTitle: Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis overallStatus: COMPLETED date: 2020-09-01 date: 2022-01-30 date: 2022-03-30 date: 2024-03-25 date: 2024-03-25 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Ozone - oxygen Therapy name: Corticosteroid measure: Visual Pain Score measure: Western Ontario and McMaster Universities Arthritis Index measure: Visual Pain Score measure: Western Ontario and McMaster Universities Arthritis Index sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06328257 id: Elderly Community Myofascial briefTitle: Impact of Myofascial Release on Preventing Dysphagia in the Elderly Community overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-08 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 impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Myofascial Release Training measure: Swallowing-Related Quality of Life Questionnaire measure: Time consumed in eating measure: Functional Oral Intake Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328244 id: Community-Based Swallowing briefTitle: Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-03-25 date: 2024-04-11 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Simple swallowing training measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328231 id: Community elderly dysphagia briefTitle: The Impact of Swallowing Intervention for Elderly Community Dwellers overallStatus: COMPLETED date: 2024-03-25 date: 2024-04-14 date: 2024-04-14 date: 2024-03-25 date: 2024-04-16 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 248 type: ACTUAL name: Systematic simple swallowing training measure: Gugging Swallowing Screen measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire measure: Eating Assessment Tool-10 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Railway Commu. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False
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<|newrecord|> nctId: NCT06328218 id: Gymnastics ParkinsonCommunity briefTitle: The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 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 impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Simple Gymnastics Training measure: Unified Parkinson's Disease Rating Scale measure: The Berg Balance Scale measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328205 id: Glossopharyngeal Nerve Block briefTitle: Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease 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 Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:
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• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Glossopharyngeal Nerve Block name: Lidocaine Hydrochloride name: placebo injection measure: penetration-aspiration scale measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328192 id: active breathing elderly briefTitle: The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 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 impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Active Breathing Exercises measure: Standardized Swallowing Assessment Scale measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328179 id: KY-2023-058-01 briefTitle: Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA. overallStatus: RECRUITING date: 2022-05-24 date: 2027-12-30 date: 2027-12-30 date: 2024-03-25 date: 2024-03-25 name: Huai'an First People's Hospital class: OTHER name: Zhenjiang First People's Hospital name: The First People's Hospital of Changzhou name: The Affiliated Hospital of Xuzhou Medical University briefSummary: This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities.
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This study includes the induction and consolidation phases of AML treatment. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Venetoclax 100 mg d1，200 mg d2，400 mg d3-14； measure: Overall response rate，ORR measure: Overall survival, OS measure: Event free survival, EFS measure: Duration of remission, DOR measure: Adverse event, AE measure: Treatment-related mortality, TRM sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital） status: RECRUITING city: Huai'an state: Jiangsu zip: 210000 country: China name: Shandong Tao role: CONTACT phone: 15252393900 email: TSD8884@126.com lat: 33.50389 lon: 119.14417 hasResults: False
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<|newrecord|> nctId: NCT06328166 id: rFGF-1 for CTS briefTitle: The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-25 name: Tri-Service General Hospital class: OTHER name: Eusol Biotech Co., Ltd. briefSummary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Sono-guided injection with ES135 name: Sono-guided injection with placebo measure: Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328153 id: BF2022-101 briefTitle: Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-01-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Guangdong Provincial Hospital of Traditional Chinese Medicine class: OTHER briefSummary: The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:
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Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.
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Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?
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Participants will:
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1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.
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2. A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
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3. Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.
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Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Fu's Subcutaneous Needling name: Celecoxib measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment. measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment. measure: Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment. measure: Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment. measure: Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment. measure: Change from Baseline in the data of the shear wave elastic imaging technology analysis at the 7th day and 14th day after the start of treatment. measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328140 id: Skyland 001 briefTitle: Sleep Quality, Cognitive Performance, and Computerized Cognitive Training overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-14 date: 2026-04-14 date: 2024-03-25 date: 2024-03-25 name: George West Mental Health Foundation d/b/a Skyland Trail class: OTHER name: Sumitomo Pharmaceuticals America briefSummary: Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.
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Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.
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Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as well
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In previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.
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Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy. conditions: Bipolar Disorder conditions: Major Depressive Disorder conditions: Psychosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Lurasidone name: FDA Approved antidepressant treatment measure: Improvement in Cognitive Performance measure: Training Engagement in Cognitive training measure: Nighttime sleep measured with actigraphy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George West Mental Health Foundation, DBA Skyland Trail city: Atlanta state: Georgia zip: 30329 country: United States name: Ben W Hunter, MD role: CONTACT phone: 866-504-4966 email: bhunter@skylandtrail.org name: Ben W Hunter, MD role: PRINCIPAL_INVESTIGATOR name: Alex O Rothbaum, PhD, MPH role: SUB_INVESTIGATOR name: Philip D Harvey, PhD role: SUB_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06328127 id: 23-691 briefTitle: Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors acronym: PATH-4 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2029-04-30 date: 2024-03-25 date: 2024-03-25 name: Brigham and Women's Hospital class: OTHER name: Dana-Farber Cancer Institute name: Duke University name: H. Lee Moffitt Cancer Center and Research Institute briefSummary: This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care. conditions: Hematopoietic Stem Cell Transplant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 400 type: ESTIMATED name: PATH measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale measure: Gratitude based on the Gratitude Questionnaire measure: Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale measure: Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20 measure: Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) measure: Flourishing based on the Flourishing Scale measure: Optimism based on the Life Orientation Test-Revised (LOT-R) measure: Coping based on the Brief-COPE questionnaire measure: Post-traumatic stress based on the Post-traumatic Stress Checklist-Civilian Version measure: Steps per day based on the ActiGraph accelerometer measure: Sedentary leisure time based on the ActiGraph accelerometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center city: Tampa state: Florida zip: 33612 country: United States name: Heather Jim, PhD role: CONTACT email: heather.jim@moffitt.org lat: 27.94752 lon: -82.45843 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Duke Cancer Institute city: Durham state: North Carolina zip: 27710 country: United States name: Thomas LeBlanc, MD role: CONTACT email: thomas.leblanc@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06328114 id: Pro00114549 briefTitle: Accelerating TMS for Cervical Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-07-01 date: 2029-07-01 date: 2024-03-25 date: 2024-04-26 name: Duke University class: OTHER name: American Academy of Neurology briefSummary: This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition. conditions: Isolated Cervical Dystonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single-arm crossover study design with subjects receiving TMS at two different intensities primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The TMS intensity delivered at each TMS visit will be masked whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) measure: Change in Neck Angles as Measured by Neck Sensor Device measure: Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI) measure: Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI) measure: Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Health System city: Durham state: North Carolina zip: 27705 country: United States name: Noreen Bukhari-Parlakturk, MD PhD role: CONTACT phone: 919-668-8248 email: movdisres@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06328101 id: 2023-02558 briefTitle: Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR) acronym: AiPPEAR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: University Medical Center Goettingen class: OTHER name: University Medical Centre Maribor name: Aalborg University Hospital name: University Hospital Munich name: Tartu University Hospital name: University Hospital in Halle briefSummary: The goal of this observational, retrospective study is to learn about cancer risk in autoimmune pancreatitis (AIP) patients. The main questions it aims to answer are:
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* Do patients with AIP have higher incidence of cancer in comparison to general population?
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* What is the overall prevalence of cancer in AIP patients?
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* What are the characteristics of AIP patients associated with the incidence of cancer? conditions: Autoimmune Pancreatitis Type 1 conditions: Autoimmune Pancreatitis Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Standardized incidence ratio (SIR) of first invasive cancer measure: The prevalence of cancer diagnoses 12 months prior to AIP diagnosis measure: Risk factor associated with cancer diagnosis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328088 id: EC/12/23/2400 briefTitle: Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study overallStatus: RECRUITING date: 2024-02-16 date: 2024-04-16 date: 2024-10-16 date: 2024-03-25 date: 2024-03-25 name: Sir Ganga Ram Hospital class: OTHER briefSummary: Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study conditions: Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Non vegetarian measure: Recurrence of overt hepatic encephalopathy measure: Hospitalization due to any cause sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Ganga Ram Hospital status: RECRUITING city: Delhi zip: 110060 country: India name: Praveen Sharma, MD,DM role: CONTACT phone: 9810365151 lat: 28.65195 lon: 77.23149 hasResults: False
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<|newrecord|> nctId: NCT06328075 id: AI-ATTR-ECHO id: 20211029191554 type: OTHER domain: registre général des traitements de l'APHP briefTitle: Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis acronym: AI-ATTR-ECHO overallStatus: RECRUITING date: 2022-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-03-25 date: 2024-03-25 name: Algalarrondo Vincent class: OTHER name: Bichat Hospital name: Bioquantis briefSummary: The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography.
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The main questions it aims to answer are:
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* is the algorithm able to diagnose ATTR-CM
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* is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt)
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This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm. conditions: Amyloid Cardiomyopathy conditions: Transthyretin Amyloid Cardiomyopathy conditions: Transthyretin Cardiac Amyloidosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 15000 type: ESTIMATED name: non interventional study measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTR-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTR-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRwt-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-V122I-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRwt-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-V122I-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) : sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bichat status: RECRUITING city: Paris zip: 75018 country: France name: Vincent Algalarrondo, MD, PhD role: CONTACT phone: +33140257785 email: vincent.algalarrondo@aphp.fr name: Gregory Ducrocq, PD, PhD role: CONTACT email: gregory.ducrocq@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06328062 id: TUH Mirogabalin TKA briefTitle: Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-25 date: 2024-03-25 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.
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The main question\[s\] it aims to answer are:
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• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.
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Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA. conditions: Pain Postoperative conditions: Osteoarthritis conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Mirogabalin name: Pregabalin measure: Pain score measure: Morphine consumption measure: Range of motion measure: Knee society score measure: Knee injury and Osteoarthritis Outcome Score (KOOS) measure: Sedation score measure: Incidence of Somnolence and dizziness measure: Total hospital stay sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 6683930257 email: y.tanariyakul@gmail.com name: Yot Tanariyakul, M.D. role: PRINCIPAL_INVESTIGATOR name: Krit Boontanapibul, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False
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<|newrecord|> nctId: NCT06328049 id: HSKY-033 briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC overallStatus: RECRUITING date: 2023-08-10 date: 2025-02-10 date: 2025-08-10 date: 2024-03-25 date: 2024-03-25 name: Taixing People's Hospital class: OTHER briefSummary: The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Trilaciclib Injection measure: Incidence of febrile neutropenia (FN) measure: Incidence of Treatment-Emergent Adverse Events measure: Antibiotic Use rate measure: Number of medication delays measure: Number of chemotherapy dose reductions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taixing People's Hospital status: RECRUITING city: Taixing state: Jiangsu zip: 225400 country: China name: liu C yang, M.D. role: CONTACT phone: 87656001 phoneExt: 0523 email: liuyctx@163.com lat: 32.16667 lon: 120.01361 hasResults: False
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<|newrecord|> nctId: NCT06328036 id: NCI-2024-02185 id: NCI-2024-02185 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10640 type: OTHER domain: University of Pittsburgh Cancer Institute LAO id: 10640 type: OTHER domain: CTEP id: UM1CA186690 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186690 briefTitle: Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2025-07-01 date: 2025-07-01 date: 2024-03-25 date: 2024-03-25 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma, IDH-Wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Atezolizumab name: Biospecimen Collection name: Magnetic Resonance Imaging name: Surgical Procedure name: Tiragolumab measure: Progression free survival (PFS) measure: Tumor infiltrating T lymphocyte density measure: Dose limiting toxicity measure: Incidence of adverse events measure: Objective response rate (ORR) measure: PFS6 measure: Overall survival measure: Tumor mutational burden (TMB) measure: Expression of immune checkpoint receptors and ligands measure: Tumor response signatures including for T-cells, interferon and cell cycle measure: T cell receptor (TCR) clonality and diversity measure: Tumor infiltrating T-cell, T-regs, and myeloid cells measure: TCR overlap and clonal expression measure: Peripheral blood mononuclear cell (PBMC) response signatures including for T-cells, interferon and cell cycle measure: TCR clonality by PBMC measure: TCR clonality measure: Trough concentrations in serum and concentrations in cerebrospinal fluid sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06328023 id: REC/MS-PT/01831 briefTitle: Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes overallStatus: RECRUITING date: 2024-03-18 date: 2024-04-23 date: 2024-06-02 date: 2024-03-25 date: 2024-03-27 name: Riphah International University class: OTHER briefSummary: This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports conditions: Concussion, Mild conditions: Sleep conditions: Physical Performance studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 115 type: ESTIMATED name: SCOAT 6 to find association measure: Cantu Scale measure: Sport Concussion Office Assessment Tool 6 sex: ALL minimumAge: 18 Years maximumAge: 36 Years stdAges: ADULT facility: HAYATABAD Sports complex status: RECRUITING city: Peshawar state: Khyber Pakhtun Khawan zip: 24730 country: Pakistan name: Nadia Ishtiaq, MSOMPT role: CONTACT phone: 03486977541 email: Nadia.Ishtiaq@riphah.edu.pk name: Muhammad haroon, MSSPT* role: CONTACT phone: 03484644733 email: muhammad-haroon6528@zu.edu.pk name: Muhammad Haroon, MS*SPT role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False
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<|newrecord|> nctId: NCT06328010 id: SIDDXAC02 briefTitle: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers acronym: SIDDX overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2028-12-31 date: 2030-06-30 date: 2024-03-25 date: 2024-04-29 name: Siddhey LLC class: INDUSTRY briefSummary: Collect data on various wound treatments and their related wound healing process, in real life settings.
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Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments. conditions: Wounds and Injuries conditions: Burns conditions: Mohs Surgery conditions: Diabetic Foot Ulcer Mixed conditions: Venous Leg Ulcer conditions: Non-healing Wound conditions: Trauma Injury conditions: Injury and Wounds conditions: Degloving Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: Advanced Treatment Modalities for wound and injuries measure: Data collection of 5000 patients measure: Different types of wounds/injuries heal rate sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Comprehensive Medicine city: Alpine state: California zip: 91901 country: United States lat: 32.83505 lon: -116.76641 facility: West Hills Hospital and Medical Centers Doctors Suites city: West Hills state: California zip: 91307 country: United States lat: 34.19731 lon: -118.64398 hasResults: False
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<|newrecord|> nctId: NCT06327997 id: BZE2203-A-01 briefTitle: An Exploratory Study by Fast CAR T Cells overallStatus: RECRUITING date: 2024-03-07 date: 2027-03-06 date: 2027-12-31 date: 2024-03-25 date: 2024-03-25 name: Shanghai Cell Therapy Group Co.,Ltd class: INDUSTRY briefSummary: The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered. conditions: Solid Tumor studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Fast CAR T cells measure: Dose-limiting toxicity(DLT) measure: Maximum tolerated dose (MTD) measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Peak Plasma Concentration (Cmax) measure: AUC measure: Pharmacodynamics (PD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Mengchao Cancer Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Lou jinxing role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06327984 id: 157354 briefTitle: Barts Sex-CAD Database overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-05 date: 2024-03-25 date: 2024-03-25 name: Queen Mary University of London class: OTHER briefSummary: There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes').
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Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area.
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Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. We think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood.
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In this study we wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. We will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. We will combine this data with the data that is routinely collected during hospital admission. In this way we hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research we will address an under researched area and find new ways of treating women and men with coronary artery disease. conditions: Coronary Artery Disease conditions: Myocardial Infarction conditions: Acute Coronary Syndrome conditions: Atherosclerosis conditions: Inflammation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: Mortality measure: Re-admission measure: MACE measure: Relationship with specific MI types measure: Relationship with inflammation sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327971 id: 0000 briefTitle: Enhanced Outcome Prediction in Cutaneous Squamous Cell Carcinoma Using Deep-learning and Computational Histopathology overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-20 date: 2028-10 date: 2028-10 date: 2024-03-25 date: 2024-03-25 name: Queen Mary University of London class: OTHER briefSummary: Evaluate a deep-learning model trained on computational histopathology for predicting outcomes in cutaneous squamous cell carcinoma conditions: Squamous Cell Carcinoma of the Skin studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: Metastasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Health NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06327958 id: protocol Number: 2021/21 briefTitle: THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES overallStatus: COMPLETED date: 2021-09-15 date: 2022-06-15 date: 2022-06-30 date: 2024-03-25 date: 2024-03-25 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients. conditions: Being a 5th Year Student at the Faculty of Medicine conditions: No Previous Laryngoscopy Experience studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 130 type: ACTUAL name: Cormack-Lehane (C&L) name: POGO score measure: The percentage of glottic opening (POGO) scores in the airway management training of medical students. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak state: Kozlu zip: 67600 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
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<|newrecord|> nctId: NCT06327945 id: 22-00009 briefTitle: Transplanting Lungs From Uncontrolled Donation After Circulatory Death overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2028-06-30 date: 2024-03-25 date: 2024-03-25 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation. conditions: Lung Transplantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Lung uDCD Protocol measure: Incidence of Primary Graft Dysfunction (PDG) Grade III measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) measure: Incidence of Re-Transplantation measure: Overall Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06327932 id: HIVEC(PRG) briefTitle: HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2028-03-31 date: 2024-03-25 date: 2024-03-25 name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University class: OTHER briefSummary: The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC). conditions: Non-Muscle-Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 320 type: ESTIMATED name: TURBT name: HIVEC name: Intravesical Chemotherapy name: Gemcitabine measure: Recurrence rate measure: 1-year recurrence rate measure: Recurrence-free survival (RFS) rate measure: Time to treatment failure measure: Success rate of therapeutic operation measure: Quality of international prostate symptom score measure: Quality of bother of score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327919 id: 62885 briefTitle: Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-25 date: 2023-09-23 date: 2024-03-25 date: 2024-03-25 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups. conditions: Weight Regain After Bariatric Surgery and Food Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Probiotic supplement name: Placebo supplement measure: Weight measure: BMI measure: Waist circumference measure: Fat mass measure: Food addiction measure: Eating behavior measure: Leptin measure: Serotonin measure: Oxytocin sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Azita Hekmatdoost city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 facility: National Nutrition and Food Technology Research Institute city: Tehran country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
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<|newrecord|> nctId: NCT06327906 id: qilu000002 briefTitle: A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China overallStatus: RECRUITING date: 2023-11-15 date: 2026-11-15 date: 2029-11-15 date: 2024-03-25 date: 2024-03-25 name: Qilu Hospital of Shandong University class: OTHER briefSummary: In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life. conditions: Child Allergy conditions: Neurodevelopmental Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: ASD measure: ADHD sex: ALL minimumAge: 1 Minute maximumAge: 42 Days stdAges: CHILD facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong country: China name: zhu mengna role: CONTACT phone: 15211482407 lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06327893 id: AQUATIC_RESCUE briefTitle: Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023 acronym: RESCUE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-03-25 date: 2024-03-25 name: Prehospital Center, Region Zealand class: OTHER briefSummary: Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues. conditions: Drowning conditions: Drowning, Near conditions: Submersion conditions: Submersion - Accidental conditions: Submersion or Drowning Due to Being Washed Overboard conditions: Submersion or Drowning Due to Being Thrown Overboard conditions: Submersion or Drowning Due to Ship Sinking, Water Skier Injured conditions: Submersion or Drowning Due to Boat Submerging, Swimmer Injured conditions: Submersion or Drowning Due to Boat Overturning, Swimmer Injured conditions: Submersion or Drowning Due to Boat Submerging, Water Skier Injured conditions: Submersion or Drowning Due to Fall From Gangplank, Swimmer Injured conditions: Submersion or Drowning Due to Ship Sinking, Docker or Stevedore Injured conditions: Submersion or Drowning Due to Fall Overboard, Docker or Stevedore Injured studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: Submersion or immersion in liquid measure: The annual incidence. measure: The annual incidence rate. measure: The spatial distribution of aquatic rescues on a map of Denmark. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False
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<|newrecord|> nctId: NCT06327880 id: C4151006 id: 2023-509339-17-00 type: REGISTRY domain: CTIS (EU) briefTitle: A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-07-02 date: 2024-07-02 date: 2024-03-25 date: 2024-04-15 name: Pfizer class: INDUSTRY briefSummary: The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.
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The study is seeking the following participants:
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* Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
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* Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
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* Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
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In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 6 type: ESTIMATED name: PF-07054894 or placebo measure: Number of participants with adverse events (AE) or serious adverse events (SAE) measure: Number of participants with clinically meaningful change from baseline in laboratory tests results measure: Number of participants with clinically meaningful change from baseline in vital signs measure: Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters measure: Maximal plasma concentration (Cmax) measure: Time to Maximum Plasma Concentration (Tmax) measure: Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt) measure: Half-life of PF-07054894 measure: Observed Accumulation Ratio (Rac) measure: Observed Accumulation Ratio Based on Cmax (Rac,Cmax) measure: Trough plasma concentrations (Ctrough) measure: Apparent Volume of Distribution (Vz/F) as data permits measure: Apparent Oral Clearance (CL/F) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - Brussels city: Brussels state: Bruxelles-capitale, Région DE zip: B-1070 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06327867 id: drs2402021836 briefTitle: Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2025-05-01 date: 2024-03-25 date: 2024-04-11 name: Patan Academy of Health Sciences class: OTHER briefSummary: This is an open-label, single center, prospective, randomized, comparative, intervention study.
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The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:
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1. To assess the adverse events during video laryngoscopy
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2. To assess the adverse events during direct Laryngoscopy
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3. To compare the first pass success rate of DL vs VL according to demographic profile (age and sex) conditions: To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An open-label, single center, prospective, randomized, comparative, intervention study. primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: Oro Tracheal Intubation by DL name: Oro Tracheal Intubation by VL measure: First pass success of direct laryngoscopy in oro tracheal intubation measure: First pass success of video laryngoscopy in oro tracheal intubation measure: Complications rates between two methods. measure: Use of alternative methods for ventilation or oxygenation between two methods measure: Better visualization of Cormack-Lehane grading between two methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327854 id: NUOROS (PI: M Briguglio) id: L4175 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: NUtrition and ORal Health in Orthopaedic Surgery overallStatus: RECRUITING date: 2024-03-18 date: 2024-03-22 date: 2024-12-10 date: 2024-03-25 date: 2024-03-25 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery). conditions: Orthopedic Disorder conditions: Metabolism and Nutrition Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED measure: Association between pre-operative oral health and diet sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milan country: Italy name: Elena Cittera role: CONTACT phone: 00390283502224 email: elena.cittera@grupposandonato.it name: Matteo Briguglio role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06327841 id: EK 1117/2022 briefTitle: Plaque Reduction Sesame Oil overallStatus: COMPLETED date: 2022-06-21 date: 2022-08-18 date: 2022-08-18 date: 2024-03-25 date: 2024-03-25 name: Medical University Innsbruck class: OTHER briefSummary: The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:
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• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.
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Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect. conditions: Dental Plaque conditions: Gingivitis conditions: Oral Microbial Colonization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: sesame oil name: distilled water measure: Rustogi Modified Navy Plaque Index (RMNPI) measure: Gingival Index (GI) measure: microbial analysis measure: Oral Health Impact Profile (OHIP) measure: Interview halitosis, xerostomia sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University city: Innsbruck state: Tyrol zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 hasResults: False
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<|newrecord|> nctId: NCT06327828 id: 32-663 briefTitle: Methimazole in Graves' Disease - a Randomised Controlled Trial Comparing the Computer-aided Treatment DigiThy Versus Usual Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-03-25 date: 2024-03-25 name: Medical University of Graz class: OTHER name: Graz University of Technology briefSummary: The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required. conditions: Graves Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) name: Usual care measure: The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices measure: Comparison in terms of dosing and penalties measure: Comparison based on free thyroxine (fT4) target range sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8044 country: Austria name: Verena Theiler-Schwetz, MD, PhD role: CONTACT lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06327815 id: D1690L00149 briefTitle: Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM overallStatus: RECRUITING date: 2024-03-27 date: 2025-04-30 date: 2025-04-30 date: 2024-03-25 date: 2024-04-15 name: AstraZeneca class: INDUSTRY briefSummary: Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM. conditions: Type 2 Diabetes Mellitus (T2DM) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 632 type: ESTIMATED name: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets name: Dapagliflozin tablets and Metformin HCl extended-release tablets measure: Change in HbA1c from baseline measure: Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24. measure: Absolute change in FPG from baseline to week 24. measure: Absolute change in PPG from baseline to week 24. measure: The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24. measure: The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24. measure: To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM. measure: AEs measure: SAE measure: ADRs measure: Temperature measure: Systolic and diastolic BP measure: Pulse rate measure: Respiratory rate measure: Weight measure: Height measure: BMI measure: Number of participants with abnormal ECG readings measure: Proportion of TITR (Time in Tight Target Range) measure: TIR (Time In Range) measure: TBR (Time Below Range) measure: TAR (Time Above Range) measure: MAGE (Mean Amplitude of Glycemic Excursion) measure: SDBG (Standard Deviation of Blood Glucose) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Beijing zip: 100020 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Wei Fang zip: 261035 country: China hasResults: False
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<|newrecord|> nctId: NCT06327802 id: 20240104 briefTitle: Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment acronym: MucoZar overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-31 date: 2024-03-25 date: 2024-03-25 name: Pole Sante Grace de Dieu class: OTHER briefSummary: The main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 360 type: ESTIMATED name: Questionnaire measure: Zarit Burden Interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PSLA GDD city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False
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<|newrecord|> nctId: NCT06327789 id: ZBEU-MS briefTitle: Trunk Control and Disability in Persons With Multiple Sclerosis overallStatus: COMPLETED date: 2021-12-21 date: 2021-12-25 date: 2022-02-21 date: 2024-03-25 date: 2024-03-25 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 23 type: ACTUAL measure: Expanded Disability Status Scale (EDSS) measure: Trunk Impairment Scale (TIS) measure: Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA) measure: Step Length (cm) measure: Stride Length (cm) measure: Step Width (cm) measure: Cadence (steps/min) measure: Velocity (m/s) measure: Step time (s) measure: Stride time (s) measure: Timed 25-Foot Walk Test (T25FW) measure: Nine-Hole Peg Test (9HPT) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
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<|newrecord|> nctId: NCT06327776 id: 21/709 briefTitle: New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI overallStatus: RECRUITING date: 2022-03-04 date: 2025-07-31 date: 2025-12-31 date: 2024-03-25 date: 2024-03-25 name: Hospital Universitario 12 de Octubre class: OTHER briefSummary: Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities. conditions: Mild Traumatic Brain Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Serum and saliva biomarkers measure: Biomarkers diagnostic performance measure: Determination of the potential of the biomarkers in predicting neurological symptoms after TBI measure: Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI measure: Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI measure: Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI measure: Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario 12 de Octubre status: RECRUITING city: Madrid zip: 28041 country: Spain name: Alfonso Lagares, MD, PhD role: CONTACT phone: +34917792389 email: alfonso.lagares@salud.madrid.org lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06327763 id: Ilioinguinal Neurectomy briefTitle: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-01 date: 2023-06-01 date: 2024-03-25 date: 2024-03-25 name: Zagazig University class: OTHER_GOV briefSummary: postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.
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Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia. conditions: Ilioinguinal Nerve Section conditions: Pain Prevention conditions: Hernioplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 196 type: ACTUAL name: ilioinguinal nerve section measure: detect postoperative pain using short form inguinal pain questionnaire sex: MALE minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: yasmine Hegab city: Zagazig zip: 7120730 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06327750 id: NL83566.018.24 briefTitle: The Microcirculation, Dialysis Modality and Sequestered Salt acronym: MIMOSA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2027-12 date: 2024-03-25 date: 2024-03-25 name: Amsterdam UMC, location VUmc class: OTHER name: Dutch Kidney Foundation name: Niercentrum aan de Amstel name: B.Braun Avitum AG briefSummary: The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:
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1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?
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* HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to
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* HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
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* HD with an expected zero diffusive sodium balance (DNa = PNa) compared to
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* HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
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* Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)
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2. Are the SSC and MC interrelated in this patient group?
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This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order. conditions: End-stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized cross-over trial primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Hemodialysis (DNa = PNa) name: Hemodialysis (DNa<PNa) name: Hemodialysis after isolated ultrafiltration (DNa=PNa) name: High volume hemodiafiltration (DNa=PNa) name: High volume hemodiafiltration (DNa<PNa) measure: Skin microcirculation measure: Sequestered salt content (SSC) measure: Intradialytic hypotension measure: Change in intradialytic blood pressure measure: Peridialytic blood pressure measure: Change in CK-MB measure: Change in high sensitivity C-reactive protein (hs-CRP) measure: Change in interleukin-6 receptor (IL-6R) measure: Change in soluble CD163 (sCD163) measure: Change in soluble intercellular adhesion molecule-1 (s-ICAM-1) measure: Change in serum glycosaminoglycans measure: Change in syndecan-1 measure: Change in vascular endothelial growth factor C (VEGF-C) measure: Change in extracellular vesicles (EVs) measure: Change in skin microcirculation measure: Change in sequestered salt content (SSC) measure: modified Dialysis symptom index (mDSI) measure: Thirst distress scale (TDS) measure: EQ Visual analogue scale (EQ VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327737 id: AKDENIZ-KAEK-916 briefTitle: Diabetic Ketoacidosis Diagnosis and Management overallStatus: COMPLETED date: 2020-12-15 date: 2022-11-15 date: 2023-03-15 date: 2024-03-25 date: 2024-03-25 name: Akdeniz University class: OTHER name: Ceren Kahraman briefSummary: This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema. conditions: Metabolic Acidosis conditions: Diabetic Ketoacidosis conditions: Brain Edema studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ACTUAL name: Capnography measure: Correlation between PCO2 and EtCO2 measure: Correlation between Integrated Pulmonary Index and degree of acidosis measure: Prediction of cerebral edema with Integrated Pulmonary Index sex: ALL minimumAge: 15 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Akdeniz University city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06327724 id: 12434 briefTitle: Belimumab in SLE Synovial Inflammation and Lymph Nodes overallStatus: RECRUITING date: 2023-09-01 date: 2025-01-01 date: 2025-03-01 date: 2024-03-25 date: 2024-03-25 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: GlaxoSmithKline briefSummary: Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported.
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In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Belimumab measure: Differences in lymph node cellular composition as assessed by advanced flow cytometry measure: Differences in peripheral blood cellular composition as assessed by advanced flow cytometry measure: Differences in synovial tissue cellular composition as assessed by advanced flow cytometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC; location Academic Medical Center status: RECRUITING city: Amsterdam zip: 1100DD country: Netherlands name: Sander W Tas, Prof. dr. role: CONTACT phone: +31 20 56 67765 email: secr-reumatologie@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06327711 id: BL77 briefTitle: Benefits of Nutritional Ingredients for Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-25 date: 2024-03-25 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements. conditions: Diabetes type2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups, non-crossover primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Control: CHO Blend name: Experimental: CHO Blend plus AN100 measure: Matsuda Index measure: Fasted Glucose measure: Fasted Insulin measure: Body Weight measure: Body Composition Measurements measure: Continuous Glucose Monitoring measure: Glycated Hemoglobin measure: Resting Energy Expenditure (REE) measure: Microbiome - Fecal measure: Microbiome - Saliva measure: Waist Circumference measure: Hip Circumference measure: Conicity Index measure: Blood Pressure measure: Accelerometry Data measure: Diabetes Distress Scale measure: Dietary Intake measure: Blood biomarkers - inflammation measure: Urine biomarkers - inflammation sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327698 id: AK104-IIT-C-S-0010 briefTitle: Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-05-31 date: 2027-05-31 date: 2024-03-25 date: 2024-03-25 name: Hunan Cancer Hospital class: OTHER briefSummary: This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma. conditions: Melanoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab name: anlotinib measure: Response Rate measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06327685 id: MCC-22318 briefTitle: Avapritinib With Decitabine in Patients With SM-AHN overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-03-25 date: 2024-04-09 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Blueprint Medicines Corporation briefSummary: Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN. conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Avapritinib name: Decitabine name: Decitabine/Cedazuridine measure: Recommended phase 2 dose (RP2D) measure: Systemic mastocytosis overall response rate (ORR) measure: Overall Responsive Rate measure: Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic - Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States name: Cecilia Arana Yi, MD role: CONTACT name: Cecilia Arana Yi, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Stanford University Medical Center status: NOT_YET_RECRUITING city: Palo Alto state: California zip: 94305 country: United States name: Jason Gotlib, MD role: CONTACT name: Jason Gotlib, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Caroline Wagstaff role: CONTACT phone: 813-745-5197 email: Caroline.Wagstaff@moffitt.org name: Andrew Kuykendall, MD role: PRINCIPAL_INVESTIGATOR name: Onyee Chan role: SUB_INVESTIGATOR name: Rami Komrokji role: SUB_INVESTIGATOR name: Timothy Kubal role: SUB_INVESTIGATOR name: Jeffrey Lancet role: SUB_INVESTIGATOR name: Eric Padron role: SUB_INVESTIGATOR name: David Sallman role: SUB_INVESTIGATOR name: Alison Walker role: SUB_INVESTIGATOR name: Seongseok Yun role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Daniel DeAngelo, MD, PhD role: CONTACT name: Daniel DeAngelo, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: University of Michigan status: NOT_YET_RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kristen Pettit, MD role: CONTACT name: Kristen Pettit, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Memorial Sloan Kettering Cancer Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: Raajit Rampal, MD, PhD role: CONTACT name: Raajit Rampal, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Utah Health status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Tsewang Tashi, MD role: CONTACT name: Tsewang Tashi, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06327672 id: 162023 briefTitle: INOCA Spanish National Registry acronym: ESP-INOCA overallStatus: RECRUITING date: 2024-03-24 date: 2025-03 date: 2026-03 date: 2024-03-25 date: 2024-03-28 name: Eva Rumiz González class: OTHER name: Hospital San Carlos, Madrid name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa name: Hospital Universitario Virgen de la Arrixaca name: University Hospital Gregorio Marañón name: Hospital Clínico Universitario de Valladolid name: Hospital Universitario Puerta del Mar name: Hospital Universitari de Bellvitge name: Hospital Universitario La Fe name: Hospital Clínico Universitario de Valencia name: Hospital Universitario La Paz name: Hospital General Universitario de Alicante name: Complejo Hospitalario Universitario de Huelva name: Hospital General Universitario de Castellón name: Hospital de Manises name: Hospital Clinic of Barcelona name: Hospital Miguel Servet name: Hospital Clínico Universitario Lozano Blesa name: Hospital Universitario Donostia name: Hospital General Universitario Elche name: Hospital Universitario Virgen del Rocio name: Hospital de la Ribera name: Hospital de la Santa creu i Sant Pau - Barcelona name: Hospital Virgen de la Salud name: Hospital Universitario San Juan de Alicante name: Hospital Universitario de Torrevieja name: University Hospital of the Nuestra Señora de Candelaria name: Hospital de Basurto name: Hospital Universitario Ramon y Cajal name: Hospital Universitario Fundación Jiménez Díaz name: Puerta de Hierro University Hospital name: Hospital Universitario 12 de Octubre name: University of Salamanca name: Hospital Universitario Marqués de Valdecilla name: Hospital Clinico Universitario de Santiago name: Complexo Hospitalario Universitario de A Coruña briefSummary: Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting. conditions: Non-Obstructive Coronary Atherosclerosis conditions: Ischemia conditions: Coronary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Prevalence of INOCA endotypes. measure: Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department. measure: Targeted pharmacological treatment measure: Prognostic markers. measure: INOCA and risk of heart failure with preserved ejection fraction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de la Princesa status: RECRUITING city: Madrid country: Spain name: Fernando Rivero Crespo, MD role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de Arrixaca status: RECRUITING city: Murcia country: Spain name: Ramón Lopez Palop, MD role: CONTACT lat: 37.98704 lon: -1.13004 facility: Hospital General Universitario de Valencia status: RECRUITING city: Valencia country: Spain name: Eva Rumiz Gonzalez, MD, PhD role: CONTACT phone: +34 626068935 email: evarumizgonzalez@gmail.com lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06327659 id: Thrombectomy by 50 ml syringe briefTitle: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-25 date: 2024-03-26 name: Helwan University class: OTHER briefSummary: In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction. conditions: STEMI - ST Elevation Myocardial Infarction conditions: Thrombosis Cardiac studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: 30 mL syringe manual thrombectomy catheter name: 50 mL syringe manual thrombectomy catheter measure: TIMI flow grade after PCI measure: MBG after PCI measure: Composite rate of occurrence of MACE measure: Rate of cardiovascular death measure: Rate of recurrent myocardial infarction measure: Rate of stroke measure: Rate of cardiogenic shock measure: Rate of NYHA IV heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr University Hospital city: Badr state: Cairo country: Egypt name: Arafa Gomaa, MD role: CONTACT name: Arafa Gomaa, MD role: PRINCIPAL_INVESTIGATOR hasResults: False
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<|newrecord|> nctId: NCT06327646 id: 66677 briefTitle: Maternal Adherence to MMS in Nepal acronym: NAMASTE MMS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-07-20 date: 2024-03-25 date: 2024-03-25 name: Helen Keller International class: OTHER name: Eleanor Crook Foundation briefSummary: Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned. conditions: Supplementation conditions: Pregnancy Related conditions: Postnatal Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 2640 type: ESTIMATED name: Multiple Micronutrient Supplement Blister name: Multiple Micronutrient Supplement Bottle name: Iron Folic Acid Blister measure: 180 days adherence: MMS (2 types) vs. IFA measure: 30, 90, and 225 days adherence measure: 180 adherence: MMS blister vs MMS bottle measure: MMS acceptability measure: Antenatal Care Utilization at 180 days sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06327633 id: ZZ2024 briefTitle: Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment overallStatus: RECRUITING date: 2024-01-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-25 date: 2024-03-26 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This is a pilot, prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI). conditions: Type 2 Diabetes Mellitus conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Olfactory Training measure: Change of olfactory brain activation by fMRI measure: Change of cognitive function measure: Olfactory threshold test measure: Change of metabolism sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Yan Bi, MD, PhD role: CONTACT phone: 86-25-83-105302 email: biyan@nju.edu.cn name: YAN BI, MD, PhD role: PRINCIPAL_INVESTIGATOR name: ZHOU ZHANG, MD, PhD role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06327620 id: A002021015 briefTitle: Treatment Of Oral Lichen Planus overallStatus: RECRUITING date: 2022-01-15 date: 2024-05-20 date: 2024-05-20 date: 2024-03-25 date: 2024-03-25 name: Mansoura University class: OTHER briefSummary: This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.
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The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.
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