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PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.
Researchers will compare data collected from patients with DBS versus patients with best medical therapy. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Clinical examinations and clinical scales administration measure: Long-term characterization of DBS-STN on cognitive outcomes measure: Beck Depression Inventory measure: State-Trait Anxiety Inventory measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson measure: Pittsburgh Sleep Quality Index measure: Parkinson's Disease Questionnaire-8 measure: Minnesota Multiphasic Personality Inventory 2-RF sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan state: Lombardia zip: 20135 country: Italy name: Eleonora Zirone, Dr role: CONTACT phone: 0255038671 phoneExt: 0039 email: eleonora.zirone@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06329713 id: 2024-03/11 briefTitle: Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-01 date: 2025-08-01 date: 2024-03-26 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Group I: 30 Min Interval Time name: Group II: 60 Min Interval Time measure: Difference between total local anaesthetic consumption sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Ayşenur Dostbil role: CONTACT phone: +905333677796 email: adostbil@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06329700 id: ParSparInLivAtrophy briefTitle: Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy overallStatus: COMPLETED date: 2010-05-01 date: 2019-12-31 date: 2022-06-30 date: 2024-03-26 date: 2024-03-26 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality. conditions: Colorectal Cancer Stage IV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 74 type: ACTUAL name: Hepatectomy measure: Postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329687 id: OPP-010 briefTitle: A Study Evaluating the Safety of the Nasal Pump overallStatus: TERMINATED date: 2024-02-21 date: 2024-02-28 date: 2024-02-28 date: 2024-03-26 date: 2024-04-18 name: Oyster Point Pharma, Inc. class: INDUSTRY briefSummary: The objective of this study is to determine the safety of the Tyrvaya nasal pump. conditions: Dry Eye conditions: Kerato Conjunctivitis Sicca studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Tyrvaya Nasal Pump measure: Incidence of Adverse Events measure: Tear Film Break up Time measure: Eye Dryness Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, California city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 hasResults: False
<\|newrecord\|> nctId: NCT06329674 id: 20DM30203 briefTitle: Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients overallStatus: COMPLETED date: 2021-04-27 date: 2022-12-01 date: 2023-06-13 date: 2024-03-26 date: 2024-03-26 name: AJU Pharm Co., Ltd. class: INDUSTRY briefSummary: A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2 conditions: Type2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 235 type: ACTUAL name: AJU-A51 name: A51R2 name: A51R3 name: AJU-A51 Placebo name: A51R2 Placebo measure: Changes in HbA1c sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06329661 id: CYS-007 briefTitle: A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-11-30 date: 2025-12-31 date: 2024-03-26 date: 2024-03-28 name: Novaliq GmbH class: INDUSTRY briefSummary: The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED) conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Cyclosporine ophthalmic solution, 0.1% (VEVYE) name: Saline solution, 0.6% measure: Change from baseline in corneal ECD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329648 id: DECIDE briefTitle: Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer acronym: DECIDE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2028-06-01 date: 2024-03-26 date: 2024-03-26 name: The Netherlands Cancer Institute class: OTHER briefSummary: Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients.
Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients.
In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting \>25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival. conditions: NSCLC studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED measure: Optimize EDIC dose measure: cardiac toxicity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329635 id: 2023070K briefTitle: Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-26 date: 2024-03-26 name: The Affiliated Hospital Of Guizhou Medical University class: OTHER briefSummary: To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage. conditions: Aneurysmal Subarachnoid Hemorrhage conditions: Vasospasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The assigned "intervention" will be performed only by a separate unblinded dedicated physician who signs the confidential agreement. The attending/investigating physician and patient are blinded to the intervention assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 396 type: ESTIMATED name: Intrathecal Nicardipine name: No intervention measure: Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6 measure: Extended Glasgow Outcome Score (GOS-E). measure: Modified Rankin Scale ordinal shift with mRS 5 and 6 combined measure: Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6 measure: Hamilton Depression Rating Scale (HAM-D) score measure: Hamilton Anxiety Rating Scale (HAM-A) score measure: Mini-Mental State Examination (MMSE) score measure: Montreal Cognitive Assessment (MoCA) scale score measure: Change of National Institutes of Health Stroke Scale (NIHSS) score measure: Cerebrospinal fluid shunt surgery rate measure: Overall mortality rate measure: Rate of CSF infection measure: Rate of any type of new intracranial hemorrhage. measure: Adverse Event measure: Serious Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329622 id: KY2023-972 briefTitle: Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-26 date: 2024-04-17 name: Huashan Hospital class: OTHER briefSummary: The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD. conditions: Chronic Kidney Disease conditions: Sarcopenia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: low-protein diet + Ketosteril name: low-protein diet measure: skeletal muscle mass index (SMI) measure: changes in eGFR(ml/min/1.73m2) measure: serum albumin(g/l) measure: grip strength(kg) measure: BMI(kg/m2) measure: 6m walking speed(s) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Nephrology, Huashan hospital city: Shanghai zip: 200040 country: China name: Mengjing Wang role: CONTACT phone: +8613764676029 email: fiyona27@126.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06329609 id: ClA-333 briefTitle: Airvo 3 Respiratory Rate Validation Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-03-26 date: 2024-03-26 name: Fisher and Paykel Healthcare class: INDUSTRY briefSummary: This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring. conditions: COPD conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Airvo 3 with respiratory rate algorithm measure: Respiratory rate measure: Respiratory rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Element Boulder city: Louisville state: Colorado zip: 80027 country: United States name: Monica Rabanal, MSc, BSN role: CONTACT email: monica.rabanal@element.com name: Blair Holman, MS role: CONTACT phone: +1 651 379 5549 email: Blair.Holman@element.com name: Monica Rabanal, MSc, BSN role: PRINCIPAL_INVESTIGATOR lat: 39.97776 lon: -105.13193 hasResults: False
<\|newrecord\|> nctId: NCT06329596 id: H-55146 id: D43TW012274 type: NIH link: https://reporter.nih.gov/quickSearch/D43TW012274 briefTitle: Microbiome Alterations With Xylitol (MAX) in Pregnancy acronym: MAX overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2026-03-31 date: 2024-03-26 date: 2024-04-19 name: Baylor College of Medicine class: OTHER name: Fogarty International Center of the National Institute of Health name: University of Washington name: Baylor College of Medicine Children's Foundation Malawi briefSummary: The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. conditions: Dysbiosis conditions: Inflammation Gum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Participants, data collectors (i.e. dental officers, study staff members, clinical officers), and data analysts will be blinded (triple-blinded) to group allocation throughout the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Xylitol gum name: Sorbitol gum measure: Periodontal disease at 28-30 weeks of pregnancy measure: Periodontal disease at 6 weeks postpartum measure: Alterations in the maternal oral microbiome communities delivery measure: Alterations in the maternal vaginal microbiome communities measure: Inflammatory mediator changes in the maternal gingival crevicular fluid at measure: Alterations within the infants' oral microbiome communities measure: Alterations within the infants' gut microbiome communities sex: FEMALE minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Area 25 Health Center city: Lilongwe country: Malawi name: Benjamin Shayo role: CONTACT phone: +265980888996 email: benjamin.shayo@bcm.edu lat: -13.96692 lon: 33.78725 hasResults: False
<\|newrecord\|> nctId: NCT06329583 id: 23-012635 briefTitle: Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm. conditions: Gastroesophageal Reflux conditions: Dysphagia conditions: Esophageal Motility Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: diaphragmatic breathing measure: Pressure at the esophagogastric junction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329570 id: NF-2023-03 briefTitle: Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM) overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-31 date: 2027-03-31 date: 2024-03-26 date: 2024-03-26 name: NaviFUS Corporation class: INDUSTRY name: NaviFUS US LLC briefSummary: This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide. conditions: Glioblastoma Multiforme conditions: Glioblastoma conditions: Glioma conditions: Brain Tumor conditions: Neoplasms conditions: Neoplasms, Nerve Tissue studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: NaviFUS System name: Lumason name: Bevacizumab measure: Adverse Events (AEs) measure: 6-month Progression-Free Survival (PFS-6) measure: Progression-Free Survival (PFS) measure: One-year Survival Rate measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Clinical Benefit Rate (CBR) measure: Local Disease Control on the MRI Images measure: Corticosteroid Consumption measure: Quality of life (QoL) assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22903 country: United States name: Jason Sheehan, M.D., Ph.D. role: CONTACT phone: 434-924-8129 email: JPS2F@uvahealth.org name: Arthur Lung, Ph.D. role: CONTACT phone: 02-25860560 phoneExt: 180 email: arthur.lung@navifus.com lat: 38.02931 lon: -78.47668 hasResults: False
<\|newrecord\|> nctId: NCT06329557 id: 23-007188 briefTitle: Optimizing the Patient Experience Through Provider Coaching or Communication Intervention overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2025-02 date: 2026-02 date: 2024-03-26 date: 2024-04-19 name: Mayo Clinic class: OTHER briefSummary: Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction. conditions: Patient Satisfaction conditions: Communication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: Intervention 1 measure: To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06329544 id: STUDY-23-01572 id: 1R01DK137968-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK137968-01 briefTitle: High Fructose Diet, the Gut Microbiome, and Metabolic Health overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02 date: 2028-11 date: 2024-03-26 date: 2024-03-26 name: Icahn School of Medicine at Mount Sinai class: OTHER name: Metabolic Solutions Inc. name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.
The research team aims to:
1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.
2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.
The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.
The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.
The research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children. conditions: MASLD conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will be a double-blinded (participants and select study personnel), randomized controlled crossover dietary intervention design. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: All participants undergo both treatment arms but will be blinded to the order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Fructose name: glucose measure: Liver proton density fat fraction (PDFF) measure: Degree of fibrosis sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Mount Sinai Morningside city: New York state: New York zip: 10025 country: United States name: Ryan Walker role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06329531 id: 2022-0992 id: NCI-2024-02555 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-22 date: 2025-04-22 date: 2024-03-26 date: 2024-03-28 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care. conditions: Cancer conditions: Occupational Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Ekta Gupta, MD role: CONTACT phone: 713-745-2327 email: egupta@mdanderson.org name: Ekta Gupta, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06329518 id: HHC-2024-0064 briefTitle: Rezafungin PK in Patients on ECMO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-26 date: 2024-03-26 name: Hartford Hospital class: OTHER name: Melinta Therapeutics, LLC briefSummary: Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 8 type: ESTIMATED name: Rezafungin measure: Rezafungin Clearance measure: Rezafungin Area Under the Curve (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hartford Hospital city: Hartford state: Connecticut zip: 06102 country: United States lat: 41.76371 lon: -72.68509 hasResults: False
<\|newrecord\|> nctId: NCT06329505 id: 111-085-B briefTitle: Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Pei-Hung Liao class: OTHER briefSummary: The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses. conditions: Learning Problem studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Comparison of knowledge and skills of nurses between groups after the intervention For 6 months. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Taipei university of nursing and health science city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06329492 id: 23-007937 briefTitle: Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis acronym: A2MRP overallStatus: ENROLLING_BY_INVITATION date: 2024-01-09 date: 2024-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-10 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA). conditions: Osteoarthritis conditions: OA conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group cohort of 20 subjects primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) measure: Adverse Events measure: Visual Analog Scale (VAS) for Pain measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): measure: Procedure Recommendation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06329479 id: 1926B briefTitle: A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI) overallStatus: RECRUITING date: 2023-06-01 date: 2024-06-01 date: 2024-09-01 date: 2024-03-26 date: 2024-03-26 name: University of Dublin, Trinity College class: OTHER briefSummary: Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention. conditions: Circadian Rhythm Disorders conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cognitive behavioural therapy for Insomnia (CBT-I) name: Bright Light Therapy name: Individualised activity plan name: Clincial review measure: Acceptability and usability of a multi-modal non-pharmacological intervention measure: Adherence to interventions measure: Adverse events measure: Completion rates of research assessments measure: Recruitment rate measure: Symptom assessment measure: Quality of Life assessment measure: Daytime Sleepiness measure: Sleep Quality measure: Physical activity assessment measure: Physical activity and sleep assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Our Lady's Hospice & Care Services status: RECRUITING city: Dublin zip: D6W RY72 country: Ireland name: Craig Gouldthorpe role: CONTACT phone: +3534986235 email: gouldthc@tcd.ie lat: 53.33306 lon: -6.24889 facility: St James's Hospital status: RECRUITING city: Dublin zip: D6W RY72 country: Ireland name: Craig Gouldthorpe role: CONTACT phone: +3534986235 email: gouldthc@tcd.ie lat: 53.33306 lon: -6.24889 hasResults: False
<\|newrecord\|> nctId: NCT06329466 id: 0000-0002-4205-669X briefTitle: The Effect of Emotional Freedom Technique (EFT) on Pain Intensity and Menstruation Symptoms acronym: EFT overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-28 date: 2024-06-25 date: 2024-07-25 date: 2024-03-26 date: 2024-03-26 name: Gulay Coskun class: OTHER name: Mersin University briefSummary: The most important indicator of the fertility period, which has an important place in a woman's life, is the menstrual cycle, which begins with menarche and continues until menopause. In this natural process that takes place every month physiologically, some women experience significant pain \[1\]. This condition, defined as dysmenorrhea (painful menstruation), is classified in two ways as primary dysmenorrhea (PD) and secondary dysmenorrhea (SD) \[2,3\]. PD is the most common women's health problem, especially in adolescents and young adults (10-20 years of age) \[1,5\].
When studies on the incidence and severity of primary dysmenorrhea are examined, the incidence of PD is seen at rates ranging from 40-90% \[5-8\].
The main goal of the treatment approach to PD, which negatively affects women's quality of life in many ways, is to relieve the woman by reducing the pain. Emotional Freedom Technique (EFT) is one of the non-pharmacological and integrated treatment methods for women with primary dysmenorrhea. This practice, which is also referred to as EFT stroke/touch in most sources, is based on expressing the problem by touching the energy meridian points of the body, as in acupuncture and acupressure.
Considering the results of the studies, it can be said that EFT is effective in the management of pain and the negative effects caused by the restrictions in the life of the person (social and daily living activities, etc.) \[27-30\]. Thanks to EFT, it is thought that women will contribute to the reduction of the fear and anxiety of experiencing pain just before menstruation and the anxiety that their life will be limited due to this.
Studies investigating the effect of EFT on pain have reported that it is effective in coping with pain \[33-35\]. However, no randomized controlled study was found in the literature search for the application of EFT in high school students with dysmenorrhea. For this reason, it is thought that if EFT is applied in this age period with a high incidence of dysmenorrhea, important findings can be achieved in terms of parameters such as pain intensity and menstrual symptoms, and it will contribute to the literature by shedding light on similar studies. \[36\]. Therefore, in this study, it was aimed to determine the effect of the emotional freedom technique applied to high school students with primary dysmenorrhea on pain severity and menstruation symptoms. conditions: Dysmenorrhea Primary studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 48 type: ACTUAL name: intervention (EFT) group measure: Mcgill Pain Scale measure: Menstruation Symptom Scale measure: VAS pain scale sex: FEMALE minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Mersin University city: Yenişehir state: Mersin zip: 33343 country: Turkey lat: 40.26444 lon: 29.65306 hasResults: False
<\|newrecord\|> nctId: NCT06329453 id: 2000033081 briefTitle: Intestinal Immunity in Neurologic Disease overallStatus: RECRUITING date: 2022-08-02 date: 2027-08-31 date: 2027-08-31 date: 2024-03-26 date: 2024-03-26 name: Yale University class: OTHER briefSummary: The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases. conditions: Multiple Sclerosis conditions: Parkinson Disease conditions: REM Sleep Behavior Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Colon Tissue Biopsy measure: Characterization of immune cells from the gastrointestinal mucosa measure: Evaluate spatial transcriptomics of intestinal tissue measure: Characterize the microbiome at different anatomic sites within the gastrointestinal tract sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale MS Clinic status: RECRUITING city: North Haven state: Connecticut zip: 06473 country: United States name: Cynthia Marques role: CONTACT phone: 203-287-6100 email: cynthia.marques@yale.edu name: Dimitri Duvilaire role: CONTACT phone: 2032876100 email: dimitri.duvilaire@yale.edu name: Erin Longbrake, MD role: PRINCIPAL_INVESTIGATOR lat: 41.39093 lon: -72.85954 hasResults: False
<\|newrecord\|> nctId: NCT06329440 id: 2023/880 briefTitle: Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-05 date: 2024-03-26 date: 2024-04-18 name: Istanbul University class: OTHER briefSummary: Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated. conditions: Diaphragm Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Ultrasonographic measurement of diaphragm thickness measure: Diaphragm thickness fraction (centimeters) measure: Diaphragm thickness at the end of expirium (centimeters). measure: Diaphragm thickness at the end of inspirium (centimeters). measure: Perfusion index change measure: Motor and sensory block onset time measure: Postoperative pain scores (0-10) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University Istanbul Faculty of Medicine status: RECRUITING city: Istanbul country: Turkey name: Meltem Savran Karadeniz, MD, Assoc Prof role: CONTACT email: mskaradeniz@gmail.com name: Ozgur Selek, MD role: CONTACT phone: 00905057883600 lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06329427 id: IRB00098063 briefTitle: Dragon Ambient eXperience (DAX) Copilot Evaluation acronym: DAX overallStatus: COMPLETED date: 2023-06-19 date: 2023-12-15 date: 2023-12-15 date: 2024-03-26 date: 2024-03-29 name: Wake Forest University Health Sciences class: OTHER name: Hieu Nguyen, MS - Biostatician name: McKenzie Isreal, MPH - project manager name: Casey Stephens, MPH - Health services researcher briefSummary: AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods. conditions: Automated Clinical Documentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 238 type: ACTUAL name: Dragon Ambient eXperience (DAX) Copilot measure: Total EHR time measure: Work outside of work measure: Time on encounter note documentation measure: Completed appointment rate measure: Same day closure rate measure: Note length measure: Gross revenue per visit measure: wRVU per visit measure: Provider satisfaction measure: Provider interview measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Navicent city: Macon state: Georgia zip: 31201 country: United States lat: 32.84069 lon: -83.6324 facility: Atrium Health Floyd city: Rome state: Georgia zip: 30165 country: United States lat: 34.25704 lon: -85.16467 facility: Atrium Health city: Charlotte state: North Carolina zip: 28203 country: United States lat: 35.22709 lon: -80.84313 facility: Scotland Health Care System city: Laurinburg state: North Carolina zip: 28352 country: United States lat: 34.77405 lon: -79.46282 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 hasResults: False
<\|newrecord\|> nctId: NCT06329414 id: 00164631 briefTitle: Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis overallStatus: RECRUITING date: 2024-01-16 date: 2026-01 date: 2026-01 date: 2024-03-25 date: 2024-03-25 name: University of Utah class: OTHER briefSummary: The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment. conditions: Multiple Sclerosis conditions: Major Depressive Disorder conditions: Treatment Resistant Depression studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 12 type: ESTIMATED measure: Feasibility of TMS treatment for MDD, per participant retention rates. measure: Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment. measure: Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment. measure: Depression remission rates will be measured using MADRS scores before and after treatment. measure: MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Health status: RECRUITING city: Salt Lake City state: Utah zip: 84108 country: United States name: Kathleen Shangraw, MD role: CONTACT phone: 801-583-2500 lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06329401 id: AP01-007 briefTitle: A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF) overallStatus: RECRUITING date: 2024-04-03 date: 2026-04 date: 2026-04 date: 2024-03-25 date: 2024-04-24 name: Avalyn Pharma Inc. class: INDUSTRY name: DevPro Biopharma briefSummary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks. conditions: Progressive Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: AP01 name: Placebo measure: To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) measure: To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL) measure: To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52) measure: To evaluate the change from baseline in quantitative lung fibrosis score. measure: To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Newport Native MD, Inc. status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Paradigm Clinical Research - Redding status: NOT_YET_RECRUITING city: Redding state: California zip: 96001 country: United States lat: 40.58654 lon: -122.39168 facility: Clinical Site Partners, LCC status: NOT_YET_RECRUITING city: Leesburg state: Florida zip: 34748 country: United States lat: 28.81082 lon: -81.87786 facility: Renstar Medical Research status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Clinical Site Partners status: NOT_YET_RECRUITING city: Winter Park state: Florida zip: 32789 country: United States lat: 28.6 lon: -81.33924 facility: Accellacare status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Southeastern Research Center status: NOT_YET_RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States lat: 36.09986 lon: -80.24422 facility: Lowcountry Lung and Critical Care status: RECRUITING city: Charleston state: South Carolina zip: 29406 country: United States lat: 32.77657 lon: -79.93092 hasResults: False
<\|newrecord\|> nctId: NCT06329388 id: CSD-SFRI-013 briefTitle: Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns overallStatus: COMPLETED date: 2023-01-18 date: 2023-07-07 date: 2023-08-11 date: 2024-03-25 date: 2024-03-26 name: TruHeight Vitamins class: INDUSTRY name: San Francisco Research Institute briefSummary: This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device. conditions: Growth Disorders conditions: Dietary Exposure conditions: Child Development conditions: Bone Development Abnormal conditions: Body Weight conditions: Child Malnutrition studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group). primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: TruHeight Growth Protein Shake measure: Change in Height measure: Change in Type X Collagen Concentration in Urine measure: Change in Body Composition measure: Incidence of Adverse Events sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD facility: SF Research Institute city: San Francisco state: California zip: 94127 country: United States lat: 37.77493 lon: -122.41942 hasResults: False
<\|newrecord\|> nctId: NCT06329375 id: 72967 briefTitle: Food Insecurity Reduction & Strategy Team acronym: FIRST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-05 date: 2025-02-05 date: 2024-03-25 date: 2024-04-17 name: Stanford University class: OTHER briefSummary: This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:
1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program. conditions: Diabetes Mellitus, Type 2 conditions: Food Insecurity conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. Patients in the intervention group will be provided the following two resources in addition to SOC:
1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge),
2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 160 type: ESTIMATED name: Nutrition program measure: Food insecurity at 30-days post initial discharge measure: Food insecurity at 60- and 90- days post post initial discharge measure: Measures of diabetes stress measure: Measures of hypoglycemia measure: Measures of medication adherence measure: Hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329362 id: 2-7-23 briefTitle: Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique overallStatus: RECRUITING date: 2023-07-31 date: 2025-07 date: 2025-07 date: 2024-03-25 date: 2024-03-26 name: The Royal College of Surgeons of Edinburgh class: OTHER briefSummary: The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density. conditions: Alveolar Bone Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Minimally invasive implantation name: Open flap procedure for ridge expansion. measure: Implant stability. measure: CBCT assessment measure: Postoperative Pain measure: Operation Time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry Cairo University status: RECRUITING city: Cairo zip: 35855 country: Egypt name: Bassem Emad, MDs role: CONTACT phone: +201001113474 email: bassem_26@hotmail.com name: Emad Deif, Prof role: CONTACT phone: +201222331938 email: daif_emad@yahoo.com lat: 30.06263 lon: 31.24967 facility: Future Dental Academy GmbH status: RECRUITING city: Flonheim state: Rheinland - Pfalz zip: D-55237 country: Germany name: Armin Nadjet, A.Prof role: CONTACT phone: +4915115253692 email: nedjat@t-online.de name: Rainer Zoppke role: CONTACT phone: +491778339601 email: Rainer.Zoppke@champions-implants.com lat: 49.785 lon: 8.04 hasResults: False
<\|newrecord\|> nctId: NCT06329349 id: EK VP57/0/2023 briefTitle: Metabolic Flexibility to Predict Lifestyle Interventions Outcomes acronym: MEPHISTO overallStatus: RECRUITING date: 2024-01-02 date: 2025-12-12 date: 2026-04-01 date: 2024-03-25 date: 2024-03-25 name: Charles University, Czech Republic class: OTHER name: Ministry of Health, Czech Republic name: EXCELES LX22NPO5104, CarDia briefSummary: Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 randomized cross-over primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Exercise name: Combined Exercise + Diet measure: Change in metabolic flexibility (MetFlex (ΔRQ 200-0)) measure: Change in insulin sensitivity measure: Glucose tolerance relate to primary outcomes changes measure: HbA1c relate to primary outcomes changes measure: Insulin sensitivity relate to primary outcomes changes measure: Microbiome composition relate to weight loss: exploratory outcome measure: Metabolomic signatures relate to weight loss: exploratory outcome sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: University Hospital Kralovske Vinohrady status: RECRUITING city: Prague zip: 10034 country: Czechia name: Jan Gojda, PhD role: CONTACT phone: +420267163031 email: jan.gojda@lf3.cuni.cz name: Katerina Koudelkova, MD role: CONTACT phone: +420267163031 email: katerina.koudelkova@fnkv.cz lat: 50.08804 lon: 14.42076 facility: Third Medical Faculty,Charles University status: RECRUITING city: Prague zip: 10084 country: Czechia name: Michaela Šiklová, PhD role: CONTACT phone: +420267102222 email: michaela.siklova@lf3.cuni.cz name: PhD role: CONTACT phone: +420267163031 email: jan.gojda@lf3.cuni.cz lat: 50.08804 lon: 14.42076 facility: Faculty of Sports Science status: RECRUITING city: Prague zip: 16000 country: Czechia name: Michal Šteffl, PhD role: CONTACT phone: +420220172072 email: michal.steffl@ftvs.cuni.cz name: Tomáš Větrovský, PhD role: CONTACT phone: +420220172072 email: tomas.vetrovsky@ftvs.cuni.cz lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06329336 id: STUDY00019653 id: UL1TR002319 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR002319 briefTitle: Parenting Support for Justice Involved Families overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-30 date: 2025-04 date: 2024-03-25 date: 2024-04-24 name: University of Washington class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: Together with the Community Care Team of King County Community Partnership for Transition Solutions (KCCPTS), the investigators propose to collaborate in adapting parenting intervention(s) to support the well-being and effective parenting of parents re-entering the community, as well as that of their children's primary caregiver. The aim is promoting the well-being of the parents/caregivers and their children, fostering positive child development, and ultimately, preventing the intergenerational transmission of adversity. The KCCPTS Community Care Team includes re-entry navigators who have lived experience of adversity and incarceration, bringing their unique insights regarding the re-entry experience, from both personal and professional experiences. This study will evaluate a task-sharing approach to offering formerly incarcerated parents and their families a parenting support intervention. That is, re-entry navigators will be trained to deliver evidence-based parenting interventions. This increases the feasibility and accessibility of the program, particularly because facilitators have shared experiences and trusted connections with their clients. This project proposes four main activities: 1) conduct focus groups with parents re-entering the community to better understand their parenting needs, 2) work with KCCPTS re-entry navigators to incorporate information from their experience and the focus group to adapt a parenting intervention, 3) train re-entry navigators to deliver the program, and 4) conduct a preliminary evaluation of the impact of the program on parents' well-being and parenting when the program is delivered by KCCPTS re-entry navigators. If this preliminary evaluation shows promise in supporting parent well-being and parenting effectiveness, the investigators will seek funding to conduct a larger, more rigorous evaluation. conditions: Parenting conditions: Well-Being, Psychological conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Social Emotional Competence for Children and Parents measure: Parenting Behavior Inventory - Very short Form measure: PHQ-9 Depressive Symptoms measure: GAD-7 Anxiety Symptoms measure: Brief Resilience Scale measure: Self-Compassion Scale - Short Form measure: Strengths and Difficulties Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329323 id: 23CX8477 briefTitle: SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours acronym: SUMMER overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2027-04 date: 2028-04 date: 2024-03-25 date: 2024-03-26 name: Imperial College London class: OTHER briefSummary: The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.
The main question\[s\] it aims to answer are:
1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)
2. To understand the imaging profile of MOGCTs compared to that of BOGCTs
3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
5. To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass. conditions: Germ Cell Ovarian Cancer conditions: Germ Cell Tumor conditions: Germ Cell Cancer conditions: Germ Cell Neoplasia conditions: Ovary Cancer conditions: Ovary Neoplasm conditions: Ovarian Cancer conditions: Ovarian Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 24 type: ESTIMATED name: Blood test name: Pathology specimen miRNA expression measure: Difference in microRNA expression (plasma) between benign and malignant masses measure: Difference in microRNA expression (serum) between benign and malignant masses measure: microRNA expression (plasma) measure: microRNA expression (serum) measure: Quantitative measure of circulating miRNA before treatment measure: Quantitative measure of circulating miRNA before treatment measure: Quantitative measure of circulating miRNA after treatment measure: Quantitative measure of circulating miRNA after treatment measure: Performance of segmentation model on ultrasound images measure: Performance of segmentation model on MRI images measure: Performance of classification model on ultrasound images measure: Performance of classification model on MRI images sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329310 id: XEL-CR-14 briefTitle: Xeltis Hemodialysis Access Conduit: aXess-E Study overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-06 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: Xeltis class: INDUSTRY briefSummary: A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: aXess-E conduit measure: Primary Patency rate measure: Freedom from device-related SAE measure: Implantation success rate measure: Primary patency rate measure: Primary assisted patency rate measure: Secondary patency rate measure: Functional patency rate measure: Time (expressed in months) to first intervention and to access abandonment measure: Rate of access-related interventions required to achieve/maintain patency measure: Freedom from device-related SAE measure: Rate of access site infections measure: Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment measure: Time to first cannulation measure: Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329297 id: NUR23-1005 INPTCGM1 briefTitle: Continuous Glucose Monitoring in Inpatients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2025-04 date: 2024-03-25 date: 2024-03-25 name: Parkview Health class: OTHER briefSummary: The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations. conditions: Hyperglycemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: CGM monitor measure: CGM vs point of care test (POCT) glucose measure: Slow downward trend arrow on CGM device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329284 id: RC 31.1.2024 briefTitle: Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia overallStatus: COMPLETED date: 2023-01-01 date: 2023-09-15 date: 2023-12-15 date: 2024-03-25 date: 2024-03-26 name: Benha University class: OTHER briefSummary: Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.
Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Newly pregnant normotensive (NT) women with singleton fetus primaryPurpose: DIAGNOSTIC masking: NONE count: 80 type: ACTUAL name: ELISA measure: Severity of Pre-Eclampsia (PE) sex: FEMALE minimumAge: 21 Years maximumAge: 50 Years stdAges: ADULT facility: Banha University city: Banhā state: El- Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False
<\|newrecord\|> nctId: NCT06329271 id: 113022-E briefTitle: After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) overallStatus: RECRUITING date: 2024-03-08 date: 2025-04-29 date: 2025-04-29 date: 2024-03-25 date: 2024-03-25 name: Far Eastern Memorial Hospital class: OTHER briefSummary: Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.
Patients and methods:
For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded. conditions: Bony Weight Bearing Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Early-Weight bearing measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Complication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Far-Eastern Memorial Hospital status: RECRUITING city: New Taipei City zip: 220 country: Taiwan name: Yen Cheng Chen role: CONTACT phone: 886919207805 email: sstteevveepp@gmail.com lat: 25.01111 lon: 121.44583 hasResults: False
<\|newrecord\|> nctId: NCT06329258 id: PTC09 briefTitle: Combination of Sotyktu and Enstilar for Plaque Psoriasis overallStatus: COMPLETED date: 2022-12-06 date: 2023-11-13 date: 2023-11-13 date: 2024-03-25 date: 2024-03-25 name: Psoriasis Treatment Center of Central New Jersey class: OTHER briefSummary: combination deucravacitinib and enstilar foam conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: open label primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Enstilar name: Deucravacitinib measure: Psoriasis Area and Severity Index 75 at week 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schweiger Derm Group city: East Windsor state: New Jersey zip: 08520 country: United States lat: 40.268 lon: -74.54043 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-08-30 uploadDate: 2024-03-14T10:41 filename: Prot_SAP_000.pdf size: 834542 hasResults: False
<\|newrecord\|> nctId: NCT06329245 id: brainpro2022 briefTitle: Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-01-01 date: 2029-07-01 date: 2024-03-25 date: 2024-03-25 name: Children's Hospital of Fudan University class: OTHER name: ShanghaiTech University briefSummary: The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state. conditions: Autism or Autistic Traits conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Do not take any interventions measure: clinical diagnosis measure: neurodevelopmental outcome measure: Prosocial behaviors measure: nuclear magnetic resonance imaging(MRI) measure: Event related potentials (ERPs) sex: ALL minimumAge: 0 Months maximumAge: 18 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06329219 id: wIRA briefTitle: Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis overallStatus: RECRUITING date: 2024-03-26 date: 2025-02-28 date: 2025-12 date: 2024-03-25 date: 2024-03-28 name: Charite University, Berlin, Germany class: OTHER briefSummary: The aim of this clinical trial is to evaluate the effects of water-filtered Infrared-A radiation on patients suffering from hand osteoarthritis. The main questions it aims to answer are:
* Does water-filtered Infrared-A radiation reduce pain and improve the function of finger joints over time?
* Are patients satisfied with the treatment results when compared to those who were on a wait-list? conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: water-filtered Infrared-A radiation measure: Pain in the finger joints on visual analogue scale measure: Hand Dynamometer measure: Disabilities of Arm, Shoulder and Hand (DASH) questionnaire measure: Pain Self-Efficacy Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: Short Form (SF)-36 Health Survey (SF-36) measure: Functional Index for Hand OsteoArthritis (FIHOA) measure: Tolerability of the intervention measure: Pain medication (number per day) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin status: RECRUITING city: Berlin-Wannsee state: Berlin zip: 14109 country: Germany name: Miriam Rösner role: CONTACT phone: +49 30 80505 682 email: naturheilkunde.studien@immanuel.de lat: 52.41915 lon: 13.15531 hasResults: False
<\|newrecord\|> nctId: NCT06329206 id: GH2616-101 briefTitle: A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-13 date: 2026-04-25 date: 2026-09-01 date: 2024-03-25 date: 2024-04-03 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER name: Zhejiang Cancer Hospital name: Henan Cancer Hospital name: Hubei Cancer Hospital name: The First Affiliated Hospital of Zhengzhou University briefSummary: This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: GH2616 Tablets measure: Safety assessment measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Plasma concentration (Cmax) measure: Area under the plasma concentration-time curve (AUC) measure: Time to achieve Cmax (Tmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Zhejiang country: China name: ZHENGBO SONG, DOCTORATE role: CONTACT phone: +8613857153345 email: zjccgcp_phase1@126.com hasResults: False
<\|newrecord\|> nctId: NCT06329193 id: CBU-FTR-ES-O4 briefTitle: Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-07 date: 2024-05-15 date: 2024-03-25 date: 2024-03-25 name: Celal Bayar University class: OTHER briefSummary: The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players. conditions: Anxiety conditions: Exercise conditions: Athletic Performance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 34 type: ESTIMATED name: Mid-Season Camp Period Loading measure: Sports Injury Anxiety measure: Muscle strength measure: Flexibility measure: Dynamic balance measure: Single-leg jump measure: Agility measure: Sprint sex: MALE minimumAge: 19 Years maximumAge: 22 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329180 id: 26.02.2024 briefTitle: Exercise in Mental Illness Questionnaire: French Validation overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2024-06-01 date: 2024-06-01 date: 2024-03-25 date: 2024-03-25 name: KU Leuven class: OTHER briefSummary: The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days. conditions: Exercise studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 42 type: ESTIMATED measure: Intra-class-correlation coefficients (ICC 3,1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Psychiatrique Chêne aux Haies city: Mons country: Belgium lat: 50.45413 lon: 3.95229 hasResults: False
<\|newrecord\|> nctId: NCT06329167 id: 2024-HS-012 briefTitle: Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery overallStatus: RECRUITING date: 2024-03-25 date: 2025-07-01 date: 2025-07-31 date: 2024-03-25 date: 2024-03-25 name: The First Hospital of Jilin University class: OTHER briefSummary: This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery. conditions: Lower Extremity Lymphedema studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Daphnetin name: Aescuven measure: The difference in the circumference of the lower limbs measure: Gynaecological Cancer Lymphedema Questionnaire measure: Fibrinogen content sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the 1st hospital of Jilin University status: RECRUITING city: Chang Chun state: Jilin country: China name: Xiaosen Li Li role: CONTACT phone: +8618343116682 email: xiaosensen@jlu.edu.cn lat: 42.74694 lon: 126.24667 hasResults: False
<\|newrecord\|> nctId: NCT06329154 id: PJ-KS-KY-2024-03(X) briefTitle: Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries overallStatus: RECRUITING date: 2024-02-27 date: 2025-01-27 date: 2025-02-27 date: 2024-03-25 date: 2024-03-25 name: Yong Liu, MD class: OTHER briefSummary: This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries. conditions: Rotator Cuff Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Extracorporeal shock wave therapy name: conventional rehabilitation therapy measure: Change from Baseline Visual Analogue Scale at 4 weeks measure: Change from Baseline Range of Motion at 4 weeks measure: Change from Baseline Constant-Murley Score at 4 weeks measure: Change from Baseline Isokinetic muscle strength testing at 4 weeks measure: Change from Baseline Magnetic resonance imaging at 4 weeks measure: Change from Baseline Musculoskeletal ultrasound at 4 weeks measure: Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks measure: Change from Baseline Shoulder Pain and Disability Index at 4 weeks measure: Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks measure: Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks measure: Change from Baseline Pittsburgh sleep quality index at 4 weeks sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116011 country: China name: yong liu role: CONTACT phone: 18098876656 email: fuwa52008@126.com lat: 38.91222 lon: 121.60222 hasResults: False
<\|newrecord\|> nctId: NCT06329141 id: HSG4112-P2-03 briefTitle: A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-25 date: 2024-03-25 name: Glaceum class: INDUSTRY briefSummary: 1. Study Objective
- To assess the efficacy and safety of vutiglabridin in early Parkindson's disease patients
2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in early Parkinson's disease patients.
3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Vutiglabridin name: Placebo measure: Change From Baseline in MDS-UPDRS Part III Subscore measure: Change From Baseline in MDS-UPDRS Part III Subscore measure: Change From Baseline in MDS-UPDRS Part II + Part III measure: Change From Baseline in CGI-C score measure: Change From Baseline in K-NMSS score measure: Change From Baseline in Modified Hoehn-Yahr stage measure: Change From Baseline in PET SNBR (Specific to Non-specific Binding Ratio) in the putamen, acudate and nucleus measure: Drop-out rate due to taking anti-parkinson drug sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329128 id: 2022/04 briefTitle: Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-09-30 date: 2024-03-25 date: 2024-03-25 name: Hasan Kalyoncu University class: OTHER briefSummary: The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided in two groups. One groups will get electrotherapy, exercise(home programme) and manuel therapy intervention. One group will be the control group. Control group will get electrotherapy and exercise (home programme). primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Experimental: Study Group name: Active Comparator: Control Group measure: The pain measure: Functional status measure: The quality of Life measure: Lower extremity functional strength and balance test measure: Functional mobility sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasan Kalyoncu University city: Gaziantep state: Şahinbey zip: 27100 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False
<\|newrecord\|> nctId: NCT06329115 id: 2024/23 briefTitle: Investigation of the Effectiveness of Regular Physical Activity in University Students overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-06-30 date: 2024-03-25 date: 2024-03-25 name: Hasan Kalyoncu University class: OTHER briefSummary: In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices. conditions: Regular Physical Activity conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Exercise training measure: Lifelong learning measure: Physical activity measure: Fatique measure: Daytime sleepiness measure: Depression, anxiety and stress measure: Quality of life measurement measure: Physiological expenditure indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasan Kalyoncu University city: Gaziantep state: Şahinbey zip: 27100 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False
<\|newrecord\|> nctId: NCT06329102 id: 93628 briefTitle: Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen acronym: RCC overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2025-09-01 date: 2024-03-25 date: 2024-03-28 name: Haukeland University Hospital class: OTHER name: Intuitive Surgical briefSummary: Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power. conditions: Right Sided Colon Cancer conditions: Right Colectomy conditions: Lymphadenectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Surgical access measure: Surgical complications defined by Calvien Dindo II to V measure: Surgical quality described by the specimen quality and number of lymph nodes harvested measure: Oncological quality will be measured by overall survival and recurrence measure: Quality of life after surgery measured with the 15D instrument sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5009 country: Norway name: Frank Pfeffer, Prof role: CONTACT phone: 48180021 phoneExt: 0047 email: frank.pfeffer@helse-bergen.no name: Havard Forsmo, PhD role: CONTACT phone: 48276232 phoneExt: 0047 email: havard.mjorud.forsmo@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False
<\|newrecord\|> nctId: NCT06329089 id: HCB/2023/0840 briefTitle: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer acronym: RENATA overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-25 date: 2024-03-25 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:
* What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?
* How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team. conditions: Recurrent Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: Reoperative Sentinel Lymph Node Biopsy measure: Re-Sentinel Lymph node harvesting rate measure: Drainage pathways description measure: Complications rate measure: Axillary metastasis rate measure: Correlation Between Axillary and Internal Mammary Chain Infiltration measure: Quality of life in recurrent breast cancer sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic de Barcelona status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Ines Torras Caral role: CONTACT phone: 93 227 54 00 phoneExt: 2499 email: itorras@clinic.cat lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06329076 id: BAM_lab_eyetracking_04 briefTitle: Losartan Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered losartan on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Randomized placebo-controlled double-blind between-subject design whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Losartan name: Placebo measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after losartan administration measure: First saccade latency(ms) for threatening versus non-threatening stimuli after losartan administration measure: Fixation duration(ms) for threatening versus non-threatening stimuli after losartan administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06329063 id: BAM_lab_eyetracking_03 briefTitle: Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Randomized placebo-controlled double-blind between-subject design whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Vasopressin name: Placebo measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after oral vasopressin administration measure: First saccade latency(ms) for threatening versus non-threatening stimuli after oral vasopressin administration measure: Fixation duration(ms) for threatening versus non-threatening stimuli after oral vasopressin administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chendu state: Sichuan country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com hasResults: False
<\|newrecord\|> nctId: NCT06329050 id: BAM_lab_eyetracking_02 briefTitle: The Effects of Losartan on Attention Control: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered Losartan on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Losartan name: Placebo measure: Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration measure: Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration measure: Saccade/antisaccade latency for different facial emotions after losartan administration measure: Error rate of saccade/antisaccade for different facial emotions after losartan administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 611731 country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06329037 id: BAM_lab_eye-tracking_01 briefTitle: The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized placebo-controlled double-blind between-subject design primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Vasopressin name: Placebo measure: Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration measure: Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration measure: Saccade/antisaccade latency for different facial emotions after oral vasopressin administration measure: Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 611731 country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06329024 id: myofascial dysphagiapoststrok briefTitle: The Impact of Myofascial Release Therapy on Dysphagia in Post-stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:
• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: Patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06329011 id: TDC+IOE briefTitle: Combining Transcranial Direct Current Stimulation With Intermittent Oral to Esophageal Tube for Stroke-related Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. conditions: Stroke 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: Comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Transcranial direct current stimulation name: Placebo Transcranial direct current stimulation measure: Penetration Aspiration Scale measure: Functional Oral Intake Scale measure: Swallowing Quality of Life Questionnaire measure: Patient Health Questionnaire-9 measure: Body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06328998 id: Intra-articular Injection briefTitle: Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
The main question it aims to answer is:
• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction conditions: Temporomandibular Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation treatment name: Intra-articular Injection name: Lidocaine Hydrochloride measure: Friction Index measure: The Visual Analog Scale measure: The maximum mouth opening limit measure: Mann Assessment of Swallowing Ability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06328985 id: IOETraumatic Brain Injury briefTitle: Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric tube feeding measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: body mass index measure: Decannulation of tracheostomy tube-placement duration measure: Decannulation of tracheostomy tube-Successful removal measure: Level of consciousness measure: Feeding Amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06328972 id: IOE-Cerebral Palsy briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06328959 id: IOE- Pierre Robin briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: intermittent oro-esophageal tube feeding name: gastric tube feeding measure: Number of patients diagnosed as the pulmonary infection "Positive" measure: Concentration of total protein measure: Concentration of hemoglobin measure: Concentration of albumin measure: Body weight measure: The Functional Oral Intake Scale for Infants sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06328946 id: IOE intracerebral hemorrhage briefTitle: The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

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