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* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.
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Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.
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* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.
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Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups. conditions: Obesity conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Gut Microbial Composition measure: Blood Microbial Composition measure: Body Weight (kg) measure: Body Height (meters) measure: Fat Mass (Kg) measure: Fat-free Mass (Kg) measure: Body water (%) measure: Skeletal Muscle Mass (kg) measure: Fasting Glucose (mg/dL) measure: Fasting Insulin (mIU/L) measure: Lipopolysaccharides (%) measure: Lipopolysaccharides binding protein (mIU/L) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-19 uploadDate: 2024-03-27T14:38 filename: Prot_SAP_000.pdf size: 316789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-27T14:39 filename: ICF_001.pdf size: 297665 hasResults: False
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<|newrecord|> nctId: NCT06342037 id: N22TON briefTitle: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial acronym: TONIC-3 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-04-01 date: 2030-04-01 date: 2024-04-02 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER name: Hoffmann-La Roche briefSummary: This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tiragolumab name: Atezolizumab name: Ipilimumab measure: PFS-12 measure: Incidence of adverse events measure: Objective response rate measure: Clinical benefit rate measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342024 id: 23-871 briefTitle: Pistachio Consumption on Inflammatory Markers and Lean Body Mass overallStatus: RECRUITING date: 2024-02-20 date: 2025-05-30 date: 2025-08-31 date: 2024-04-02 date: 2024-04-02 name: Virginia Polytechnic Institute and State University class: OTHER briefSummary: Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.
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The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.
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This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.
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The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants will be randomized to one of two groups (pistachio vs. control) using permuted block randomization with stratification to balance assignment by sex. Randomization allocation tables will be created by a biostatistician not involved in the clinical trial using SAS software, version 9.4 (SAS Institute, Cary, NC, USA). The tables will be stored within the REDCap system at Virginia Tech, in such a way that only the biostatistician will be able to view them. Study outcomes will be analyzed blind to allocation status. primaryPurpose: OTHER masking: NONE maskingDescription: Not apply count: 144 type: ESTIMATED name: Pistachio group measure: C-reactive protein concentrations in the blood measure: Creatine kinase concentrations in the blood measure: Cortisol concentrations in the blood measure: Interleukin-8 concentrations in the blood measure: Tumor necrosis factor-alpha concentrations in the blood measure: Copper-zinc superoxide dismutase concentrations in the blood measure: Glutathione peroxidase concentrations in the blood measure: Lean body mass measure: Body weight measure: Height measure: Body Mass Index measure: Magnesium concentrations in the blood measure: Iron concentrations in the blood measure: Zinc concentrations in the blood sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Virginia Polytechnic Institute and State University status: RECRUITING city: Blacksburg state: Virginia zip: 24061 country: United States name: Stella L Volpe, PhD role: CONTACT phone: 540-231-3805 email: stellalv@vt.edu name: Alexandra Hanlon, PhD role: CONTACT phone: 540-231-5657 email: alhanlon@vt.edu lat: 37.22957 lon: -80.41394 hasResults: False
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<|newrecord|> nctId: NCT06342011 id: KY-2024-039 briefTitle: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ESTIMATED name: Anti-inflammatory diet group measure: C-reactive protein measure: Erythrocyte sedimentation rate (ESR) measure: Leukocyte measure: Self-Rating Anxiety Scale，SAS measure: Self-Rating depression scale，SDS measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ) measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES) measure: Body Mass Index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine city: Yiwu state: Zhejiang zip: 322000 country: China name: Xia Qian, BA role: CONTACT phone: 15968110117 email: 1632936247@qq.com lat: 29.31506 lon: 120.07676 hasResults: False
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<|newrecord|> nctId: NCT06341998 id: HERO2020 briefTitle: Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children acronym: SCRRYST overallStatus: COMPLETED date: 2020-06-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Shandong First Medical University class: OTHER briefSummary: Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST). conditions: Germ Cell Tumor conditions: Yolk Sac Tumor studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children measure: Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate measure: Progression-free Survival sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shandong Cancer Hospital and Institute city: Jinan state: Shandong zip: 250117 country: China lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06341985 id: IEO 1593 briefTitle: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers acronym: DORIAN overallStatus: RECRUITING date: 2021-11-15 date: 2024-11-15 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).
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The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Exclusive radiotherapy measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0 measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire measure: Identification of the organs at risk most strongly correlated with the onset of nausea measure: Identification of dosimetric cutoffs for the onset of nausea measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques measure: Development of machine-learning predictive models for the onset of nausea sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona status: RECRUITING city: Ancona country: Italy name: Giovanna Mantello role: CONTACT email: clelia.dicarlo@ospedaliriuniti.marche.it lat: 43.5942 lon: 13.50337 facility: Ospedale "Mons. Dimiccoli" status: RECRUITING city: Barletta country: Italy name: Alessia Di Rito role: CONTACT email: aledirito@yahoo.it lat: 41.31429 lon: 16.28165 facility: Azienda Ospedaliera S.Pio status: RECRUITING city: Benevento country: Italy name: Angela Argenone role: CONTACT email: angela.argenone@ao-rummo.it lat: 41.1307 lon: 14.77816 facility: Ospedale MultiMedica status: RECRUITING city: Castellanza country: Italy name: Gianpiero Catalano role: CONTACT email: gianpiero.catalano@multimedica.it lat: 45.61079 lon: 8.89616 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Liliana Belgioia role: CONTACT email: liliana.belgioia@unige.it lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Stefania Volpe role: CONTACT lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan country: Italy name: Italo Dell'Oca role: CONTACT email: delloca.italo@hsr.it lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliero-Universitaria di Modena status: RECRUITING city: Modena country: Italy name: Elisa D'Angelo role: CONTACT email: dangelo.elisa@policlinico.mo.it lat: 44.64783 lon: 10.92539 facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara status: RECRUITING city: Novara country: Italy name: Carla Pisani role: CONTACT email: carla.pisani@maggioreosp.novara.it lat: 45.44694 lon: 8.62118 facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Sara Colombo role: CONTACT email: s.colombo@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata status: RECRUITING city: Roma country: Italy name: Giuseppina Apicella role: CONTACT email: gapicella@hsangiovanni.roma.it lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero Universitaria Policlinico Umberto I status: RECRUITING city: Roma country: Italy name: Francesca De Felice role: CONTACT email: francesca.defelice@uniroma1.it lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina status: RECRUITING city: Roma country: Italy name: Orietta Caspiani role: CONTACT email: o.caspiani@gmail.com lat: 41.89193 lon: 12.51133 facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni status: RECRUITING city: Sesto San Giovanni country: Italy name: Gianpiero Catalano role: CONTACT email: gianpiero.catalano@multimedica.it lat: 45.53329 lon: 9.22585 hasResults: False
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<|newrecord|> nctId: NCT06341972 id: IRB00247005 id: K23HL155735 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL155735 briefTitle: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention acronym: SMARA overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-02-01 date: 2027-09-01 date: 2024-04-02 date: 2024-04-02 name: Johns Hopkins University class: OTHER name: Francis Family Foundation name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.
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The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.
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The main question\[s\] it aims to answer are:
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* Is this intervention feasible and acceptable in ARF patients?
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* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?
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Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up. conditions: Respiratory Failure conditions: Anxiety conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pilot randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cognitive behavioral therapy based self-management for anxiety measure: Treatment Satisfaction Questionnaire measure: average accrual rate of 2 patients/month across all patients measure: treatment feasibility as assessed by sessions completed measure: treatment feasibility as assessed by drop out rate measure: Visual Analog Scale - Anxiety measure: State Anxiety Inventory measure: Hopkins Rehab Engagement Scale measure: Self Efficacy for Managing Chronic Disease Rating Scale measure: Hospital Anxiety and Depression Scale measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D) measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6 measure: Healthcare Utilization as assessed by Healthcare Utilization interview measure: Montreal Cognitive Assessment - Blind sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341959 id: GerodentPLUS1 briefTitle: Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-26 name: University Ghent class: OTHER briefSummary: There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older). conditions: Oral Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.
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In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 194 type: ESTIMATED name: Oral screening measure: Contacted a dentist sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-25T05:59 filename: Prot_SAP_ICF_000.pdf size: 743439 hasResults: False
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<|newrecord|> nctId: NCT06341946 id: Soh-Med-24-02-05MD briefTitle: Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-10-01 date: 2025-11 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV). conditions: Hydrocephalus conditions: Shunt Malfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients with malfunctioning VP shunt will be included in this study primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Endoscopic third ventriculostomy measure: Glasgow Coma Scale (GCS) measure: visual analogue scale( VAS ) measure: visual acuity measure: radiological CT brain and or MRI brain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341933 id: 2024-BÇEK/41 briefTitle: Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-02 date: 2024-04-02 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.
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The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.
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Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.
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The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications. conditions: Acute Kidney Injury conditions: Surgery conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Duration of Surgery name: Volume of Fluid in Surgery name: Blood Loss measure: Glomerular Filtration Rate measure: Serum Creatinine measure: Amount of Urine sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey name: Ali ALAGÖZ, professor role: CONTACT phone: 5079193765 phoneExt: +9 email: mdalagoz@gmail.com name: Fatma ÖZTÜRK YALÇIN, specialist role: SUB_INVESTIGATOR name: Onur KÜÇÜK, specialist role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06341920 id: RS198 - 332551 briefTitle: BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery acronym: BoneFit overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-07-01 date: 2027-12-01 date: 2024-04-02 date: 2024-04-02 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery. conditions: Orthopedic Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention v control primaryPurpose: TREATMENT masking: NONE maskingDescription: Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not. count: 50 type: ESTIMATED name: Experimental: BoneFit intervention name: Placebo Comparator: Control measure: Recruitment measure: Adherence and attendance measure: Acceptability measure: Physical fitness measure: Length of stay measure: Readmission rates measure: Overall quality of life measure: Knee or hip specific pain, function and quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-13 uploadDate: 2024-03-12T06:12 filename: Prot_000.pdf size: 218343 hasResults: False
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<|newrecord|> nctId: NCT06341907 id: SAHoWMU-CR2024-07-107 briefTitle: Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Neoantigen polypeptide vaccine measure: ORR measure: PFS measure: OS measure: CA 125 measure: Safety Index sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Xinxin Zhang role: CONTACT phone: +86 150 6781 0815 email: zhxinxin1122@163.com lat: 27.99942 lon: 120.66682 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-13 uploadDate: 2024-03-13T05:17 filename: Prot_SAP_000.pdf size: 541225 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-16 uploadDate: 2024-03-13T05:18 filename: ICF_001.pdf size: 254239 hasResults: False
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<|newrecord|> nctId: NCT06341894 id: OBU-II-BC-126 briefTitle: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer overallStatus: RECRUITING date: 2023-11-17 date: 2027-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer. conditions: Early Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1163 type: ESTIMATED name: Dalpiciclib name: Endocrine therapy measure: invasive Disease-free Survival (iDFS) measure: Disease-free Survival (DFS) measure: AEs and SAEs sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Xiaoan Liu, Professor role: CONTACT phone: 025-68308162 email: liuxiaoan@126.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06341881 id: KMU/DIR/CTU/2024/006 id: KMU-CTU-2024-2001 type: OTHER domain: Khyber Medical University Clinical Trial Unit briefTitle: Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan overallStatus: RECRUITING date: 2024-02-27 date: 2024-05 date: 2025-01 date: 2024-04-02 date: 2024-04-02 name: Khyber Medical University Peshawar class: OTHER briefSummary: The main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in Pakistan conditions: Stroke conditions: Stroke, Ischemic conditions: Stroke Hemorrhagic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The most commonly two armed parallel study design would be used to conduct the current study. The study participants in an intervention group would be compared with that of a control group. Equal number of Participants would be allocated with random assignment in the two groups. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The study participants would not be informed of what group they are in. Independent outcome assessors would be utilized for the assessment. Further outcomes assessors and data analysts' would be kept unaware of intervention or group allocations to carry out their assessment after inclusion of participants into the study. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transitional Care Training Program measure: Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Social Care measured via Training Evaluation Assessment Checklist (TEAC) measure: Training Need Assessment measure: Training Program Development sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Khyber Medical University status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Sardar Ali, PHD Scholar role: CONTACT phone: +92 349-5182270 email: sardar.ins@kmu.edu.pk lat: 34.008 lon: 71.57849 facility: MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Awal Khan, MSN role: CONTACT phone: +92 343 9757103 email: awalkhanmsn@gmail.com name: Sardar Ali, PHD Scholar role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 facility: MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Asmat Pasha, MSN role: CONTACT phone: +92 3319205016 email: asmat.pasha@kth.edu.pk lat: 34.008 lon: 71.57849 hasResults: False
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<|newrecord|> nctId: NCT06341868 id: KACH.2023.0067 id: 23KACH008 type: OTHER domain: Keller Army Community Hospital briefTitle: Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-09-01 date: 2024-04-02 date: 2024-04-02 name: Keller Army Community Hospital class: FED name: Medical Technology Enterprise Consortium briefSummary: The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:
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* Examine the effects of KneeStim wear on cadets' post-operative gait
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* Examine changes in site-specific skeletal muscle mass
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* Examine the changes in patient-reported outcomes
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* Assess time to return to full duty
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* Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)
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* Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)
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Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.
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Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned.. conditions: Anterior Cruciate Ligament Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: KneeStim measure: Change in gait post-operatively assessed by the KneeStimTM Device measure: change in gait post-operatively assessed by 3D Motion capture measure: change in gait post-operatively assessed by force plate instrumented treadmill measure: change in muscle volume assessed by MRI measure: ACL graft healing assessed by MRI measure: Change in isometric muscle strength assessed by CSMi HUMAC NORM measure: Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS) measure: Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) measure: Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29) measure: Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE) measure: Change in knee function assessed by the Marx Activity Rating Scale (MARS) measure: Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL) measure: Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI) measure: Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS) measure: Time to return to full duty sex: ALL minimumAge: 17 Years maximumAge: 27 Years stdAges: CHILD stdAges: ADULT facility: Keller Army Community Hospital status: RECRUITING city: West Point state: New York zip: 10996 country: United States name: Natalia B Prando, BA role: CONTACT phone: 845-938-5325 email: natalia.b.prando.ctr@health.mil name: Paige A McHenry, MS role: CONTACT phone: 845-938-2630 email: paige.a.mchenry.ctr@health.mil lat: 41.39148 lon: -73.95597 hasResults: False
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<|newrecord|> nctId: NCT06341855 id: 23K294001 briefTitle: Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer overallStatus: RECRUITING date: 2024-01-25 date: 2026-01-30 date: 2026-01-30 date: 2024-04-02 date: 2024-04-02 name: The First Hospital of Jilin University class: OTHER name: Geneplus-Beijing Co. Ltd. briefSummary: Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: MRD-ctDNA measure: monitoring recurrence and evaluating prognosis measure: Treatment benefit 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
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<|newrecord|> nctId: NCT06341842 id: EudraCT 2022-003377-28 briefTitle: Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity acronym: PROTECT overallStatus: RECRUITING date: 2023-10-19 date: 2025-04-19 date: 2025-04-19 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigator initiated Phase II "proof of concept", multicentre, randomized 1:1, open label, parallel-groups study, designed to evaluate if dapagliflozin reduces chemotherapy induced cardiotoxicity in participants with breast cancer treated with (neo-) adjuvant Anthracycline-based chemotherapy +/- trastuzumab. primaryPurpose: TREATMENT masking: NONE count: 316 type: ESTIMATED name: Dapagliflozin 10mg Tab measure: Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up. measure: Difference in severe, moderate and mild asymptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ and with or without the use of any of ACEi, angiotensin receptor blockers, or b-blockers measure: Difference in symptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ (subgroup analysis) measure: Change from baseline in end diastolic and systolic left ventricular volumes and in left atrial volume during 18 months measure: Change from baseline of at least of one grade of diastolic disfunction (according to ESC guidelines during 18 months. measure: Change in plasma levels of the bio-humoral marker NT-pro-BNP between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsTNI between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker CKD-EPI eGFR between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsCRP between baseline and follow-up measure: Safety Outcomes: TEAE incidence measure: Toxicity: renal failure evaluation. measure: Toxicity: hypoglycaemia evaluation measure: Tolerability: genito-urinary tract infections measure: Tolerability: symptomatic hypotension measure: Quality of Life questionaire: EQ-5D-5L sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Gianpiero Rizzo, Oncologist role: CONTACT phone: +390382502094 email: g.rizzo@smatteo.pv.it name: Alessandra Greco, Cardiologist role: CONTACT phone: +390382501326 email: a.greco@smatteo.pv.it lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06341829 id: PRISM1 briefTitle: Visuospatial and Affective Abilities in Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-17 date: 2024-04-18 date: 2026-02-28 date: 2024-04-02 date: 2024-04-16 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). conditions: Parkinson Disease conditions: Alexithymia conditions: Visuospatial/Perceptual Abilities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 63 type: ESTIMATED name: Prismatic adaptation measure: Improve visuospatial skills; measure: Modulate alexithymia; measure: Investigation of brain activity; measure: Improve the quality of life with PDQ-39 questionnaire sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341816 id: VEXUS2 briefTitle: Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-10-01 date: 2024-12-01 date: 2024-04-02 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3).
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Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4).
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Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. conditions: Heart Failure conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: VEXUS score name: NGAL measure: acute kidney injury measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341803 id: DSRB 2023/00397 briefTitle: Personalized Transcranial Magnetic Stimulation Treatment for Depression acronym: APIC-TMS overallStatus: RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: Institute of Mental Health, Singapore class: OTHER name: National University of Singapore briefSummary: This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.
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Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.
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All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.
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Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).
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Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.
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All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.
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The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Individually Neuronavigated accelerated intermittent theta burst stimulation with Magpro X100 measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16) measure: Montreal Cognitive Assessment (MoCA), measure: EuroQol- 5 Dimension (EQ-5D) measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) measure: Correlation of changes in functional connectivity with changes in MADRS scores sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Mental Health status: RECRUITING city: Singapore country: Singapore name: Phern-Chern Tor, MBBS role: CONTACT lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06341790 id: NAFLD-02 briefTitle: Effect of Consumption of Millet Diet in Patients With NAFLD overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-07-05 date: 2026-07-05 date: 2024-04-02 date: 2024-04-02 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, this study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor.
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It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Managing our cereals from being refined to the more complex ones being rich in fibre, protein and good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be in increasing the consumption of cereals that are not only high in fibre, low in carbohydrates but also that have the potential to modulate the intestinal bacterial ecology to a more favourable type thus helping in intensifying the effects of overall dietary modifications.
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Gut microbiota is currently explored for its role in NAFLD and there are gaps in knowledge which preclude having therapeutic strategies through its modulation. Millets, which were once considered to be poor man's diet are now becoming a part of the plate more frequently, especially for its unique nutritive content, with increased fiber, low carbohydrates, high protein and good quality fats. The processing methods may alter glycemic responses. Thus, the present study is proposed to look into the effect of millet based diets in reduction of hepatic steatosis and the resultant alterations in the gut microbiota . conditions: NAFLD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: jowar based products measure: Assessment of hepatic steatosis in NAFLD patients measure: Assessment of blood sugar measure: Assessment of lipid function measure: Assessment of liver transaminases measure: Assessment of body composition measure: Assessment of Gut Microbiota sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: ILBS city: New Delhi zip: 110070 country: India name: Nida Athar, Msc role: CONTACT phone: 8601079163 email: nidaathar.20@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06341777 id: 25M621 briefTitle: Multisensory Telerehabilitation for Visual Field Defects acronym: MUST overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: IRCCS Fondazione Stella Maris name: Azienda Ospedaliero, Universitaria Meyer briefSummary: Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements. conditions: Visual Field Defect Following Cerebrovascular Accident conditions: Hemianopia conditions: Brain Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Audio-visual training (AVT) telerehabilitation measure: Change from baseline in Accuracy on the EF Task measure: Change from baseline in Response Times (RTs) on the EF Task measure: Change from baseline in Accuracy on the Triangle Task measure: Change from baseline in RTs on the Triangle Task measure: Change from baseline in RTs on the Numbers Task measure: Change from baseline in omissions on the Bell Test (only children) measure: Change from baseline in RTs on the Bell Test (only children) measure: Change from baseline in Accuracy on the Small Faces Test (only children) measure: Change from baseline in RTs on the Small Faces Test (only children) measure: Change from baseline in Daily Living Dependent on Vision Questionnaire (total score) measure: Change from baseline in the Reading test (reading time) measure: Change from baseline in the Hamilton Anxiety Scale (total score; only adults) measure: Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults) measure: Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children) measure: Change from baseline in the Children Depression Inventory (CDI; total score; only children) measure: Change from baseline in the visual field size (only adults) measure: Change from baseline in the amplitude of Visual Evoked Potentials (VEPs) measure: Change from baseline in the latency of Visual Evoked Potentials (VEPs) measure: Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus measure: Change from baseline in the connectivity of the Superior Longitudinal Fasciculus measure: Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus measure: Change from baseline in the connectivity of the Optic Radiations measure: Change from baseline in the connectivity of the Optic Tracts sex: ALL minimumAge: 6 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS city: Milan state: Lombardia zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06341764 id: CITATION id: 7/23 type: OTHER domain: IRCCS I.N.T. "G. Pascale" briefTitle: Neo-adjuvant Chemo and Immunotherapy in The Pre-operAtive Treatment of Locally Advanced cholangIOcarciNoma overallStatus: RECRUITING date: 2023-09-01 date: 2024-09 date: 2025-09 date: 2024-04-02 date: 2024-04-02 name: National Cancer Institute, Naples class: OTHER briefSummary: Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery. conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Durvalumab 1120 mg name: Durvalumab 1500 mg name: Tremelimumab i.v. at 300 mg name: Cisplatin (CDDP) 25 mg/mq i.v name: Gemcitabine (GEM) 1000 mg/mq i.v. measure: Recurrence rate of CCA measure: Rate of R0 resections measure: Radiologic responses measure: Pathologic responses measure: Toxicity assessed measure: PFS measure: OS measure: Exploratory objectives measure: Exploratory objectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale status: RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Alessandro Ottaiano role: CONTACT phone: 08117770344 email: a.ottaiano@istitutotumori.na.it name: Alessandro Ottaiano role: PRINCIPAL_INVESTIGATOR name: Guglielmo Nasti role: SUB_INVESTIGATOR name: Francesco Izzo role: SUB_INVESTIGATOR name: Andrea Belli role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Ospedale Cardarelli, Napoli status: NOT_YET_RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Giovanni Vennarecci role: CONTACT phone: 0817472372 email: giovanni.vennarecci@aocardarelli.it name: Giovanni Vennarecci role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Università di Napoli "Federico II", Napoli status: NOT_YET_RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Roberto Bianco role: CONTACT phone: 0817462061 email: robianco@unina.it name: Roberto Bianco role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Ospedale san Camillo Forlanini/Spallanzani, Roma status: NOT_YET_RECRUITING city: Roma state: Italia zip: 00152 country: Italy name: Viola Barucca role: CONTACT phone: 3391333211 email: viola.barucca.scf@gmail.com name: Viola Barucca role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Ospedale Mauriziano, Umberto I° status: NOT_YET_RECRUITING city: Torino state: Italia zip: 10128 country: Italy name: Massimo Di Maio role: CONTACT phone: 0115082032 email: massimo.dimaio@unito.it name: Massimo Di Maio role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 facility: Università di Verona, Ospedale Borgoroma, Verona status: NOT_YET_RECRUITING city: Verona state: Italia zip: 37134 country: Italy name: Alessandra Auriemma role: CONTACT phone: 3483148292 email: alessandra.auriemma@aovr.veneto.it name: Alessandra Auriemma role: PRINCIPAL_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06341751 id: 2024-00393-01 briefTitle: Psychological Treatment for Persistent Fatigue overallStatus: RECRUITING date: 2024-04-11 date: 2024-12 date: 2025-04 date: 2024-04-02 date: 2024-04-12 name: Karolinska Institutet class: OTHER name: Forte name: The Swedish Research Council name: Region Stockholm briefSummary: This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue. conditions: Fatigue conditions: Fatigue Syndrome, Chronic conditions: Exhaustion; Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Psychological treatment for persistent fatigue measure: Treatment adherence and completion measure: Treatment credibility measure: Patient satisfaction measure: Working alliance measure: Negative effects of treatment measure: Open-ended questions regarding treatment content and presentation measure: Feasibility of study inclusion procedures and data-collection measure: Fatigue severity, primary self-rated symptom outcome measure: Problems concentrating measure: Reduced physical activity measure: Reduced motivation measure: Depressive symptoms measure: Somatic symptoms measure: General anxiety measure: Insomnia measure: Perceived Stress measure: Burnout measure: Self-rated health measure: Cognitive and behavioral responses to symptoms measure: General self-efficacy measure: Functional disability measure: Work and Social Adjustment measure: Treatment fidelity measure: Evaluation of participants' experience of treatment measure: Acceptability, Appropriateness, and Feasibility from the perspective of the clinic sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustavsberg University Primary Care Clinic status: RECRUITING city: Stockholm zip: 134 40 country: Sweden name: Jacob Andersson Emad, MD, PhD role: CONTACT phone: 0736566876 phoneExt: +46 email: jacob.andersson-emad@regionstockholm.se name: Kersti Ejeby, MD, PhD role: CONTACT phone: 0704848104 phoneExt: +46 email: kersti.ejeby@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06341738 id: 421/215/404.102.28/VI/2023 briefTitle: The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates overallStatus: COMPLETED date: 2023-07-05 date: 2024-02-01 date: 2024-02-29 date: 2024-04-02 date: 2024-04-02 name: Kaohsiung Medical University class: OTHER briefSummary: The goal of this clinical trial is to examine in the parental HPV knowledge and attitude, and their children's completion rates in Indonesia. The main question\[s\] it aims to answer are:
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* Is the digital educational intervention in improving parent's HPV knowledge in the intervention group compared to the control group?
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* Is the digital educational intervention in improving parent's attitude toward HPV vaccine in the intervention group compared to the control group?
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* Is the digital educational intervention more effective in increasing children's HPV vaccine completion rates in the intervention group compared to the control group?
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Participants in intervention group will:
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* watch a 8 minutes video in front of class at once.
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* after video education intervention, in 2 weeks, participants received 2 reminder messages before first and second vaccination event, respectively.
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Participants in control group will:
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• Receive usual announcement regarding vaccine by staff conditions: Health Services Research studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 10 units are divided into 2 arms (e.g. intervention and control) by cluster randomisation using the number of units into a sealed envelope. the participants are unaware of which group they were placed in primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 374 type: ACTUAL name: Video education about HPV and HPV vaccine name: Electronic reminder messages name: Usual Information Service measure: Human Papillomavirus Knowledge Scale (HPV-KS) measure: Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) measure: Vaccine completion rate sex: ALL minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Elementary school city: Ngawi state: East Java zip: 63271 country: Indonesia lat: -7.4038 lon: 111.4461 hasResults: False
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<|newrecord|> nctId: NCT06341725 id: LinfoK EUS 2016 briefTitle: EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging overallStatus: TERMINATED date: 2018-02-15 date: 2018-02-15 date: 2018-09-11 date: 2024-04-02 date: 2024-04-02 name: Paolo Giorgio Arcidiacono, MD class: OTHER briefSummary: Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)
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* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).
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* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.
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Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature) conditions: Pancreatic Adenocarcinoma conditions: Lymph Node Metastasis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: malignant lymph nodes measure: CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence measure: OVERALL SURVIVAL (MONTHS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Hospital city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06341712 id: CLIN-60000-461 id: 2023-506229-12-00 type: OTHER domain: Ipsen briefTitle: Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma acronym: CabOSTar overallStatus: NOT_YET_RECRUITING date: 2024-06-13 date: 2026-10-26 date: 2028-06-15 date: 2024-04-02 date: 2024-04-02 name: Ipsen class: INDUSTRY briefSummary: The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery.
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Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid.
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Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults.
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In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines.
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It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy.
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Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met.
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Participants may withdraw consent to participate at any time.
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The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit. conditions: Osteosarcoma conditions: Osteosarcoma in Children conditions: Osteosarcoma in Adolescents and Young Adults studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Cabozantinib name: Best Supportive Care (BSC) name: Best Supportive Care (BSC) measure: Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC) measure: Progression-free survival (PFS) rate assessed by BIRC measure: Objective response rate (ORR) assessed by BIRC measure: Disease control rate (DCR) assessed by BIRC measure: PFS assessed by investigator measure: PFS rate assessed by investigator measure: ORR assessed by investigator measure: DCR assessed by investigator measure: Overall survival (OS) measure: 1-year overall survival rate measure: Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs). measure: Area Under Curve (AUC) at steady state. measure: Average concentration (Cavg) at steady state measure: Minimum concentration (Cmin) at steady state measure: Maximal concentration (Cmax) at steady state measure: Acceptability and palatability in children and adolescents assessed using a horizontal visual assessment scale. measure: Change from baseline in score for all Paediatric QoL Inventory (PedsQL) Scales including Generic Core Scales and Cancer Modules. measure: Change from baseline in European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) for adult participants sex: ALL minimumAge: 5 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06341699 id: 05C308 briefTitle: Study of the Steroid Hormone Milieu in Obese Patients acronym: MiSterO overallStatus: RECRUITING date: 2023-05-16 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: Ministry of Health, Italy briefSummary: The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.
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It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.
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Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.
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Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis. conditions: Obesity, Morbid studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED measure: Association of androgen milieu with the severity of obesity measure: Association of cortisol milieu with the severity of obesity measure: Algorithm fo CV risk in obesity measure: Prevalence of hypogonadism in morbid obesity measure: Prevalence of patients with morbid obesity unresponsive to overnight suppression test measure: Enrichment in rare HH variants in obese patients with central hypogonadism measure: Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Biagio Cangiano, MD role: CONTACT phone: 3343177491 email: b.cangiano@auxologico.it name: Massimo Scacchi, Professor role: CONTACT email: massimo.scacchi@unimi.it lat: 45.99088 lon: 8.64663 hasResults: False
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<|newrecord|> nctId: NCT06341686 id: 75471023.2.0000.0082 briefTitle: Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-03 date: 2025-05 date: 2024-04-02 date: 2024-04-02 name: Hospital do Rim e Hipertensão class: OTHER briefSummary: The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations. conditions: CMV Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after the kidney transplant.
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2. Patients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, evaluating CMV DNAnemia weekly until D98.CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemiaDNAemia \> 5,000 IU in a single measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (CMV syndrome or disease).
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3. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Letermovir 480 MG name: Ganciclovir measure: Incidence of CMV syndrome or disease measure: Incidence of patients with plasma CMV DNAemia > 200 IU measure: Incidence of patients with CMV infection/syndrome/disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341673 id: IRB-2023-O3-442 briefTitle: Impact of TTNS on Bladder Symptoms Among People With MS, A RCT overallStatus: RECRUITING date: 2024-03-15 date: 2024-04-28 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Hawra Al-Dandan class: OTHER briefSummary: Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardize the conduct and reporting of the current protocol. The recruitment plan is twofold: 1) Open recruitment for people with MS through King Fahd Hospital of the University communication channels; 2) people with any type of MS attending their routine appointments in MS clinic at King Fahd Hospital of the University, Al Khobar. The investigators will investigate the effectiveness of TTNS compared to sham TTNS on bladder storage symptoms and the effect on quality of life using ICIQ-OAB, ICIQ 3-day bladder diary, ICIQ-LUTS qol, and PSQI. Participant's perception of change post intervention will be evaluated using GPE. Outcomes will be measured at 0, 6 weeks and at 6 months post intervention. A sample size of 72 patients (36 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05.
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Conclusion: Multiple sclerosis is a long-term condition, and self-management is important. TTNS provide a safe, non-invasive intervention that can be administered at home. Should the trial determine that TTNS is effective compared to sham TTNS, the investigators will plan to integrate TTNS into standard clinical care pathways in MS. conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, sham-controlled, double blind study with 1:1 allocation ratio. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and those who undertake data input and data analysis will be blind to group allocation to reduce the risk of performance bias. A principal investigator and co-investigator will insert data into SPSS so that the researchers can analyse data without having access to the allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Active Transcutaneous Electrical Nerve Stimulation (TENS) name: Sham Transcutaneous Electrical Nerve Stimulation (TENS) measure: The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB) measure: 3- day Bladder diary measure: Urinary sensation scale. measure: The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol) measure: Pittsburgh Sleep Quality Index (PSQI)-item 6 measure: Global Perceived Effect (GPE) Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Fahd Hospital of the University status: RECRUITING city: Khobar state: Eastern Providence country: Saudi Arabia name: Dr Hawra Al Dandan, PhD role: CONTACT phone: +966555901977 email: hdandan@iau.edu.sa name: Dr Saad Al Saadi, PhD role: CONTACT phone: +966552519515 email: ssaadi@iau.edu.sa lat: 26.27944 lon: 50.20833 hasResults: False
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<|newrecord|> nctId: NCT06341660 id: CROC202313 briefTitle: To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) overallStatus: RECRUITING date: 2023-05-25 date: 2025-06 date: 2025-07 date: 2024-04-02 date: 2024-04-02 name: Guangzhou Institute of Respiratory Disease class: OTHER briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: cadonilimab measure: Safety assessments and ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangdong state: Guangzhou zip: 510000 country: China name: zhou chegnzhi, doctor role: CONTACT phone: 13560351186 email: doctorzcz@163.com hasResults: False
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<|newrecord|> nctId: NCT06341647 id: AB-201-01 id: 103300 (HREC 233/23) type: OTHER domain: TGA (Australia) briefTitle: Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-04 date: 2029-02 date: 2024-04-02 date: 2024-04-02 name: GC Cell Corporation class: INDUSTRY briefSummary: This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. conditions: Breast Cancer conditions: Gastric Cancer conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: * Safety: incidence and severity of AE and SAE \[Time Frame: From the time of consent through End of Study (up to 18 months per patient)\]
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* Determination of Recommended Phase 2 Dose (RP2D) primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: AB-201 name: Cyclophosphamide name: Fludarabine measure: Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability] measure: Determination of Recommended Phase 2 Dose (RP2D) measure: To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3000 country: Australia name: Michael Michael role: CONTACT phone: +6138559-5000 email: Michael.Michael@petermac.org lat: -37.814 lon: 144.96332 facility: The Alfred Hosptial city: Melbourne state: Victoria zip: 3004 country: Australia name: Mark Voskoboynik role: CONTACT phone: +613-9076-3129 email: m.voskoboynik@alfred.org.au lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06341634 id: VISIA id: TED2021-130747B-C22 type: OTHER_GRANT domain: European Union id: 3494130747-130747-28-521 type: OTHER domain: Ministry of Science and Innovation briefTitle: Surveillance of Suicide Ideation in Adolescents (VISIA) acronym: VISIA overallStatus: ENROLLING_BY_INVITATION date: 2024-02-06 date: 2024-11-24 date: 2024-11-24 date: 2024-04-02 date: 2024-04-02 name: Servicio Gallego de Salud class: OTHER_GOV name: University of Vigo name: Complejo Hospitalario Universitario de Vigo name: Complexo Hospitalario de Ourense name: Fundacin Biomedica Galicia Sur briefSummary: The goal of this observational study is to validate an AI algorithm's capability to differentiate the population with suicidal ideation from a control population using various multimodal variables, including voice analysis, facial emotions, natural language, and proteomics data.
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The primary research question it aims to answer is:
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Is it possible to identify suicidal ideation and suicide risk in adolescents early and non-intrusively using multimodal data analysis through digital instruments equipped with artificial intelligence?
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Participants in this study will be asked to:
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Complete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation.
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Provide voice recordings, facial emotion data, and linguistic content in natural and specific contexts.
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Participate in salivary proteomics data collection.
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This study compares three distinct groups:
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Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.
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