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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: [email protected] name: Paige A McHenry, MS role: CONTACT phone: 845-938-2630 email: [email protected] 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: [email protected] 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: [email protected] name: Alessandra Greco, Cardiologist role: CONTACT phone: +390382501326 email: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Kersti Ejeby, MD, PhD role: CONTACT phone: 0704848104 phoneExt: +46 email: [email protected] 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: [email protected] name: Massimo Scacchi, Professor role: CONTACT email: [email protected] 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: [email protected] name: Dr Saad Al Saadi, PhD role: CONTACT phone: +966552519515 email: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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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