hackint0sh/New-Dataset huggingface dataset:
The study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA. conditions: Amyotrophic Lateral Sclerosis conditions: Alzheimer's Disease conditions: Lewy Body Dementia conditions: Frontotemporal Degeneration conditions: Cerebrovascular Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 280 type: ESTIMATED name: Telephone-based neuropsychological assessment - ALS name: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD name: Telephone-based and in-person cognitive screening - NIs measure: ALS Cognitive Behavioral Screen-Phone Version in ALS patients measure: Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients measure: Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients measure: Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients measure: Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients measure: Mini-Mental State Examination in NI measure: Montreal Cognitive Assessment in NI sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20149 country: Italy name: Barbara Poletti, Ph.D. role: CONTACT phone: +390261911 phoneExt: 2609 email: b.poletti@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06337565 id: GIS-DUMBO 2-2024 briefTitle: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2030-05-20 date: 2030-05-20 date: 2024-03-29 date: 2024-03-29 name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa class: OTHER briefSummary: This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment. conditions: Drusgs for IBD studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: To assess the safety of new drugs (non-anti-TNF biologics and targeted small molecules) used for IBD treatment both for pregnancy and in offspring, mainly focused on the risk of serious infections (from birth and in the first 4 years of life). measure: To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD. measure: To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life. measure: To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different new drugs to treat IBD with that of children who were not exposed to these agents. measure: To compare the prevalence of malformations in children exposed to new drugs to treat IBD in utero with that of children who were not exposed to these agents. measure: To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD. sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de La Princesa city: Madrid zip: 28006 country: Spain name: Javier P. Gisbert, PhD, MD role: CONTACT phone: 913093911 email: javier.p.gisbert@gmail.com name: María G Donday, PhD role: CONTACT phone: 913093911 email: mariagdonday@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False
nctId: NCT06337552 id: MCC-22709 briefTitle: High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) overallStatus: RECRUITING date: 2024-02-19 date: 2027-03 date: 2027-03 date: 2024-03-29 date: 2024-03-29 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER briefSummary: The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT). conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Clincial response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention. whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: FEED-FF name: Standard of Care (SUC) measure: Effects of the FEED-FF diet on clinical response to chemoradiation measure: Effects of FEED-FF diet on the gut microbiome measure: Effects of FEED-FF diet on local immune-related biomarkers measure: Effects of FEED-FF diet on quality of life measure: Efficacy of the FEED-FF intervention measure: Feasibility of the FEED-FF intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Stephanie Hogue role: CONTACT phone: 813-745-1891 email: Stephanie.Hogue@moffitt.org name: Doratha (Armen) Byrd, MPH, PhD role: PRINCIPAL_INVESTIGATOR name: Sylvia Crowder, PhD, RDN, LDN role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
nctId: NCT06337539 id: PI-23-185 briefTitle: Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants acronym: LYMPHODEP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-07-31 date: 2024-03-29 date: 2024-03-29 name: Germans Trias i Pujol Hospital class: OTHER briefSummary: Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs).
Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group.
Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model. conditions: Depression conditions: Inflammation conditions: Antidepressants conditions: Immunity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: SSRI measure: Treatment Response measure: Lymphocyte subpopulations measure: Biochemical variables measure: Single-cell CITEseq sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Germans Trias i Pujol city: Badalona state: Catalonia zip: 08916 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False
nctId: NCT06337526 id: IRB-71503 briefTitle: Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-03-29 date: 2024-04-10 name: Stanford University class: OTHER name: Medeloop.ai briefSummary: objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS. conditions: Complex Regional Pain Syndromes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Apple Watch v8 measure: Change from baseline in pain score sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Pediatric Pain Clinic city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False
nctId: NCT06337513 id: S-20230055 briefTitle: Spondyloarthritis Inception Cohort of Southern Denmark acronym: SPINCODE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: The Danish Center for Expertise in Rheumatology class: OTHER briefSummary: People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.
The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA. conditions: Axial Spondyloarthritis conditions: Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In the rehabilitation feasibility study: pre-post design. In the rehabilitation RCT, participants are allocated to either the intervention or control group with standard care. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Rehabilitation intervention name: Usual care measure: Clinicians diagnosis of axSpA measure: Health related quality of life measure: axSpA disease activity measure: axSpA disease mobility measure: axSpA patient-reported physical function measure: Inflammatory back pain (IBP) symptoms measure: Physical examination I measure: Physical examination II measure: Symptomatic SpA features I measure: Symptomatic SpA features II measure: Symptomatic SpA features III measure: Symptomatic SpA features IV measure: Symptomatic SpA features V measure: Symptomatic SpA features VI measure: Physicians global assessment of disease activity measure: Magnetic resonance imaging of sacroiliac joints (SIJ) and spine measure: low dose computed tomography of SIJ and spine measure: dual energy computed tomography of SIJ measure: radiography SIJ measure: Work measure: Fatigue measure: Physical activity measure: Sleep measure: Self-efficacy measure: Objective physical function measure: Aerobic capacity measure: Patient global assessment measure: Acceptable state measure: Mental state sex: ALL minimumAge: 18 Years maximumAge: 48 Years stdAges: ADULT hasResults: False
nctId: NCT06337500 id: 2023/764 briefTitle: Validation of a Making Decision Hybrid (Ecologic and Virtual) Task acronym: LABLife overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-01 date: 2025-06-01 date: 2024-03-29 date: 2024-03-29 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated. conditions: Healthy Volunteers conditions: Behavior and Behavior Mechanisms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Neurophysiological measure (EEG) name: Survey measure: Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06337487 id: 2022/716 briefTitle: Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients acronym: SOS-DETEQT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-08 date: 2024-03-29 date: 2024-03-29 name: Centre Hospitalier Universitaire de Besancon class: OTHER name: Direction Générale de l'Offre de Soins briefSummary: The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire \[QLQ\] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows:
During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS. conditions: Oncology studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients, nurses and health professionals and professionals assimilated to the health are recruited in 3 different groups but no comparison will be made between them. Recruitment of patients will be stopped once 79 analyzable patients will be enrolled. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 93 type: ESTIMATED name: QoL questionnaires name: Qualitative Interview (for one part of nurses only) name: ORIC questionnaire name: Professionals satisfaction survey name: Patients satisfaction survey measure: Change between pre and post QoL Questionnaires measure: The nurse's assessement of the relevance of the information provided by each patients's QoL scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Besançon city: Besançon zip: 25000 country: France name: Magalie Pagnot, Nurse role: CONTACT email: m1courgey@chu-besancon.fr lat: 47.24878 lon: 6.01815 facility: Groupement Hospitalier de Haute-Saône city: Vesoul country: France name: Cathy Pothier, Nurse role: CONTACT lat: 47.63333 lon: 6.16667 hasResults: False
nctId: NCT06337474 id: [2023]YLJSA089 briefTitle: An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-03-30 date: 2024-03-29 date: 2024-03-29 name: Changzhou No.2 People's Hospital class: OTHER name: Rui Therapeutics Co., Ltd briefSummary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\^9 cells, 13.5×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia. conditions: Thrombocytopenia Alloimmune studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: anti-CD19 CAR NK cells (KN5501) measure: Incidence of Dose Limiting Toxicity (DLTs) measure: Treatment Emergent Adverse Events (TEAEs) measure: Objective Response Rate of subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06337461 id: CCM1930 briefTitle: Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography acronym: CONCERTO overallStatus: RECRUITING date: 2023-05-22 date: 2025-05-30 date: 2025-05-30 date: 2024-03-29 date: 2024-03-29 name: Centro Cardiologico Monzino class: OTHER name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari name: Politecnico di Milano briefSummary: Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).
On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques. conditions: Chronic Coronary Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED measure: Development of a computational model to predict MBF avoiding CT stress protocol measure: Improvement of CAD risk assesment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20131 country: Italy name: Chiara Centenaro role: CONTACT phone: 0258002031 phoneExt: +39 email: chiara.centenaro@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06337435 id: 8223 briefTitle: Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding overallStatus: COMPLETED date: 2022-12-15 date: 2023-07-10 date: 2024-01-18 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding conditions: Crowding of Anterior Mandibular Teeth studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 12 type: ACTUAL name: multi-looped wire measure: The improvement of lower incisors irregularity using Little Irregularity Index. measure: The stability of lower incisor positioning after ending treatment sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: faculty of dentistry Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False