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4. Healthy control group primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: PreKUnil® LNAA Medical Food for PKU measure: Dynamic positron emission tomography (PET) imaging with the fluorine-18-labeled tracer [18F]-(E)-N-(3-iodoprop-2-enyl)-2β-carbofluoroethoxy-3β-(4'-methyl phenyl)nortropane ([18F]FE-PE2I) measure: Computerized neuropsychological testing (responses over study iPad) measure: Behaviour Rating Inventory of Executive Function - Adult version (BRIEF-A) measure: Behaviour Rating Inventory of Executive Function - Second edition (BRIEF-2) measure: Adult attention deficit hyperactivity disorder (ADHD) Self-Report Scale (ASRS v1.1) measure: Adolescent ADHD Self-Report Scale measure: PKU-QOL Questionnaire Adolescent or Adult version measure: Symptom Checklist-90-Revised (SCL-90-R) measure: Behavior Assessment System for Children, Third Edition (BASC-3) measure: Neuropsychological testing of flexibility and verbal fluency measure: Urine peripheral biomarkers of neurotransmitters measure: Incidence and severity of treatment-emergent adverse events (TEAEs) measure: Fasting plasma amino acids, dried blood spots (finger-prick method) measure: Brain perfusion measures measure: Adherence to dietary treatment measure: Brain Magnetic Resonance Imaging (MRI) measure: Wechsler Adult Intelligence Scale (WAIS) - IV sex: ALL minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen country: Denmark name: Olivia Welle Fjellbirkeland, MD role: CONTACT email: olivia.welle.fjellbirkeland@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06337851 id: AtaturkTRH2003/9 briefTitle: Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma overallStatus: COMPLETED date: 2003-11 date: 2010-04 date: 2011-04 date: 2024-03-29 date: 2024-03-29 name: Ataturk Training and Research Hospital class: OTHER briefSummary: Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.
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In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.
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Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH
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Exclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery
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Randomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).
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Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.
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Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.
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Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.
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Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.
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Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.
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In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.
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This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery. conditions: Subdural Hematoma, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 43 type: ACTUAL name: Simultaneous burr hole craniostomy name: Consecutive burr hole craniostomy measure: The Primary Outcome: Mortality measure: The Primary Outcome: Early Postoperative Success Rate (Redo Surgery) measure: The secondary outcome: Follow-up assessment (Age) measure: The secondary outcome: Follow-up assessment (Sex) measure: The secondary outcome: Follow-up assessment (Trauma-Relation) measure: The secondary outcome: Follow-up assessment (Concomitant Pathologies) measure: The secondary outcome: Follow-up assessment (The Glasgow Coma Scale) measure: The secondary outcome: Follow-up assessment (The Markwalder Grading Scale) measure: The secondary outcome: Follow-up assessment (Neurological Examination - Motor) measure: The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi) measure: The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign) measure: The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift) measure: The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Ataturk Training and Research Hospital city: Izmir zip: 35360 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06337838 id: 2024.BRACKETS-Pilot briefTitle: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial acronym: BRACKETS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-03-29 date: 2024-03-29 name: Population Health Research Institute class: OTHER briefSummary: The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo. conditions: Chronic Kidney Diseases conditions: Acute Kidney Injury conditions: Bleeding conditions: Surgery studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Study drugs will be sourced locally and will be prepared by appropriately qualified center personnel who are independent of the study team to ensure blinding is maintained. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Desmopressin Injectable Solution name: Tranexamic Acid Injectable Product name: Placebo measure: Rate of recruitment measure: Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial measure: Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial measure: Completion of 30-day follow-up measure: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS) measure: Reoperation for reasons of bleeding measure: Blood (red blood cells or whole blood) transfused measure: Blood (red blood cells or whole blood) transfused measure: Any blood transfusion (red blood cells or whole blood) measure: Any blood transfusion (red blood cells or whole blood) measure: Lowest measured hemoglobin concentration measure: Most recent hemoglobin concentration measure: Death measure: Major arterial and venous thrombosis measure: Myocardial Injury after Noncardiac Surgery (MINS) measure: Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction measure: MINS that is an isolated ischemic troponin elevation measure: Stroke measure: Non-hemorrhagic stroke measure: Hemorrhagic stroke measure: Peripheral arterial thrombosis measure: Thrombosis of arteriovenous fistula or graft measure: Symptomatic proximal venous thromboembolism measure: Symptomatic pulmonary embolism measure: Symptomatic proximal leg or arm deep venous thrombosis (DVT) measure: Non-fatal cardiac arrest measure: Coronary revascularization procedure measure: Clinically important atrial fibrillation or flutter measure: Acute heart failure measure: Acute kidney injury (for patients not receiving dialysis before surgery) measure: New start of dialysis measure: Seizure measure: Clinically significant intraoperative hypotension measure: Clinically significant postoperative hypotension measure: Sepsis measure: Duration of surgery measure: Receipt of platelets measure: Receipt of fibrinogen measure: Receipt of fresh frozen plasma measure: Receipt of cryoprecipitate measure: Receipt of recombinant Factor VIIa measure: Receipt of prothrombin complex concentrate measure: Prescribed erythropoiesis stimulating agent measure: Severe hyponatremia measure: Duration of hospital stay after surgery measure: Duration of critical care stay after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06337825 id: 22-727 briefTitle: Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-19 date: 2024-03-12 date: 2024-06-29 date: 2024-03-29 date: 2024-04-15 name: The Cleveland Clinic class: OTHER briefSummary: Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated. conditions: Primary Hyperparathyroidism conditions: Multinodular Goiter studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Activity Tracker (Fitbit) name: HbA1C name: The PROMPT Questionnaire measure: Change in resting heart rate over time among study participants as monitored by fitness tracker measure: Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker measure: Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker measure: Change in steps over time among study participants as monitored by fitness tracker measure: Change in total active minutes over time among study participants as monitored by fitness tracker measure: Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker measure: Change in glucose levels (HbA1C) measure: Correlation of Quality of Life surveys with the PROMPT survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06337812 id: HUM00240473 briefTitle: Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2025-06 date: 2024-03-29 date: 2024-03-29 name: University of Michigan class: OTHER briefSummary: The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health. conditions: Type2diabetes conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: Potato Starch measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma measure: Changes in propionate levels - stool measure: Changes in propionate levels- plasma measure: Changes in acetate levels- stool measure: Changes in acetate levels- plasma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Hayley Billingsley, PhD role: CONTACT phone: 734-726-0308 email: hbilings@med.umich.edu name: Scott Hummel, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06337799 id: 202210411 briefTitle: Use of Allied-health Professionals to Improve Treatment of Disease overallStatus: NOT_YET_RECRUITING date: 2026-10 date: 2030-03 date: 2030-03 date: 2024-03-29 date: 2024-03-29 name: University of Iowa class: OTHER briefSummary: The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.
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Participants will:
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Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months. conditions: Preeclampsia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Research Pharmacist measure: Number of Subjects at Risk for Hypertension measure: Number of Subjects Exposed to a Screening Clinic measure: Number of Subjects Screened at a Screening Clinic measure: Number of Subjects Followed-Up by the Research Pharmacist measure: Number of Subjects Diagnosed with Hypertension measure: Number of Subjects Treated for Hypertension, if Diagnosed sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06337786 id: MSK-2023-TSJ1 briefTitle: Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-29 date: 2024-04-05 name: Henning Bliddal class: OTHER name: Eurostars name: DAMAN name: Medical University of Vienna briefSummary: Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability.
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There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease.
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The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual.
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The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial is an open-label matched register controlled clinical trial with two parallel groups (intervention and matched controls from the DANBIO register).
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The number of study participants is 40 in the intervention arm and up to 120 in the matched control arm. primaryPurpose: OTHER masking: NONE count: 160 type: ESTIMATED name: Digital app RB4.1 name: Control arm measure: Primary Outcome measure: Disease-activity Score28 using C-reactive protein (DAS28-CRP) measure: Self-Efficacy measure: Pain and Fatigue measure: Health related quality of life measure: Physical function/activity measure: Well-Being measure: Medication Adherence measure: Better alignment between patient and health care professionals sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital city: Frederiksberg state: Copenhagen F zip: 2000 country: Denmark name: Tanja Schjødt Jørgensen role: CONTACT phone: +4538164173 email: tanja.schjoedt.joergensen@regionh.dk name: Lars Erik Kristensen role: CONTACT phone: +4538164157 email: lars.erik.kristensen@regionh.dk lat: 55.67938 lon: 12.53463 hasResults: False
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<|newrecord|> nctId: NCT06337773 id: B-BR-112-036 briefTitle: Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2026-12-25 date: 2024-03-29 date: 2024-03-29 name: Fooyin University class: OTHER briefSummary: This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: 8-weeks's on-line precision nursing education program measure: The depression symptoms on young colorectal cancer survivors measure: Dispositional mindfulness status on young colorectal cancer survivors measure: General quality of life on young colorectal cancer survivors measure: Colorectal specific quality of life on young colorectal cancer survivors measure: Cancer threat appraisal on young colorectal cancer survivors sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06337760 id: IEO 1669 briefTitle: YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. acronym: YOUNGSTER overallStatus: RECRUITING date: 2023-03-10 date: 2026-12-31 date: 2027-06-30 date: 2024-03-29 date: 2024-03-29 name: European Institute of Oncology class: OTHER briefSummary: The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available. conditions: Neuroendocrine Neoplasm conditions: Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 90 type: ESTIMATED measure: Numbers of partecipants with genetic alterations measure: Number of partecipants with survival outcomes measure: Number of partecipants toxicities sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Lorenzo Gervaso, MD role: CONTACT name: Chiara Alessandra Cella, MD role: SUB_INVESTIGATOR name: Luca Mazzarella, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06337747 id: 04-2023-PLLA briefTitle: Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline overallStatus: RECRUITING date: 2023-05-19 date: 2024-04-30 date: 2024-06 date: 2024-03-29 date: 2024-03-29 name: Erevna Innovations Inc. class: OTHER briefSummary: The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A prospective, randomized-controlled trial primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Traditional technique name: Experimental technique measure: To access the efficacy of the tradition and experimental technique measure: To access the safety of the tradition and experimental technique sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc status: RECRUITING city: Montreal state: Quebec zip: H3R 3A1 country: Canada name: Andreas Nikolis, MD role: CONTACT phone: 514-488-0163 email: research@vicpark.com lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06337734 id: 2 briefTitle: An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension overallStatus: COMPLETED date: 2021-11-01 date: 2023-08-01 date: 2023-08-01 date: 2024-03-29 date: 2024-04-01 name: University of California, San Diego class: OTHER briefSummary: This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 141 type: ACTUAL name: AI-Driven Lifestyle Coaching Program measure: Average change in systolic blood pressure (SBP) from baseline to 12 weeks measure: Average change in diastolic blood pressure (DBP) from baseline to 12 weeks measure: Average change in SBP from baseline to 24 weeks measure: Average change in DBP from baseline to 24 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks measure: Average weekly percentage of active participants measuring their BP measure: Average weekly percentage of active participants syncing their wearable measure: Average weekly percentage of active participants answering the mobile app questionnaire measure: Number of manual clinician outreaches based on the escalation rules set for the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego city: La Jolla state: California zip: 92093 country: United States lat: 32.84727 lon: -117.2742 hasResults: False
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<|newrecord|> nctId: NCT06337721 id: R01AA030786 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA030786 briefTitle: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-05 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: University of California, Riverside class: OTHER briefSummary: This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT). conditions: Alcohol Use Disorder conditions: Alcohol; Harmful Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group. primaryPurpose: PREVENTION masking: NONE count: 240 type: ESTIMATED name: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) measure: Heavy Episodic Drinking (HED) Days measure: Alcohol Consumption sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: UC Riverside city: Riverside state: California zip: 91784 country: United States lat: 33.95335 lon: -117.39616 hasResults: False
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<|newrecord|> nctId: NCT06337708 id: STUDY00017286 id: R01HL168170 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168170 briefTitle: Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women overallStatus: RECRUITING date: 2024-01-19 date: 2027-03-31 date: 2028-03-31 date: 2024-03-29 date: 2024-03-29 name: Arizona State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women. conditions: Physical Activity conditions: Exercise conditions: Heart Diseases conditions: Diabetes Mellitus conditions: Physical Inactivity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Smart Walk name: Fitbit measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months measure: Change in cardiorespiratory fitness from baseline to 4- and 12-months measure: Change in aortic pulse wave velocity from baseline to 4- and 12-months measure: Change in body weight from baseline to 4- and 12-months. measure: Change in body mass index from baseline to 4- and 12-months measure: Change in waste circumference from baseline to 4- and 12-months measure: Change in blood pressure (mmHG) from baseline to 4- and 12-months measure: Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months measure: Change in interleukin 6 (IL-6) from baseline to 4- and 12-months measure: Change in interleukin 10 (IL-10) from baseline to 4- and 12-months measure: Change in interleukin 15 (IL-15) from baseline to 4- and 12-months measure: Change in fasting blood glucose glucose from baseline to 4- and 12-months measure: Change in serum insulin from baseline to 4- and 12-months measure: Change in serum lipids (mg/DL) from baseline to 4- and 12-months measure: Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months measure: Change in exercise self-efficacy from baseline to 4- and 12-months measure: Change in self-regulation for physical activity from baseline to 4- and 12-months measure: Change in social support for physical activity from baseline to 4- and 12-months measure: Change in outcome expectations for physical activity from baseline to 4- and 12-months measure: Change in behavioral capability for physical activity from baseline to 4- and 12-months measure: Treatment acceptance measure: Protocol Adherence measure: Program costs measure: Participant costs measure: Cost-effectiveness measure: Objectively-measured home neighborhood characteristics measure: Subjectively-measured Neighborhood environment walkability measure: Race-related Stress measure: Perceived Structural Racism sex: FEMALE minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona State University status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Carina Platte, PhD role: CONTACT phone: 602-543-2213 email: carina.platte@asu.edu name: Rodney Joseph, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 hasResults: False
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<|newrecord|> nctId: NCT06337695 id: HREBA.CC-23-0271 briefTitle: VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-11-01 date: 2026-12-01 date: 2024-03-29 date: 2024-04-02 name: University of Calgary class: OTHER briefSummary: The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy conditions: Cancer conditions: Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Double-Blinded, Placebo Controlled Trial primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 298 type: ESTIMATED name: Vedolizumab name: Placebo measure: Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months measure: Proportion of patients with histologically confirmed colitis-free survival at 6 months measure: Proportion of patients with severe diarrhea or colitis at 6 months measure: Hazard Ratio of patients with diarrhea or colitis after 6 months measure: Total average dose of checkpoint inhibitor therapy received within 6 and 12 months measure: Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs) measure: Proportion of participants who require permanent ICI discontinuation due to irAEs measure: Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis measure: Total average prednisone equivalent dose of rescue corticosteroids required measure: Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365 measure: Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365 measure: Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline measure: Overall survival (measured as death) at +180 and Day +365 compared to baseline measure: Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176 measure: Proportion of participants experiencing any adverse events (AEs) measure: Proportion of participants experiencing serious AEs measure: Proportion of participants experiencing other irAEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06337682 id: CB_CY_P09_23_11 briefTitle: Blood Pressure Management in the Care Home Population acronym: BPITCH overallStatus: ACTIVE_NOT_RECRUITING date: 2016-01 date: 2020-01 date: 2024-06 date: 2024-03-29 date: 2024-03-29 name: University of Leeds class: OTHER name: Bradford Teaching Hospitals NHS Foundation Trust briefSummary: The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents. conditions: Aging conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Frequency of blood pressure measurements measure: change in antihypertensive medication measure: Injurious falls measure: Prevalence of hypertension measure: Antihypertensive medication measure: Blood pressure treatment measure: change in systolic pressure following care home admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Academic Unit for Ageing and Stroke Research city: Bradford state: West Yorkshire zip: BD9 6RJ country: United Kingdom lat: 53.79391 lon: -1.75206 hasResults: False
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<|newrecord|> nctId: NCT06337669 id: OSRSCP-GUP21006 briefTitle: Characterization of DupEx2 Duchenne Muscular Dystrophy acronym: DMDDup2 overallStatus: RECRUITING date: 2022-01-31 date: 2025-01-31 date: 2025-01-31 date: 2024-03-29 date: 2024-03-29 name: IRCCS San Raffaele class: OTHER briefSummary: To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.
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Background/Rationale DMD is caused by mutations in the DMD gene and in 11% of cases is due to duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the "average" DMD population. It is thus mandatory to have more information on genotype-phenotype correlations and patterns of progression related to different genotypes.
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Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.
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Research design and methods Clinical information regarding a cohort of 26 Italian Dup2 patients will be collected. Differences in time to loss of ambulation compared to a DMD control group will be achieved. Finally, we will retrieve DNA for correlative WGS studies.
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Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies. conditions: Muscular Dystrophy, Duchenne studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 26 type: ESTIMATED measure: Age at loss of ambulation measure: Time test for motor function measure: Respiratory function sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Neurology, IRCCS Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Stefano C Previtali, MD role: CONTACT phone: 00390226433036 email: neuromuscolare@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06337656 id: VITAL_0 briefTitle: Vibration Training Approach in Liver Cirrhosis acronym: VITAL overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-29 date: 2024-04-01 name: University Hospital of Cologne class: OTHER briefSummary: * Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia
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* Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Galileo WBV measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle mass measure: Evaluation of the Effectiveness on muscle thickness measure: Evaluation of the Effectiveness on mobility, in particular the risk of falling measure: Evaluation of the Effectiveness on physical function measure: Evaluation of Safety of the Training Method measure: Health-Related Quality of Life measure: Health-Related Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06337643 id: MVX01-01 briefTitle: A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-07 date: 2024-04-16 date: 2024-04-16 date: 2024-03-29 date: 2024-03-29 name: Matrivax Research and Development Corporation class: INDUSTRY briefSummary: The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels. conditions: Pneumococcal Vaccine studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Cohort 1 is open-label. Cohorts 2-5 include two open-label sentinel participants each and the remainder of the participants are randomized and double-blind to either MVX01 or MVX01 Placebo (Participant \& Site). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 75 type: ESTIMATED name: MVX01 name: MVX01 Placebo measure: Incidence of immediate reactogenicity adverse events measure: Incidence of solicited reactogenicity events measure: Incidence of adverse events (AEs) measure: Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI) measure: Changes in safety laboratory results compared to baseline measure: Changes in vital signs compared to baseline measure: Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity (Meridian) Clinical Research city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Alliance for Multispecialty Research (AMR) city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 hasResults: False
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<|newrecord|> nctId: NCT06337630 id: IC 2022-10 briefTitle: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors acronym: POP-ART overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-06-15 date: 2029-02-15 date: 2024-03-29 date: 2024-03-29 name: Institut Curie class: OTHER name: ProLynx LLC name: Merck Sharp & Dohme LLC briefSummary: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: PLX038 + Tuvusertib measure: Dose escalation step : Dose limiting toxicities (DLTs) measure: Expansion cohorts : Best tumor response measure: Expansion cohorts : Serious Adverse Events (SAEs) measure: Expansion cohorts : Adverse Events (AEs) measure: Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Dose escalation step : objective response rate (ORR) measure: Dose escalation step : Time to response (TTR) measure: Dose escalation step : Duration of Response (DoR) measure: Dose escalation step : Progression free survival (PFS) measure: Expansion cohorts : Time to response (TTR) measure: Expansion cohorts : Duration of Response (DoR) measure: Expansion cohorts : Progression free survival (PFS) measure: Expansion cohorts : Overall Survival (OS) measure: Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups measure: Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Exploratory endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Curie city: Paris zip: 75005 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Institut Curie city: Saint-Cloud zip: 92210 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.84598 lon: 2.20289 hasResults: False
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<|newrecord|> nctId: NCT06337617 id: CDRB436B2407 briefTitle: A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma overallStatus: COMPLETED date: 2022-05-10 date: 2023-06-29 date: 2023-06-29 date: 2024-03-29 date: 2024-03-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record. conditions: BRAF V600 Mutation Positive Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 90 type: ACTUAL measure: Real-world overall response rate (rwORR) measure: Mean Age measure: Percentage of patients per sex measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis measure: Number and percentage of patients per anatomic sites of origin measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis measure: Number and percentage of patients per tumor stage measure: Number and percentage of patients with occurrence of tumor metastasis measure: Number and percentage of patients per metastatic location measure: Number and percentage of patients per metastases measure: Lactate dehydrogenase (LDH) levels measure: Eastern Cooperative Oncology Group (ECOG) performance status measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment measure: Number and percentage of patients per type of surgery measure: Number and percentage of patients per name of surgery measure: Number and percentage of patients per surgical and medical procedure measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting measure: Number and percentage of patients per radiation site measure: Mean total dosage for all radiotherapy measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting measure: Number and percentage of patients per type of D+T treatment change measure: Number and percentage of patients per reason for D+T treatment change measure: Mean duration of D+T, if not ongoing to end of study follow-up measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS) measure: Real-world disease control rate (rwDCR) of D+T (FAS) measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS) measure: Real-world overall survival (rwOS) since D+T initiation (FAS) measure: Time to treatment discontinuation (FAS) measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS) measure: Number and percentage of patients with serious adverse events (SAEs) (FAS) measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use measure: rwOS since D+T initiation (MMS), by immunotherapy use measure: rwOS since D+T initiation (NMS), by immunotherapy use measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication measure: Number and percentage of patients per concomitant medication measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS) measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Shanghai zip: 201203 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06337604 id: TNP-2092-04 briefTitle: The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets overallStatus: COMPLETED date: 2017-10-10 date: 2017-11-23 date: 2017-11-23 date: 2024-03-29 date: 2024-04-01 name: TenNor Therapeutics Inc. class: INDUSTRY briefSummary: A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: TNP-2092 capsules name: TNP-2092 capsules placebo name: Rabeprazole sodium enteric-coated tablets measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t) measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092 measure: Percentage of Participants With Adverse Events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
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<|newrecord|> nctId: NCT06337591 id: INRCA_003_2024 briefTitle: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location acronym: VI-RADS overallStatus: COMPLETED date: 2022-10-15 date: 2024-03-10 date: 2024-03-10 date: 2024-03-29 date: 2024-03-29 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER briefSummary: VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: VI-RADS measure: Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: IRCCS INRCA Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: Carlo Urbani Hospital city: Jesi country: Italy lat: 43.52142 lon: 13.24368 hasResults: False
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<|newrecord|> nctId: NCT06337578 id: 23C308 briefTitle: Advances in Telephone-based Cognitive Screening Procedures acronym: TBCS overallStatus: RECRUITING date: 2023-10-25 date: 2026-10-25 date: 2026-10-25 date: 2024-03-29 date: 2024-03-29 name: Istituto Auxologico Italiano class: OTHER briefSummary: 1. Background
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Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture).
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The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.
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2. Aims
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The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.
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3. Methods
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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
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<|newrecord|> 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
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<|newrecord|> 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
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<|newrecord|> 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).
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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.
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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
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<|newrecord|> 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
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<|newrecord|> 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.
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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
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<|newrecord|> 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
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<|newrecord|> 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:
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* Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained
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* The nurse's assessment of the relevance of the information provided by the QOL scores.
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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
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<|newrecord|> 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
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<|newrecord|> 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).
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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
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<|newrecord|> nctId: NCT06337448 id: 74090923.9.0000.5544 briefTitle: Light Emitting Diode in the Treatment of Vulvodynia overallStatus: RECRUITING date: 2024-01-16 date: 2026-01 date: 2026-12 date: 2024-03-29 date: 2024-03-29 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "What is your perception of improvement" and "What is your level of satisfaction with the treatment?". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends. conditions: Vulvodynia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Blue LED measure: Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale. measure: Tolerability of participants to the treatment assessed by Likert Scale. measure: Evaluate the clinical response assessed by the Visual Analogue Scale. measure: Evaluate the clinical response assessed by a questionnaire. measure: Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI). measure: Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV). sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao assoalho pélvico status: RECRUITING city: Salvador state: Bahia zip: 40290000 country: Brazil name: Patricia Lordelo, post doc role: CONTACT phone: +5571988592400 email: pvslordelo@hotmail.com lat: -12.97111 lon: -38.51083 hasResults: False
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<|newrecord|> 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
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<|newrecord|> nctId: NCT06337422 id: BE21-023 briefTitle: Bioequivalence Study of Generic Celecoxib 200 mg Capsules overallStatus: NOT_YET_RECRUITING date: 2024-09-23 date: 2024-09-27 date: 2024-10-04 date: 2024-03-29 date: 2024-04-02 name: International Bio service class: NETWORK briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Celecoxib 200 mg capsule measure: Bioequivalence based on Cmax period measure: Bioequivalence based on AUC parameters sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06337409 id: BE24-004 briefTitle: Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-07-05 date: 2024-07-13 date: 2024-03-29 date: 2024-04-02 name: International Bio service class: NETWORK briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Generic empagliflozin 25 mg film-coated tablets measure: Bioequivalence based on Cmax period measure: Bioequivalence based on AUC parameters sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06337396 id: 1001 briefTitle: Omic Approaches to Neurodevelopmental Disabilities overallStatus: COMPLETED date: 2021-05-05 date: 2023-07-28 date: 2023-12-31 date: 2024-03-29 date: 2024-03-29 name: IRCCS Eugenio Medea class: OTHER briefSummary: to bridge the gap between the molecular structure of CNV and the effect on the phenotype, considering NDDs as complex diseases, as they are a consequence of the imbalance in several dosage-sensitive genes, we might try to approach them through different --omics investigations (genomics, epigenomics, transcriptomics) according to the emerging field of network medicine. This holistic can provide valuable insight into understanding peculiar molecular mechanisms and unsuspected molecular interactions that contribute to the pathogenesis of the condition and possibly pave the way for uncovering new drug strategies that even if they do not heal the patient may improve his performance and the social interaction conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 22 type: ACTUAL name: WGS and transcriptome analysis measure: Number of likely pathogenic structural variants measure: Number of patients for whom a genotype-phenotype correlation is found sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Scientific Institute IRCCS Eugenio Medea city: Bosisio Parini state: LC zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False
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<|newrecord|> nctId: NCT06337383 id: 12.2021 ANGELMAN briefTitle: Study of the Prevalence of Autistic Traits in Angelman Syndrome overallStatus: RECRUITING date: 2022-03-15 date: 2024-06 date: 2024-06 date: 2024-03-29 date: 2024-04-18 name: IRCCS Eugenio Medea class: OTHER briefSummary: The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:
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* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.
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* which clinical variables differentiate parenting styles and levels of perceived stress.
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Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development ("Bayely Scales of Infant Development-III", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder ("Autism Diagnostic Observational Schedule-2"); parental stress and parenting styles; social-communicative skills; motor development. conditions: Angelman Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 46 type: ESTIMATED measure: Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1, measure: Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III) measure: Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire measure: Global score at the Aberrant Behaviour Checklist (ABC) measure: Total Raw score at the Social Communication Questionnaire - Current version(SCQ) sex: ALL minimumAge: 4 Years maximumAge: 14 Years stdAges: CHILD facility: I.R.C.C.S. "E.Medea" status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Martina Baggio role: CONTACT phone: +39 340 802 1282 email: martina.baggio@lanostrafamiglia.it lat: 45.88805 lon: 12.30201 hasResults: False
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<|newrecord|> nctId: NCT06337370 id: 61284 briefTitle: Self-management Nursing Intervention for Women With Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-10 date: 2024-09-10 date: 2024-03-29 date: 2024-03-29 name: Universidad Nacional de Colombia class: OTHER briefSummary: Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the QOLRA-II; self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care. conditions: Arthritis, Rheumatoid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CDSMP is a group-based chronic disease self-management education intervention comprised of 2.5-hour sessions, including time for a break and snack. The maximum number of participants per session ranges from 12 to 16. In total the program consists of 6 sessions that take place once a week for a total duration of 6 weeks. The development of each of the sessions is standardized and scripted; two group leaders previously trained by a Master Trainer, who in turn was trained to train leaders with Stanford University, guide the sessions. In the case of the present study, the main researcher and a nursing professional with experience in health education will receive the training from a Master Trainer of the program. Participants receive the book "Taking Control of Your Health" at the beginning of the program. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 55 type: ESTIMATED name: Chronic Disease Self Management Program name: Conventional Care Group measure: Self-management behaviors measure: Perceived Self-efficacy, measure: Health-related quality of life sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Santa Fe de Bogotá city: Bogotá country: Colombia name: Klaus Mieth Alviar, Dr. role: CONTACT phone: 601 6030303 phoneExt: 5402 email: comiteinvestigativo@fsfb.org.co lat: 4.60971 lon: -74.08175 hasResults: False
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<|newrecord|> nctId: NCT06337357 id: NatGerHos-Sarcopenia briefTitle: Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-03-29 date: 2024-04-12 name: National Geriatric Hospital class: OTHER_GOV briefSummary: A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks. conditions: Sarcopenia conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Progressive Resistance Training measure: Physical performance 1 - Handgrip strength measure: Physical performance 2 - Gait speed measure: Physical performance 3 - Short Physical Performance Battery (SPPB) measure: Muscle mass measure: Nutritional status measure: Health-related Quality of Life measure: Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Geriatric Hospital city: Hanoi zip: 100000 country: Vietnam name: Huyen TT Vu, PhD role: CONTACT phone: +84913531579 email: vuthanhhuyen11@yahoo.com lat: 21.0245 lon: 105.84117 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-23 uploadDate: 2024-03-22T11:34 filename: ICF_000.pdf size: 212556 hasResults: False
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<|newrecord|> nctId: NCT06337344 id: HSEARS20230213007 briefTitle: Neurophysiological Effects of Mind-body Exercise in Healthy Adults overallStatus: RECRUITING date: 2024-02-01 date: 2024-04 date: 2024-04 date: 2024-03-29 date: 2024-03-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Baduanjin name: Exercise name: Video Viewing measure: Change in cognitive function as assessed by verbal fluency task (VFT) measure: Hemodynamic changes as assessed by fNIRS sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 2766 7578 lat: 22.30715 lon: 114.18532 hasResults: False
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<|newrecord|> nctId: NCT06337331 id: NSH 1401 briefTitle: Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-08-31 date: 2027-08-31 date: 2024-03-29 date: 2024-04-02 name: Northside Hospital, Inc. class: OTHER briefSummary: Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter. conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Venetoclax name: Decitabine name: Fludarabine name: Busulfan name: Total Body Irradiation measure: Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant measure: Number of patients alive at one-year post transplant measure: Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures measure: Number of patients who died one year post-transplant not related to recurrence of disease measure: Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant measure: Number of patients who developed acute graft-versus-host disease by recording signs and symptoms of acute GVHD according to MAGIC standards at one-year post-transplant measure: Number of patients who developed chronic graft-versus-host disease by recording signs and symptoms of chronic GVHD according to NIH standards at one-year post-transplant measure: Number of patients who are alive at one-year post transplant who also did not develop GVHD measure: Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Caitlin Guzowski city: Atlanta state: Georgia zip: 30342 country: United States lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06337318 id: NCI-2024-02361 id: NCI-2024-02361 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: S2308 type: OTHER domain: SWOG id: S2308 type: OTHER domain: CTEP id: U10CA180888 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180888 briefTitle: Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2032-03-31 date: 2032-03-31 date: 2024-03-29 date: 2024-04-05 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden. conditions: Classic Follicular Lymphoma conditions: Follicular Lymphoma With Unusual Cytological Features studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Mosunetuzumab name: Positron Emission Tomography name: Rituximab name: Rituximab and Hyaluronidase Human measure: 3-year milestone progression free survival (PFS) measure: PFS measure: Overall survival measure: Overall response rate measure: Event free survival (EFS) measure: Incidence of adverse events measure: Restricted chance of longer PFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06337305 id: STUDY00146138 briefTitle: Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer overallStatus: COMPLETED date: 2020-08-19 date: 2022-08-19 date: 2023-08-19 date: 2024-03-29 date: 2024-03-29 name: University of Kansas Medical Center class: OTHER briefSummary: This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ACTUAL measure: Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25). measure: Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys). measure: Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29. measure: Identification of clinical and demographic factors in bladder cancer patients measure: Demographics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 hasResults: False
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<|newrecord|> nctId: NCT06337292 id: IRB00440042 briefTitle: Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial acronym: iVAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-09-30 date: 2028-12-31 date: 2024-03-29 date: 2024-03-29 name: Major Extremity Trauma Research Consortium class: OTHER briefSummary: This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome. conditions: Fracture of Tibia conditions: Wound Heal conditions: Infected Wound conditions: Wound Complication conditions: Wound Dehiscence studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health. primaryPurpose: TREATMENT masking: NONE count: 352 type: ESTIMATED name: Incisional Negative Pressure Wound Therapy (NPWT) measure: Complication composite outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06337279 id: FMUUH-0322 briefTitle: Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk overallStatus: COMPLETED date: 2022-12-10 date: 2023-08-20 date: 2024-03-20 date: 2024-03-29 date: 2024-03-29 name: Fujian Medical University class: OTHER name: Fujian Medical University Union Hospital briefSummary: The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3820 type: ACTUAL measure: 5-year OS measure: 5-year DFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06337266 id: 2024KY246 briefTitle: A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-20 date: 2024-03-19 date: 2024-03-29 date: 2024-03-29 name: Fujian Medical University class: OTHER name: Fujian Medical University Union Hospital briefSummary: This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC). conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3622 type: ACTUAL measure: 5-year OS measure: 5-year DFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06337253 id: MOZ202401 briefTitle: Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-05-26 date: 2024-11-26 date: 2024-03-29 date: 2024-03-29 name: Malaria Consortium class: OTHER briefSummary: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.
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The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.
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These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region. conditions: Malaria,Falciparum conditions: Chemoprevention studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd.
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Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets. primaryPurpose: PREVENTION masking: NONE count: 1000 type: ESTIMATED name: Sulfadoxine/pyrimethamine plus amodiaquine measure: Chemoprevention failure measure: Uncomplicated malaria within 28 days sex: ALL minimumAge: 3 Months maximumAge: 59 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06337240 id: pelvic floor exercise briefTitle: Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease overallStatus: RECRUITING date: 2024-03-29 date: 2024-07-02 date: 2024-07-02 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients. conditions: Urinary Incontinence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pelvic floor on COPD patients name: Pilates exercises on COPD patients measure: Urinary incontinence (1 Hour and 24- Hour pad test) measure: Incontinence severity index: measure: Urinary incontinence quality of life questionnaire (I-QOL) measure: Cough symptoms score measure: Cough symptoms questionnaire measure: The COPD Assessment Tool (CAT) sex: FEMALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo country: Egypt name: Donia El masry, doctorate role: CONTACT phone: 01005587119 email: donia.elmasry@cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06337227 id: 2/22 briefTitle: Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis overallStatus: RECRUITING date: 2023-10-19 date: 2024-10 date: 2026-10 date: 2024-03-29 date: 2024-04-02 name: IRCCS SYNLAB SDN class: OTHER name: Federico II University briefSummary: The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells. conditions: Atherosclerosis and Calcific Aortic Stenosis With and Without Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3 type: ESTIMATED name: lncRNA signature analyses measure: To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis measure: To evaluate the experimental results achieved in the clinical-diagnostic context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Synlab Sdn status: RECRUITING city: Naples zip: 80143 country: Italy name: Monica Franzese, PhD role: CONTACT phone: +393334041413 email: direzionescientifica.irccssdn@synlab.it lat: 40.85216 lon: 14.26811 hasResults: False
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<|newrecord|> nctId: NCT06337214 id: TCHIRB-11301014-E briefTitle: TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy overallStatus: RECRUITING date: 2024-03-13 date: 2025-02-28 date: 2025-02-28 date: 2024-03-29 date: 2024-04-02 name: Taipei City Hospital class: OTHER_GOV briefSummary: The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:
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Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?
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Participants will:
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Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.
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Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.
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This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer. conditions: Breast Cancer conditions: Neoplasm, Breast conditions: Patient Participation conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy measure: Questionnaire: Constitution in Chinese Medicine Questionnaire measure: Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4) measure: Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23) measure: Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy" sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei City Hospital status: RECRUITING city: Taipei zip: 10845 country: Taiwan name: Yu-Hsuan Tai, MD role: CONTACT phone: +886918130891 email: daidayangisele@gmail.com,dbb02@tpech.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06337201 id: BTH-6.1.1-0138-2023 briefTitle: A Digital Life Story to Support Person-centred Care for Older Adults With Dementia Perspectives overallStatus: RECRUITING date: 2022-08-15 date: 2026-01 date: 2027-06 date: 2024-03-29 date: 2024-03-29 name: Blekinge Institute of Technology class: OTHER briefSummary: Person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. Active use of the life story can create security for a person with dementia and their carers. The written life story describes the person and their life experiences, which can define the person's identity. National guidelines for care and nursing in dementia and Blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. Research shows that a life story can be designed in several ways. For example, in book form, as a brochure, collage, memory box or electronically. The life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. As more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document.
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Overall aim: To test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. Study I: Exploring the research area of the life story in digital form. Study II: Focus group interviews with healthcare professionals. Study III: Test the application, Min Memoria. Study IV: Observations on the use of the application. conditions: Cognitive Impairment conditions: Dementia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 30 type: ESTIMATED name: Test of the application Min Memoria measure: Healthcare professionals' experiences using a written life story in the daily care of older adults with dementia measure: Data on the use of a digital life story tool. measure: Observation when using a digital life story sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Blekinge Institute of Technology status: RECRUITING city: Karlskrona state: Blekinge zip: 37179 country: Sweden name: Johan Sanmartin Berglund, MD, PhD role: CONTACT phone: +46455385471 email: johan.sanmartin.berglund@bth.se name: Peter Anderberg, PhD role: CONTACT phone: +46455385436 email: peter.anderberg@bth.se lat: 56.16156 lon: 15.58661 hasResults: False
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<|newrecord|> nctId: NCT06337188 id: AAC PhII briefTitle: Adaptive and Individualized AAC Phase II overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-29 date: 2024-03-29 name: Altec Inc. class: INDUSTRY name: University of Nebraska briefSummary: The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication. conditions: Communication Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Experimental AAC name: Generic AAC measure: Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) measure: Information Transfer Rate measure: National Aeronautics and Space Administration (NASA) Task Load Index measure: Character-to-character Movement Time measure: Path Efficiency measure: Frequency of Selecting Word Completion Options measure: Number of Written Disfluencies sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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