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## Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema - NCT ID: NCT06338059 - Study ID: Gulcanozturkchatipchousein - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital ### Study Description Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema. ### Conditions - Vitamin D Deficiency - B12 Deficiency Vitamin - Lipedema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vitamin B12 Level ### Outcomes Primary Outcomes - Vitamin B12 Level - 25 OH Vitamin D Level Secondary Outcomes ### Location - Facility: Gulcan Ozturk, Istanbul, N/A, 34752, Turkey @@
## In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY - NCT ID: NCT06338046 - Study ID: EAShi23M01 - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2023-12-22 - Lead Sponsor: Ritamaria Di Lorenzo ### Study Description This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:* Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.* Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).* Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.* Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28). ### Conditions - SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Corthellus Shiitake(Mushroom) Extract - Placebo ### Outcomes Primary Outcomes - Soothing Test Secondary Outcomes - Detox and adaptogen Test ### Location - Facility: RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II, Naples, N/A, 80131, Italy @@
## Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction - NCT ID: NCT06338033 - Study ID: 2024-03-23 - Status: COMPLETED - Start Date: 2020-09-19 - Completion Date: 2023-11-30 - Lead Sponsor: Chongqing Medical University ### Study Description Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population. ### Conditions - Heart Failure With Preserved Ejection Fraction and Visceral Fat ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause mortality Secondary Outcomes - Rehospitalization for heart failure ### Location - Facility: The First Affiliated Hospital of Chongqing Medical University, Chongqing, N/A, N/A, China @@
## Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia - NCT ID: NCT06338020 - Study ID: RHPT/0022/0042 - Status: COMPLETED - Start Date: 2022-12-29 - Completion Date: 2024-01-04 - Lead Sponsor: Cairo University ### Study Description This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment. ### Conditions - Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adaptive variable-resistance training - Standard physical therapy ### Outcomes Primary Outcomes - Thigh muscle thickness - Muscle strength Secondary Outcomes - Fatigue - Six-minute walk test - 4x10 meter Shuttle Run test - Timed up and down stairs test ### Location - Facility: Ragab K. Elnaggar, Al Kharj, Riyadh, N/A, Saudi Arabia @@
## Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes - NCT ID: NCT06338007 - Study ID: 2012-KAEK-15/2702 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-01 - Lead Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital ### Study Description The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy. ### Conditions - Complication,Postoperative - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hand Dynamometer - Pulmonary Function Test - Modified Frailty Index ### Outcomes Primary Outcomes - Complication Secondary Outcomes ### Location - Facility: Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Keçiören, 06290, Turkey @@
## Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury - NCT ID: NCT06337994 - Study ID: AUH-Neurol-TBI_2024 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-30 - Lead Sponsor: Assiut University ### Study Description Posttraumatic consequences are common causes of disability and long-term morbidity. They include cognitive dysfunction, seizures, headache, dizziness, fatigue, sensory deficits, neurodegeneration and psychiatric disorders (e.g. posttraumatic stress disorder, depression, anxiety, etc). Diffuse axonal injury and disruption of normal neuronal function are the most common and important pathologic features of traumatic primary closed head injury. depression, anxiety, etc). Excitotoxicity and apoptosis caused by activation of N-methyl-D-aspartate (NMDA) glutamate receptors, are two main suggested mechanisms of traumatic neuronal cell death and posttraumtic neurologic adverse consequences. Experimental and clinical studies have demonstrated that memantine hydrochloride, NMDA-type glutamate receptor antagonist, could have beneficial effect in treatment of posttraumatic cognitive dysfunction. Memantine may contribute to cognitive improvements in TBI by decreasing the synaptic 'noise' resulting from excessive NMDA receptor activation, inhibition of β-amyloid mediated toxicity and readjustment of the balance between inhibition and excitation on neuronal networks in the central nervous system (CNS). ### Conditions - Treatment of Posttraumatic Cognitive Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Memantine Hydrochloride ### Outcomes Primary Outcomes - The severity of traumatic brain injury (TBI) - The symptoms of depression - The symptoms of anxiety - The cognitive function Secondary Outcomes - Quality of life - The cognitive function ### Location - Facility: Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery, Assiut, N/A, 71516, Egypt @@
## Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients - NCT ID: NCT06337981 - Study ID: 21DE20901 - Status: COMPLETED - Start Date: 2021-11-22 - Completion Date: 2022-11-28 - Lead Sponsor: AJU Pharm Co., Ltd. ### Study Description This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease. ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - (AJU-S56 5% and placebo) - AJU-S56 5% - Placebo(Vehicle) ### Outcomes Primary Outcomes - Total corneal staining score (TCSS) Secondary Outcomes - LGCSS - TFBUT ### Location - Facility: AJU Pharm Co., Ltd., Seoul, N/A, N/A, Korea, Republic of @@
## CPB for Arthroscopic Hip Surgery - NCT ID: NCT06337968 - Study ID: Circum-Psoas Block LN - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-31 - Lead Sponsor: The Second Hospital of Shandong University ### Study Description Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy. ### Conditions - Acute Pain - Opioid Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Circum-psoas Block - Sham block ### Outcomes Primary Outcomes - pain severity at 6 hours postoperatively Secondary Outcomes - Postoperative opioid consumption - Postoperative nausea and vomiting - neurologic evaluation - Patient satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non Primary HCMV Infection: Natural History and Immune Response - NCT ID: NCT06337955 - Study ID: 20170007596 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2017-06-06 - Completion Date: 2024-12 - Lead Sponsor: Foundation IRCCS San Matteo Hospital ### Study Description The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers. ### Conditions - Cytomegalovirus Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - HCMV non-primary infection (reinfection or reactivation). Secondary Outcomes - HCMV-specific humoral and cell-mediated immune response during non-primary infection. - Maternal behaviours and occurrence of non-primary infection ### Location - Facility: Fondazione IRCCS Policlinico San Matteo, Pavia, PV, 27100, Italy @@
## Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study - NCT ID: NCT06337942 - Study ID: 23-001621 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04 - Lead Sponsor: University of California, Los Angeles ### Study Description The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:* Is human bladder transplantation feasible and safe?* How will the new bladder function in terms of storage and emptying?Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant. ### Conditions - Bladder Disease - Bladder, Neurogenic - Bladder Cancer - Kidney Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bladder Transplantation - Combined Kidney and Bladder Transplantation ### Outcomes Primary Outcomes - Demonstrating the technical success of bladder or combined kidney-bladder transplantation Secondary Outcomes - Incidence of adverse events after bladder or combined kidney-bladder transplantation - Incidence of immune rejection after bladder or combined kidney-bladder transplantation - Evaluate the functionality of the transplanted bladder ### Location - Facility: UCLA, Los Angeles, California, 90095, United States @@
## Effects of Capoeira on the Physical and Psychological Performance of Adults - NCT ID: NCT06337929 - Study ID: Ethics Approval: n. 6.683.936 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2024-12-13 - Lead Sponsor: Universidade Federal do vale do São Francisco ### Study Description Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\'s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults. ### Conditions - Training - Mental Health - Physical Fitness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - CAPOEIRA TRAINING - CONTROL GROUP ### Outcomes Primary Outcomes - Change from baseline in aerobic fitness (maximal oxygen uptake and anaerobic threshold) at week 12 - Change from baseline in anaerobic fitness (Peak, average and minimum power in the Wingate test) at week 12 - Change from baseline in muscle strength (Horizontal Leg Press) at week 12 - Change from baseline in muscle power (Vertical Jump Tests from Squat Jump and Counter Movement Jump) on force platform at week 12 - Change from baseline in balance (Center of Pressure) on force platform at week 12 - Change from baseline in motor coordination (Test of Gross Motor Development) at week 12 - Change from baseline in Emotional Intelligence to sport (Likert-type scales with 26 items) at week 12 - Change from baseline in Motivation for Sport II (Likert-type scales with 18 items) at week 12 - Change from baseline in Quality of life measuring by Questionnaire of Word Health Organization (WHOQOL-bref) at week 12 Secondary Outcomes ### Location - Facility: UNIVASF, Petrolina, Pernambuco, 56300000, Brazil @@
## The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain - NCT ID: NCT06337916 - Study ID: 2021/16-01 - Status: COMPLETED - Start Date: 2022-10-07 - Completion Date: 2023-01-30 - Lead Sponsor: Şenay Özdolap ### Study Description Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, \<6 weeks; subacute, ≤3 months; chronic, \>3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM). ### Conditions - Neck Pain - Chronic Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cervical Stabilization Exercise - Cervical Standard Exercise Group ### Outcomes Primary Outcomes - assessment of cervical joint position sense Secondary Outcomes - assessment of cervical range of motion - assessment of neck disability - assessment of pain - assessment of life quality ### Location - Facility: Zonguldak Bülent Ecevit University, Zonguldak, N/A, 67100, Turkey @@
## Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study - NCT ID: NCT06337903 - Study ID: Self-compassion for PwMS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-30 - Lead Sponsor: Robert Simpson ### Study Description The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement. ### Conditions - Multiple Sclerosis - Self-Compassion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Self-compassion intervention (the Mindful Self-Compassion course) ### Outcomes Primary Outcomes - Recruitment - Retention - Adherence - Follow-up rates Secondary Outcomes - Stress - Anxiety - Depression - Self-compassion - Emotion Regulation - Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29) - Participant Experiences and Perspectives - Adjustment ### Location - Facility: Unity Health Toronto, Toronto, N/A, N/A, Canada @@
## CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR. - NCT ID: NCT06337890 - Study ID: FEZECO - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Bologna ### Study Description Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms. ### Conditions - Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Zero contrast FEVAR ### Outcomes Primary Outcomes - Rate of technical success - Reintervention and mortality - Number of participants with perioperative renal function worsening - Rate of TVVs instability - Rate of survival - Rate of reintervention - Number of participants with renal function worsening Secondary Outcomes ### Location - Facility: University of Bologna, Bologna, Emilia Romagna, 40138, Italy @@
## Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis - NCT ID: NCT06337877 - Study ID: pEEG ARDS - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-04-24 - Lead Sponsor: Tepecik Training and Research Hospital ### Study Description "In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used." ### Conditions - Sedation Complication - Acute Respiratory Distress Syndrome Due to COVID-19 - Anesthesia Awareness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Depth of sedation monitoring ### Outcomes Primary Outcomes - To determine the sedation levels of patients during paralysis - The prevalence of inadequate or excessive sedation, Secondary Outcomes - Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS), ### Location - Facility: Aykut Saritaş, İ̇zmi̇r, N/A, 35640, Turkey @@
## Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria - NCT ID: NCT06337864 - Study ID: H-24017055 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-12 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted. ### Conditions - Brain Diseases - Brain Diseases, Metabolic - Brain Diseases, Metabolic, Inborn - Genetic Diseases, Inborn - Metabolism, Inborn Errors - Amino Acid Metabolism, Inborn Errors - Metabolic Disease - Phenylketonurias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - PreKUnil® LNAA Medical Food for PKU ### Outcomes Primary Outcomes - 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) - Computerized neuropsychological testing (responses over study iPad) Secondary Outcomes - Behaviour Rating Inventory of Executive Function - Adult version (BRIEF-A) - Behaviour Rating Inventory of Executive Function - Second edition (BRIEF-2) - Adult attention deficit hyperactivity disorder (ADHD) Self-Report Scale (ASRS v1.1) - Adolescent ADHD Self-Report Scale - PKU-QOL Questionnaire Adolescent or Adult version - Symptom Checklist-90-Revised (SCL-90-R) - Behavior Assessment System for Children, Third Edition (BASC-3) - Neuropsychological testing of flexibility and verbal fluency - Urine peripheral biomarkers of neurotransmitters - Incidence and severity of treatment-emergent adverse events (TEAEs) ### Location - Facility: Copenhagen University Hospital, Rigshospitalet, Copenhagen, N/A, N/A, Denmark @@
## Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma - NCT ID: NCT06337851 - Study ID: AtaturkTRH2003/9 - Status: COMPLETED - Start Date: 2003-11 - Completion Date: 2011-04 - Lead Sponsor: Ataturk Training and Research Hospital ### Study Description Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.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.Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDHExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgeryRandomization 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).Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.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.Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Simultaneous burr hole craniostomy - Consecutive burr hole craniostomy ### Outcomes Primary Outcomes - The Primary Outcome: Mortality - The Primary Outcome: Early Postoperative Success Rate (Redo Surgery) Secondary Outcomes - The secondary outcome: Follow-up assessment (Age) - The secondary outcome: Follow-up assessment (Sex) - The secondary outcome: Follow-up assessment (Trauma-Relation) - The secondary outcome: Follow-up assessment (Concomitant Pathologies) - The secondary outcome: Follow-up assessment (The Glasgow Coma Scale) - The secondary outcome: Follow-up assessment (The Markwalder Grading Scale) - The secondary outcome: Follow-up assessment (Neurological Examination - Motor) - The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi) - The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign) - The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift) - The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum) ### Location - Facility: Izmir Ataturk Training and Research Hospital, Izmir, N/A, 35360, Turkey @@
## Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial - NCT ID: NCT06337838 - Study ID: 2024.BRACKETS-Pilot - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-03 - Lead Sponsor: Population Health Research Institute ### Study Description 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 - Acute Kidney Injury - Bleeding - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Desmopressin Injectable Solution - Tranexamic Acid Injectable Product - Placebo ### Outcomes Primary Outcomes - Rate of recruitment - Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial - Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial - Completion of 30-day follow-up Secondary Outcomes - Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS) - Reoperation for reasons of bleeding - Blood (red blood cells or whole blood) transfused - Blood (red blood cells or whole blood) transfused - Any blood transfusion (red blood cells or whole blood) - Any blood transfusion (red blood cells or whole blood) - Lowest measured hemoglobin concentration - Most recent hemoglobin concentration - Death - Major arterial and venous thrombosis - Myocardial Injury after Noncardiac Surgery (MINS) - Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction - MINS that is an isolated ischemic troponin elevation - Stroke - Non-hemorrhagic stroke - Hemorrhagic stroke - Peripheral arterial thrombosis - Thrombosis of arteriovenous fistula or graft - Symptomatic proximal venous thromboembolism - Symptomatic pulmonary embolism - Symptomatic proximal leg or arm deep venous thrombosis (DVT) - Non-fatal cardiac arrest - Coronary revascularization procedure - Clinically important atrial fibrillation or flutter - Acute heart failure - Acute kidney injury (for patients not receiving dialysis before surgery) - New start of dialysis - Seizure - Clinically significant intraoperative hypotension - Clinically significant postoperative hypotension - Sepsis - Duration of surgery - Receipt of platelets - Receipt of fibrinogen - Receipt of fresh frozen plasma - Receipt of cryoprecipitate - Receipt of recombinant Factor VIIa - Receipt of prothrombin complex concentrate - Prescribed erythropoiesis stimulating agent - Severe hyponatremia - Duration of hospital stay after surgery - Duration of critical care stay after surgery ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism - NCT ID: NCT06337825 - Study ID: 22-727 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-07-19 - Completion Date: 2024-06-29 - Lead Sponsor: The Cleveland Clinic ### Study Description 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 - Multinodular Goiter ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Activity Tracker (Fitbit) - HbA1C - The PROMPT Questionnaire ### Outcomes Primary Outcomes - Change in resting heart rate over time among study participants as monitored by fitness tracker - Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker - Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker - Change in steps over time among study participants as monitored by fitness tracker - Change in total active minutes over time among study participants as monitored by fitness tracker - Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker - Change in glucose levels (HbA1C) - Correlation of Quality of Life surveys with the PROMPT survey Secondary Outcomes ### Location - Facility: The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States @@
## Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF) - NCT ID: NCT06337812 - Study ID: HUM00240473 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: University of Michigan ### Study Description 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 - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Potato Starch ### Outcomes Primary Outcomes - Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool - Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma - Changes in propionate levels - stool - Changes in propionate levels- plasma - Changes in acetate levels- stool - Changes in acetate levels- plasma Secondary Outcomes ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Use of Allied-health Professionals to Improve Treatment of Disease - NCT ID: NCT06337799 - Study ID: 202210411 - Status: NOT_YET_RECRUITING - Start Date: 2026-10 - Completion Date: 2030-03 - Lead Sponsor: University of Iowa ### Study Description 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.Participants will: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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Research Pharmacist ### Outcomes Primary Outcomes - Number of Subjects at Risk for Hypertension - Number of Subjects Exposed to a Screening Clinic - Number of Subjects Screened at a Screening Clinic - Number of Subjects Followed-Up by the Research Pharmacist - Number of Subjects Diagnosed with Hypertension - Number of Subjects Treated for Hypertension, if Diagnosed Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis - NCT ID: NCT06337786 - Study ID: MSK-2023-TSJ1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: Henning Bliddal ### Study Description 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.There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease.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.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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Digital app RB4.1 - Control arm ### Outcomes Primary Outcomes - Primary Outcome Secondary Outcomes - Disease-activity Score28 using C-reactive protein (DAS28-CRP) - Self-Efficacy - Pain and Fatigue - Health related quality of life - Physical function/activity - Well-Being ### Location - Facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Copenhagen F, 2000, Denmark @@
## Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors - NCT ID: NCT06337773 - Study ID: B-BR-112-036 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-12-25 - Lead Sponsor: Fooyin University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 8-weeks's on-line precision nursing education program ### Outcomes Primary Outcomes - The depression symptoms on young colorectal cancer survivors Secondary Outcomes - Dispositional mindfulness status on young colorectal cancer survivors - General quality of life on young colorectal cancer survivors - Colorectal specific quality of life on young colorectal cancer survivors - Cancer threat appraisal on young colorectal cancer survivors ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. - NCT ID: NCT06337760 - Study ID: IEO 1669 - Status: RECRUITING - Start Date: 2023-03-10 - Completion Date: 2027-06-30 - Lead Sponsor: European Institute of Oncology ### Study Description 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 - Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Numbers of partecipants with genetic alterations Secondary Outcomes - Number of partecipants with survival outcomes - Number of partecipants toxicities ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline - NCT ID: NCT06337747 - Study ID: 04-2023-PLLA - Status: RECRUITING - Start Date: 2023-05-19 - Completion Date: 2024-06 - Lead Sponsor: Erevna Innovations Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Traditional technique - Experimental technique ### Outcomes Primary Outcomes - To access the efficacy of the tradition and experimental technique Secondary Outcomes - To access the safety of the tradition and experimental technique ### Location - Facility: Erevna Innovations Inc, Montreal, Quebec, H3R 3A1, Canada @@
## An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension - NCT ID: NCT06337734 - Study ID: 2 - Status: COMPLETED - Start Date: 2021-11-01 - Completion Date: 2023-08-01 - Lead Sponsor: University of California, San Diego ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - AI-Driven Lifestyle Coaching Program ### Outcomes Primary Outcomes - Average change in systolic blood pressure (SBP) from baseline to 12 weeks - Average change in diastolic blood pressure (DBP) from baseline to 12 weeks - Average change in SBP from baseline to 24 weeks - Average change in DBP from baseline to 24 weeks - Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks - Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks - Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks - Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks Secondary Outcomes - Average weekly percentage of active participants measuring their BP - Average weekly percentage of active participants syncing their wearable - Average weekly percentage of active participants answering the mobile app questionnaire - Number of manual clinician outreaches based on the escalation rules set for the study ### Location - Facility: University of California, San Diego, La Jolla, California, 92093, United States @@
## Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults - NCT ID: NCT06337721 - Study ID: R01AA030786 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-08 - Lead Sponsor: University of California, Riverside ### Study Description 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 - Alcohol; Harmful Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) ### Outcomes Primary Outcomes - Heavy Episodic Drinking (HED) Days Secondary Outcomes - Alcohol Consumption ### Location - Facility: UC Riverside, Riverside, California, 91784, United States @@
## Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women - NCT ID: NCT06337708 - Study ID: STUDY00017286 - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2028-03-31 - Lead Sponsor: Arizona State University ### Study Description 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 - Exercise - Heart Diseases - Diabetes Mellitus - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Smart Walk - Fitbit ### Outcomes Primary Outcomes - Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months - Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months Secondary Outcomes - Change in cardiorespiratory fitness from baseline to 4- and 12-months - Change in aortic pulse wave velocity from baseline to 4- and 12-months - Change in body weight from baseline to 4- and 12-months. - Change in body mass index from baseline to 4- and 12-months - Change in waste circumference from baseline to 4- and 12-months - Change in blood pressure (mmHG) from baseline to 4- and 12-months - Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months - Change in interleukin 6 (IL-6) from baseline to 4- and 12-months - Change in interleukin 10 (IL-10) from baseline to 4- and 12-months - Change in interleukin 15 (IL-15) from baseline to 4- and 12-months - Change in fasting blood glucose glucose from baseline to 4- and 12-months - Change in serum insulin from baseline to 4- and 12-months - Change in serum lipids (mg/DL) from baseline to 4- and 12-months - Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months - Change in exercise self-efficacy from baseline to 4- and 12-months - Change in self-regulation for physical activity from baseline to 4- and 12-months - Change in social support for physical activity from baseline to 4- and 12-months - Change in outcome expectations for physical activity from baseline to 4- and 12-months - Change in behavioral capability for physical activity from baseline to 4- and 12-months ### Location - Facility: Arizona State University, Phoenix, Arizona, 85004, United States @@
## VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer - NCT ID: NCT06337695 - Study ID: HREBA.CC-23-0271 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-12-01 - Lead Sponsor: University of Calgary ### Study Description 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 - Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vedolizumab - Placebo ### Outcomes Primary Outcomes - Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months Secondary Outcomes - Proportion of patients with histologically confirmed colitis-free survival at 6 months - Proportion of patients with severe diarrhea or colitis at 6 months - Hazard Ratio of patients with diarrhea or colitis after 6 months - Total average dose of checkpoint inhibitor therapy received within 6 and 12 months - Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs) - Proportion of participants who require permanent ICI discontinuation due to irAEs - Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis - Total average prednisone equivalent dose of rescue corticosteroids required - Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365 - Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365 - Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline - Overall survival (measured as death) at +180 and Day +365 compared to baseline - Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176 - Proportion of participants experiencing any adverse events (AEs) - Proportion of participants experiencing serious AEs - Proportion of participants experiencing other irAEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Blood Pressure Management in the Care Home Population - NCT ID: NCT06337682 - Study ID: CB_CY_P09_23_11 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2016-01 - Completion Date: 2024-06 - Lead Sponsor: University of Leeds ### Study Description 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 - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Frequency of blood pressure measurements - change in antihypertensive medication - Injurious falls Secondary Outcomes - Prevalence of hypertension - Antihypertensive medication - Blood pressure treatment ### Location - Facility: Academic Unit for Ageing and Stroke Research, Bradford, West Yorkshire, BD9 6RJ, United Kingdom @@
## Characterization of DupEx2 Duchenne Muscular Dystrophy - NCT ID: NCT06337669 - Study ID: OSRSCP-GUP21006 - Status: RECRUITING - Start Date: 2022-01-31 - Completion Date: 2025-01-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description 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.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.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.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.Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies. ### Conditions - Muscular Dystrophy, Duchenne ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Age at loss of ambulation Secondary Outcomes - Time test for motor function - Respiratory function ### Location - Facility: Dept. of Neurology, IRCCS Ospedale San Raffaele, Milano, N/A, 20132, Italy @@
## Vibration Training Approach in Liver Cirrhosis - NCT ID: NCT06337656 - Study ID: VITAL_0 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: University Hospital of Cologne ### Study Description * 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* 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Galileo WBV ### Outcomes Primary Outcomes - Evaluation of the Effectiveness on muscle strength - Evaluation of the Effectiveness on muscle strength - Evaluation of the Effectiveness on muscle strength - Evaluation of the Effectiveness on muscle strength - Evaluation of the Effectiveness on muscle mass - Evaluation of the Effectiveness on muscle thickness - Evaluation of the Effectiveness on mobility, in particular the risk of falling - Evaluation of the Effectiveness on physical function Secondary Outcomes - Evaluation of Safety of the Training Method - Health-Related Quality of Life - Health-Related Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine - NCT ID: NCT06337643 - Study ID: MVX01-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-07 - Completion Date: 2024-04-16 - Lead Sponsor: Matrivax Research and Development Corporation ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - MVX01 - MVX01 Placebo ### Outcomes Primary Outcomes - Incidence of immediate reactogenicity adverse events - Incidence of solicited reactogenicity events - Incidence of adverse events (AEs) - Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI) - Changes in safety laboratory results compared to baseline - Changes in vital signs compared to baseline - Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA) Secondary Outcomes ### Location - Facility: Velocity (Meridian) Clinical Research, Savannah, Georgia, 31406, United States @@
## A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors - NCT ID: NCT06337630 - Study ID: IC 2022-10 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2029-02-15 - Lead Sponsor: Institut Curie ### Study Description Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PLX038 + Tuvusertib ### Outcomes Primary Outcomes - Dose escalation step : Dose limiting toxicities (DLTs) - Expansion cohorts : Best tumor response - Expansion cohorts : Serious Adverse Events (SAEs) - Expansion cohorts : Adverse Events (AEs) Secondary Outcomes - Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib - Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib - Dose escalation step : objective response rate (ORR) - Dose escalation step : Time to response (TTR) - Dose escalation step : Duration of Response (DoR) - Dose escalation step : Progression free survival (PFS) - Expansion cohorts : Time to response (TTR) - Expansion cohorts : Duration of Response (DoR) - Expansion cohorts : Progression free survival (PFS) - Expansion cohorts : Overall Survival (OS) - Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups - Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib - Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib - Exploratory endpoints ### Location - Facility: Institut Curie, Paris, N/A, 75005, France @@
## 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 - NCT ID: NCT06337617 - Study ID: CDRB436B2407 - Status: COMPLETED - Start Date: 2022-05-10 - Completion Date: 2023-06-29 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Real-world overall response rate (rwORR) Secondary Outcomes - Mean Age - Percentage of patients per sex - Number of years of disease history at treatment initiation since initial melanoma diagnosis - Number and percentage of patients per anatomic sites of origin - Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis - Number and percentage of patients per tumor stage - Number and percentage of patients with occurrence of tumor metastasis - Number and percentage of patients per metastatic location - Number and percentage of patients per metastases - Lactate dehydrogenase (LDH) levels - Eastern Cooperative Oncology Group (ECOG) performance status - Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment - Number and percentage of patients per type of surgery - Number and percentage of patients per name of surgery - Number and percentage of patients per surgical and medical procedure - Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment - Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent - Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting - Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment - Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type - Number and percentage of patients per reason for immunotherapy discontinuation - Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response - Number and percentage of patients per prior anti-neoplastic drug for melanoma - Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment - Number and percentage of patients with prior radiotherapy for melanoma per treatment intent - Number and percentage of patients with prior radiotherapy for melanoma per treatment setting - Number and percentage of patients per radiation site - Mean total dosage for all radiotherapy - Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response - Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment - Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent - Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting - Number and percentage of patients per type of D+T treatment change - Number and percentage of patients per reason for D+T treatment change - Mean duration of D+T, if not ongoing to end of study follow-up - rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS) - Real-world disease control rate (rwDCR) of D+T (FAS) - Real-world duration of response (rwDOR) of dabrafenib plus trametinib - Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS) - Real-world overall survival (rwOS) since D+T initiation (FAS) - Time to treatment discontinuation (FAS) - Number and percentage of patients with adverse events of special interest (AESIs) (FAS) - Number and percentage of patients with serious adverse events (SAEs) (FAS) - rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use - rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use - rwOS since D+T initiation (MMS), by immunotherapy use - rwOS since D+T initiation (NMS), by immunotherapy use - Number and percentage of patients with systemic anti-neoplastic treatment after D+T - Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment - Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up - Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type - Number and percentage of patients per reason for immunotherapy discontinuation - Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response - Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment - Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication - Number and percentage of patients per concomitant medication - Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS) - Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use ### Location - Facility: Novartis, Shanghai, N/A, 201203, China @@
## The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets - NCT ID: NCT06337604 - Study ID: TNP-2092-04 - Status: COMPLETED - Start Date: 2017-10-10 - Completion Date: 2017-11-23 - Lead Sponsor: TenNor Therapeutics Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TNP-2092 capsules - TNP-2092 capsules placebo - Rabeprazole sodium enteric-coated tablets ### Outcomes Primary Outcomes - Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) - Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t) - Maximum Observed Plasma Concentration (Cmax) of TNP-2092 - Percentage of Participants With Adverse Events (AEs) Secondary Outcomes ### Location - Facility: The First Hospital of Jilin University, Changchun, Jilin, N/A, China @@
## 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 - NCT ID: NCT06337591 - Study ID: INRCA_003_2024 - Status: COMPLETED - Start Date: 2022-10-15 - Completion Date: 2024-03-10 - Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VI-RADS ### Outcomes Primary Outcomes - Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection Secondary Outcomes ### Location - Facility: AOU Hospital, Ancona, N/A, N/A, Italy @@
## Advances in Telephone-based Cognitive Screening Procedures - NCT ID: NCT06337578 - Study ID: 23C308 - Status: RECRUITING - Start Date: 2023-10-25 - Completion Date: 2026-10-25 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description 1. Background 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). 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.2. Aims 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.3. MethodsThe 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 - Alzheimer's Disease - Lewy Body Dementia - Frontotemporal Degeneration - Cerebrovascular Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Telephone-based neuropsychological assessment - ALS - Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD - Telephone-based and in-person cognitive screening - NIs ### Outcomes Primary Outcomes - ALS Cognitive Behavioral Screen-Phone Version in ALS patients - Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients - Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients - Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients - Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients - Mini-Mental State Examination in NI - Montreal Cognitive Assessment in NI Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Milano, N/A, 20149, Italy @@
## Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes - NCT ID: NCT06337565 - Study ID: GIS-DUMBO 2-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2030-05-20 - Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 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). Secondary Outcomes - To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD. - To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life. - 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. - 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. - To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD. ### Location - Facility: Hospital Universitario de La Princesa, Madrid, N/A, 28006, Spain @@
## High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) - NCT ID: NCT06337552 - Study ID: MCC-22709 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2027-03 - Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - FEED-FF - Standard of Care (SUC) ### Outcomes Primary Outcomes - Effects of the FEED-FF diet on clinical response to chemoradiation - Effects of FEED-FF diet on the gut microbiome - Effects of FEED-FF diet on local immune-related biomarkers - Effects of FEED-FF diet on quality of life - Efficacy of the FEED-FF intervention - Feasibility of the FEED-FF intervention Secondary Outcomes ### Location - Facility: Moffitt Cancer Center, Tampa, Florida, 33612, United States @@
## Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants - NCT ID: NCT06337539 - Study ID: PI-23-185 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-07-31 - Lead Sponsor: Germans Trias i Pujol Hospital ### Study Description Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs).Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group.Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model. ### Conditions - Depression - Inflammation - Antidepressants - Immunity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SSRI ### Outcomes Primary Outcomes - Treatment Response Secondary Outcomes - Lymphocyte subpopulations - Biochemical variables - Single-cell CITEseq ### Location - Facility: Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, 08916, Spain @@
## Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS) - NCT ID: NCT06337526 - Study ID: IRB-71503 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: Stanford University ### Study Description objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS. ### Conditions - Complex Regional Pain Syndromes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Apple Watch v8 ### Outcomes Primary Outcomes - Change from baseline in pain score Secondary Outcomes ### Location - Facility: Pediatric Pain Clinic, Stanford, California, 94305, United States @@
## Spondyloarthritis Inception Cohort of Southern Denmark - NCT ID: NCT06337513 - Study ID: S-20230055 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-08 - Lead Sponsor: The Danish Center for Expertise in Rheumatology ### Study Description People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA. ### Conditions - Axial Spondyloarthritis - Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Rehabilitation intervention - Usual care ### Outcomes Primary Outcomes - Clinicians diagnosis of axSpA - Health related quality of life Secondary Outcomes - axSpA disease activity - axSpA disease mobility - axSpA patient-reported physical function - Inflammatory back pain (IBP) symptoms - Physical examination I - Physical examination II - Symptomatic SpA features I - Symptomatic SpA features II - Symptomatic SpA features III - Symptomatic SpA features IV - Symptomatic SpA features V - Symptomatic SpA features VI - Physicians global assessment of disease activity - Magnetic resonance imaging of sacroiliac joints (SIJ) and spine - low dose computed tomography of SIJ and spine - dual energy computed tomography of SIJ - radiography SIJ - Work - Fatigue - Physical activity - Sleep - Self-efficacy - Objective physical function - Aerobic capacity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validation of a Making Decision Hybrid (Ecologic and Virtual) Task - NCT ID: NCT06337500 - Study ID: 2023/764 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description 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 - Behavior and Behavior Mechanisms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Neurophysiological measure (EEG) - Survey ### Outcomes Primary Outcomes - 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. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients - NCT ID: NCT06337487 - Study ID: 2022/716 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-08 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description 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:* Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained* The nurse's assessment of the relevance of the information provided by the QOL scores.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 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - QoL questionnaires - Qualitative Interview (for one part of nurses only) - ORIC questionnaire - Professionals satisfaction survey - Patients satisfaction survey ### Outcomes Primary Outcomes - Change between pre and post QoL Questionnaires - The nurse's assessement of the relevance of the information provided by each patients's QoL scores Secondary Outcomes ### Location - Facility: CHU de Besançon, Besançon, N/A, 25000, France @@
## An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia - NCT ID: NCT06337474 - Study ID: [2023]YLJSA089 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-03-30 - Lead Sponsor: Changzhou No.2 People's Hospital ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anti-CD19 CAR NK cells (KN5501) ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicity (DLTs) - Treatment Emergent Adverse Events (TEAEs) Secondary Outcomes - Objective Response Rate of subjects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography - NCT ID: NCT06337461 - Study ID: CCM1930 - Status: RECRUITING - Start Date: 2023-05-22 - Completion Date: 2025-05-30 - Lead Sponsor: Centro Cardiologico Monzino ### Study Description Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques. ### Conditions - Chronic Coronary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Development of a computational model to predict MBF avoiding CT stress protocol Secondary Outcomes - Improvement of CAD risk assesment ### Location - Facility: Centro Cardiologico Monzino, Milan, N/A, 20131, Italy @@
## Light Emitting Diode in the Treatment of Vulvodynia - NCT ID: NCT06337448 - Study ID: 74090923.9.0000.5544 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2026-12 - Lead Sponsor: Centro de Atenção ao Assoalho Pélvico ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Blue LED ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale. - Tolerability of participants to the treatment assessed by Likert Scale. - Evaluate the clinical response assessed by the Visual Analogue Scale. - Evaluate the clinical response assessed by a questionnaire. Secondary Outcomes - Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI). - Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV). ### Location - Facility: Centro de Atenção ao assoalho pélvico, Salvador, Bahia, 40290000, Brazil @@
## Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding - NCT ID: NCT06337435 - Study ID: 8223 - Status: COMPLETED - Start Date: 2022-12-15 - Completion Date: 2024-01-18 - Lead Sponsor: Cairo University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - multi-looped wire ### Outcomes Primary Outcomes - The improvement of lower incisors irregularity using Little Irregularity Index. Secondary Outcomes - The stability of lower incisor positioning after ending treatment ### Location - Facility: faculty of dentistry Cairo university, Cairo, N/A, N/A, Egypt @@
## Bioequivalence Study of Generic Celecoxib 200 mg Capsules - NCT ID: NCT06337422 - Study ID: BE21-023 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-23 - Completion Date: 2024-10-04 - Lead Sponsor: International Bio service ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Celecoxib 200 mg capsule ### Outcomes Primary Outcomes - Bioequivalence based on Cmax period - Bioequivalence based on AUC parameters Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers - NCT ID: NCT06337409 - Study ID: BE24-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2024-07-13 - Lead Sponsor: International Bio service ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Generic empagliflozin 25 mg film-coated tablets ### Outcomes Primary Outcomes - Bioequivalence based on Cmax period Secondary Outcomes - Bioequivalence based on AUC parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Omic Approaches to Neurodevelopmental Disabilities - NCT ID: NCT06337396 - Study ID: 1001 - Status: COMPLETED - Start Date: 2021-05-05 - Completion Date: 2023-12-31 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - WGS and transcriptome analysis ### Outcomes Primary Outcomes - Number of likely pathogenic structural variants - Number of patients for whom a genotype-phenotype correlation is found Secondary Outcomes ### Location - Facility: Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, LC, 23842, Italy @@
## Study of the Prevalence of Autistic Traits in Angelman Syndrome - NCT ID: NCT06337383 - Study ID: 12.2021 ANGELMAN - Status: RECRUITING - Start Date: 2022-03-15 - Completion Date: 2024-06 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description 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:* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.* which clinical variables differentiate parenting styles and levels of perceived stress.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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1, Secondary Outcomes - Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III) - Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire - Global score at the Aberrant Behaviour Checklist (ABC) - Total Raw score at the Social Communication Questionnaire - Current version(SCQ) ### Location - Facility: I.R.C.C.S. "E.Medea", Conegliano, Treviso, 31015, Italy @@
## Self-management Nursing Intervention for Women With Rheumatoid Arthritis - NCT ID: NCT06337370 - Study ID: 61284 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-10 - Lead Sponsor: Universidad Nacional de Colombia ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Chronic Disease Self Management Program - Conventional Care Group ### Outcomes Primary Outcomes - Self-management behaviors Secondary Outcomes - Perceived Self-efficacy, - Health-related quality of life ### Location - Facility: Fundación Santa Fe de Bogotá, Bogotá, N/A, N/A, Colombia @@
## Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia - NCT ID: NCT06337357 - Study ID: NatGerHos-Sarcopenia - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: National Geriatric Hospital ### Study Description 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 - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive Resistance Training ### Outcomes Primary Outcomes - Physical performance 1 - Handgrip strength - Physical performance 2 - Gait speed - Physical performance 3 - Short Physical Performance Battery (SPPB) - Muscle mass Secondary Outcomes - Nutritional status - Health-related Quality of Life - Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) ### Location - Facility: National Geriatric Hospital, Hanoi, N/A, 100000, Vietnam @@
## Neurophysiological Effects of Mind-body Exercise in Healthy Adults - NCT ID: NCT06337344 - Study ID: HSEARS20230213007 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-04 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baduanjin - Exercise - Video Viewing ### Outcomes Primary Outcomes - Change in cognitive function as assessed by verbal fluency task (VFT) - Hemodynamic changes as assessed by fNIRS Secondary Outcomes ### Location - Facility: The Hong Kong Polytechnic University, Hung Hom, Kowloon, N/A, Hong Kong @@
## Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant - NCT ID: NCT06337331 - Study ID: NSH 1401 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2027-08-31 - Lead Sponsor: Northside Hospital, Inc. ### Study Description 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 - Myelodysplastic Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Venetoclax - Decitabine - Fludarabine - Busulfan - Total Body Irradiation ### Outcomes Primary Outcomes - Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant Secondary Outcomes - Number of patients alive at one-year post transplant - Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures - Number of patients who died one year post-transplant not related to recurrence of disease - Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant - 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 - 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 - Number of patients who are alive at one-year post transplant who also did not develop GVHD - Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0 ### Location - Facility: Caitlin Guzowski, Atlanta, Georgia, 30342, United States @@
## Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma - NCT ID: NCT06337318 - Study ID: NCI-2024-02361 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2032-03-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description 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 - Follicular Lymphoma With Unusual Cytological Features ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Computed Tomography - Mosunetuzumab - Positron Emission Tomography - Rituximab - Rituximab and Hyaluronidase Human ### Outcomes Primary Outcomes - 3-year milestone progression free survival (PFS) - PFS Secondary Outcomes - Overall survival - Overall response rate - Event free survival (EFS) - Incidence of adverse events - Restricted chance of longer PFS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer - NCT ID: NCT06337305 - Study ID: STUDY00146138 - Status: COMPLETED - Start Date: 2020-08-19 - Completion Date: 2023-08-19 - Lead Sponsor: University of Kansas Medical Center ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25). - Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys). - Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29. Secondary Outcomes - Identification of clinical and demographic factors in bladder cancer patients - Demographics ### Location - Facility: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States @@
## Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial - NCT ID: NCT06337292 - Study ID: IRB00440042 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: Major Extremity Trauma Research Consortium ### Study Description 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 - Wound Heal - Infected Wound - Wound Complication - Wound Dehiscence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Incisional Negative Pressure Wound Therapy (NPWT) ### Outcomes Primary Outcomes - Complication composite outcome Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk - NCT ID: NCT06337279 - Study ID: FMUUH-0322 - Status: COMPLETED - Start Date: 2022-12-10 - Completion Date: 2024-03-20 - Lead Sponsor: Fujian Medical University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 5-year OS - 5-year DFS Secondary Outcomes ### Location - Facility: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350000, China @@
## A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma - NCT ID: NCT06337266 - Study ID: 2024KY246 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-19 - Lead Sponsor: Fujian Medical University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 5-year OS - 5-year DFS Secondary Outcomes ### Location - Facility: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350000, China @@
## Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique - NCT ID: NCT06337253 - Study ID: MOZ202401 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-11-26 - Lead Sponsor: Malaria Consortium ### Study Description 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.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.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 - Chemoprevention ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Sulfadoxine/pyrimethamine plus amodiaquine ### Outcomes Primary Outcomes - Chemoprevention failure Secondary Outcomes - Uncomplicated malaria within 28 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease - NCT ID: NCT06337240 - Study ID: pelvic floor exercise - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-07-02 - Lead Sponsor: Cairo University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pelvic floor on COPD patients - Pilates exercises on COPD patients ### Outcomes Primary Outcomes - Urinary incontinence (1 Hour and 24- Hour pad test) - Incontinence severity index: Secondary Outcomes - Urinary incontinence quality of life questionnaire (I-QOL) - Cough symptoms score - Cough symptoms questionnaire - The COPD Assessment Tool (CAT) ### Location - Facility: Faculty of Physical Therapy, Cairo, N/A, N/A, Egypt @@
## Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis - NCT ID: NCT06337227 - Study ID: 2/22 - Status: RECRUITING - Start Date: 2023-10-19 - Completion Date: 2026-10 - Lead Sponsor: IRCCS SYNLAB SDN ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lncRNA signature analyses ### Outcomes Primary Outcomes - 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 Secondary Outcomes - To evaluate the experimental results achieved in the clinical-diagnostic context ### Location - Facility: Irccs Synlab Sdn, Naples, N/A, 80143, Italy @@
## TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy - NCT ID: NCT06337214 - Study ID: TCHIRB-11301014-E - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-02-28 - Lead Sponsor: Taipei City Hospital ### Study Description 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: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?Participants will:Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.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 - Neoplasm, Breast - Patient Participation - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy ### Outcomes Primary Outcomes - Questionnaire: Constitution in Chinese Medicine Questionnaire - Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4) - Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23) Secondary Outcomes - Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy" ### Location - Facility: Taipei City Hospital, Taipei, N/A, 10845, Taiwan @@
## A Digital Life Story to Support Person-centred Care for Older Adults With Dementia Perspectives - NCT ID: NCT06337201 - Study ID: BTH-6.1.1-0138-2023 - Status: RECRUITING - Start Date: 2022-08-15 - Completion Date: 2027-06 - Lead Sponsor: Blekinge Institute of Technology ### Study Description 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.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 - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Test of the application Min Memoria ### Outcomes Primary Outcomes - Healthcare professionals' experiences using a written life story in the daily care of older adults with dementia - Data on the use of a digital life story tool. - Observation when using a digital life story Secondary Outcomes ### Location - Facility: Blekinge Institute of Technology, Karlskrona, Blekinge, 37179, Sweden @@
## Adaptive and Individualized AAC Phase II - NCT ID: NCT06337188 - Study ID: AAC PhII - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Altec Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Experimental AAC - Generic AAC ### Outcomes Primary Outcomes - Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) - Information Transfer Rate - National Aeronautics and Space Administration (NASA) Task Load Index Secondary Outcomes - Character-to-character Movement Time - Path Efficiency - Frequency of Selecting Word Completion Options - Number of Written Disfluencies ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction - NCT ID: NCT06337175 - Study ID: 000000230988 - Status: RECRUITING - Start Date: 2021-06-01 - Completion Date: 2024-04-30 - Lead Sponsor: Kafrelsheikh University ### Study Description The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction. ### Conditions - Ischemic Stroke - Alteplase Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alteplase - Alteplase ### Outcomes Primary Outcomes - predictors of the hemorrhagic infarction type 1 Secondary Outcomes - predictors of the hemorrhagic infarction type 2 - predictors of the parenchymal hematoma type 1 - predictors of the parenchymal hematoma type 2 ### Location - Facility: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, N/A, 33155, Egypt @@
## Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) - NCT ID: NCT06337162 - Study ID: UPCC 20223 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-09-01 - Lead Sponsor: Abramson Cancer Center at Penn Medicine ### Study Description This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INCB099280 ### Outcomes Primary Outcomes - Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy Secondary Outcomes - Acute Cellular Rejection of Liver Transplant Within 3 Months - Acute Cellular Rejection of Liver Transplant Within 1 Year - Toxicity Rates by Category and Grade - Proportion of Patients Downstaged - Pathologic Complete Response Rate - Recurrence-Free Survival at 1 Year After Transplant - Overall Survival at 1 Year After Transplant ### Location - Facility: Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## Relationship Between Breathing and Attention in Children With Ondine Syndrome - NCT ID: NCT06337149 - Study ID: APHP230348 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2026-09-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children ### Conditions - Ondine Syndrome - Congenital Central Hypoventilation Syndrome (CCHS) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task) ### Outcomes Primary Outcomes - Wechsler scale - Nepsy II test Secondary Outcomes ### Location - Facility: Robert Debre Hospital, Paris, N/A, 75019, France @@
## neonAtal motoR paTtErn autoMatIc analySis - NCT ID: NCT06337136 - Study ID: 2022-A01837-36 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ... ### Conditions - Automated Computer Analysis - Neonatal Motor Pattern ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - comparison of the computer score with the clinical examination Secondary Outcomes - Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients ### Location - Facility: Department of paediatric neurological care and intentive care unity (PICU), Raymond Poincaré hospital - APHP, Garches, N/A, 92380, France @@
## Physica TT Tibial Plate Follow up Study - NCT ID: NCT06337123 - Study ID: K-38 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-12 - Lead Sponsor: Limacorporate S.p.a ### Study Description This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications. ### Conditions - Knee Arthropathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Device: Physica TT TIbial Plate and Physica Porous KR - Device: Physica TT TIbial Plate and Physica Porous PS ### Outcomes Primary Outcomes - Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery Secondary Outcomes - Changes in Range of Motion over time up to 2 years after surgery - Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery. - Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery. - Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery. - Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery - Survival rate (Kaplan-Meier) at 2 years after surgery - Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up ### Location - Facility: Casa di Cura San Camillo Hopital, Forte Dei Marmi, Lucca, 55042, Italy @@
## A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men - NCT ID: NCT06337110 - Study ID: 20436A - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-05-25 - Lead Sponsor: H. Lundbeck A/S ### Study Description The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lu AF28996 ### Outcomes Primary Outcomes - Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces) - AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity - Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material - Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material - T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material - AUC0-infinity of Lu AF28996 - Cmax of Lu AF28996 - Tmax of Lu AF28996 - T½ of Lu AF28996 Secondary Outcomes ### Location - Facility: Fortrea Clinical Research Unit Ltd, Holbeck, Leeds, LS11 9EH, United Kingdom @@
## STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy - NCT ID: NCT06337097 - Study ID: 2023-1021 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2028-12-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects. ### Conditions - Immune Checkpoint Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Troponin surveillance - Standard of care ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Diagnostic Efficacy and Dosimetry of MNPR-101-DFO-89Zr in Patients With Solid Tumors - NCT ID: NCT06337084 - Study ID: MNPR-101-D001 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-06 - Lead Sponsor: Monopar Therapeutics ### Study Description The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.The amount of radioactivity injected will range between 37-74 MBq (±10%). ### Conditions - Solid Tumor, Adult - Bladder Cancer - Urothelial Carcinoma - Triple-negative Breast Cancer - Lung Cancer - Colorectal Cancer - Gastric Cancer - Ovarian Cancer - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Diagnostic Test: MNPR-101-DFO-89Zr PET Scan ### Outcomes Primary Outcomes - assess dosimetry and biodistribution of product - assess tumor Standard Uptake Values (SUV) of product Secondary Outcomes - assess pharmacokinetics (PK) levels of product ### Location - Facility: Melbourne Theranostic Innovation Centre (MTIC), North Melbourne, Victoria, 3051, Australia @@
## A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine - NCT ID: NCT06337071 - Study ID: AM2023MCV4Ⅱ - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-06 - Lead Sponsor: Aimei Vacin BioPharm (Zhejiang) Co., Ltd. ### Study Description The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination. ### Conditions - Meningococcal Meningitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ACYW135 Meningococcal Polysaccharide Conjugate Vaccine - ACYW135 Meningococcal Polysaccharide Vaccine ### Outcomes Primary Outcomes - Immunogenicity 1 - Immunogenicity 2 - Immunogenicity 3 - Safety 1 Secondary Outcomes - Immunogenicity 4 - Immunogenicity 5 - Immunogenicity 6 - Immunogenicity 7 - Immunogenicity 8 - Immune persistence 1 - Immune persistence 2 - Safety 2 - Safety 3 - Safety 4 ### Location - Facility: Yunnan Center For Disease Control and Prevention, Kunming, Yunnan, 650022, China @@
## Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period - NCT ID: NCT06337058 - Study ID: KSUHULYAKAMALAK001 - Status: COMPLETED - Start Date: 2020-06-15 - Completion Date: 2022-12-15 - Lead Sponsor: Hülya KAMALAK ### Study Description The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used. ### Conditions - Sexual Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental group (motivational interview) ### Outcomes Primary Outcomes - Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) - Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) - Sexual Quality of Life-Female Questionnaire (SQOL-F) - Sexual Quality of Life-Female Questionnaire (SQOL-F) - Sexual Self-Efficacy Scale (SSES) - Sexual Self-Efficacy Scale (SSES) Secondary Outcomes ### Location - Facility: Kahramanmaras Sutçu Imam University, Kahramanmaraş, N/A, N/A, Turkey @@
## Atrial Fibrillation, Prevention and Rehabilitation - NCT ID: NCT06337045 - Study ID: AF-rehab - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2020-06-30 - Lead Sponsor: Odense University Hospital ### Study Description Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.There were the following four secondary objectives:1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.2. To explore the participant's needs and preferences of the interventions.3. To explore changes in HRQoL, anxiety and depression.4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression. ### Conditions - Atrial Fibrillation - Prevention - Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Complex prevention and rehabilitation intervention ### Outcomes Primary Outcomes - HeartQoL - The hospital anxiety and depression scale (HADS) - Experience of participating, experiences needs and preferences of interventions - Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale. Secondary Outcomes ### Location - Facility: Department of Cardiology, Odense University Hospital, Odense, Region Of Southern Denmark, 5000, Denmark @@
## A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments - NCT ID: NCT06337032 - Study ID: GS-US-380-6684 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2034-03 - Lead Sponsor: Gilead Sciences ### Study Description The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.The primary objectives of this study are as follows:* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.* To evaluate the safety of the study drug(s) in participants with HIV-1. ### Conditions - HIV-1-infection ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - F/TAF (High Dose Tablet) - F/TAF (Low Dose Tablet) - F/TAF (Lowest Dose Tablet) - F/TAF (High Dose TOS) - F/TAF (Low Dose TOS) - F/TAF (Lowest Dose TOS) - E/C/F/TAF - E/C/F/TAF (Low Dose) - Cobicistat (High Dose) - Cobicistat (Low Dose) - Cobicistat (TOS) - B/F/TAF (High Dose) - B/F/TAF (Low Dose) - B/F/TAF (High Dose TOS) - B/F/TAF (Low Dose TOS) - B/F/TAF (Lowest Dose TOS) - 3rd ARV Agent - Nucleos(t)ide reverse transcriptase inhibitors (NRTI) - ATV - DRV - Lopinavir Boosted with ritonavir (LPV/r) ### Outcomes Primary Outcomes - Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study Secondary Outcomes - Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Italian Registry of Malnutrition in Oncology - NCT ID: NCT06337019 - Study ID: IRMO - Status: RECRUITING - Start Date: 2022-10-25 - Completion Date: 2027-10 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL. ### Conditions - Cancer - Cancer Metastatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cohort observational ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Progression-free survival - Treatment toxicity ### Location - Facility: IRCCS Istituto Tumori Giovanni Paolo II,, Bari, BA, N/A, Italy @@
## Laryngeal Mask Airway Failure in Pediatric Patients - NCT ID: NCT06337006 - Study ID: SÜKAEK 2023/14/1 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2024-05-15 - Lead Sponsor: Samsun University ### Study Description There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures.The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data. ### Conditions - Airway Management ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Placement of the laryngeal mask airway ### Outcomes Primary Outcomes - Evaluation of the success of placement of the laryngeal mask airway Secondary Outcomes ### Location - Facility: Samsun University, Samsun, Canik, 55090, Turkey @@
## Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP - NCT ID: NCT06336993 - Study ID: liuxianguiji - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-12-15 - Lead Sponsor: Zhejiang Provincial Tongde Hospital ### Study Description The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - herbal compound - Celecoxib ### Outcomes Primary Outcomes - Visual Analogue Scale - Oswestry disability index - Japanese Orthopaedic Association Scores Secondary Outcomes ### Location - Facility: Tongde Hospital, Hangzhou, Zhejiang, 310000, China @@
## Creating Welcoming Faith Communities for People With Serious Mental Illnesses - NCT ID: NCT06336980 - Study ID: 31021 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-12 - Lead Sponsor: Temple University ### Study Description The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices. ### Conditions - Other ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Increasing Inclusionary Practices in Faith Communities ### Outcomes Primary Outcomes - Inclusionary practices - Indicators of Welcome - Mental Health Knowledge Questionnaire - Social Distance Scale - Community Attitudes Toward the Mentally Ill - Reported and Intended Behavior Scale - Sense of Belonging Scale Secondary Outcomes - University of California Los Angeles Loneliness Scale - Lerman Quality of Life Interview ### Location - Facility: Temple Univeristy, Philadelphia, Pennsylvania, 19121, United States @@
## Testing a Wellness App for First Responders, Military Personnel and Veterans - NCT ID: NCT06336967 - Study ID: 855282 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2026-01-01 - Lead Sponsor: University of Pennsylvania ### Study Description The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants. ### Conditions - Mental Health Wellness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - GUIDE ### Outcomes Primary Outcomes - PERMA-Profiler Overall Wellbeing Score - Patient Health Questionnaire for depression symptoms (PHQ-8) - Generalized Anxiety Disorder (GAD-7) - WHO Well-being Index (WHO-5) - Personal Wellbeing Score (PWS) - Difficulties in Emotion Regulation Scale Short Form (DERS-SF) Secondary Outcomes - Positive Emotion (Positive emotion subscale of the PERMA-Profiler) - Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler) - Social Connectedness (Number of posts/comments in the app) - Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler) - Personal Growth (Total GUIDE lessons and courses completed) - Utrecht Work Engagement Scale (UWES-17) - Maslach Burnout Inventory (MBI) - Job Retention (Employment status) ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19146, United States @@
## Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure - NCT ID: NCT06336954 - Study ID: MA-NSCLC-#-037 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-12-31 - Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University ### Study Description This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adibelimab ### Outcomes Primary Outcomes - Progression-free survival time (PFS) Secondary Outcomes - Objective Response Rate - Duration of Response - Overall Survival - Treatment-Related Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## "Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON) - NCT ID: NCT06336941 - Study ID: 32822 - Status: RECRUITING - Start Date: 2018-06-07 - Completion Date: 2030-12-31 - Lead Sponsor: University of Pisa ### Study Description Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions. ### Conditions - Oral Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Depth of invasion Secondary Outcomes ### Location - Facility: Università di Pisa, Pisa, N/A, 56126, Italy @@
## A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis - NCT ID: NCT06336928 - Study ID: 1B-23-6 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-04-01 - Lead Sponsor: University of Southern California ### Study Description This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer. ### Conditions - Breast Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Assess the sensitivity and specificity of LBx as a screening method for breast cancer Secondary Outcomes ### Location - Facility: Keck Medicine of USC Koreatown, Los Angeles, California, 90020, United States @@
## Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics - NCT ID: NCT06336915 - Study ID: 121.NUR.2022.D - Status: RECRUITING - Start Date: 2023-01-03 - Completion Date: 2024-12-30 - Lead Sponsor: Methodist Health System ### Study Description The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care ### Conditions - Wellness, Psychological ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physician-Nurse Dyad Rounding ### Outcomes Primary Outcomes - Difference in percentage of discharged patients before 1400 (Mon-Fri) after project implementation compared to before implementation Secondary Outcomes - Difference in Top Box Patient Satisfaction Scores and Doctor Domain - Difference in LOS of private hospitalist patients after project implementation compared to before implementation - Difference in collaboration and build positive relationships scores after project implementation compared to before implementation ### Location - Facility: Clinical Research Institute at Methodist Health System, Dallas, Texas, 75203, United States @@
## Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer - NCT ID: NCT06336902 - Study ID: 3C-23-11 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: University of Southern California ### Study Description This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer. ### Conditions - Metastatic Colorectal Adenocarcinoma - Stage IV Colorectal Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Balstilimab - Biospecimen Collection - Botensilimab - Computed Tomography - Dietary Intervention - Magnetic Resonance Imaging - Vitamin C ### Outcomes Primary Outcomes - Proportion of patients who adhere to the fast mimicking diet - Incidence of adverse events (AEs) Secondary Outcomes - Overall response rate (ORR) - Progression-free survival (PFS) - Overall survival (OS) ### Location - Facility: Los Angeles General Medical Center, Los Angeles, California, 90033, United States @@
## Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used) - NCT ID: NCT06336889 - Study ID: 092.TRA.2018.D - Status: RECRUITING - Start Date: 2017-10-26 - Completion Date: 2024-10 - Lead Sponsor: Methodist Health System ### Study Description The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization. ### Conditions - Pelvic Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pelvic Angioembolization ### Outcomes Primary Outcomes - Mortality outcome - transfusion requirements - thromboembolic events Secondary Outcomes - Patient demographics(age, sex) ### Location - Facility: Methodist Dallas Medical Center, Dallas, Texas, 75201, United States @@
## Perceived Coping, Meaning, and Joy at Work - NCT ID: NCT06336876 - Study ID: 080.EDU.2019.R - Status: RECRUITING - Start Date: 2020-06-30 - Completion Date: 2024-12 - Lead Sponsor: Methodist Health System ### Study Description The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction. ### Conditions - Undefined ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Survey ### Outcomes Primary Outcomes - Workplace Incivil Behavior - Meaning, Joy in Work - Occupational Coping Self-Efficacy - Demographic Secondary Outcomes ### Location - Facility: Methodist Richardson Medical Center, Richardson, Texas, 75082, United States @@
## Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression - NCT ID: NCT06336863 - Study ID: STU-2023-1151 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients." ### Conditions - Kidney Transplant Immunosuppression ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Allosure and TruGraf - Immunosuppression Taper ### Outcomes Primary Outcomes - Incidence of acute kidney graft rejection - Incidence of facilitation to Belatacept monotherapy Secondary Outcomes - Patient Survival after Immunosuppression Wean - Kidney Graft Failure after Immunosuppression Wean - Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean - Incidence of Proteinuria after Immunosuppression Wean - Incidence of de-novo donor specific antibodies (dnDSA) ### Location - Facility: University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States @@
## Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement - NCT ID: NCT06336850 - Study ID: 069.GID.2020.D - Status: RECRUITING - Start Date: 2020-12-23 - Completion Date: 2025-01-01 - Lead Sponsor: Methodist Health System ### Study Description The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies. ### Conditions - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement ### Outcomes Primary Outcomes - Portal Pressure Gradient Measurements from Hepatic and Portal Veins Secondary Outcomes - Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension - Clinical significance between portal pressure gradient measurement and portal hypertension ### Location - Facility: Methodist Dallas Medical Center, Dallas, Texas, 75203, United States @@
## False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study - NCT ID: NCT06336837 - Study ID: 24-3T/48 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-01 - Lead Sponsor: Ege University ### Study Description Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases. ### Conditions - Nurse's Role - Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - blood culture contamination rate Secondary Outcomes ### Location - Facility: Ege University, İzmir, N/A, 35100, Turkey @@
## Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia - NCT ID: NCT06336824 - Study ID: EVOS 1.2 dated 25/10/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Clinical Research Centre, Malaysia ### Study Description The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB. ### Conditions - Staphylococcus Aureus Bacteremia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid - IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline ### Outcomes Primary Outcomes - Rate of SAB-relapse Secondary Outcomes - Number of days of hospitalization - Rate of all-cause mortality - Rate of complications related to IV therapy - Rate of Clostridium difficile diarrhoea - Rate of adverse events ### Location - Facility: Hospital Sultanah Aminah, Johor Bahru, Johor, 80100, Malaysia @@
## Virtual Reality Distraction During Phlebotomy in Children - NCT ID: NCT06336811 - Study ID: DEU active-pasive VR - Status: COMPLETED - Start Date: 2023-05-30 - Completion Date: 2023-12-30 - Lead Sponsor: Dokuz Eylul University ### Study Description This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit. ### Conditions - Pain, Acute - Child, Only - Anxiety and Fear ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - passive virtual reality distraction - active virtual reality distraction ### Outcomes Primary Outcomes - procedure related pain - anxiety - fear - emotional apperance Secondary Outcomes ### Location - Facility: Gülçin Özalp Gerçeker, İzmir, N/A, 35100, Turkey @@
## Bioenergetic Effect of Pioglitazone in CLD-PH - NCT ID: NCT06336798 - Study ID: STUDY00005871 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-08 - Lead Sponsor: Emory University ### Study Description The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo). ### Conditions - Pulmonary Hypertension - Pulmonary Hypertension Due to Lung Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Pioglitazone 30mg - Placebo - Labs ### Outcomes Primary Outcomes - Change in Mitochondrial metabolism parameters: Spare respiratory capacity - Change in Mitochondrial metabolism parameters: Maximal respiration - Change in Mitochondrial metabolism parameters: Basal respiration Secondary Outcomes - Number of hypoglycemia incidences - Number of participants with leg edema - Change in BNP levels - Change in Six minute walk distance (6MWT) - Change in Borg dyspnea score - Change in NYHA/WHO Functional Classification - Change in University of California San Diego Shortness of Breath Questionnaire score - Change in emPHasis-10 Questionnaire score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Kiss and Smile HIT - NCT ID: NCT06336785 - Study ID: 04-2023-HIT-K&S - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2025-11-30 - Lead Sponsor: Erevna Innovations Inc. ### Study Description The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression). ### Conditions - Aesthetic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Restylane line of dermal fillers and Dysport neuromodulator ### Outcomes Primary Outcomes - Global Aesthetic Improvement Scale (GAIS) Secondary Outcomes ### Location - Facility: Erevna Innovations Inc., Montréal, Quebec, H3R3A1, Canada @@
## Restylane Shaype Versus Juvederm Volux for Chin Augmentation - NCT ID: NCT06336772 - Study ID: 10-2023-GAL-SHYP - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-11-01 - Lead Sponsor: Erevna Innovations Inc. ### Study Description This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin ### Conditions - Chin Retrusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Restylane Shaype - Juvéderm Volux ### Outcomes Primary Outcomes - Statistically significant group differences in the average three-dimensional volumetric increase since baseline Secondary Outcomes - Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale) - Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale) - Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues) ### Location - Facility: Erevna Innovations Inc., Montréal, Quebec, H3R3A1, Canada @@

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