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## Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel - NCT ID: NCT06309446 - Study ID: 381001BS - Status: COMPLETED - Start Date: 2020-01-14 - Completion Date: 2020-07-02 - Lead Sponsor: Oystershell NV ### Study Description Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel. ### Conditions - Wound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Zoralan Wound ### Outcomes Primary Outcomes - Wound healing efficacy (clinical) - Wound healing efficacy (global) - Cooling properties Secondary Outcomes - Local tolerability (clinical) - Local tolerability (global) - Signs of infection - Time until 100% healing - Time until 75% healing - Presence of crusts - Questionnaire on product performance - Cosmetic outcome/acceptance - Photographic documentation of the wound - visual of the wound to support previous outcomes. ### Location - Facility: Bioskin GmbH, Hamburg, N/A, 20095, Germany @@
## Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design - NCT ID: NCT06309433 - Study ID: DXA-TKA - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2028-04 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up. ### Conditions - Periprosthetic Osteolysis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - dual energy x-ray absorptiometry ### Outcomes Primary Outcomes - Periprosthetic bone mineral density measurement - Periprosthetic bone mineral density measurement - Periprosthetic bone mineral density measurement - Periprosthetic bone mineral density measurement Secondary Outcomes - Knee Society Score - Knee Society Score - Knee Society Score - Knee Society Score - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey ### Location - Facility: Stefano Zaffagnini, Bologna, Italia, N/A, Italy @@
## Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts - NCT ID: NCT06309420 - Study ID: 19E0566 - Status: COMPLETED - Start Date: 2019-11-07 - Completion Date: 2020-08-10 - Lead Sponsor: Oystershell NV ### Study Description The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts. ### Conditions - Warts ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryogenic treatment of warts (Pixie CO2) - Cryogenic treatment of warts (Wortie®) ### Outcomes Primary Outcomes - Percentage of subjects with clinical wart remission Secondary Outcomes - Number of treatments - Efficacy of the freezing process (Surface Area) - Diameter of the wart - Roughness of the wart - Thickness of the wart (For common warts only) - Presence of small dark spot (For plantar warts only) - Healing process of the wart - Local & general tolerance ### Location - Facility: Dermscan Poland, Gdansk, N/A, 80-288, Poland @@
## Dosimeter Location in Pain Physicians - NCT ID: NCT06309407 - Study ID: STUDY00024903 - Status: COMPLETED - Start Date: 2022-09-23 - Completion Date: 2023-04-21 - Lead Sponsor: Oregon Health and Science University ### Study Description The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event. ### Conditions - RAD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Hand Dosimeters - Standard Practice ### Outcomes Primary Outcomes - Radiation Readings Secondary Outcomes - Number of Glove Breach Events ### Location - Facility: Oregon Health & Science University, Portland, Oregon, 97239, United States @@
## A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants - NCT ID: NCT06309394 - Study ID: INCB99280-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-06-03 - Lead Sponsor: Incyte Corporation ### Study Description This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]INCB099280 in Healthy Male Participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INCB099280 ### Outcomes Primary Outcomes - Total recovery of radioactivity from urine and feces. - Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion Secondary Outcomes - Pharmacokinetic (PK) in Plasma - PK for whole blood and plasma total radioactivity - Number of participants with Treatment Emergent Adverse Events (TEAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block. - NCT ID: NCT06309381 - Study ID: CEIm2.23 - Status: RECRUITING - Start Date: 2023-02-08 - Completion Date: 2024-10 - Lead Sponsor: Hospital Universitario Doctor Peset ### Study Description Rebound pain after surgeries under peripheral nerve block is defined as the appearance of severe acute postoperative pain after regression of the sensory block. The incidence of this condition can reach up to 40-50% in patients undergoing ambulatory surgeries. Rebound pain represents a clinically significant issue that may outweigh the benefits of regional anaesthesia. This is particularly significant for painful outpatient surgeries, where inadequately managed pain can result in distress, potentially affecting patient satisfaction and recovery. It may also lead to unplanned utilization of healthcare resources or readmissions.Orthopaedic foot surgery is a prevalent outpatient surgery, potentially painful, where rebound may be a difficult challenge. However, to date, prospective studies focusing specifically on rebound pain in outpatient foot surgery are limited. Identifying conditions associated with rebound pain or at-risk patients could facilitate the development of preventive and treatment strategies, thereby enhancing pain management or relief. Younger age, female sex and bone surgery are non-modifiable factors associated with severe rebound pain. Perioperative intravenous dexamethasone has been identified as a modifiable independent risk factor associated with a reduced incidence of rebound pain. Regarding anaesthetic factors, the duration of the peripheral block has been proposed as a potentially modifiable factor influencing rebound pain; however, current evidence does not support this hypothesis.The goal of this prospective observational study is to evaluate the incidence of rebound pain specifically in outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block and to assess the possible association between sensory block duration and the incidence of rebound pain. ### Conditions - Rebound Pain - Sciatic Nerve Block - Foot Surgery - Outpatient Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of rebound pain. - Sensory block duration of the sciatic nerve block. Secondary Outcomes ### Location - Facility: Av. de Gaspar Aguilar, 90, Valencia, N/A, 46017, Spain @@
## Ostomy Primary Closure With 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Compared to Pursestring Closure - NCT ID: NCT06309368 - Study ID: 003875 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-12 - Lead Sponsor: University of Nevada, Las Vegas ### Study Description The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are:1. Surgical site infection rates2. Patient quality of life3. Time to wound healingParticipants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above. ### Conditions - Surgical Site Infection - Wound Surgical - Colorectal Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation - Pursestring Closure ### Outcomes Primary Outcomes - Surgical Site Infection Rates Secondary Outcomes - Acceptability of wound and scar healing by patient - Acceptability of wound and scar healing by patient - Acceptability of wound and scar healing by patient - Acceptability of wound and scar healing by patient - Wound healing ### Location - Facility: University Medical Center, Las Vegas, Nevada, 89102, United States @@
## Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis - NCT ID: NCT06309355 - Study ID: YR001-A03 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd ### Study Description This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - YR001 ointment - Placebo ### Outcomes Primary Outcomes - The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50. Secondary Outcomes - all treatment-emergents AEs - Efficacy of YR001 Ointment ### Location - Facility: DelRicht Research, Baton Rouge, Louisiana, 70809, United States @@
## Prevention of Lifestyle-related Disorders Based on Functional Examinations - NCT ID: NCT06309342 - Study ID: VGRFOU-278257 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Lena Bornhoft ### Study Description The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life. ### Conditions - Lifestyle-related Condition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PREVFUNKTION - Control ### Outcomes Primary Outcomes - Change in objectively measured physical activity - Change in objectively measured sedentary behaviour Secondary Outcomes - Change in cardiovascular fitness - Change in motivation level - Proportion achieved goals - Change in fitness level - Change in strength upper extremity - Change in strength lower extremity - Change in strength trunk muscles - Change in balance - Change in mobility - Change in posture - Change in weight measures - Change in pain - Change in physical activity - Change in handgrip strength - Change in biceps strength - Change in leg strength - Change in calf strength - Change in ventral trunk strength - Change in dorsal trunk strength - Change in lower trunk strength - Change in static balance - 1 - Change in static balance - 2 - Change in static balance - 3 - Change in dynamic balance - Change in mobility - 1 - Change in mobility - 2 - Change in mobility - 3 - Change in hypermobility score - Change in neck mobility - Change in foot pronation - Change in habitual stance - Change in health-related quality of life assessed with EQ5D index - Change in health-related quality of life assessed with EQ5D VAS - Change in self-reported physical activity assessed with Swedish questionnaire - Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS) - Change in self-reported sedentary time - Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire - Change in number of pain locations - Change in proportion smokers - Change in proportion acceptable level blood glucose - Change in proportion acceptable level serum cholesterol - Change in proportion acceptable level triglycerides - Change in proportion acceptable blood pressure - Change in proportion normal body mass index (BMI) - Change in proportion acceptable waist circumference - Change in stress symptoms assessed with Stress and Crisis Inventory-93 - Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale - Correlation between self-assessed and objectively measured fitness - Correlation between self-assessed and objectively measured fitness - 2 - Correlation between self-assessed and objectively measured strength upper extremity - Correlation between self-assessed and objectively measured strength lower extremity - Correlation between self-assessed and objectively measured balance - Correlation between self-assessed and objectively measured physical activity - Correlation between self-assessed and objectively measured physical activity - 2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Strength at Home - Parents RCT - NCT ID: NCT06309329 - Study ID: 1770023-2 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-30 - Completion Date: 2029-05 - Lead Sponsor: VISN 17 Center of Excellence ### Study Description The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question\[s\]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources. ### Conditions - Parent-Child Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Strength at Home Parents - VA treatment as usual ### Outcomes Primary Outcomes - Parenting Stress Index total score - Parenting Stress Index total score - Parenting Stress Index total score Secondary Outcomes - Laxness subscale on the Parenting Scale - Laxness subscale on the Parenting Scale - Laxness subscale on the Parenting Scale - Over reactivity subscale on the Parenting scale - Over reactivity subscale on the Parenting scale - Over reactivity subscale on the Parenting scale ### Location - Facility: Central Texas Veterans Healthcare System, Temple, Texas, 76504, United States @@
## The Impact of Person Centred Care (PCC) in Grave's Disease - NCT ID: NCT06309316 - Study ID: Grace-PCC - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2028-12-30 - Lead Sponsor: Vastra Gotaland Region ### Study Description Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.WP2 Investigate the cost-effectiveness of the interventionPatients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness. ### Conditions - Graves Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Person-centred care (PCC) ### Outcomes Primary Outcomes - Composite score of changes Secondary Outcomes - General Self-Efficacy Scale (GSE) - General Self-Efficacy Scale (GSE) - General Self-Efficacy Scale (GSE) - General Self-Efficacy Scale (GSE) - Days of sick-leave - Days of sick-leave - Days of sick-leave - Days of sick-leave - Mental fatigue score - Mental fatigue score - Mental fatigue score - Mental fatigue score - Coping Orientations to Problems Experienced (Brief cope) - Coping Orientations to Problems Experienced (Brief cope) - Coping Orientations to Problems Experienced (Brief cope) - Coping Orientations to Problems Experienced (Brief cope) - Perceived Stress Scale (PSS-14) - Perceived Stress Scale (PSS-14) - Perceived Stress Scale (PSS-14) - Perceived Stress Scale (PSS-14) - Personality Assessment Guardian NEO-FFI-3 - Personality Assessment Guardian NEO-FFI-3 - Personality Assessment Guardian NEO-FFI-3 - Personality Assessment Guardian NEO-FFI-3 - Comprehensive psychopathological rating questionnaire (CPRS) - Comprehensive psychopathological rating questionnaire (CPRS) - Comprehensive psychopathological rating questionnaire (CPRS) - Comprehensive psychopathological rating questionnaire (CPRS) - Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) - Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) - Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) - Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) - Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). - Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). - Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). - Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). - EuroQol- health questionnaire (EQ-5D) - EuroQol- health questionnaire (EQ-5D) - EuroQol- health questionnaire (EQ-5D) - EuroQol- health questionnaire (EQ-5D) - Frenchay Activities Index (FAI) - Frenchay Activities Index (FAI) - Frenchay Activities Index (FAI) - Frenchay Activities Index (FAI) - Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) - Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) - Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) - Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) - Levels of thyroid autoantibodies - Levels of thyroid autoantibodies - Levels of thyroid autoantibodies - Levels of thyroid autoantibodies - Levels of thyroid hormones - Levels of thyroid hormones - Levels of thyroid hormones - Levels of thyroid hormones - Clinical Activity Score (CAS) - Clinical Activity Score (CAS) - Clinical Activity Score (CAS) - Clinical Activity Score (CAS) - Severity score - Severity score - Severity score - Severity score - Saltin-Grimby Physical Activity Scale (SGPAS) - Saltin-Grimby Physical Activity Scale (SGPAS) - Saltin-Grimby Physical Activity Scale (SGPAS) - Saltin-Grimby Physical Activity Scale (SGPAS) - Composite score of changes ### Location - Facility: Agneta Lindo, Göteborg, N/A, 413 45, Sweden @@
## Kawasaki Disease During the COVID-19 Epidemic - NCT ID: NCT06309303 - Study ID: RC 12/20 - Status: COMPLETED - Start Date: 2020-07-01 - Completion Date: 2023-12-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The common manifestations are: "middle aged" children (6-9 y/o) with a history of persistent high spiking fever in the last days, abdominal pain, diarrhea, skin rash and rapidly deteriorating clinical condition with the onset of shock, without clear signs of dehydration. Other less common features are arthralgia, cough, meningism, conjunctivitis and reddened, cracked lips. Labworks usually show high inflammatory markers, low lymphocyte counts, low sodium, and high troponin levels. Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities. Patients have been diagnosed as Kawasaki disease (typical or incomplete) and treated accordingly with IntraVenous ImmunoGlobulin (IVIG) and/or steroids. One patient refractory to such treatments responded successfully to intravenous Anakinra. All the patients reported a family history consistent with COVID-19, serology and naso-pharyngeal swabs were inconsistently positive. To date we are aware of at least 10 such cases. KSS is a rare and dreadful complication, with an estimated prevalence of 5% of patients with Kawasaki Disease (KD). Given the extreme rarity of this condition, the occurrence of so many cases in the last weeks points to a possible causative agent. As our hospitals are in high endemic area, SARS-COV2 seems the most obvious, although testing for such infection in patients returned conflicting results. It is not clear, at this moment, if this clinical entity is a proper KD triggered by SARS-COV2, or a systemic vasculitis with similar features of KD, secondary to SARS-COV2 infection. The aim of this nationwide study is to better define this clinical entity. ### Conditions - Kawasaki Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical evaluation ### Outcomes Primary Outcomes - Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection Secondary Outcomes - Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection ### Location - Facility: IRCCS Burlo Garofolo, Trieste, N/A, 34137, Italy @@
## Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy - NCT ID: NCT06309290 - Study ID: FAPESP-UFRO - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01 - Lead Sponsor: Universidad de La Frontera ### Study Description Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown. ### Conditions - Prehabilitation - Breast Cancer - Postmenopause - Resistance Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prehabilitation with resistance-exercise training - Usual care program ### Outcomes Primary Outcomes - Change in skeletal muscle mass (measured via Computed tomography (CT) scan) Secondary Outcomes - Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) - Change in hand grip strength (measured via JAMAR handheld dynamometer) - Change in physical performance measured via Short physical performance battery - Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) - Change in points Brief fatigue inventory (BFI) - Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA - Change in pathological complete response rate - Change quantification proteins ### Location - Facility: Fundación Arturo López Pérez, Santiago, N/A, N/A, Chile @@
## A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD - NCT ID: NCT06309277 - Study ID: GLG-100X - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-07 - Lead Sponsor: Gilgamesh Pharmaceuticals ### Study Description The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - GM-1020 ### Outcomes Primary Outcomes - Incidence of treatment emergent adverse events Secondary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) Change from baseline to 72 hours ### Location - Facility: MAC Clinical Research, Manchester, N/A, N/A, United Kingdom @@
## Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans - NCT ID: NCT06309264 - Study ID: C5059-R - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03-31 - Lead Sponsor: VA Office of Research and Development ### Study Description Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs. ### Conditions - Auditory Diseases, Central ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Phonak Lumina P90 ### Outcomes Primary Outcomes - Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks - Abbreviated Profile of Hearing Aid Benefit (APHAB) Secondary Outcomes - Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks ### Location - Facility: VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, 92357-1000, United States @@
## Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients - NCT ID: NCT06309251 - Study ID: KetoSTrENgTH - Status: RECRUITING - Start Date: 2022-03-01 - Completion Date: 2026-05-31 - Lead Sponsor: Danone Nutricia SpA Società Benefit ### Study Description The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.The main question\[s\] it aims to answer are:* does KD support adequate growth?* does KD improve clinical symptoms?* how does KD impact quality of life? Participants will be followed up as per clinical practice ### Conditions - Drug Resistant Epilepsy - Autism Spectrum Disorder - Chronic Migraine - Brain Tumor, Pediatric ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ketogenic diet (as per clinical practice) ### Outcomes Primary Outcomes - Nutritional adequacy Secondary Outcomes - Nutritional adequacy - % of responders to KD - Health related quality of life improvement through parent questionnaire ### Location - Facility: ASST Fatebenefratelli Sacco (PO "V. Buzzi"), Milan, MI, 20154, Italy @@
## Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial - NCT ID: NCT06309238 - Study ID: LightBAR - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2048-12 - Lead Sponsor: Carsten Dirksen ### Study Description With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intensive weight loss intervention - Bariatric surgery ### Outcomes Primary Outcomes - MetS-Z Secondary Outcomes - Weight - Gait speed - Short-Form-36, mental component score ### Location - Facility: Steno Diabetes Center Aarhus, Aarhus Universitets Hospital, Aarhus, N/A, 8200, Denmark @@
## Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly - NCT ID: NCT06309225 - Study ID: BMDA-2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-06-01 - Lead Sponsor: Omar Mahmoud ### Study Description Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.For this reason this study is looking at a different regimen of reducing the intensity of the treatment.The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects. ### Conditions - Oropharynx Cancer - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Modified dose and fields intensity modulated radiotherapy ### Outcomes Primary Outcomes - Two-year progression free survival Secondary Outcomes - Benefit and Tolerance of Treatment - Acute Toxicity - Late toxicity - Failure pattern ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing the Impact of COVID-19 on HMPV Incidence and Severity Among Adults - NCT ID: NCT06309212 - Study ID: 2023-20/687 - Status: COMPLETED - Start Date: 2023-12-15 - Completion Date: 2024-01-30 - Lead Sponsor: Acibadem University ### Study Description Human metapneumovirus (HMPV) is primarily recognized as a childhood pathogen, but its impact on adults remains largely underestimated. This study investigates the prevalence, clinical characteristics, and post-COVID-19 trends of HMPV infection among adults in Istanbul, Turkey. ### Conditions - The Prevalance of HMPV After COVID-19 Pandemic - The Importance of Accurate Diagnosis for HPMV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - Prevalence of HMPV infection in adults pre- and post-COVID-19 pandemic Secondary Outcomes - Comparison of HMPV with other respiratory viruses in adults ### Location - Facility: Acibadem University, Istanbul, N/A, N/A, Turkey @@
## Prevalence of FGIDs and Probiotics Study - NCT ID: NCT06309199 - Study ID: 0855/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-02 - Lead Sponsor: Chulalongkorn University ### Study Description This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants. ### Conditions - Functional Gastrointestinal Disorders - Infant Conditions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biogaia - Placebo ### Outcomes Primary Outcomes - The prevalence of functional gastrointestinal disorders in the treatment group Secondary Outcomes - The prevalence of functional gastrointestinal disorders in the placebo group ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19 - NCT ID: NCT06309186 - Study ID: RC 30/2023 - Status: RECRUITING - Start Date: 2023-01-09 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Evaluation of midwifes' burnout ### Outcomes Primary Outcomes - Evaluation of empowerment of midwives - Number of midwives affected by burnout Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2 - NCT ID: NCT06309173 - Study ID: 0000-00000; ko23Hemkens - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). Diagnosis is established by clinical assessment of persons with MS (PwMS), in combination with imaging and body fluid assessments. Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments.The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited. Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely, in real-world settings, with minimal disruption of patients' life.Using the investigators' self developed dreaMS software program the investigators previously identified digital biomarkers (DB) that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical, imaging, or body fluid assessments.This international, observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care, research, and regulatory decisions. Beyond this, the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies, including pragmatic trials, promoting new long-term international academic collaborations. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation of the digital features with the respective measurements of the clinical reference tests - The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables Secondary Outcomes - The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence - The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids) - The ability of the digital biomarker to detect change of Patient Reported Outcomes - The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity) - The relationship of the digital biomarkers with imaging and body fluid markers - The relationship of the digital biomarkers with Patient Reported Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD - NCT ID: NCT06309160 - Study ID: R324A230008 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2027-07 - Lead Sponsor: Ball State University ### Study Description Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students. ### Conditions - Autism - Autism Spectrum Disorder - Autistic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - COMPASS Across Settings (CAST) ### Outcomes Primary Outcomes - Goal Attainment of IEP progress (Ruble et al., 2012; 2018). - Attainment of Postsecondary Goals (Ruble et al., 2019) Secondary Outcomes - Fidelity Assessment of Initial CAST consultation (Ruble et al., 2018) - Fidelity Assessment of CAST Coaching (Ruble et al., 2018) - Organizational Connectedness - Transition Plan Quality (Ruble et al., 2019) ### Location - Facility: Ball State University, Muncie, Indiana, 47306, United States @@
## A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's - NCT ID: NCT06309147 - Study ID: ALX-923-107 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-07-15 - Lead Sponsor: Allyx Therapeutics ### Study Description A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BMS-9894923 ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling ### Location - Facility: Duke Clinical Research Institute, Durham, North Carolina, 27701, United States @@
## The Healthy Families Bright Futures Program - NCT ID: NCT06309134 - Study ID: R34AA030662 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2026-08 - Lead Sponsor: University of Colorado, Colorado Springs ### Study Description The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers. ### Conditions - Alcohol Drinking - Violence in Adolescence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Healthy Families Bright Futures Program ### Outcomes Primary Outcomes - Measure of Adolescent Relationships and Harassment and Abuse - Victimization - Measure of Adolescent Relationships and Harassment and Abuse - Perpetration - Monitoring the future alcohol use intentions - Monitoring the future alcohol use items - Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version - Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration) - Conflict Tactics Scale- 2 (SGM Specific IPV Victimization) - Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner) Secondary Outcomes - PHQ-8 (modified for adolescents) - LGBTQ+ teen perceived drinking norms - LGBTQ+ teen perceived dating violence norms - Sexual communication self-efficacy scale - Communication skills test (modified to assess self-efficacy) - Short Internalized Homonegativity Scale. - Self-Efficacy for Parenting Adolescents Scale - Parental Monitoring Short Scale - Parent Adolescent Communication Scale - Alabama Parenting Questionnaire- Short form - Social and Emotional Competencies Questionnaire - LGBTQ+ Microaggressions and Microaffirmations in Families ### Location - Facility: University of Colorado Colorado Springs, Colorado Springs, Colorado, 80918-3733, United States @@
## Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents - NCT ID: NCT06309121 - Study ID: PIC-11-24 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-04-30 - Lead Sponsor: Fundació Sant Joan de Déu ### Study Description This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat. ### Conditions - Obesity, Childhood - Obesity, Adolescent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Postbiotic ABB C3 - Placebo - Follow-up Postbiotic ABB C3 (Optional) ### Outcomes Primary Outcomes - Incidence of Adverse Events - Change in adiposity (% fat body mass) - Change in blood glycated hemoglobin (HbA1c) levels Secondary Outcomes - Change in adiposity (% fat body mass) - Change in blood glycated hemoglobin (HbA1c) levels - Change in BMI z-score - Change in body composition - Change in insulin sensitivity - Change in lipid profile (triglycerides, cholesterol) - Change in blood pressure - Change in Beck Depression Inventory-II (BDI-2) - Change in Beck Anxiety Inventory-II (BAI-2) ### Location - Facility: Hospital Sant Joan de Déu, Barcelona, N/A, 08950, Spain @@
## Bariatric Surgery and Patient Education - NCT ID: NCT06309108 - Study ID: 2022/68-04 - Status: COMPLETED - Start Date: 2022-01-02 - Completion Date: 2023-07-18 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Obesity is a disease that poses a health risk and is increasing worldwide. Bariatric surgery is the most effective method used in the treatment of obesity. Preoperative health education for bariatric surgery patients is important to support surgery. There is not enough nursing research in the literature regarding training patients with two different materials before bariatric surgery. The purpose of the randomized controlled experimental study designed in light of this information was to determine the effect of education given to patients with two different materials before bariatric surgery on early complications. The rates of the study were determined by randomizing trial I, trial II, and control treatment in 66 rooms that met the interval and study screening criteria offered between May 2022 and June 2023 in the general surgery service of a university hospital. Data from the research; was collected with the Veria Total Form, Autar Risk Assessment Scale, Apfel Risk Score, Visual Comparison Scale-VAS (Visual Analog Scale-VAS), Training Satisfaction Survey, and Complication Monitoring Form. In the first face-to-face meeting in the experimental groups, we were given training by the researcher with the removable Training Booklet I and Training Booklet II and were monitored until discharge. No control group training was given. ### Conditions - Bariatric Surgery Candidate - Education - Patient Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Education Booklet - Augmented Reality Group ### Outcomes Primary Outcomes - Veria Total Form for sociodemographic features Secondary Outcomes - Autar Risk Assessment Scale for DVT ### Location - Facility: İstanbul University- Cerrahpasa Instutite Graduate Studies, İstanbul, Avcılar, 34320, Turkey @@
## Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment - NCT ID: NCT06309095 - Study ID: AFSU_AhmetDemirhanUygun_001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-04-15 - Lead Sponsor: Afyonkarahisar Health Sciences University ### Study Description Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. The force required to rotate the Ni-Ti file is defined as the torque force and is considered a parameter for the stress produced within the canal. Ni-Ti rotary instruments can be used with a wide speed scale between 150 rpm (rotary per minute) and 40,000 rpm in conventional endodontic engines.Low torque and speed values mean low pressure applied by the instruments in the root canal. With low forces and vibrations, motor noise is generally negligible, and the instruments can easily shape most root canals in a reasonable amount of time and with minimal mechanical stress (in medium-easy canals). The use of lower torque values has been shown to reduce cyclic fatigue of Ni-Ti rotary tools. With reduced cyclic fatigue, the risk of instrument breakage in complex root canal morphologies is minimized and complications that may occur during root canal treatment are reduced. However, with low torque and speed values, cutting efficiency decreases and the process time increases as the instrument advances in the canal and during possible treatment. Decreasing cutting efficiency may also result in the operator applying force to move through the canal. With the applied force, the friction resistance within the canal increases and the heat produced increases. For this reason, it is thought that the risk of post-operative pain may increase during or after the procedure.The aim of this study is to investigate the incidence of post-operative pain and procedure time using the visual analog scale (VAS) among groups where low torque and speed values were applied during the use of the Ni-Ti rotary instrument system. ### Conditions - Dental Pulp Necrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - use of VDW Silver Endodontic motor ### Outcomes Primary Outcomes - Visual analog scale Secondary Outcomes - Preparation time ### Location - Facility: Afyonkarahisar Health Science University, Afyonkarahisar, N/A, 03030, Turkey @@
## Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound - NCT ID: NCT06309082 - Study ID: DFU - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-12 - Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University ### Study Description The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows:* What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging?* Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds.Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds. ### Conditions - Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - H-CEUS score Secondary Outcomes ### Location - Facility: the First Affiliated Hospital the First Affiliated Hospital, Wenzhou, Zhejiang, 325006, China @@
## Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort - NCT ID: NCT06309069 - Study ID: LOCAL/2024/TP-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-04 - Lead Sponsor: Centre Hospitalier Universitaire de Nīmes ### Study Description Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics. ### Conditions - Calcified Cerebral Embolism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - None, purely observational study ### Outcomes Primary Outcomes - Calcified aortic brachiocephalic - cardiovascular risk - history of stroke - Population - Population - history of surgical/endovascular cardiovascular intervention - NIHSS - calcified aortic arch - calcified carotid - atherosclerotic plaques - calcified aortic valves - calcified mitral valves - CCE diameter - density - involved cerebral artery Secondary Outcomes ### Location - Facility: CHU de Nîmes, Nîmes, N/A, 30029, France @@
## Neuromuscular Electrical Stimulation for Children With Dysphagia - NCT ID: NCT06309056 - Study ID: MP-05-2024-3903 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital ### Study Description This study aims to measure if using neuromuscular electrical stimulation (NMES) effectively improves swallowing, drooling (if applicable), feeding ability, physical growth and quality of life in children with severe dysphagia. This pilot study is for children aged over 18 months old with dysphagia. It aims to investigate a new approach to help children improve their swallowing function. Some published studies have shown that electrical stimulation to muscles involved in swallowing may help children with dysphagia.In this pilot study, NMES will be used. This procedure delivers electrical stimulation to make participants' muscles contract. Electrodes are placed on the skin, over the muscles that help with swallowing, and an electric current is delivered through wires which are connected to a small machine. The current is controlled through a small, handheld device. NMES will be applied to muscles involved in eating, drinking and swallowing. NMES will be applied to the participant alongside their regular treatment. No medications or treatments will be added, modified or discontinued as part of this study.The overall duration of the study per participant will last a total of nine months. For the first three months, the participant will receive the NMES twice a week. There will be no interventions or follow-up appointments scheduled for the following 6 months. Then, there will be a final follow-up meeting 9 months following the start of the intervention to evaluate for lasting changes. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VitalStim ### Outcomes Primary Outcomes - Feeding Intake - Functional Oral Intake Scale Secondary Outcomes - Penetration and Aspiration Scale - Quality of Life - Pediatric Quality of Life Inventory 4.0 Generic Core Scale for Toddlers, Young Children, Children 8-12 years old OR Teenagers. - Body Mass Index (kg/m^2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects - NCT ID: NCT06309043 - Study ID: HLX05-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Henlius Biotech ### Study Description This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts. ### Conditions - EGFR Overexpression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - recombinant anti-EGFR human/murine chimeric monoclonal antibody injection ### Outcomes Primary Outcomes - AUC0-inf Secondary Outcomes - Cmax - Tmax - CL - λz ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction - NCT ID: NCT06309030 - Study ID: ZRJY2023-QM21 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-08-01 - Lead Sponsor: Liu Longxiao ### Study Description The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bushen quhan zhiwang decoction - Bushen quhan zhiwang decoction placebo ### Outcomes Primary Outcomes - disease activity score derivative for 28 joints (DAS28) Secondary Outcomes - patient reported outcomes（PRO） - visual analogue scale for pain - withdrawl mechanical threshold - erythrocyte sedimentation Rate（ESR） - C-reactive protein（CRP） - TCM symptom score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease - NCT ID: NCT06309017 - Study ID: 23-01243 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-04 - Lead Sponsor: NYU Langone Health ### Study Description This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nutrition specialist - Ensure Surgery Immunonutrition shakes ### Outcomes Primary Outcomes - Length of hospital stay - Proportion of patients who experienced postoperative major complications Secondary Outcomes - Proportion of patients who participated in a nutritional intervention program before surgery - Proportion of patients who participated in a nutritional intervention program after surgery - Number of nutritional shakes completed - Percentage of nutritional shakes completed overall - Percentage of nutritional shakes completed pre-surgery - Percentage of nutritional shakes completed post-surgery - Proportion of patients who experienced any postoperative complications - Proportion of patients with 30 day readmission ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction - NCT ID: NCT06309004 - Study ID: 2023-00741a - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-31 - Lead Sponsor: Örebro University, Sweden ### Study Description The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention ### Conditions - Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Focus group interviews Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration - NCT ID: NCT06308991 - Study ID: IDU-SBF-SD-01 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2023-06-01 - Lead Sponsor: Izmir Democracy University ### Study Description The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants. ### Conditions - Endotracheal Aspiration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Yakson touch - Gentle Human Touch - Routine care ### Outcomes Primary Outcomes - Neonatal Pain Agitation and Sedation Scale (N-PASS) - Change in Oxygen saturation - Change in Heart rate Secondary Outcomes - COMFORTneo Scale ### Location - Facility: Izmir Democracy University, Karabağlar, Izmir, 35140, Turkey @@
## FT819 in Moderate to Severe Active Systemic Lupus Erythematosus - NCT ID: NCT06308978 - Study ID: FT819-102 - Status: RECRUITING - Start Date: 2024-02-24 - Completion Date: 2042-09-30 - Lead Sponsor: Fate Therapeutics ### Study Description This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FT819 - Fludarabine - Cyclophosphamide - Bendamustine ### Outcomes Primary Outcomes - Number of participants with treatment-emergent adverse events (TEAEs) - Number of participants with serious TEAEs - Number of participants with adverse events of special interest (AESI) - Number of participants with TEAEs by severity - Number of participants with dose-limiting toxicities (DLTs) - Recommend Phase 2 dose (RP2D) of FT819 Secondary Outcomes - Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time - Percentage of participants achieving DORIS clinical remission over time - Percentage of participants achieving lupus low disease activity state (LLDS) over time - Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time - Change in Physician Global Assessment (PGA) over time - Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time - Change in estimated glomerular filtration rate (eGFR) over time - Change in urine creatinine over time - Change in urine protein over time - Change in protein to creatinine ratio over time - Concomitant lupus therapies prior to and following study intervention - Plasma concentration of FT819 ### Location - Facility: University of Minnesota Medical School, Minneapolis, Minnesota, 55455, United States @@
## Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome? - NCT ID: NCT06308965 - Study ID: Z-2023088 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Ziekenhuis Oost-Limburg ### Study Description During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower. ### Conditions - Tensor Fasciae Latae Syndrome - Arthroplasty Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vessel technique ### Outcomes Primary Outcomes - a) Incidence of TFL tendinopathy - b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) - b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) - b-3) Patient-reported outcome 3: Forgotten Joint Score - b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). - c) Component placement (x-rays) Secondary Outcomes - Vessel sparing succesfull ### Location - Facility: Ziekenhuis Oost-Limburg, Genk, Limburg, 3600, Belgium @@
## Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation - NCT ID: NCT06308952 - Study ID: 2024SL0006 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2027-07-31 - Lead Sponsor: Zhujiang Hospital ### Study Description In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery.At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients.Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees.However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad.Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation. ### Conditions - Efficacy Endpoint: no New Cerebrovascular Adverse Events Within 1 Year - Safety Endpoint: no New Moderate or Serious Adverse Events Within 1 Year - All-cause Mortality Events (Within 1 Year) - Incident Ischemic Stroke Events (Within 1 Year) - New Hemorrhagic Stroke Events (Within 1 Year) - New Stent Thrombosis Events (Within 1 Year) - New Symptomatic Stenosis Events (Within 1 Year) - Occurrence of In-stent Stenosis 12th ±1 Month Annual Angiographic Follow-up - Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up - Target Aneurysm Embolization Rate at 12±1 Month Annual Angiographic Follow-up (Raymond and OKM Classification) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Atorvastatin 20mg ### Outcomes Primary Outcomes - Efficacy endpoint: no new cerebrovascular adverse events within 1 year Secondary Outcomes - Safety endpoint: no new moderate or serious adverse events within 1 year ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial - NCT ID: NCT06308939 - Study ID: IRB-2024-198 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2026-08-31 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer. ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Eribulin - Sintilimab ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Progression-Free Survival (PFS) - Clinical Benefit Rate (CBR) - Duration of Overall Response(DoR) - Time to response (TTR) - Overall survival (OS) - adverse event(AE) ### Location - Facility: zhejiangCH, Hangzhou, Zhejiang, 310000, China @@
## MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients - NCT ID: NCT06308926 - Study ID: MRG23ARDS - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-07-01 - Lead Sponsor: MedRegen LLC ### Study Description This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges. ### Conditions - Acute Respiratory Distress Syndrome - Respiratory Failure - Respiratory Distress Syndrome - Respiratory Tract Diseases - Cytokine Storm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MRG-001 (Low-dose) - MRG-001 (High-dose) - Placebo ### Outcomes Primary Outcomes - Hemopoietic stem cell mobilization - Organ Failure Secondary Outcomes - Pharmacokinetics - Pharmacokinetics - Pharmacodynamics - Cytokine Changes - Respiratory-Free Days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma - NCT ID: NCT06308913 - Study ID: 2023-1722 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-08 - Lead Sponsor: University of Wisconsin, Madison ### Study Description This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INCB081776 - Pembrolizumab - Palliative RT ### Outcomes Primary Outcomes - Incidence of Adverse Events (AEs) - Duration of Adverse Events - Severity of Adverse Events Secondary Outcomes - Overall response rate (ORR) - Disease control rate (DCR) - Duration of response (DoR) ### Location - Facility: UW Carbone Cancer Center, Madison, Wisconsin, 53792, United States @@
## Non-technical Skills of Clinical Simulation in Physiotherapy Students - NCT ID: NCT06308900 - Study ID: CL_SIMULATION_01 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-04-30 - Lead Sponsor: University of Valencia ### Study Description Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Clinical simulation ### Outcomes Primary Outcomes - Ottawa Scale Secondary Outcomes ### Location - Facility: David Hernández-Guillén, Valencia, N/A, 46010, Spain @@
## Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis - NCT ID: NCT06308887 - Study ID: 01 - Status: COMPLETED - Start Date: 2023-10-02 - Completion Date: 2024-03-02 - Lead Sponsor: Kastamonu University ### Study Description Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection. ### Conditions - Gonarthrosis - Meniscus; Degeneration - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Triamcinolone Hexacetonide - Dextrose 5% in water ### Outcomes Primary Outcomes - Visual Analogue Scale Secondary Outcomes - Western Ontario and McMaster University Osteoarthritis Index ### Location - Facility: Gamze Gül Güleç, Kastamonu, N/A, 37150, Turkey @@
## Phase 1 Study to Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females - NCT ID: NCT06308874 - Study ID: JH-222-101 - Status: COMPLETED - Start Date: 2023-01-02 - Completion Date: 2023-02-17 - Lead Sponsor: J2H Biotech ### Study Description - Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects. ### Conditions - Non-alcoholic Steatohepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amg dose administration group - Amg dose administration group- Placebo - Bmg dose administration group - Bmg dose administration group- Placebo ### Outcomes Primary Outcomes - Cmax - Emax Secondary Outcomes ### Location - Facility: J2H Biotech, Suwon, Gyeonggi-do, 16684, Korea, Republic of @@
## Phase 1 Study to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males - NCT ID: NCT06308861 - Study ID: JH-201-101 - Status: COMPLETED - Start Date: 2020-08-12 - Completion Date: 2021-07-13 - Lead Sponsor: J2H Biotech ### Study Description 1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial ### Conditions - Non-alcoholic Steatohepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single administration Amg dose Group - Single administration Bmg dose Group - Single administration Cmg dose Group - Single administration Dmg dose Group - Single administration Emg dose Group - Single administration Amg dose Group-Placebo - Single administration Bmg dose Group-Placebo - Single administration Cmg dose Group-Placebo - Single administration Dmg dose Group-Placebo - Single administration Emg dose Group-Placebo - Multiple administration Amg dose group - Multiple administration Bmg dose group - Multiple administration Cmg dose group - Multiple administration Dmg dose group - Multiple administration Emg dose group - Multiple administration Amg dose group - Placebo - Multiple administration Bmg dose group - Placebo - Multiple administration Cmg dose group - Placebo - Multiple administration Dmg dose group - Placebo - Multiple administration Emg dose group - Placebo ### Outcomes Primary Outcomes - Cmax - Emax Secondary Outcomes ### Location - Facility: J2H Biotech, Suwon, Gyeonggi-do, 16684, Korea, Republic of @@
## Microbiota Directed Food for Children With Severe Acute Malnutrition - NCT ID: NCT06308848 - Study ID: PR-22077 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-12-31 - Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh ### Study Description Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF. ### Conditions - Severe Acute Malnutrition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Microbiota-Directed Food - Ready-to-Use Therapeutic Food ### Outcomes Primary Outcomes - Mean change in Weight-for-Length Z-score (WLZ) Secondary Outcomes - Gut microbial community repair - Improvement in the levels of plasma protein biomarkers of healthy growth - Mean change in Weight-for-Age Z-score (WAZ) - Mean change in Length-for-Age Z-score (LAZ) - Mean change in body composition (% body fat mass and % fat-free mass) ### Location - Facility: Kurigram Study site, Kurigram, N/A, N/A, Bangladesh @@
## Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU - NCT ID: NCT06308835 - Study ID: APHP231652 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-08 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it. ### Conditions - Post Intensive Care Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaires ### Outcomes Primary Outcomes - Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom - Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom - Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom - Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom. Secondary Outcomes ### Location - Facility: GH Pitié Salpêtrière, Paris, N/A, 75013, France @@
## Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) - NCT ID: NCT06308822 - Study ID: NCI-2024-01151 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-06-19 - Completion Date: 2024-06-30 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well JNJ-42756493 (erdafitinib) works in treating patients with tumors that have more copies of the FGFR gene than is normal (amplification). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Erdafitinib - Magnetic Resonance Imaging ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Overall survival - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student - NCT ID: NCT06308809 - Study ID: Shuzhen Ma - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-06-20 - Lead Sponsor: Ma Shuzhen ### Study Description The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany. ### Conditions - Adolescent Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - PNF training ### Outcomes Primary Outcomes - CAIT score - Lower limb stability test - Star offset balance test - Muscle strength test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy - NCT ID: NCT06308796 - Study ID: RADIOCARIES2023 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2026-03-31 - Lead Sponsor: University of Milan ### Study Description One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions. ### Conditions - Caries,Dental - Head and Neck Cancer - Radiotherapy; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Application of CaP dental mousse ### Outcomes Primary Outcomes - Number of new cavitated caries per each patient (incidence of caries) Secondary Outcomes - Number of extracted teeth per patient (incidence of extracted teeth) - Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis) - Number of dental surfaces with caries or filling, and missed teeth - Rate of dentinal hypersensitivity per patient - Rate of dental surface with plaque per patient - Rate of bleeding gingival sites per patient ### Location - Facility: Univeristy of Milan, Milan, N/A, 20142, Italy @@
## Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students - NCT ID: NCT06308783 - Study ID: UFranciscoVitoriaRPGBREATH23 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2024-07-18 - Lead Sponsor: Universidad Francisco de Vitoria ### Study Description Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students.Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.Ethical considerations:The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques.The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants.Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time. ### Conditions - Stress - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Diaphragmatic Breathing - Global Postural Reeducation ### Outcomes Primary Outcomes - Stress - Sleep Quality Secondary Outcomes - Sleep Quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fatigue in Lupus Intervention Programmes (FLIP) - NCT ID: NCT06308770 - Study ID: AC21137 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04 - Lead Sponsor: University of Edinburgh ### Study Description Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in healthcare settings. Fatigue is more prevalent in SLE than other Rheumatic diseases. Management across the NHS is very variable ranging from a booklet to one to one appointments or, less often, a group intervention. Previous studies in other Rheumatic diseases have shown that a group cognitive behavioural approach can be effective in helping patients manage their fatigue. The COVID-19 pandemic changed the way healthcare is delivered in the NHS . Healthcare professionals had to find alternate solutions e.g. Virtual appointments.Our study aims to establish whether a virtual group Fatigue Management Programme and a fatigue booklet (Versus Arthritis and Lupus UK) is more effective at reducing the impact of fatigue in SLE participants than the fatigue booklet alone.The investigators will also compare a shortened 4-week to the standard 7-week programme to lessen the time commitment for participants and potentially reduce waiting times.The investigators will measure the effectiveness of the interventions through the use of Patient Reported Outcome Measures (PROMs) at several intervals whilst the participant is enrolled in the study.The pilot study will run in a single site in Edinburgh. The investigators aim to find a manageable, cost effective solution for the NHS and patients to address this frequently unmet need. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standard Care - 4 week FMP - 7 week FMP ### Outcomes Primary Outcomes - Modified Fatigue Impact Score (MFIS) Secondary Outcomes - Lupus quality of life questionnaire (LupusQoL) - Pittsburgh Sleep quality Inventory ( PSQI) - Visual Analog scale of fatigue impact (FI-VAS) - Participant Health Questionnaire (PHQ4) - Self-Efficacy for Managing Chronic Diseases 6-item Scale - Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ) - Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis - NCT ID: NCT06308757 - Study ID: 495/2021/Sper/AOUBo - Status: RECRUITING - Start Date: 2021-09-29 - Completion Date: 2026-12-12 - Lead Sponsor: University of Bologna ### Study Description The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD). ### Conditions - NASH - NAFLD - Obesity - Liver Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Very-low-calorie ketogenic diet (VLCKD) with meal replacements - Mediterranean low-calorie diet (LCD) ### Outcomes Primary Outcomes - Change of at least one grade of liver fibrosis - Change of histological features of NASH Secondary Outcomes - Histological NIH NASH CRN Score - Histological FLIP/SAF changes - Biochemical test changes 1 - Biochemical test changes 2 - Biochemical test changes 3 - Biochemical test changes 4 - Biochemical test changes 5 - Biochemical test changes 6 - Biochemical test changes 7 - Biochemical test changes 8 - Biochemical test changes 9 - Biochemical test changes 10 - Biochemical test changes 11 - Biochemical test changes 12 - Biochemical test changes 13 - Fibrosis-4 test (FIB-4 ) variation - NAFLD Fibrosis Score (NFS) change - FAST (FibroScan-AST) score variation - Fatty Liver Index (FLI) modification - Changes in LSM - Variation of steatosis by CAP - Body Mass Index (BMI) improvement - Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale) - Compliance to VLCKD evaluated by VAS (Visual Analogue Scale) - Variation of steatosis by ultrasound assessment - Questionnaires 1 - Questionnaires 2 - Questionnaires 3 - Questionnaires 4 ### Location - Facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, N/A, 40138, Italy @@
## A Large Multi-site Study on Self-administered Mindfulness - NCT ID: NCT06308744 - Study ID: 2021-5212-4387 - Status: COMPLETED - Start Date: 2022-03-23 - Completion Date: 2022-06-30 - Lead Sponsor: Swansea University ### Study Description The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found \[evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises\] with an estimated mean effect size of \[xx/xx\]. This means that... or The investigators recommend that... \[recommendation will be provided\]. ### Conditions - Body Scan Meditation - Loving-Kindness Meditation - Mindful Breathing Meditation - Mindful Walking Meditation - Control Condition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Body-scan meditation - Mindful Breathing meditation - Loving Kindness meditation - Mindful Walking - Listening of a story ### Outcomes Primary Outcomes - Stress Secondary Outcomes - Emotion dimensions ### Location - Facility: Swansea University, Swansea, Wales, UK, SA2 8PP, United Kingdom @@
## Exercise-Induced Rates of Fat Oxidation With and Without Ingestion of a Caffeine-Based Energy Drink - NCT ID: NCT06308731 - Study ID: 23-26 - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2024-07-01 - Lead Sponsor: Lindenwood University ### Study Description The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink. ### Conditions - Substrate Oxidation - Energy Expenditure - Reaction Time - Cognition - Exercise Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Caffeine-Based Energy Drink - Placebo ### Outcomes Primary Outcomes - Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise. Secondary Outcomes - Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise. - Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise - Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration - Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration - Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion - Impact of a caffeine-based energy drink ingestion on exercise performance - Impact of a caffeine-based energy drink ingestion on reaction time - Impact of a caffeine-based energy drink ingestion on trail making test performance - Impact of a caffeine-based energy drink ingestion on Cognition ### Location - Facility: Exercise and Performance Nutrition Laboratory, Saint Charles, Missouri, 63301, United States @@
## Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients - NCT ID: NCT06308718 - Study ID: FBX-101-LTFU - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-12 - Lead Sponsor: Forge Biologics, Inc ### Study Description This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101. ### Conditions - Krabbe Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FBX-101 ### Outcomes Primary Outcomes - Long Term safety as assessed by incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) that are attributed to FBX-101 Secondary Outcomes - Efficacy as assessed by change of gross motor function measured longitudinally by Peabody Developmental Motor Scale (PDMS-2) - Efficacy as assessed by change of gross motor function measured longitudinally by Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) - Efficacy as assessed by change of gross motor function measured longitudinally by Gross Motor Function Measure 88 (GMFM-88) - Efficacy as assessed by change of fine motor function measured longitudinally by Mullen Scales of Early Learning (MSEL) - Efficacy as assessed by change of fine motor function measured longitudinally by Beery VMI Sixth Edition (VMI) - Efficacy as assessed by change of fine motor function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) - Efficacy as assessed by change of fine motor function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3) - Efficacy as assessed by change of cognitive function measured longitudinally by Mullen Scales of Early Learning (MSEL) - Efficacy as assessed by change of cognitive function measured longitudinally by the Differential Ability Scale II (DAS-II) - Efficacy as assessed by change of cognitive function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) - Efficacy as assessed by change of adaptive behaviour function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3). - Efficacy as assessed by change of language function measured longitudinally by Mullen Scales of Early Learning (MSEL). - Efficacy as assessed by change of language function measured longitudinally by Clinical Evaluation of Language Fundamentals Fifth Edition (CELF-5) - Efficacy as assessed by change of language function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) - Efficacy as assessed by change of language function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3). - Efficacy as assessed by change of quality of life measured longitudinally by the Pediatric Quality of Life (PedsQL) Generic Core Scales with Family Impact Module and Multidimensional Fatigue Scale - Efficacy as assessed by change of developmental milestones such as language and motor skills as measured longitudinally by an specific Developmental Milestones questionnaire - Efficacy as assessed by change of hearing function measured longitudinally by Auditory Brainstem Responses (ABRs) - Efficacy as assessed by change of hearing function measured longitudinally by Behavior Audiometry (BAUD) - Efficacy as assessed by change of peripheral nerve conduction velocity measured longitudinally by Nerve Conduction Velocity (NCV) assessments - Efficacy as assessed by change of Fractional Anisotropy (FA) as measured longitudinally by brain Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) - Efficacy as assessed by change of visual function as measured longitudinally by visual evoked potentials (VEP) - Efficacy as assessed by change of visual function as measured longitudinally by visual acuity - Efficacy as assessed by change of whole blood donor chimerism - Efficacy as assessed by change of psychosine in whole blood and plasma - Efficacy as assessed by change of Galactosylceramidase (GALC) levels in plasma and Cerebrospinal Fluid (CSF) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis - NCT ID: NCT06308705 - Study ID: 2022-19 - Status: COMPLETED - Start Date: 2023-06-06 - Completion Date: 2023-10-18 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is a single-center interventional study with an IVD medical device.The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests. ### Conditions - Strongyloides Stercoralis Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - InBios Strongy Detect TM IgG ELISA ### Outcomes Primary Outcomes - Result of the SsIR/NIE ELISA Secondary Outcomes - Seroconversion ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods - NCT ID: NCT06308692 - Study ID: 2022-11 - Status: RECRUITING - Start Date: 2022-06-28 - Completion Date: 2024-12 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM. ### Conditions - Drug Resistant Bacterial Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - ARES PCR ### Outcomes Primary Outcomes - PCR results Secondary Outcomes - Gene mutations ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions - NCT ID: NCT06308679 - Study ID: BE 001-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-28 - Completion Date: 2024-06-07 - Lead Sponsor: Pharma Nueva ### Study Description Objectives:Primary:to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditionsSecondary:To examine the pharmacokinetics and safety of test and reference formulationsStudy Design:A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions ### Conditions - Healthy Vollunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Empagliflozin 10 mg tablets - JARDIANCE® ### Outcomes Primary Outcomes - Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin - Peak Plasma Concentration (Cmax) of Empagliflozin Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use - NCT ID: NCT06308666 - Study ID: 46091 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-07-18 - Lead Sponsor: University of Waterloo ### Study Description The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day). ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Delefilcon A contact lenses ### Outcomes Primary Outcomes - Subjective Rating of Comfort After 8 Hours or More of Digital Device Use - Subjective Rating of Dryness After 8 Hours or More of Digital Device Use - Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use Secondary Outcomes ### Location - Facility: Centre for Ocular Research & Education, Waterloo, Ontario, N2L 3G1, Canada @@
## Psilocybin for Major Depressive Disorder (MDD) - NCT ID: NCT06308653 - Study ID: PSIL301 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2026-04 - Lead Sponsor: Usona Institute ### Study Description Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo.The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period. ### Conditions - Depressive Disorder, Major ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psilocybin 25 mg - Inactive Placebo - Psilocybin 5 mg - Psychosocial Support ### Outcomes Primary Outcomes - Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43 Secondary Outcomes - Change in central rater Clinical Global Impression-Severity (CGI-S) total score from Baseline to Trial Day 43 - Change in on-site rater administered Sheehan Disability Scale (SDS) score from Baseline to post-dose Day 43 ### Location - Facility: Mountain View Clinical Research, Denver, Colorado, 80209, United States @@
## Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography - NCT ID: NCT06308640 - Study ID: ORTH 11-23 2097 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-10 - Completion Date: 2026-01-10 - Lead Sponsor: Tanta University ### Study Description The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molarsThe patients will be selected according to the following criteria:1. Patient with full permanent dentition.2. Good oral hygiene.3. None of the patients had received any orthodontic treatment.4. Class II molar relationship.5. Minimal or no crowding in the mandibular arch.6. Non-extraction treatment plan with molar distalization.7. Low angle cases.8. No medical problems or active periodontal disease.Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization. ### Conditions - Class II Malocclusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Insertion of the device intraorally ### Outcomes Primary Outcomes - 3D Dental and skeletal Cephalometric Measurements - 2D Dental and skeletal Cephalometric Measurements Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Tanta, Gharbia, 6620010, Egypt @@
## A One-year Trajectory of Depression Status Changes in Elderly Patients With MCI and SD: a Longitudinal Cohort Study - NCT ID: NCT06308627 - Study ID: K2022-03-074 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-07-01 - Lead Sponsor: Fujian Medical University ### Study Description The purpose of this study is to investigate the one-year trajectory of changes in depression status in elderly patients with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in the elderly, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subliminal depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states. ### Conditions - Mild Cognitive Impairment - Subthreshold Depression - Older Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Depressive state Secondary Outcomes - General information of patients - Cognitive - Cognitive - Activity of Daily Living - Anxiety - Social Function - Social Function - Sleep Quality - Resilience ### Location - Facility: Fujian provincial hospital, Fuzhou, Fujian, 350000, China @@
## Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women - NCT ID: NCT06308614 - Study ID: MIT-Do001-C206 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2024-12 - Lead Sponsor: Estetra ### Study Description The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants. ### Conditions - Sexual Dysfunction, Physiological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 20 mg estetrol monohydrate - Placebo ### Outcomes Primary Outcomes - Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14. - Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9). Secondary Outcomes - Change from Baseline to Week 12 in arousal and lubrication assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures (PROMISSexFS Questionnaire). - Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score. - Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary). - Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score. - Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS. - Patient Global Impression of Change (PGIC) at Week 12. - Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS). ### Location - Facility: Estetra Study Site, Phoenix, Arizona, 85032, United States @@
## The Effect of Laughter Yoga on Loneliness, Anger and Salivary Cortisol Levels in Visually Impaired Individuals - NCT ID: NCT06308601 - Study ID: 23-12.1T/60 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-16 - Completion Date: 2024-06-27 - Lead Sponsor: Ege University ### Study Description Purpose: This project aimed to examine the effects of laughter yoga, which is accepted as an international nursing initiative, on loneliness, anger and salivary cortisol levels in visually impaired individuals. When the national and international literature was examined, no project was found that measured the results of laughter yoga as an intervention for visually impaired individuals. For this reason, planning an original project in this field aims to contribute to the literature. Thanks to the evidence obtained, laughter yoga, an innovative approach, can be disseminated in institutions and organizations serving visually impaired individuals as an evidence-based practice that can improve the social skills of individuals.Scope and Target Audience: The project will be carried out with visually impaired individuals receiving services in the Disabled Persons Department within the Atatürk Provincial Public Library located in Konak district of Izmir. In this section, services are provided to 250 members who actively use the library and to visually impaired people from all over Turkey.Method and Expected Result: The project was planned in a randomized controlled, pre-test post-test, single-blind follow-up consultancy design. With this initiative, a social rehabilitation environment will be provided for visually impaired individuals by taking an approach based on respect, understanding and awareness. Laughter yoga is expected to reduce the level of anger and loneliness in visually impaired individuals. At the same time, laughter yoga is expected to reduce cortisol levels, which are known to increase when faced with stress factors, and increase serotonin, which is associated with happiness and vitality, and endorphine, known as the body's natural painkiller. With laughter yoga sessions, a social environment will be created where visually impaired individuals will have an active and independent experience. Thanks to the expected evidence, laughter yoga can be popularized both in visually impaired individuals and in individuals with other disabilities. Within the scope of protecting and improving health, laughter yoga can be planned to be carried out as a routine nursing practice in disabled centers. Thus, by creating an environment where visually impaired individuals and nurses come together, a more accessible health service will be provided to individuals with special needs. ### Conditions - Nursing Caries - Laughter - Visual Impairment - Loneliness - Anger ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Laughter yoga ### Outcomes Primary Outcomes - salivary cortisol test - UCLA(University of California, Los Angeles) Loneliness Scale - Trait Anger Scale Secondary Outcomes ### Location - Facility: Ege University, Bornova, İ̇zmi̇r, 35030, Turkey @@
## Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia - NCT ID: NCT06308588 - Study ID: 2024-0054 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2029-05 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL. ### Conditions - Philadelphia Chromosome-Positive - Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Blinatumomab - Asciminib ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma - NCT ID: NCT06308575 - Study ID: 2023-0771 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2028-11-30 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied. ### Conditions - Metastatic Olfactory Neuroblastoma - Recurrent Olfactory Neuroblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rivoceranib ### Outcomes Primary Outcomes - Safety and Adverse Events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease - NCT ID: NCT06308562 - Study ID: 23-010717 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-08 - Lead Sponsor: Mayo Clinic ### Study Description The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking. ### Conditions - Peripheral Arterial Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Fuzzy Wale Compression Stockinet ### Outcomes Primary Outcomes - Surgical site infection - Wound dehiscence - Days on negative pressure wound therapy - Pain control - Time to prosthetic fitting Secondary Outcomes - Length of hospital stay ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY) - NCT ID: NCT06308549 - Study ID: 2023.0714 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: Maartje de Wit ### Study Description In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany. ### Conditions - Type 1 Diabetes - Diabetes Distress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - MyDiaMate ### Outcomes Primary Outcomes - Diabetes Distress Secondary Outcomes - Emotional well-being - Psychological self-efficacy in relation to diabetes - Social Engagement - Fatigue - HbA1c - Time in/above/below range - Events of ketoacidosis/severe hypoglycaemia ### Location - Facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim, Bad Mergentheim, Baden-Württemberg, 97980, Germany @@
## Application of Concentrated Growth Factors in Alveolar Ridge Preservation - NCT ID: NCT06308536 - Study ID: KY-2023-045 - Status: RECRUITING - Start Date: 2023-05-09 - Completion Date: 2025-04-01 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery. ### Conditions - Alveolar Ridge Preservation - Concentrated Growth Factor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - bone powder + collagen membrane - bone powder + collagen membrane + CGF membrane - bone powder mixed wih CGF gel + collagen membrane + CGF membrane - bone powder + CGF membrane ### Outcomes Primary Outcomes - the width of keratinized gingiva - the horizontal width (from buccal to lingual at the alveolar top ) of gingiva - the horizontal bone resorption of alveolar crest - the vertical bone resorption of alveolar crest - the average gray value of alveolar bone Secondary Outcomes - Landry wound healing index - reduction in membrane exposure area - pain score ### Location - Facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine, Yiwu, Zhejiang Procince, 310000, China @@
## A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants - NCT ID: NCT06308523 - Study ID: AP303-PK-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-06-30 - Lead Sponsor: Alebund Pharmaceuticals ### Study Description The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AP303 150 μg - Placebo 150 μg - AP303 300 μg - Placebo 300 μg ### Outcomes Primary Outcomes - Cmax - Tmax - AUC0-24h - AUC0-last - AUC0-inf - AUC0-t - t1/2 - CL/F - V/F - Cav - Ctrough - Rac - Incidence and severity of adverse events - Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results - Effect of AP303 on ECG parameters - Effect of AP303 on ECG parameters - Effect of AP303 on ECG parameters - Effect of AP303 on ECG parameters - Effect of AP303 on ECG parameters - Effect of AP303 on ECG parameters - Vital signs - Effect of AP303 on physical examination result - body weight Secondary Outcomes - Fasting glucose - Fasting lipid profile - Serum creatinine - eGFR ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer - NCT ID: NCT06308510 - Study ID: MEC-2024tba - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-07 - Lead Sponsor: Erasmus Medical Center ### Study Description Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - collection additional peritoneal lavage fluid ### Outcomes Primary Outcomes - Sensitivity mFast-SeqS Secondary Outcomes - DFS - Concordance detection rates peritoneal dissemination ### Location - Facility: Erasmus MC, Rotterdam, N/A, 3015GD, Netherlands @@
## Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women - NCT ID: NCT06308497 - Study ID: 2024-Q10PREGNANT - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-10 - Completion Date: 2024-10-20 - Lead Sponsor: University of Pavia ### Study Description The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. ### Conditions - Periodontal Diseases - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic Treatment - Standard Treatment ### Outcomes Primary Outcomes - Change in Plaque Index - Change in Recession (R) - Change in Clinical Attachment Loss (CAL) - Change in Bleeding on Probing (BoP) - Change in Probing Pocket Depth (PPD) - Change in API - Approximal Plaque Index - Change in Plaque Control Record (PCR%) - Change in Papillary Marginal Gingival Index (PMGI) - Change in modified Marginal Gingival Index (mMGI) Secondary Outcomes ### Location - Facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Neuromodulation and Mindfulness Patients With AUD - NCT ID: NCT06308484 - Study ID: TRR265 C02 FP2 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-06-30 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2). ### Conditions - Alcohol Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Transcutaneous vagus nerve stimulation - Closed-loop AM-tACS ### Outcomes Primary Outcomes - Cognitive Control - Interoception - Cue-Reactivity Secondary Outcomes - Heartrate - Heartrate Variability - Mindfulness - Alcohol consumption - Dependence Severity (Alcohol Dependence Scale) ### Location - Facility: Charité - Berlin University of Medicine, Berlin, N/A, 10117, Germany @@
## Effect of Baby Massage on Oral Motor Skills of Premature Babies - NCT ID: NCT06308471 - Study ID: ege üniversitesi - Status: COMPLETED - Start Date: 2021-09-01 - Completion Date: 2023-05-01 - Lead Sponsor: Ege University ### Study Description This experimental research was conducted in a single-blind, block randomized controlled design type.The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).Comparative results were evaluated statistically. ### Conditions - Infant, Premature ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Baby massage was applied to the intervention group (n=20) of the study - Oral stimulation ### Outcomes Primary Outcomes - time for first oral feeding - time for full oral feeding Secondary Outcomes - discharge time ### Location - Facility: Ege University, Izmir, Bornova, 35040, Turkey @@
## Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness - NCT ID: NCT06308458 - Study ID: P.T.REC/012/003966 - Status: COMPLETED - Start Date: 2023-03-30 - Completion Date: 2024-03-01 - Lead Sponsor: Adly A Adam ### Study Description The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly. ### Conditions - Aging Well ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Breather Exerciser Trainer - Conventional Breathing Exercise ### Outcomes Primary Outcomes - Diaphragmatic thickness in millimeters - Diaphragmatic mobility in centimeters Secondary Outcomes - Functional Capacity - Geriatric Quality of life Questionnaire - Geriatric Quality of Life ### Location - Facility: Faculty of Physical Therapy, Giza, N/A, N/A, Egypt @@
## Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis - NCT ID: NCT06308445 - Study ID: RC31/23/0388 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2029-08 - Lead Sponsor: University Hospital, Toulouse ### Study Description The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen. ### Conditions - Familial Adenomatous Polyposis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rapamycin ### Outcomes Primary Outcomes - Evaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis. Secondary Outcomes - Evaluation of the effect of rapamycin on the number of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis - Evaluation of the effect of rapamycin on the size of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis. - Evaluation of the effect of rapamycin on the size of the largest polyp in each segment (rectum, left colon, transverse colon and right colon) in adolescents with Familial Adenomatous Polyposis ### Location - Facility: CHU Bordeaux Hôpital Pellegrin, Bordeaux, N/A, 33076, France @@
## Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists. - NCT ID: NCT06308432 - Study ID: UCAMCFE-00036 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-05-20 - Lead Sponsor: Universidad Católica San Antonio de Murcia ### Study Description Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists. ### Conditions - Sweat ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Low intensity - Low temperature - Low Humidity - High intensity - High temperature - High humidity ### Outcomes Primary Outcomes - Sweat Secondary Outcomes - Microcapillary Blood - Heart Rate - Fatigue - Temperature on the forehead - Temperature in the ear - Sleep efficiency - Karolinska drowsiness scale ### Location - Facility: Catholic University of Murcia, Murcia, N/A, 30107, Spain @@
## A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions - NCT ID: NCT06308419 - Study ID: 2023-0900 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2031-02-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas. ### Conditions - Leiomyosarcoma - Soft-tissue Sarcomas ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Gemcitabine - Nab-Sirolimus ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer - NCT ID: NCT06308406 - Study ID: HRS-1167-201-Bev - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-10 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer. ### Conditions - Recurrent Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bevacizumab； HRS-1167 ### Outcomes Primary Outcomes - The number of subjects with dose-limiting toxicity (DLT) - Determination of Recommended Phase II dose (RP2D) Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DoR) - Progression free Survival (PFS) - Overall Survival (OS) - Time To Response(TTR) ### Location - Facility: First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, 230002, China @@
## Randomized, Double-blind, Placebo-controlled Study of RSS0393 Ointment in Healthy and Psoriatic Subjects - NCT ID: NCT06308393 - Study ID: RSP61418 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects ### Conditions - Healthy - Psoriatic Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RSS0393 ointment；Placebo ### Outcomes Primary Outcomes - The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects） - The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects） - Measurement of blood examination（Multiple dose in patients ） - Measurement of urine examination（Multiple dose in patients ） - Measurement of Blood Chemistry examination（Multiple dose in patients ） - Measurement of coagulation function examination（Multiple dose in patients ） Secondary Outcomes - AUC0-t （Single dose in healthy subjects） - AUC0-∞（Single dose in healthy subjects） - Tmax（Single dose in healthy subjects） - Cmax（Single dose in healthy subjects） - t1/2（Single dose in healthy subjects） - CL/F（Single dose in healthy subjects） - Vz/F（Single dose in healthy subjects） - AUC0-t （Multiple dose in healthy subjects） - AUC0-∞（Multiple dose in healthy subjects） - Tmax（Multiple dose in healthy subjects） - Cmax（Multiple dose in healthy subjects） - t1/2（Multiple dose in healthy subjects） - CL/F（Multiple dose in healthy subjects） - Vz/F（Multiple dose in healthy subjects） - Absolute change in PASI score relative to baseline（Multiple dose in patients ） - The percentage change in PASI score relative to baseline（（Multiple dose in patients ） - The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ） - The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ） - The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ） - Absolute change in BSA score relative to baseline（Multiple dose in patients ） - The percentage change in BSA score relative to baseline（Multiple dose in patients ） - Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ） - Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ） ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles - NCT ID: NCT06308380 - Study ID: UCV/2022-2023/158 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-03-10 - Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir ### Study Description The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. The primary focus is to assess disparities in outcomes, particularly in the recovery of ankle mobility degrees. Additionally, for patients opting for minimally invasive ultrasound-guided surgery, the study aims to evaluate the resumption of both sporting activities and daily routines using the aforementioned specific rehabilitation protocol.The primary questions this study aims to answer are:* How does the proposed rehabilitation protocol impact ankle mobility recovery for patients with foot pathologies and calf muscle shortening?* What are the differences observed in the return to sporting activities and daily life among patients undergoing minimally invasive ultrasound-guided surgery, following the prescribed protocol?Participants enrolled in this study will be engaged in:Undertaking the specified rehabilitation exercises tailored for foot pathologies and calf muscle shortening.Those opting for minimally invasive ultrasound-guided surgery will follow the same rehabilitation protocol post-surgery to assess its impact on their return to normal activities.If there exists a comparison group:Researchers will compare participants who undergo minimally invasive ultrasound-guided surgery against those who choose other treatment options to discern any differential effects on ankle mobility recovery and resumption of activities. ### Conditions - Equinus Deformity of Foot - Gastrocnemius Equinus - Contracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Specific protocol of rehabilitation exercise - Short gastrocnemius surgery. ### Outcomes Primary Outcomes - Gait Analysis - Baropodometric examination Secondary Outcomes - Passive ankle mobility - Short Form Health Survey 36 score - Foot Function Index - American Orthopedic Foot and Ankle Score - Halasi score ### Location - Facility: Podologia Avançada, Granollers, Barcelona, 08401, Spain @@
## The Therapeutic Effect of Betaine in Syringomyelia - NCT ID: NCT06308367 - Study ID: XWTEBS - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia.Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage. ### Conditions - Syringomyelia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Betaine - Placebo ### Outcomes Primary Outcomes - ASIA Score Secondary Outcomes - syringomyelia remission - Electrophysiology results - Visual Analog Scale (VAS) - Klekamp and Sammi syringomyelia scale - modified Japanese Orthopaedic Association Scores (mJOA) - xuanwu syringomyelia scale - Incidence of complications ### Location - Facility: Fengzeng Jian, Beijing, Beijing, 100053, China @@
## Colorectal Cancer Dataset in Xijing Hospital From 2011 - NCT ID: NCT06308354 - Study ID: CRC dataset - Status: RECRUITING - Start Date: 2011-01-01 - Completion Date: 2048-01-01 - Lead Sponsor: Xijing Hospital ### Study Description To compare the differences of clinical pathological, treatment and prognosis in the guided subgroups in colorectal cancer, the investigator enrolled all the colorectal cancer patients who underwent surgery and were hospitalized in the Xijing hospital. ### Conditions - Prognostic Cancer Model - Chemotherapy - Nutrition Related Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - overall survival - DFS Secondary Outcomes ### Location - Facility: Fourth Military Medical University, Xi'an, Shaanxi, N/A, China @@
## Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients - NCT ID: NCT06308341 - Study ID: REC/RCR&AHS/23/0295 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-28 - Lead Sponsor: Riphah International University ### Study Description Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy - Virtual Reality + Routine Physical Therapy - Motor Imagery +Routine Physical Therapy ### Outcomes Primary Outcomes - Berg Balance Scale - Fugal-Meyer Scale - Barthel Index Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis - NCT ID: NCT06308328 - Study ID: NFEC-2024-090 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-01-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. ### Conditions - Radiation-induced Oropharyngeal Mucositis - Swallowing-induced Breakthrough Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The AUC of the predictive model Secondary Outcomes - The accuracy of the predictive model - The sensitivity of the predictive model - The specificity of the predictive model - The positive predictive value of the predictive model - The negative predictive value of the predictive model - The F1 score of the predictive model - The important predictors of severe oropharyngeal mucositis in the predictive model ### Location - Facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, Guangdong, N/A, China @@
## Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder. - NCT ID: NCT06308315 - Study ID: REC/RCR&AHS/23/0297 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rhythmic balance visual auditory exercise + Routine physical therapy - Strength Training + Routine Physical Therapy ### Outcomes Primary Outcomes - Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) Secondary Outcomes - Wisconsin Card Sorting Test (WCST) ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients - NCT ID: NCT06308302 - Study ID: REC/RCR&AHS/23/0355 - Status: COMPLETED - Start Date: 2023-05-23 - Completion Date: 2024-02-15 - Lead Sponsor: Riphah International University ### Study Description Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD). ### Conditions - COPD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Group A (Inspiratory Muscles Training + Aerobic Interval Training) - Group B (Expiratory Muscles Training +Aerobic Interval Training) ### Outcomes Primary Outcomes - Modified Medical Research Council (mMRC) Dyspnea Scale - 6 Minute Walk Test - Karnofsky Performance Scale (KPS) - Fatigue Severity Scale (FSS) - FEV1 - FVC - FEV1/FVC Secondary Outcomes ### Location - Facility: Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital, Lahore, Punjab, 42000, Pakistan @@
## Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD - NCT ID: NCT06308289 - Study ID: REC/RCR&AHS/23/0361 - Status: RECRUITING - Start Date: 2024-03-03 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Global Posture Re-education - Active Cycle of Breathing Technique ### Outcomes Primary Outcomes - SF- 36 Questionnaire - FEV1/FVC ratio - 6-minute walk test - Photogrammetry - Forced expiratory volume (FEV1) - Forced vital capacity (FVC) Secondary Outcomes ### Location - Facility: Social Security Hospital, Gujranwala, Punjab, 52200, Pakistan @@
## Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients - NCT ID: NCT06308276 - Study ID: REC/RCR&AHS/23/0363 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. ### Conditions - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic Training - Resistance Training ### Outcomes Primary Outcomes - Blood Pressure - Six Minute Walk Test - SF 36 Questionnaire Secondary Outcomes ### Location - Facility: Sialkot Medical and Physiotherapy Center, Sialkot, Punjab, 51310, Pakistan @@
## M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303) - NCT ID: NCT06308263 - Study ID: MS201924_0003 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-11-26 - Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany ### Study Description This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. Thereafter, participants may enter an optional extension phase (Period 2) where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - M1774 [14C]M1774 microtracer - M1774 ### Outcomes Primary Outcomes - Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection - Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection - Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection - Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774 - Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774 - Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774 - Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774 - Period 1: Apparent Terminal Half-Life (t1/2) Of M1774 - Period 1: Apparent Total Body Clearance (CL/F) Of M1774 - Period 1: Apparent Volume of Distribution (Vz/F) Of M1774 - Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood - Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood - Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood - Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood - Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood Secondary Outcomes - Period 1,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings ### Location - Facility: Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely, Budapest, N/A, N/A, Hungary @@
## Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy - NCT ID: NCT06308250 - Study ID: REC/RCR&AHS/23/0294 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism. ### Conditions - Bell Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MIME THERAPY - ACTION OBSERVATION THERAPY ### Outcomes Primary Outcomes - Sunny Brook Facial Grading System - Facial Disability Index Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment - NCT ID: NCT06308237 - Study ID: REC/RCR&AHS/23/0293 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-06-25 - Lead Sponsor: Riphah International University ### Study Description Mild cognitive impairment affects older adults and it includes memory and attentions deficits, and problem-solving difficulties in activities of daily living. Resisted exercises is considered a viable strategy to improve balance and motor function in older population. Balance exercises comprises proprioceptive, visual and motor learning to a larger degree and has positive effects on memory and spatial cognition and improves balance and motor function. This study aims to determine the effects of resisted and balance exercises on cognition and motor function in patients with mild cognitive impairment. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RESISTED EXERCISES - BALANCE EXERCISES ### Outcomes Primary Outcomes - MoCA (Montreal Cognitive Assessment ) - Mini-Balance Evaluation Systems Test (BESTest). - Timed UP and GO Test (TUG) : - Computerized battery test (CBT) Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke - NCT ID: NCT06308224 - Study ID: REC/RCR&AHS/23/0290 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-24 - Lead Sponsor: Riphah International University ### Study Description The study aims to determine the comparative effects of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients with Stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified-Otago Exercises - Tai-Chi Exercises ### Outcomes Primary Outcomes - Berg Balance Scale (BBS) - Timed Up and Go (TUG) - Motor Assessment Scale (MAS) Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients - NCT ID: NCT06308211 - Study ID: REC/RCR&AHS/23/0289 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY - MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY ### Outcomes Primary Outcomes - Berg balance scale (BBS) - FUGL-MEYER ASSESMENT (FMA) - FUNCTIONAL INDEPENDENCE MEASURE (FIM) Secondary Outcomes ### Location - Facility: Muhammad Kashif, Lahore, Punjab, 54660, Pakistan @@
## A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines - NCT ID: NCT06308198 - Study ID: M24-008 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-03-22 - Lead Sponsor: AbbVie ### Study Description Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions - Glabellar Lines ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AGN-151586 - Placebo ### Outcomes Primary Outcomes - Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown - Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown - Number of Participants with Adverse Events (AEs) Secondary Outcomes - Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown - Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown - Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL - Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL - Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time - Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown - Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown - Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time - Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time - Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown - Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown - Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time - Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time - Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown - Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown - Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL - Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL - Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL - Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time ### Location - Facility: Beijing Hospital /ID# 256084, Beijing, Beijing, 100730, China @@
## Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations - NCT ID: NCT06308185 - Study ID: EPINEO - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-06-01 - Completion Date: 2024-07-01 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years.The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures.The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade. ### Conditions - Neonatal Seizure - Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational study ### Outcomes Primary Outcomes - Seizure Type and etiology correlation - EEG and etiology correlation Secondary Outcomes - Etiology and and effective drug correlation - Etiology and neurobehavioral outcome correlation ### Location - Facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial - NCT ID: NCT06308172 - Study ID: CSI/2021 - Status: RECRUITING - Start Date: 2021-12-01 - Completion Date: 2026-12-01 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups ### Conditions - Cesarean Section; Dehiscence - Uterine Bleeding - Uterus; Scar - Uterus Abnormal - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Hysterotomy closure ### Outcomes Primary Outcomes - Intermenstrual bleeding reduction (days) Secondary Outcomes - Intra-operatory time - Blood loss - Analgesics - Post-operatory recovery time - Time to full patient mobilization - Isthmocele ### Location - Facility: Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano, Milan, Mi, 20122, Italy @@
## An Open-label Study of a Gene Therapy Product in Beta-Thalassemia - NCT ID: NCT06308159 - Study ID: LT02-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Lantu Biopharma ### Study Description This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem Cells (HSCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia. ### Conditions - Beta-Thalassemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vebeglogene autotemcel ### Outcomes Primary Outcomes - Time and duration of the subject's hemoglobin (Hb)≥9.0 g/dL without receiving red blood cell infusion Secondary Outcomes - The prevalence and severity of adverse events (AEs) and serious adverse events (SAEs) - The reduction of red blood cells (RBCs) transfusion requirement after product infusion compared to previous transfusion records - Number of days required to achieve successful neutrophil and platelet engraftment - Vector copy number (VCN) in peripheral blood over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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